Trial Outcomes & Findings for 42-Day Repeat Oral Dose Study of AKB-6548 in Participants With Chronic Kidney Disease and Anemia (NCT NCT01381094)

Last Updated: 2022-07-01

Results Overview

Absolute change from Baseline was calculated as the Week 6 (end of treatment) value minus the Baseline value. Baseline Hgb was defined as the average of the last two measurements obtained prior to dosing. If there was only one measurement prior to dosing, this measurement served as Baseline. A positive change from Baseline indicated that hemoglobin concentration increased.

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

93 participants

Primary outcome timeframe

Baseline, Week 6

Results posted on

2022-07-01

Participant Flow

A total of 93 participants were enrolled and randomized into the study. Only 91 participants received the treatment.

Participant milestones

Participant milestones
Measure	AKB-6548 240 mg Participants with anemia secondary to chronic kidney disease (CKD), stages 3 and 4 were administered with an oral dose of AKB-6548 240 milligrams (mg) capsule once daily (QD) for 42 days.	AKB-6548 370 mg Participants with anemia secondary to CKD, stages 3 and 4 were administered with an oral dose of AKB-6548 370 mg capsule QD for 42 days.	AKB-6548 500 mg Participants with anemia secondary to CKD, stages 3 and 4 were administered with an oral dose of AKB-6548 500 mg capsule QD for 42 days.	AKB-6548 630 mg Participants with anemia secondary to CKD, stages 3 and 4 were administered with an oral dose of AKB-6548 630 mg capsule QD for 42 days.	Placebo Participants with anemia secondary to CKD, stages 3 and 4 were administered with an oral dose of matching Placebo QD for 42 days.
Overall Study STARTED	18	18	17	19	19
Overall Study COMPLETED	16	15	17	18	18
Overall Study NOT COMPLETED	2	3	0	1	1

Reasons for withdrawal

Reasons for withdrawal
Measure	AKB-6548 240 mg Participants with anemia secondary to chronic kidney disease (CKD), stages 3 and 4 were administered with an oral dose of AKB-6548 240 milligrams (mg) capsule once daily (QD) for 42 days.	AKB-6548 370 mg Participants with anemia secondary to CKD, stages 3 and 4 were administered with an oral dose of AKB-6548 370 mg capsule QD for 42 days.	AKB-6548 630 mg Participants with anemia secondary to CKD, stages 3 and 4 were administered with an oral dose of AKB-6548 630 mg capsule QD for 42 days.	Placebo Participants with anemia secondary to CKD, stages 3 and 4 were administered with an oral dose of matching Placebo QD for 42 days.
Overall Study Adverse Event	1	2	1	0
Overall Study Lost to Follow-up	0	0	0	1
Overall Study Withdrawal of informed consent	0	1	0	0
Overall Study Participant given Aranesp injection	1	0	0	0

Baseline Characteristics

42-Day Repeat Oral Dose Study of AKB-6548 in Participants With Chronic Kidney Disease and Anemia

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	AKB-6548 240 mg n=18 Participants Participants with anemia secondary to chronic kidney disease (CKD), stages 3 and 4 were administered with an oral dose of AKB-6548 240 milligrams (mg) capsule once daily (QD) for 42 days.	AKB-6548 370 mg n=18 Participants Participants with anemia secondary to CKD, stages 3 and 4 were administered with an oral dose of AKB-6548 370 mg capsule QD for 42 days.	AKB-6548 500 mg n=17 Participants Participants with anemia secondary to CKD, stages 3 and 4 were administered with an oral dose of AKB-6548 500 mg capsule QD for 42 days.	AKB-6548 630 mg n=19 Participants Participants with anemia secondary to CKD, stages 3 and 4 were administered with an oral dose of AKB-6548 630 mg capsule QD for 42 days.	Placebo n=19 Participants Participants with anemia secondary to CKD, stages 3 and 4 were administered with an oral dose of matching Placebo QD for 42 days.	Total n=91 Participants Total of all reporting groups
Age, Continuous	64.2 Years STANDARD_DEVIATION 12.17 • n=93 Participants	68.9 Years STANDARD_DEVIATION 7.84 • n=4 Participants	64.7 Years STANDARD_DEVIATION 9.47 • n=27 Participants	64.9 Years STANDARD_DEVIATION 8.79 • n=483 Participants	64.9 Years STANDARD_DEVIATION 9.97 • n=36 Participants	65.5 Years STANDARD_DEVIATION 9.69 • n=10 Participants
Sex: Female, Male Female	9 Participants n=93 Participants	7 Participants n=4 Participants	13 Participants n=27 Participants	7 Participants n=483 Participants	12 Participants n=36 Participants	48 Participants n=10 Participants
Sex: Female, Male Male	9 Participants n=93 Participants	11 Participants n=4 Participants	4 Participants n=27 Participants	12 Participants n=483 Participants	7 Participants n=36 Participants	43 Participants n=10 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	7 Participants n=93 Participants	4 Participants n=4 Participants	4 Participants n=27 Participants	4 Participants n=483 Participants	5 Participants n=36 Participants	24 Participants n=10 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	11 Participants n=93 Participants	14 Participants n=4 Participants	13 Participants n=27 Participants	15 Participants n=483 Participants	14 Participants n=36 Participants	67 Participants n=10 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants	0 Participants n=483 Participants	0 Participants n=36 Participants	0 Participants n=10 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants	1 Participants n=483 Participants	0 Participants n=36 Participants	1 Participants n=10 Participants
Race (NIH/OMB) Asian	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants	1 Participants n=483 Participants	0 Participants n=36 Participants	1 Participants n=10 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=93 Participants	1 Participants n=4 Participants	0 Participants n=27 Participants	0 Participants n=483 Participants	1 Participants n=36 Participants	2 Participants n=10 Participants
Race (NIH/OMB) Black or African American	6 Participants n=93 Participants	4 Participants n=4 Participants	4 Participants n=27 Participants	7 Participants n=483 Participants	3 Participants n=36 Participants	24 Participants n=10 Participants
Race (NIH/OMB) White	10 Participants n=93 Participants	13 Participants n=4 Participants	13 Participants n=27 Participants	9 Participants n=483 Participants	14 Participants n=36 Participants	59 Participants n=10 Participants
Race (NIH/OMB) More than one race	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants	0 Participants n=483 Participants	0 Participants n=36 Participants	0 Participants n=10 Participants
Race (NIH/OMB) Unknown or Not Reported	2 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants	1 Participants n=483 Participants	1 Participants n=36 Participants	4 Participants n=10 Participants
CKD stage Stage 3	5 Participants n=93 Participants	4 Participants n=4 Participants	4 Participants n=27 Participants	5 Participants n=483 Participants	5 Participants n=36 Participants	23 Participants n=10 Participants
CKD stage Stage 4	13 Participants n=93 Participants	14 Participants n=4 Participants	13 Participants n=27 Participants	14 Participants n=483 Participants	14 Participants n=36 Participants	68 Participants n=10 Participants

PRIMARY outcome

Timeframe: Baseline, Week 6

Population: Modified intent-to-treat (MITT) population: All randomized participants who received at least one dose of study medication and had a Baseline (both Screening and Baseline for Hgb and red blood cells \[RBC\] count) and at least one post-baseline measurement. Participants with available data were included in the analysis.

Outcome measures

Outcome measures
Measure	AKB-6548 240 mg n=18 Participants Participants with anemia secondary to chronic kidney disease (CKD), stages 3 and 4 were administered with an oral dose of AKB-6548 240 milligrams (mg) capsule once daily (QD) for 42 days.	AKB-6548 370 mg n=16 Participants Participants with anemia secondary to CKD, stages 3 and 4 were administered with an oral dose of AKB-6548 370 mg capsule QD for 42 days.	AKB-6548 500 mg n=17 Participants Participants with anemia secondary to CKD, stages 3 and 4 were administered with an oral dose of AKB-6548 500 mg capsule QD for 42 days.	AKB-6548 630 mg n=19 Participants Participants with anemia secondary to CKD, stages 3 and 4 were administered with an oral dose of AKB-6548 630 mg capsule QD for 42 days.	Placebo n=19 Participants Participants with anemia secondary to CKD, stages 3 and 4 were administered with an oral dose of matching Placebo QD for 42 days.
Absolute Change From Baseline in Hemoglobin (Hgb) to End of Treatment (Week 6) Baseline	9.46 Grams per deciliter (g/dL) Standard Deviation 0.792	9.93 Grams per deciliter (g/dL) Standard Deviation 0.643	9.86 Grams per deciliter (g/dL) Standard Deviation 0.606	9.67 Grams per deciliter (g/dL) Standard Deviation 0.796	9.83 Grams per deciliter (g/dL) Standard Deviation 0.677
Absolute Change From Baseline in Hemoglobin (Hgb) to End of Treatment (Week 6) Change from Baseline at Week 6	0.77 Grams per deciliter (g/dL) Standard Deviation 0.665	0.73 Grams per deciliter (g/dL) Standard Deviation 0.623	1.25 Grams per deciliter (g/dL) Standard Deviation 0.644	1.43 Grams per deciliter (g/dL) Standard Deviation 0.668	-0.03 Grams per deciliter (g/dL) Standard Deviation 0.649

SECONDARY outcome

Timeframe: Baseline, Week 1, Week 2, Week 4, Week 6, Follow-up Visit (up to Week 8)

Population: MITT population. Participants with available data were included in the analysis.

Change from Baseline was calculated as the visit value minus the Baseline value. Baseline Hgb was defined as the average of the last two measurements obtained prior to dosing; if there was only one value prior to dosing, this value served as Baseline. A positive change from Baseline indicated that hemoglobin concentration increased.

Outcome measures

Outcome measures
Measure	AKB-6548 240 mg n=18 Participants Participants with anemia secondary to chronic kidney disease (CKD), stages 3 and 4 were administered with an oral dose of AKB-6548 240 milligrams (mg) capsule once daily (QD) for 42 days.	AKB-6548 370 mg n=16 Participants Participants with anemia secondary to CKD, stages 3 and 4 were administered with an oral dose of AKB-6548 370 mg capsule QD for 42 days.	AKB-6548 500 mg n=17 Participants Participants with anemia secondary to CKD, stages 3 and 4 were administered with an oral dose of AKB-6548 500 mg capsule QD for 42 days.	AKB-6548 630 mg n=19 Participants Participants with anemia secondary to CKD, stages 3 and 4 were administered with an oral dose of AKB-6548 630 mg capsule QD for 42 days.	Placebo n=19 Participants Participants with anemia secondary to CKD, stages 3 and 4 were administered with an oral dose of matching Placebo QD for 42 days.
Change From Baseline in Hgb at Week 1, Week 2, Week 4, Week 6, and Follow-up Visit (up to Week 8) Baseline	9.46 g/dL Standard Deviation 0.792	9.93 g/dL Standard Deviation 0.643	9.86 g/dL Standard Deviation 0.606	9.67 g/dL Standard Deviation 0.796	9.83 g/dL Standard Deviation 0.677
Change From Baseline in Hgb at Week 1, Week 2, Week 4, Week 6, and Follow-up Visit (up to Week 8) Change from Baseline to Week 1	0.06 g/dL Standard Deviation 0.559	-0.12 g/dL Standard Deviation 0.452	0.28 g/dL Standard Deviation 0.439	0.29 g/dL Standard Deviation 0.622	0.04 g/dL Standard Deviation 0.531
Change From Baseline in Hgb at Week 1, Week 2, Week 4, Week 6, and Follow-up Visit (up to Week 8) Change from Baseline to Week 2	0.16 g/dL Standard Deviation 0.575	0.00 g/dL Standard Deviation 0.590	0.54 g/dL Standard Deviation 0.586	0.53 g/dL Standard Deviation 0.455	0.14 g/dL Standard Deviation 0.654
Change From Baseline in Hgb at Week 1, Week 2, Week 4, Week 6, and Follow-up Visit (up to Week 8) Change from Baseline to Week 4	0.54 g/dL Standard Deviation 0.659	0.36 g/dL Standard Deviation 0.605	0.85 g/dL Standard Deviation 0.650	1.06 g/dL Standard Deviation 0.900	0.08 g/dL Standard Deviation 0.613
Change From Baseline in Hgb at Week 1, Week 2, Week 4, Week 6, and Follow-up Visit (up to Week 8) Change from Baseline to Week 6	0.77 g/dL Standard Deviation 0.665	0.73 g/dL Standard Deviation 0.623	1.25 g/dL Standard Deviation 0.644	1.43 g/dL Standard Deviation 0.668	-0.03 g/dL Standard Deviation 0.649
Change From Baseline in Hgb at Week 1, Week 2, Week 4, Week 6, and Follow-up Visit (up to Week 8) Change from Baseline to Follow-up Visit (up to Week 8)	0.78 g/dL Standard Deviation 0.685	0.40 g/dL Standard Deviation 0.553	1.04 g/dL Standard Deviation 0.848	1.01 g/dL Standard Deviation 0.872	0.06 g/dL Standard Deviation 0.877

SECONDARY outcome

Timeframe: Baseline, Week 1, Week 2, Week 4, Week 6, Follow-up Visit (up to Week 8)

Population: MITT population. Participants with available data were included in the analysis.

Change from Baseline was calculated as the visit value minus the Baseline value. Baseline HCT was defined as the average of the last two measurements obtained prior to dosing; if there was only one value prior to dosing, this value served as Baseline. A positive change from Baseline indicated HCT concentration increased.

Outcome measures

Outcome measures
Measure	AKB-6548 240 mg n=18 Participants Participants with anemia secondary to chronic kidney disease (CKD), stages 3 and 4 were administered with an oral dose of AKB-6548 240 milligrams (mg) capsule once daily (QD) for 42 days.	AKB-6548 370 mg n=16 Participants Participants with anemia secondary to CKD, stages 3 and 4 were administered with an oral dose of AKB-6548 370 mg capsule QD for 42 days.	AKB-6548 500 mg n=14 Participants Participants with anemia secondary to CKD, stages 3 and 4 were administered with an oral dose of AKB-6548 500 mg capsule QD for 42 days.	AKB-6548 630 mg n=19 Participants Participants with anemia secondary to CKD, stages 3 and 4 were administered with an oral dose of AKB-6548 630 mg capsule QD for 42 days.	Placebo n=19 Participants Participants with anemia secondary to CKD, stages 3 and 4 were administered with an oral dose of matching Placebo QD for 42 days.
Change From Baseline in Hematocrit (HCT) at Week 1, Week 2, Week 4, Week 6, and Follow-up Visit (up to Week 8) Change from Baseline to Week 1	0.5 Percentage of red blood cells in blood Standard Deviation 2.28	0.2 Percentage of red blood cells in blood Standard Deviation 1.87	1.2 Percentage of red blood cells in blood Standard Deviation 1.25	1.6 Percentage of red blood cells in blood Standard Deviation 2.65	0.2 Percentage of red blood cells in blood Standard Deviation 1.70
Change From Baseline in Hematocrit (HCT) at Week 1, Week 2, Week 4, Week 6, and Follow-up Visit (up to Week 8) Change from Baseline to Week 4	1.7 Percentage of red blood cells in blood Standard Deviation 2.37	0.6 Percentage of red blood cells in blood Standard Deviation 1.67	3.1 Percentage of red blood cells in blood Standard Deviation 2.59	3.4 Percentage of red blood cells in blood Standard Deviation 3.52	0.1 Percentage of red blood cells in blood Standard Deviation 2.34
Change From Baseline in Hematocrit (HCT) at Week 1, Week 2, Week 4, Week 6, and Follow-up Visit (up to Week 8) Change from Baseline to Week 2	0.2 Percentage of red blood cells in blood Standard Deviation 2.46	0.1 Percentage of red blood cells in blood Standard Deviation 1.59	1.6 Percentage of red blood cells in blood Standard Deviation 2.33	1.5 Percentage of red blood cells in blood Standard Deviation 2.04	0.3 Percentage of red blood cells in blood Standard Deviation 2.06
Change From Baseline in Hematocrit (HCT) at Week 1, Week 2, Week 4, Week 6, and Follow-up Visit (up to Week 8) Baseline	29.0 Percentage of red blood cells in blood Standard Deviation 2.57	29.6 Percentage of red blood cells in blood Standard Deviation 2.45	30.4 Percentage of red blood cells in blood Standard Deviation 2.41	29.6 Percentage of red blood cells in blood Standard Deviation 3.68	29.8 Percentage of red blood cells in blood Standard Deviation 1.96
Change From Baseline in Hematocrit (HCT) at Week 1, Week 2, Week 4, Week 6, and Follow-up Visit (up to Week 8) Change from Baseline to Week 6	1.8 Percentage of red blood cells in blood Standard Deviation 2.71	2.1 Percentage of red blood cells in blood Standard Deviation 2.46	3.4 Percentage of red blood cells in blood Standard Deviation 2.47	4.3 Percentage of red blood cells in blood Standard Deviation 2.74	-0.4 Percentage of red blood cells in blood Standard Deviation 2.40
Change From Baseline in Hematocrit (HCT) at Week 1, Week 2, Week 4, Week 6, and Follow-up Visit (up to Week 8) Change from Baseline to Follow-up Visit (up to Week 8)	1.9 Percentage of red blood cells in blood Standard Deviation 2.30	0.7 Percentage of red blood cells in blood Standard Deviation 1.90	2.4 Percentage of red blood cells in blood Standard Deviation 2.62	2.8 Percentage of red blood cells in blood Standard Deviation 3.44	0.0 Percentage of red blood cells in blood Standard Deviation 2.78

SECONDARY outcome

Timeframe: Baseline, Week 1, Week 2, Week 4, Week 6, Follow-up Visit (up to Week 8)

Population: MITT population. Participants with available data were included in the analysis.

Change from Baseline was calculated as the visit value minus the Baseline value. Baseline RBC count was defined as the average of the last two measurements obtained prior to dosing; if there was only one value prior to dosing, this value served as Baseline. A positive change from Baseline indicated RBC count increased.

Outcome measures

Outcome measures
Measure	AKB-6548 240 mg n=18 Participants Participants with anemia secondary to chronic kidney disease (CKD), stages 3 and 4 were administered with an oral dose of AKB-6548 240 milligrams (mg) capsule once daily (QD) for 42 days.	AKB-6548 370 mg n=16 Participants Participants with anemia secondary to CKD, stages 3 and 4 were administered with an oral dose of AKB-6548 370 mg capsule QD for 42 days.	AKB-6548 500 mg n=17 Participants Participants with anemia secondary to CKD, stages 3 and 4 were administered with an oral dose of AKB-6548 500 mg capsule QD for 42 days.	AKB-6548 630 mg n=19 Participants Participants with anemia secondary to CKD, stages 3 and 4 were administered with an oral dose of AKB-6548 630 mg capsule QD for 42 days.	Placebo n=19 Participants Participants with anemia secondary to CKD, stages 3 and 4 were administered with an oral dose of matching Placebo QD for 42 days.
Change From Baseline in Red Blood Cell (RBC) Count at Week 1, Week 2, Week 4, Week 6, and Follow-up Visit (up to Week 8) Baseline	3.21 10^6 cells/microliter (10^6 cells/μL) Standard Deviation 0.415	3.38 10^6 cells/microliter (10^6 cells/μL) Standard Deviation 0.286	3.37 10^6 cells/microliter (10^6 cells/μL) Standard Deviation 0.286	3.25 10^6 cells/microliter (10^6 cells/μL) Standard Deviation 0.366	3.34 10^6 cells/microliter (10^6 cells/μL) Standard Deviation 0.463
Change From Baseline in Red Blood Cell (RBC) Count at Week 1, Week 2, Week 4, Week 6, and Follow-up Visit (up to Week 8) Change from Baseline to Week 1	-0.01 10^6 cells/microliter (10^6 cells/μL) Standard Deviation 0.185	-0.07 10^6 cells/microliter (10^6 cells/μL) Standard Deviation 0.178	0.09 10^6 cells/microliter (10^6 cells/μL) Standard Deviation 0.187	0.04 10^6 cells/microliter (10^6 cells/μL) Standard Deviation 0.227	-0.02 10^6 cells/microliter (10^6 cells/μL) Standard Deviation 0.231
Change From Baseline in Red Blood Cell (RBC) Count at Week 1, Week 2, Week 4, Week 6, and Follow-up Visit (up to Week 8) Change from Baseline to Week 2	0.02 10^6 cells/microliter (10^6 cells/μL) Standard Deviation 0.183	-0.05 10^6 cells/microliter (10^6 cells/μL) Standard Deviation 0.186	0.14 10^6 cells/microliter (10^6 cells/μL) Standard Deviation 0.229	0.11 10^6 cells/microliter (10^6 cells/μL) Standard Deviation 0.172	0.03 10^6 cells/microliter (10^6 cells/μL) Standard Deviation 0.281
Change From Baseline in Red Blood Cell (RBC) Count at Week 1, Week 2, Week 4, Week 6, and Follow-up Visit (up to Week 8) Change from Baseline to Week 4	0.16 10^6 cells/microliter (10^6 cells/μL) Standard Deviation 0.213	0.01 10^6 cells/microliter (10^6 cells/μL) Standard Deviation 0.202	0.26 10^6 cells/microliter (10^6 cells/μL) Standard Deviation 0.251	0.27 10^6 cells/microliter (10^6 cells/μL) Standard Deviation 0.294	0.02 10^6 cells/microliter (10^6 cells/μL) Standard Deviation 0.229
Change From Baseline in Red Blood Cell (RBC) Count at Week 1, Week 2, Week 4, Week 6, and Follow-up Visit (up to Week 8) Change from Baseline to Week 6	0.17 10^6 cells/microliter (10^6 cells/μL) Standard Deviation 0.243	0.18 10^6 cells/microliter (10^6 cells/μL) Standard Deviation 0.273	0.39 10^6 cells/microliter (10^6 cells/μL) Standard Deviation 0.252	0.41 10^6 cells/microliter (10^6 cells/μL) Standard Deviation 0.243	-0.02 10^6 cells/microliter (10^6 cells/μL) Standard Deviation 0.223
Change From Baseline in Red Blood Cell (RBC) Count at Week 1, Week 2, Week 4, Week 6, and Follow-up Visit (up to Week 8) Change from Baseline to Follow-up Visit (up to Week 8)	0.24 10^6 cells/microliter (10^6 cells/μL) Standard Deviation 0.242	0.06 10^6 cells/microliter (10^6 cells/μL) Standard Deviation 0.199	0.30 10^6 cells/microliter (10^6 cells/μL) Standard Deviation 0.248	0.26 10^6 cells/microliter (10^6 cells/μL) Standard Deviation 0.273	0.01 10^6 cells/microliter (10^6 cells/μL) Standard Deviation 0.290

SECONDARY outcome

Timeframe: Baseline, Week 1, Week 2, Week 4, Week 6, Follow-up Visit (up to Week 8)

Population: MITT population. Participants with available data were included in the analysis.

Change from Baseline was calculated as the visit value minus the Baseline value. Baseline Reticulocyte count was defined as the average of the last two measurements obtained prior to dosing; if there was only one value prior to dosing, this value served as Baseline. A positive change from Baseline indicated reticulocyte count increased.

Outcome measures

Outcome measures
Measure	AKB-6548 240 mg n=18 Participants Participants with anemia secondary to chronic kidney disease (CKD), stages 3 and 4 were administered with an oral dose of AKB-6548 240 milligrams (mg) capsule once daily (QD) for 42 days.	AKB-6548 370 mg n=16 Participants Participants with anemia secondary to CKD, stages 3 and 4 were administered with an oral dose of AKB-6548 370 mg capsule QD for 42 days.	AKB-6548 500 mg n=14 Participants Participants with anemia secondary to CKD, stages 3 and 4 were administered with an oral dose of AKB-6548 500 mg capsule QD for 42 days.	AKB-6548 630 mg n=19 Participants Participants with anemia secondary to CKD, stages 3 and 4 were administered with an oral dose of AKB-6548 630 mg capsule QD for 42 days.	Placebo n=18 Participants Participants with anemia secondary to CKD, stages 3 and 4 were administered with an oral dose of matching Placebo QD for 42 days.
Change From Baseline in Absolute Reticulocyte Count at Week 1, Week 2, Week 4, Week 6, and Follow-up Visit (up to Week 8) Baseline	0.0766 10^6 cells/μL Standard Deviation 0.02855	0.0569 10^6 cells/μL Standard Deviation 0.01891	0.0811 10^6 cells/μL Standard Deviation 0.01993	0.0674 10^6 cells/μL Standard Deviation 0.02715	0.0700 10^6 cells/μL Standard Deviation 0.03319
Change From Baseline in Absolute Reticulocyte Count at Week 1, Week 2, Week 4, Week 6, and Follow-up Visit (up to Week 8) Change from Baseline to Week 4	0.0029 10^6 cells/μL Standard Deviation 0.01181	0.0128 10^6 cells/μL Standard Deviation 0.01586	0.0234 10^6 cells/μL Standard Deviation 0.02685	0.0206 10^6 cells/μL Standard Deviation 0.02369	-0.0023 10^6 cells/μL Standard Deviation 0.01636
Change From Baseline in Absolute Reticulocyte Count at Week 1, Week 2, Week 4, Week 6, and Follow-up Visit (up to Week 8) Change from Baseline to Week 1	0.0022 10^6 cells/μL Standard Deviation 0.01279	0.0134 10^6 cells/μL Standard Deviation 0.01733	0.0259 10^6 cells/μL Standard Deviation 0.02223	0.0289 10^6 cells/μL Standard Deviation 0.03152	0.0010 10^6 cells/μL Standard Deviation 0.01677
Change From Baseline in Absolute Reticulocyte Count at Week 1, Week 2, Week 4, Week 6, and Follow-up Visit (up to Week 8) Change from Baseline to Week 2	0.0012 10^6 cells/μL Standard Deviation 0.01505	0.0196 10^6 cells/μL Standard Deviation 0.01919	0.0346 10^6 cells/μL Standard Deviation 0.01997	0.0292 10^6 cells/μL Standard Deviation 0.01625	-0.0015 10^6 cells/μL Standard Deviation 0.01091
Change From Baseline in Absolute Reticulocyte Count at Week 1, Week 2, Week 4, Week 6, and Follow-up Visit (up to Week 8) Change from Baseline to Week 6	-0.0020 10^6 cells/μL Standard Deviation 0.01736	0.0116 10^6 cells/μL Standard Deviation 0.02390	0.0061 10^6 cells/μL Standard Deviation 0.02217	0.0047 10^6 cells/μL Standard Deviation 0.02639	-0.0004 10^6 cells/μL Standard Deviation 0.01788
Change From Baseline in Absolute Reticulocyte Count at Week 1, Week 2, Week 4, Week 6, and Follow-up Visit (up to Week 8) Change from Baseline to Follow-up Visit (up to Week 8)	-0.0042 10^6 cells/μL Standard Deviation 0.01900	0.0015 10^6 cells/μL Standard Deviation 0.02616	-0.0152 10^6 cells/μL Standard Deviation 0.01467	-0.0119 10^6 cells/μL Standard Deviation 0.02494	-0.0035 10^6 cells/μL Standard Deviation 0.01522

SECONDARY outcome

Timeframe: Baseline, Week 6

Population: MITT population. Participants with available data were included in the analysis.

Change from Baseline was calculated as the Week 6 value minus the Baseline value. Baseline Reticulocyte count was defined as the average of the last two measurements obtained prior to dosing; if there was only one value prior to dosing, this value served as Baseline. A positive change from Baseline indicated reticulocyte Hgb content increased.

Outcome measures

Outcome measures
Measure	AKB-6548 240 mg n=18 Participants Participants with anemia secondary to chronic kidney disease (CKD), stages 3 and 4 were administered with an oral dose of AKB-6548 240 milligrams (mg) capsule once daily (QD) for 42 days.	AKB-6548 370 mg n=16 Participants Participants with anemia secondary to CKD, stages 3 and 4 were administered with an oral dose of AKB-6548 370 mg capsule QD for 42 days.	AKB-6548 500 mg n=14 Participants Participants with anemia secondary to CKD, stages 3 and 4 were administered with an oral dose of AKB-6548 500 mg capsule QD for 42 days.	AKB-6548 630 mg n=19 Participants Participants with anemia secondary to CKD, stages 3 and 4 were administered with an oral dose of AKB-6548 630 mg capsule QD for 42 days.	Placebo n=19 Participants Participants with anemia secondary to CKD, stages 3 and 4 were administered with an oral dose of matching Placebo QD for 42 days.
Change From Baseline in Reticulocyte Hgb Content at Week 6 Baseline	31.02 Picogram Standard Deviation 2.945	31.44 Picogram Standard Deviation 2.257	30.26 Picogram Standard Deviation 2.605	31.54 Picogram Standard Deviation 2.575	30.73 Picogram Standard Deviation 2.634
Change From Baseline in Reticulocyte Hgb Content at Week 6 Change From Baseline at Week 6	0.37 Picogram Standard Deviation 0.971	0.29 Picogram Standard Deviation 0.742	0.06 Picogram Standard Deviation 0.964	0.15 Picogram Standard Deviation 1.214	0.03 Picogram Standard Deviation 1.104

SECONDARY outcome

Timeframe: Baseline; up to Week 8

Population: MITT population. Participants with available data were included in the analysis.

Change from Baseline was calculated as the maximum value minus the Baseline value. Baseline Hgb was defined as the average of the last two measurements obtained prior to dosing; if there was only one value prior to dosing, this value served as Baseline. A positive change from Baseline indicated that hemoglobin concentration increased.

Outcome measures

Outcome measures
Measure	AKB-6548 240 mg n=18 Participants Participants with anemia secondary to chronic kidney disease (CKD), stages 3 and 4 were administered with an oral dose of AKB-6548 240 milligrams (mg) capsule once daily (QD) for 42 days.	AKB-6548 370 mg n=16 Participants Participants with anemia secondary to CKD, stages 3 and 4 were administered with an oral dose of AKB-6548 370 mg capsule QD for 42 days.	AKB-6548 500 mg n=17 Participants Participants with anemia secondary to CKD, stages 3 and 4 were administered with an oral dose of AKB-6548 500 mg capsule QD for 42 days.	AKB-6548 630 mg n=19 Participants Participants with anemia secondary to CKD, stages 3 and 4 were administered with an oral dose of AKB-6548 630 mg capsule QD for 42 days.	Placebo n=19 Participants Participants with anemia secondary to CKD, stages 3 and 4 were administered with an oral dose of matching Placebo QD for 42 days.
Maximum Change From Baseline in Hgb Baseline	9.46 g/dL Standard Deviation 0.792	9.93 g/dL Standard Deviation 0.643	9.86 g/dL Standard Deviation 0.606	9.67 g/dL Standard Deviation 0.796	9.83 g/dL Standard Deviation 0.677
Maximum Change From Baseline in Hgb Maximum change from Baseline (up to Week 8)	1.04 g/dL Standard Deviation 0.585	0.82 g/dL Standard Deviation 0.581	1.44 g/dL Standard Deviation 0.675	1.54 g/dL Standard Deviation 0.911	0.59 g/dL Standard Deviation 0.568

SECONDARY outcome

Timeframe: Baseline; up to Week 8

Population: MITT population. Participants with available data were included in the analysis.

Change from Baseline was calculated as the maximum value minus the Baseline value. Baseline HCT was defined as the average of the last two measurements obtained prior to dosing; if there was only one value prior to dosing, this value served as Baseline. A positive change from Baseline indicated that HCT concentration increased.

Outcome measures

Outcome measures
Measure	AKB-6548 240 mg n=18 Participants Participants with anemia secondary to chronic kidney disease (CKD), stages 3 and 4 were administered with an oral dose of AKB-6548 240 milligrams (mg) capsule once daily (QD) for 42 days.	AKB-6548 370 mg n=16 Participants Participants with anemia secondary to CKD, stages 3 and 4 were administered with an oral dose of AKB-6548 370 mg capsule QD for 42 days.	AKB-6548 500 mg n=14 Participants Participants with anemia secondary to CKD, stages 3 and 4 were administered with an oral dose of AKB-6548 500 mg capsule QD for 42 days.	AKB-6548 630 mg n=19 Participants Participants with anemia secondary to CKD, stages 3 and 4 were administered with an oral dose of AKB-6548 630 mg capsule QD for 42 days.	Placebo n=19 Participants Participants with anemia secondary to CKD, stages 3 and 4 were administered with an oral dose of matching Placebo QD for 42 days.
Maximum Change From Baseline in HCT Maximum change from Baseline (up to Week 8)	2.94 Percentage of red blood cells Standard Deviation 2.578	2.56 Percentage of red blood cells Standard Deviation 2.097	4.43 Percentage of red blood cells Standard Deviation 2.277	4.84 Percentage of red blood cells Standard Deviation 3.452	1.89 Percentage of red blood cells Standard Deviation 1.729
Maximum Change From Baseline in HCT Baseline	29.0 Percentage of red blood cells Standard Deviation 2.57	29.6 Percentage of red blood cells Standard Deviation 2.45	30.4 Percentage of red blood cells Standard Deviation 2.41	29.6 Percentage of red blood cells Standard Deviation 3.68	29.8 Percentage of red blood cells Standard Deviation 1.96

SECONDARY outcome

Timeframe: Baseline; up to Week 8

Population: MITT population. Participants with available data were included in the analysis.

Change from Baseline was calculated as the maximum value minus the Baseline value. Baseline RBC Count was defined as the average of the last two measurements obtained prior to dosing; if there was only one value prior to dosing, this value served as Baseline. A positive change from Baseline indicated that RBC count increased.

Outcome measures

Outcome measures
Measure	AKB-6548 240 mg n=18 Participants Participants with anemia secondary to chronic kidney disease (CKD), stages 3 and 4 were administered with an oral dose of AKB-6548 240 milligrams (mg) capsule once daily (QD) for 42 days.	AKB-6548 370 mg n=16 Participants Participants with anemia secondary to CKD, stages 3 and 4 were administered with an oral dose of AKB-6548 370 mg capsule QD for 42 days.	AKB-6548 500 mg n=17 Participants Participants with anemia secondary to CKD, stages 3 and 4 were administered with an oral dose of AKB-6548 500 mg capsule QD for 42 days.	AKB-6548 630 mg n=19 Participants Participants with anemia secondary to CKD, stages 3 and 4 were administered with an oral dose of AKB-6548 630 mg capsule QD for 42 days.	Placebo n=19 Participants Participants with anemia secondary to CKD, stages 3 and 4 were administered with an oral dose of matching Placebo QD for 42 days.
Maximum Change From Baseline in RBC Count Baseline	3.21 10^6 cells/μL Standard Deviation 0.415	3.38 10^6 cells/μL Standard Deviation 0.286	3.37 10^6 cells/μL Standard Deviation 0.286	3.25 10^6 cells/μL Standard Deviation 0.366	3.34 10^6 cells/μL Standard Deviation 0.463
Maximum Change From Baseline in RBC Count Maximum change from Baseline (up to Week 8)	0.31 10^6 cells/μL Standard Deviation 0.210	0.22 10^6 cells/μL Standard Deviation 0.239	0.44 10^6 cells/μL Standard Deviation 0.249	0.44 10^6 cells/μL Standard Deviation 0.291	0.18 10^6 cells/μL Standard Deviation 0.183

SECONDARY outcome

Timeframe: Baseline; up to Week 8

Population: MITT population. Participants with available data were included in the analysis.

Change from Baseline was calculated as the maximum value minus the Baseline value. Baseline absolute reticulocyte count was defined as the average of the last two measurements obtained prior to dosing; if there was only one value prior to dosing, this value served as Baseline. A positive change from Baseline indicated that reticulocyte count increased.

Outcome measures

Outcome measures
Measure	AKB-6548 240 mg n=18 Participants Participants with anemia secondary to chronic kidney disease (CKD), stages 3 and 4 were administered with an oral dose of AKB-6548 240 milligrams (mg) capsule once daily (QD) for 42 days.	AKB-6548 370 mg n=16 Participants Participants with anemia secondary to CKD, stages 3 and 4 were administered with an oral dose of AKB-6548 370 mg capsule QD for 42 days.	AKB-6548 500 mg n=14 Participants Participants with anemia secondary to CKD, stages 3 and 4 were administered with an oral dose of AKB-6548 500 mg capsule QD for 42 days.	AKB-6548 630 mg n=19 Participants Participants with anemia secondary to CKD, stages 3 and 4 were administered with an oral dose of AKB-6548 630 mg capsule QD for 42 days.	Placebo n=18 Participants Participants with anemia secondary to CKD, stages 3 and 4 were administered with an oral dose of matching Placebo QD for 42 days.
Maximum Change in Absolute Reticulocyte Count From Baseline Baseline	0.0766 10^6 cells/μL Standard Deviation 0.02855	0.0569 10^6 cells/μL Standard Deviation 0.01891	0.0811 10^6 cells/μL Standard Deviation 0.01993	0.0674 10^6 cells/μL Standard Deviation 0.02715	0.0700 10^6 cells/μL Standard Deviation 0.03319
Maximum Change in Absolute Reticulocyte Count From Baseline Maximum Change from Baseline (up to Week 8)	0.013 10^6 cells/μL Standard Deviation 0.0145	0.028 10^6 cells/μL Standard Deviation 0.0184	0.040 10^6 cells/μL Standard Deviation 0.0200	0.042 10^6 cells/μL Standard Deviation 0.0263	0.011 10^6 cells/μL Standard Deviation 0.0129

SECONDARY outcome

Timeframe: Up to Week 6 (End of the Dosing Period)

Population: MITT population. Participants with available data were included in the analysis.

Outcome measures

Outcome measures
Measure	AKB-6548 240 mg n=18 Participants Participants with anemia secondary to chronic kidney disease (CKD), stages 3 and 4 were administered with an oral dose of AKB-6548 240 milligrams (mg) capsule once daily (QD) for 42 days.	AKB-6548 370 mg n=16 Participants Participants with anemia secondary to CKD, stages 3 and 4 were administered with an oral dose of AKB-6548 370 mg capsule QD for 42 days.	AKB-6548 500 mg n=17 Participants Participants with anemia secondary to CKD, stages 3 and 4 were administered with an oral dose of AKB-6548 500 mg capsule QD for 42 days.	AKB-6548 630 mg n=19 Participants Participants with anemia secondary to CKD, stages 3 and 4 were administered with an oral dose of AKB-6548 630 mg capsule QD for 42 days.	Placebo n=19 Participants Participants with anemia secondary to CKD, stages 3 and 4 were administered with an oral dose of matching Placebo QD for 42 days.
Number of Participants With Absolute Change From Baseline in Hgb ≥ 0.4, 0.6, 0.8, and 1.0 g/dL at the End of Dosing Period Change from Baseline in Hgb ≥0.6 g/dL	3 Participants	2 Participants	0 Participants	1 Participants	0 Participants
Number of Participants With Absolute Change From Baseline in Hgb ≥ 0.4, 0.6, 0.8, and 1.0 g/dL at the End of Dosing Period Change from Baseline in Hgb ≥0.8 g/dL	3 Participants	2 Participants	3 Participants	1 Participants	0 Participants
Number of Participants With Absolute Change From Baseline in Hgb ≥ 0.4, 0.6, 0.8, and 1.0 g/dL at the End of Dosing Period Change from Baseline in Hgb ≥1.0 g/dL	5 Participants	6 Participants	11 Participants	14 Participants	2 Participants
Number of Participants With Absolute Change From Baseline in Hgb ≥ 0.4, 0.6, 0.8, and 1.0 g/dL at the End of Dosing Period Change from Baseline in Hgb ≥0.4 g/dL	3 Participants	2 Participants	2 Participants	1 Participants	2 Participants

SECONDARY outcome

Timeframe: Up to Week 6 (End of The Dosing Period)

Population: MITT population. Participants with available data were included in the analysis.

Outcome measures

Outcome measures
Measure	AKB-6548 240 mg n=18 Participants Participants with anemia secondary to chronic kidney disease (CKD), stages 3 and 4 were administered with an oral dose of AKB-6548 240 milligrams (mg) capsule once daily (QD) for 42 days.	AKB-6548 370 mg n=16 Participants Participants with anemia secondary to CKD, stages 3 and 4 were administered with an oral dose of AKB-6548 370 mg capsule QD for 42 days.	AKB-6548 500 mg n=17 Participants Participants with anemia secondary to CKD, stages 3 and 4 were administered with an oral dose of AKB-6548 500 mg capsule QD for 42 days.	AKB-6548 630 mg n=19 Participants Participants with anemia secondary to CKD, stages 3 and 4 were administered with an oral dose of AKB-6548 630 mg capsule QD for 42 days.	Placebo n=19 Participants Participants with anemia secondary to CKD, stages 3 and 4 were administered with an oral dose of matching Placebo QD for 42 days.
Number of Participants With Change From Baseline in Hgb ≥5.0, 7.5, and 10.0% by the End of Dosing Period % Change from Baseline in Hgb ≥5%	4 Participants	3 Participants	1 Participants	1 Participants	2 Participants
Number of Participants With Change From Baseline in Hgb ≥5.0, 7.5, and 10.0% by the End of Dosing Period % Change from Baseline in Hgb ≥7.5%	4 Participants	3 Participants	3 Participants	1 Participants	0 Participants
Number of Participants With Change From Baseline in Hgb ≥5.0, 7.5, and 10.0% by the End of Dosing Period % Change from Baseline in Hgb ≥10.0%	5 Participants	5 Participants	11 Participants	14 Participants	2 Participants

SECONDARY outcome

Timeframe: Up to Week 6 (End of The Dosing Period)

Population: MITT population. Participants with available data were included in the analysis.

Outcome measures

Outcome measures
Measure	AKB-6548 240 mg n=18 Participants Participants with anemia secondary to chronic kidney disease (CKD), stages 3 and 4 were administered with an oral dose of AKB-6548 240 milligrams (mg) capsule once daily (QD) for 42 days.	AKB-6548 370 mg n=16 Participants Participants with anemia secondary to CKD, stages 3 and 4 were administered with an oral dose of AKB-6548 370 mg capsule QD for 42 days.	AKB-6548 500 mg n=17 Participants Participants with anemia secondary to CKD, stages 3 and 4 were administered with an oral dose of AKB-6548 500 mg capsule QD for 42 days.	AKB-6548 630 mg n=19 Participants Participants with anemia secondary to CKD, stages 3 and 4 were administered with an oral dose of AKB-6548 630 mg capsule QD for 42 days.	Placebo n=19 Participants Participants with anemia secondary to CKD, stages 3 and 4 were administered with an oral dose of matching Placebo QD for 42 days.
Number of Participants With Change From Baseline in HCT ≥5.0, 7.5, and 10.0% by the End of Dosing Period % Change from Baseline in HCT ≥5%	4 Participants	3 Participants	2 Participants	0 Participants	1 Participants
Number of Participants With Change From Baseline in HCT ≥5.0, 7.5, and 10.0% by the End of Dosing Period % Change from Baseline in HCT ≥7.5%	1 Participants	0 Participants	0 Participants	4 Participants	1 Participants
Number of Participants With Change From Baseline in HCT ≥5.0, 7.5, and 10.0% by the End of Dosing Period % Change from Baseline in HCT ≥10.0%	4 Participants	6 Participants	9 Participants	11 Participants	1 Participants

SECONDARY outcome

Timeframe: Up to Week 6 (End of The Dosing Period)

Population: MITT population. Participants with available data were included in the analysis.

Outcome measures

Outcome measures
Measure	AKB-6548 240 mg n=18 Participants Participants with anemia secondary to chronic kidney disease (CKD), stages 3 and 4 were administered with an oral dose of AKB-6548 240 milligrams (mg) capsule once daily (QD) for 42 days.	AKB-6548 370 mg n=16 Participants Participants with anemia secondary to CKD, stages 3 and 4 were administered with an oral dose of AKB-6548 370 mg capsule QD for 42 days.	AKB-6548 500 mg n=17 Participants Participants with anemia secondary to CKD, stages 3 and 4 were administered with an oral dose of AKB-6548 500 mg capsule QD for 42 days.	AKB-6548 630 mg n=19 Participants Participants with anemia secondary to CKD, stages 3 and 4 were administered with an oral dose of AKB-6548 630 mg capsule QD for 42 days.	Placebo n=19 Participants Participants with anemia secondary to CKD, stages 3 and 4 were administered with an oral dose of matching Placebo QD for 42 days.
Number of Participants With Change From Baseline in RBC Count ≥5.0, 7.5, and 10.0% by the End of Dosing Period % Change from Baseline in RBCs ≥5%	4 Participants	3 Participants	2 Participants	3 Participants	1 Participants
Number of Participants With Change From Baseline in RBC Count ≥5.0, 7.5, and 10.0% by the End of Dosing Period % Change from Baseline in RBCs ≥7.5%	2 Participants	2 Participants	3 Participants	1 Participants	0 Participants
Number of Participants With Change From Baseline in RBC Count ≥5.0, 7.5, and 10.0% by the End of Dosing Period % Change from Baseline in RBCs ≥10.0%	2 Participants	4 Participants	8 Participants	11 Participants	1 Participants

SECONDARY outcome

Timeframe: Up to Week 6 (End of The Dosing Period)

Population: MITT population. Participants with available data were included in the analysis.

Change from Baseline was calculated as the maximum value minus the Baseline value. Baseline reticulocytes count was defined as the average of the last two measurements obtained prior to dosing; if there was only one value prior to dosing, this value served as Baseline.

Outcome measures

Outcome measures
Measure	AKB-6548 240 mg n=18 Participants Participants with anemia secondary to chronic kidney disease (CKD), stages 3 and 4 were administered with an oral dose of AKB-6548 240 milligrams (mg) capsule once daily (QD) for 42 days.	AKB-6548 370 mg n=16 Participants Participants with anemia secondary to CKD, stages 3 and 4 were administered with an oral dose of AKB-6548 370 mg capsule QD for 42 days.	AKB-6548 500 mg n=17 Participants Participants with anemia secondary to CKD, stages 3 and 4 were administered with an oral dose of AKB-6548 500 mg capsule QD for 42 days.	AKB-6548 630 mg n=19 Participants Participants with anemia secondary to CKD, stages 3 and 4 were administered with an oral dose of AKB-6548 630 mg capsule QD for 42 days.	Placebo n=19 Participants Participants with anemia secondary to CKD, stages 3 and 4 were administered with an oral dose of matching Placebo QD for 42 days.
Number of Participants With Change From Baseline in Reticulocyte Count ≥6000, 12000, and 18000 Cells/uL by the End of Dosing Period Change from Baseline in Reticulocytes ≥6000 cells/uL	1 Participants	1 Participants	4 Participants	2 Participants	3 Participants
Number of Participants With Change From Baseline in Reticulocyte Count ≥6000, 12000, and 18000 Cells/uL by the End of Dosing Period Change from Baseline in Reticulocytes ≥12000 cells/uL	1 Participants	3 Participants	0 Participants	3 Participants	1 Participants
Number of Participants With Change From Baseline in Reticulocyte Count ≥6000, 12000, and 18000 Cells/uL by the End of Dosing Period Change from Baseline in Reticulocytes ≥18000 cells/uL	2 Participants	5 Participants	4 Participants	5 Participants	2 Participants

SECONDARY outcome

Timeframe: Baseline, Week 2, Week 4, Week 6, Follow-up Visit (up to Week 8)

Population: MITT population. Participants with available data were included in the analysis.

Change from Baseline was calculated as the visit value minus the Baseline value. Baseline total iron was defined as the average of the last two measurements obtained prior to dosing; if there was only one value prior to dosing, this value served as Baseline.

Outcome measures

Outcome measures
Measure	AKB-6548 240 mg n=18 Participants Participants with anemia secondary to chronic kidney disease (CKD), stages 3 and 4 were administered with an oral dose of AKB-6548 240 milligrams (mg) capsule once daily (QD) for 42 days.	AKB-6548 370 mg n=16 Participants Participants with anemia secondary to CKD, stages 3 and 4 were administered with an oral dose of AKB-6548 370 mg capsule QD for 42 days.	AKB-6548 500 mg n=15 Participants Participants with anemia secondary to CKD, stages 3 and 4 were administered with an oral dose of AKB-6548 500 mg capsule QD for 42 days.	AKB-6548 630 mg n=19 Participants Participants with anemia secondary to CKD, stages 3 and 4 were administered with an oral dose of AKB-6548 630 mg capsule QD for 42 days.	Placebo n=19 Participants Participants with anemia secondary to CKD, stages 3 and 4 were administered with an oral dose of matching Placebo QD for 42 days.
Change From Baseline in Total Iron at Week 2, Week 4, Week 6, and Follow-up Visit (up to Week 8) Baseline	66.0 Micrograms per deciliter (µg/dL) Standard Deviation 18.68	77.8 Micrograms per deciliter (µg/dL) Standard Deviation 22.47	76.1 Micrograms per deciliter (µg/dL) Standard Deviation 32.01	60.7 Micrograms per deciliter (µg/dL) Standard Deviation 20.51	67.6 Micrograms per deciliter (µg/dL) Standard Deviation 21.12
Change From Baseline in Total Iron at Week 2, Week 4, Week 6, and Follow-up Visit (up to Week 8) Change from Baseline to Week 2	-1.8 Micrograms per deciliter (µg/dL) Standard Deviation 15.87	-3.7 Micrograms per deciliter (µg/dL) Standard Deviation 18.96	10.9 Micrograms per deciliter (µg/dL) Standard Deviation 22.93	10.4 Micrograms per deciliter (µg/dL) Standard Deviation 24.54	-4.1 Micrograms per deciliter (µg/dL) Standard Deviation 18.55
Change From Baseline in Total Iron at Week 2, Week 4, Week 6, and Follow-up Visit (up to Week 8) Change from Baseline to Week 4	-1.5 Micrograms per deciliter (µg/dL) Standard Deviation 21.62	4.0 Micrograms per deciliter (µg/dL) Standard Deviation 16.36	-1.6 Micrograms per deciliter (µg/dL) Standard Deviation 20.49	13.2 Micrograms per deciliter (µg/dL) Standard Deviation 24.18	-2.2 Micrograms per deciliter (µg/dL) Standard Deviation 20.47
Change From Baseline in Total Iron at Week 2, Week 4, Week 6, and Follow-up Visit (up to Week 8) Change from Baseline to Week 6	3.6 Micrograms per deciliter (µg/dL) Standard Deviation 23.26	2.8 Micrograms per deciliter (µg/dL) Standard Deviation 15.44	3.7 Micrograms per deciliter (µg/dL) Standard Deviation 25.19	0.7 Micrograms per deciliter (µg/dL) Standard Deviation 16.54	-8.6 Micrograms per deciliter (µg/dL) Standard Deviation 25.81
Change From Baseline in Total Iron at Week 2, Week 4, Week 6, and Follow-up Visit (up to Week 8) Change from Baseline to Follow-up Visit (up to Week 8)	-7.4 Micrograms per deciliter (µg/dL) Standard Deviation 19.25	-7.5 Micrograms per deciliter (µg/dL) Standard Deviation 22.90	0.9 Micrograms per deciliter (µg/dL) Standard Deviation 31.90	6.2 Micrograms per deciliter (µg/dL) Standard Deviation 18.50	3.4 Micrograms per deciliter (µg/dL) Standard Deviation 16.05

SECONDARY outcome

Timeframe: Baseline, Week 2, Week 4, Week 6, Follow-up Visit (up to Week 8)

Population: MITT population. Participants with available data were included in the analysis.

Change from Baseline was calculated as the visit value minus the Baseline value. Baseline Unsaturated Iron Binding Capacity was defined as the average of the last two measurements obtained prior to dosing; if there was only one value prior to dosing, this value served as Baseline.

Outcome measures

Outcome measures
Measure	AKB-6548 240 mg n=18 Participants Participants with anemia secondary to chronic kidney disease (CKD), stages 3 and 4 were administered with an oral dose of AKB-6548 240 milligrams (mg) capsule once daily (QD) for 42 days.	AKB-6548 370 mg n=16 Participants Participants with anemia secondary to CKD, stages 3 and 4 were administered with an oral dose of AKB-6548 370 mg capsule QD for 42 days.	AKB-6548 500 mg n=15 Participants Participants with anemia secondary to CKD, stages 3 and 4 were administered with an oral dose of AKB-6548 500 mg capsule QD for 42 days.	AKB-6548 630 mg n=19 Participants Participants with anemia secondary to CKD, stages 3 and 4 were administered with an oral dose of AKB-6548 630 mg capsule QD for 42 days.	Placebo n=19 Participants Participants with anemia secondary to CKD, stages 3 and 4 were administered with an oral dose of matching Placebo QD for 42 days.
Change From Baseline in Unsaturated Iron Binding Capacity at Week 2, Week 4, Week 6, and Follow-up Visit (up to Week 8) Baseline	153.4 µg/dL Standard Deviation 34.26	168.0 µg/dL Standard Deviation 52.46	173.1 µg/dL Standard Deviation 56.48	171.2 µg/dL Standard Deviation 38.77	175.5 µg/dL Standard Deviation 33.14
Change From Baseline in Unsaturated Iron Binding Capacity at Week 2, Week 4, Week 6, and Follow-up Visit (up to Week 8) Change from Baseline to Week 2	10.9 µg/dL Standard Deviation 18.78	22.4 µg/dL Standard Deviation 19.52	17.2 µg/dL Standard Deviation 32.16	21.3 µg/dL Standard Deviation 27.40	-1.5 µg/dL Standard Deviation 20.61
Change From Baseline in Unsaturated Iron Binding Capacity at Week 2, Week 4, Week 6, and Follow-up Visit (up to Week 8) Change from Baseline to Week 4	14.4 µg/dL Standard Deviation 25.96	26.1 µg/dL Standard Deviation 22.30	31.5 µg/dL Standard Deviation 27.08	37.4 µg/dL Standard Deviation 20.16	-3.7 µg/dL Standard Deviation 27.89
Change From Baseline in Unsaturated Iron Binding Capacity at Week 2, Week 4, Week 6, and Follow-up Visit (up to Week 8) Change from Baseline to Week 6	15.3 µg/dL Standard Deviation 30.52	34.0 µg/dL Standard Deviation 25.62	29.3 µg/dL Standard Deviation 16.06	49.6 µg/dL Standard Deviation 26.50	-1.3 µg/dL Standard Deviation 17.81
Change From Baseline in Unsaturated Iron Binding Capacity at Week 2, Week 4, Week 6, and Follow-up Visit (up to Week 8) Change from Baseline to Follow-up Visit (up to Week 8)	15.1 µg/dL Standard Deviation 30.46	16.2 µg/dL Standard Deviation 22.74	-0.7 µg/dL Standard Deviation 23.06	3.9 µg/dL Standard Deviation 42.20	0.7 µg/dL Standard Deviation 20.72

SECONDARY outcome

Timeframe: Baseline, Week 2, Week 4, Week 6, Follow-up Visit (up to Week 8)

Population: MITT population. Participants with available data were included in the analysis.

Change from Baseline was calculated as the visit value minus the Baseline value. Baseline iron saturation was defined as the average of the last two measurements obtained prior to dosing; if there was only one value prior to dosing, this value served as Baseline.

Outcome measures

Outcome measures
Measure	AKB-6548 240 mg n=18 Participants Participants with anemia secondary to chronic kidney disease (CKD), stages 3 and 4 were administered with an oral dose of AKB-6548 240 milligrams (mg) capsule once daily (QD) for 42 days.	AKB-6548 370 mg n=16 Participants Participants with anemia secondary to CKD, stages 3 and 4 were administered with an oral dose of AKB-6548 370 mg capsule QD for 42 days.	AKB-6548 500 mg n=15 Participants Participants with anemia secondary to CKD, stages 3 and 4 were administered with an oral dose of AKB-6548 500 mg capsule QD for 42 days.	AKB-6548 630 mg n=19 Participants Participants with anemia secondary to CKD, stages 3 and 4 were administered with an oral dose of AKB-6548 630 mg capsule QD for 42 days.	Placebo n=19 Participants Participants with anemia secondary to CKD, stages 3 and 4 were administered with an oral dose of matching Placebo QD for 42 days.
Change From Baseline in Iron Saturation at Week 2, Week 4, Week 6, and Follow-up Visit (up to Week 8) Baseline	30.4 Percentage of saturation Standard Deviation 7.56	32.4 Percentage of saturation Standard Deviation 9.82	31.4 Percentage of saturation Standard Deviation 13.35	26.5 Percentage of saturation Standard Deviation 10.17	27.7 Percentage of saturation Standard Deviation 6.60
Change From Baseline in Iron Saturation at Week 2, Week 4, Week 6, and Follow-up Visit (up to Week 8) Change from Baseline to Week 2	-1.5 Percentage of saturation Standard Deviation 6.26	-3.8 Percentage of saturation Standard Deviation 7.34	1.4 Percentage of saturation Standard Deviation 9.15	0.6 Percentage of saturation Standard Deviation 8.81	-0.9 Percentage of saturation Standard Deviation 7.86
Change From Baseline in Iron Saturation at Week 2, Week 4, Week 6, and Follow-up Visit (up to Week 8) Change from Baseline to Week 4	-1.9 Percentage of saturation Standard Deviation 8.10	-2.3 Percentage of saturation Standard Deviation 7.00	-3.7 Percentage of saturation Standard Deviation 7.91	-0.2 Percentage of saturation Standard Deviation 6.52	-0.2 Percentage of saturation Standard Deviation 8.65
Change From Baseline in Iron Saturation at Week 2, Week 4, Week 6, and Follow-up Visit (up to Week 8) Change from Baseline to Week 6	-0.3 Percentage of saturation Standard Deviation 9.24	-3.8 Percentage of saturation Standard Deviation 6.36	-2.3 Percentage of saturation Standard Deviation 7.69	-4.6 Percentage of saturation Standard Deviation 6.44	-2.1 Percentage of saturation Standard Deviation 9.09
Change From Baseline in Iron Saturation at Week 2, Week 4, Week 6, and Follow-up Visit (up to Week 8) Change from Baseline to Follow-up Visit (up to Week 8)	-4.1 Percentage of saturation Standard Deviation 7.08	-3.9 Percentage of saturation Standard Deviation 8.90	0.5 Percentage of saturation Standard Deviation 9.94	1.6 Percentage of saturation Standard Deviation 9.27	1.2 Percentage of saturation Standard Deviation 5.80

SECONDARY outcome

Timeframe: Baseline, Week 2, Week 4, Week 6, Follow-up Visit (up to Week 8)

Population: MITT population. Participants with available data were included in the analysis.

Change from Baseline was calculated as the visit value minus the Baseline value. Baseline TIBC was defined as the average of the last two measurements obtained prior to dosing; if there was only one value prior to dosing, this value served as Baseline.

Outcome measures

Outcome measures
Measure	AKB-6548 240 mg n=18 Participants Participants with anemia secondary to chronic kidney disease (CKD), stages 3 and 4 were administered with an oral dose of AKB-6548 240 milligrams (mg) capsule once daily (QD) for 42 days.	AKB-6548 370 mg n=16 Participants Participants with anemia secondary to CKD, stages 3 and 4 were administered with an oral dose of AKB-6548 370 mg capsule QD for 42 days.	AKB-6548 500 mg n=15 Participants Participants with anemia secondary to CKD, stages 3 and 4 were administered with an oral dose of AKB-6548 500 mg capsule QD for 42 days.	AKB-6548 630 mg n=19 Participants Participants with anemia secondary to CKD, stages 3 and 4 were administered with an oral dose of AKB-6548 630 mg capsule QD for 42 days.	Placebo n=19 Participants Participants with anemia secondary to CKD, stages 3 and 4 were administered with an oral dose of matching Placebo QD for 42 days.
Change From Baseline in Total Iron Binding Capacity (TIBC) at Week 2, Week 4, Week 6, and Follow-up Visit (up to Week 8) Baseline	219.4 µg/dL Standard Deviation 39.39	245.8 µg/dL Standard Deviation 54.61	249.2 µg/dL Standard Deviation 45.29	231.8 µg/dL Standard Deviation 36.19	243.1 µg/dL Standard Deviation 40.02
Change From Baseline in Total Iron Binding Capacity (TIBC) at Week 2, Week 4, Week 6, and Follow-up Visit (up to Week 8) Change from Baseline to Week 2	9.2 µg/dL Standard Deviation 16.34	18.7 µg/dL Standard Deviation 18.09	28.1 µg/dL Standard Deviation 22.32	31.7 µg/dL Standard Deviation 28.73	-5.5 µg/dL Standard Deviation 22.51
Change From Baseline in Total Iron Binding Capacity (TIBC) at Week 2, Week 4, Week 6, and Follow-up Visit (up to Week 8) Change from Baseline to Week 4	12.9 µg/dL Standard Deviation 24.97	30.1 µg/dL Standard Deviation 16.20	29.9 µg/dL Standard Deviation 24.08	50.5 µg/dL Standard Deviation 28.64	-5.9 µg/dL Standard Deviation 17.96
Change From Baseline in Total Iron Binding Capacity (TIBC) at Week 2, Week 4, Week 6, and Follow-up Visit (up to Week 8) Change from Baseline to Week 6	18.8 µg/dL Standard Deviation 28.81	36.8 µg/dL Standard Deviation 27.76	33.0 µg/dL Standard Deviation 28.54	50.3 µg/dL Standard Deviation 27.80	-9.9 µg/dL Standard Deviation 25.70
Change From Baseline in Total Iron Binding Capacity (TIBC) at Week 2, Week 4, Week 6, and Follow-up Visit (up to Week 8) Change from Baseline to Follow-up Visit (up to Week 8)	7.8 µg/dL Standard Deviation 34.88	8.7 µg/dL Standard Deviation 18.15	0.2 µg/dL Standard Deviation 25.82	10.2 µg/dL Standard Deviation 30.15	4.1 µg/dL Standard Deviation 23.83

SECONDARY outcome

Timeframe: Baseline, Week 2, Week 4, Week 6, Follow-up (up to Week 8)

Population: MITT population. Participants with available data were included in the analysis.

Change from Baseline was calculated as the visit value minus the Baseline value. Baseline ferritin was defined as the average of the last two measurements obtained prior to dosing; if there was only one value prior to dosing, this value served as Baseline.

Outcome measures

Outcome measures
Measure	AKB-6548 240 mg n=18 Participants Participants with anemia secondary to chronic kidney disease (CKD), stages 3 and 4 were administered with an oral dose of AKB-6548 240 milligrams (mg) capsule once daily (QD) for 42 days.	AKB-6548 370 mg n=16 Participants Participants with anemia secondary to CKD, stages 3 and 4 were administered with an oral dose of AKB-6548 370 mg capsule QD for 42 days.	AKB-6548 500 mg n=15 Participants Participants with anemia secondary to CKD, stages 3 and 4 were administered with an oral dose of AKB-6548 500 mg capsule QD for 42 days.	AKB-6548 630 mg n=19 Participants Participants with anemia secondary to CKD, stages 3 and 4 were administered with an oral dose of AKB-6548 630 mg capsule QD for 42 days.	Placebo n=19 Participants Participants with anemia secondary to CKD, stages 3 and 4 were administered with an oral dose of matching Placebo QD for 42 days.
Change From Baseline in Ferritin at Week 2, Week 4, Week 6, and Follow-up Visit (up to Week 8) Baseline	349.5 Nanograms per milliliter (ng/mL) Standard Deviation 226.27	245.8 Nanograms per milliliter (ng/mL) Standard Deviation 215.18	332.3 Nanograms per milliliter (ng/mL) Standard Deviation 330.81	240.2 Nanograms per milliliter (ng/mL) Standard Deviation 142.10	200.8 Nanograms per milliliter (ng/mL) Standard Deviation 115.99
Change From Baseline in Ferritin at Week 2, Week 4, Week 6, and Follow-up Visit (up to Week 8) Change from Baseline to Week 2	-66.0 Nanograms per milliliter (ng/mL) Standard Deviation 67.72	-41.7 Nanograms per milliliter (ng/mL) Standard Deviation 53.18	-72.0 Nanograms per milliliter (ng/mL) Standard Deviation 75.89	-58.9 Nanograms per milliliter (ng/mL) Standard Deviation 54.72	-12.9 Nanograms per milliliter (ng/mL) Standard Deviation 35.49
Change From Baseline in Ferritin at Week 2, Week 4, Week 6, and Follow-up Visit (up to Week 8) Change from Baseline to Week 4	-69.8 Nanograms per milliliter (ng/mL) Standard Deviation 101.67	-48.7 Nanograms per milliliter (ng/mL) Standard Deviation 63.08	-89.6 Nanograms per milliliter (ng/mL) Standard Deviation 138.80	-80.6 Nanograms per milliliter (ng/mL) Standard Deviation 64.50	-20.5 Nanograms per milliliter (ng/mL) Standard Deviation 39.24
Change From Baseline in Ferritin at Week 2, Week 4, Week 6, and Follow-up Visit (up to Week 8) Change from Baseline to Week 6	-65.5 Nanograms per milliliter (ng/mL) Standard Deviation 115.89	-59.4 Nanograms per milliliter (ng/mL) Standard Deviation 58.76	-88.9 Nanograms per milliliter (ng/mL) Standard Deviation 64.66	-86.6 Nanograms per milliliter (ng/mL) Standard Deviation 62.73	-19.6 Nanograms per milliliter (ng/mL) Standard Deviation 41.72
Change From Baseline in Ferritin at Week 2, Week 4, Week 6, and Follow-up Visit (up to Week 8) Change from Baseline to Follow-up Visit (up to Week 8)	-50.4 Nanograms per milliliter (ng/mL) Standard Deviation 91.22	-37.7 Nanograms per milliliter (ng/mL) Standard Deviation 73.31	-86.1 Nanograms per milliliter (ng/mL) Standard Deviation 67.75	-27.4 Nanograms per milliliter (ng/mL) Standard Deviation 107.42	-20.2 Nanograms per milliliter (ng/mL) Standard Deviation 39.35

SECONDARY outcome

Timeframe: Baseline, Week 2, Week 6, Follow-up Visit (up to Week 8)

Population: Intent-to-treat (ITT) population: All randomized participants who received at least one dose of study medication. Participants with available data were included in the analysis.

Change from Baseline was calculated as the visit value minus the Baseline value. Baseline erythropoietin was defined as the average of the last two measurements obtained prior to dosing; if there was only one value prior to dosing, this value served as Baseline.

Outcome measures

Outcome measures
Measure	AKB-6548 240 mg n=18 Participants Participants with anemia secondary to chronic kidney disease (CKD), stages 3 and 4 were administered with an oral dose of AKB-6548 240 milligrams (mg) capsule once daily (QD) for 42 days.	AKB-6548 370 mg n=18 Participants Participants with anemia secondary to CKD, stages 3 and 4 were administered with an oral dose of AKB-6548 370 mg capsule QD for 42 days.	AKB-6548 500 mg n=15 Participants Participants with anemia secondary to CKD, stages 3 and 4 were administered with an oral dose of AKB-6548 500 mg capsule QD for 42 days.	AKB-6548 630 mg n=19 Participants Participants with anemia secondary to CKD, stages 3 and 4 were administered with an oral dose of AKB-6548 630 mg capsule QD for 42 days.	Placebo n=19 Participants Participants with anemia secondary to CKD, stages 3 and 4 were administered with an oral dose of matching Placebo QD for 42 days.
Change From Baseline in Erythropoietin at Week 2, Week 6, and Follow-up Visit (up to Week 8) Baseline	18.011 ng/mL Standard Deviation 56.3608	4.339 ng/mL Standard Deviation 4.1462	7.287 ng/mL Standard Deviation 8.8333	8.826 ng/mL Standard Deviation 10.2773	6.963 ng/mL Standard Deviation 14.1425
Change From Baseline in Erythropoietin at Week 2, Week 6, and Follow-up Visit (up to Week 8) Change from Baseline to Week 2	-3.538 ng/mL Standard Deviation 20.3172	0.606 ng/mL Standard Deviation 3.2070	1.142 ng/mL Standard Deviation 11.8961	-2.483 ng/mL Standard Deviation 9.5483	-0.850 ng/mL Standard Deviation 9.3370
Change From Baseline in Erythropoietin at Week 2, Week 6, and Follow-up Visit (up to Week 8) Change from Baseline to Week 6	-3.050 ng/mL Standard Deviation 15.1756	-1.013 ng/mL Standard Deviation 3.9836	-3.329 ng/mL Standard Deviation 5.9821	-0.372 ng/mL Standard Deviation 14.4615	-1.492 ng/mL Standard Deviation 10.1597
Change From Baseline in Erythropoietin at Week 2, Week 6, and Follow-up Visit (up to Week 8) Change from Baseline to Follow-up Visit (up to Week 8)	-3.853 ng/mL Standard Deviation 15.1335	-0.563 ng/mL Standard Deviation 5.5372	-2.061 ng/mL Standard Deviation 6.2689	-4.844 ng/mL Standard Deviation 9.4601	-2.650 ng/mL Standard Deviation 8.2146

SECONDARY outcome

Timeframe: Baseline, Week 6

Population: MITT population. Participants with available data were included in the analysis.

Change from Baseline was calculated as the Week 6 value minus the Baseline value. Baseline hepcidin was defined as the average of the last two measurements obtained prior to dosing; if there was only one value prior to dosing, this value served as Baseline.

Outcome measures

Outcome measures
Measure	AKB-6548 240 mg n=18 Participants Participants with anemia secondary to chronic kidney disease (CKD), stages 3 and 4 were administered with an oral dose of AKB-6548 240 milligrams (mg) capsule once daily (QD) for 42 days.	AKB-6548 370 mg n=16 Participants Participants with anemia secondary to CKD, stages 3 and 4 were administered with an oral dose of AKB-6548 370 mg capsule QD for 42 days.	AKB-6548 500 mg n=15 Participants Participants with anemia secondary to CKD, stages 3 and 4 were administered with an oral dose of AKB-6548 500 mg capsule QD for 42 days.	AKB-6548 630 mg n=19 Participants Participants with anemia secondary to CKD, stages 3 and 4 were administered with an oral dose of AKB-6548 630 mg capsule QD for 42 days.	Placebo n=19 Participants Participants with anemia secondary to CKD, stages 3 and 4 were administered with an oral dose of matching Placebo QD for 42 days.
Change From Baseline in Hepcidin at Week 6 Baseline	326.35 ng/mL Standard Deviation 222.037	241.03 ng/mL Standard Deviation 158.871	242.51 ng/mL Standard Deviation 117.326	282.75 ng/mL Standard Deviation 239.266	258.29 ng/mL Standard Deviation 144.115
Change From Baseline in Hepcidin at Week 6 Change from Baseline at Week 6	-28.64 ng/mL Standard Deviation 185.263	-90.91 ng/mL Standard Deviation 106.826	-85.01 ng/mL Standard Deviation 45.864	-144.90 ng/mL Standard Deviation 184.640	-32.54 ng/mL Standard Deviation 103.937

SECONDARY outcome

Timeframe: Week 2: Pre-dose and post-dose; Week 4: Pre-dose

Population: Pharmacokinetic (PK) Population: All participants in the ITT population that had pre-dose PK sampling that fell within a range of 18 to 30 hours after the previous dose of study medication or post-dose PK sampling that fell in a range of 2 to 8 hours post-dose. Participants with available data were included in the analysis.

Plasma samples were collected for the analysis.

Outcome measures

Outcome measures
Measure	AKB-6548 240 mg n=17 Participants Participants with anemia secondary to chronic kidney disease (CKD), stages 3 and 4 were administered with an oral dose of AKB-6548 240 milligrams (mg) capsule once daily (QD) for 42 days.	AKB-6548 370 mg n=16 Participants Participants with anemia secondary to CKD, stages 3 and 4 were administered with an oral dose of AKB-6548 370 mg capsule QD for 42 days.	AKB-6548 500 mg n=16 Participants Participants with anemia secondary to CKD, stages 3 and 4 were administered with an oral dose of AKB-6548 500 mg capsule QD for 42 days.	AKB-6548 630 mg n=18 Participants Participants with anemia secondary to CKD, stages 3 and 4 were administered with an oral dose of AKB-6548 630 mg capsule QD for 42 days.	Placebo Participants with anemia secondary to CKD, stages 3 and 4 were administered with an oral dose of matching Placebo QD for 42 days.
Mean Plasma Vadadustat Concentrations on Week 2 and Week 4 Week 2 Pre-Dose	4358.28 μg/mL Standard Deviation 2549.623	6640.04 μg/mL Standard Deviation 5141.484	10791.79 μg/mL Standard Deviation 9823.143	12443.17 μg/mL Standard Deviation 17095.495	—
Mean Plasma Vadadustat Concentrations on Week 2 and Week 4 Week 2 Post-Dose	17036.82 μg/mL Standard Deviation 8035.308	21371.63 μg/mL Standard Deviation 8664.304	39892.00 μg/mL Standard Deviation 19891.284	41656.11 μg/mL Standard Deviation 20002.713	—
Mean Plasma Vadadustat Concentrations on Week 2 and Week 4 Week 4 Pre-Dose	4698.21 μg/mL Standard Deviation 3520.520	7884.56 μg/mL Standard Deviation 5517.132	14274.80 μg/mL Standard Deviation 16141.439	17700.17 μg/mL Standard Deviation 19532.648	—

SECONDARY outcome

Timeframe: Week 2: Pre-dose; Week 4: Pre-dose

Population: PK population. Participants with available data were included in the analysis.

Plasma samples were collected for the analysis.

Outcome measures

Outcome measures
Measure	AKB-6548 240 mg n=15 Participants Participants with anemia secondary to chronic kidney disease (CKD), stages 3 and 4 were administered with an oral dose of AKB-6548 240 milligrams (mg) capsule once daily (QD) for 42 days.	AKB-6548 370 mg n=15 Participants Participants with anemia secondary to CKD, stages 3 and 4 were administered with an oral dose of AKB-6548 370 mg capsule QD for 42 days.	AKB-6548 500 mg n=13 Participants Participants with anemia secondary to CKD, stages 3 and 4 were administered with an oral dose of AKB-6548 500 mg capsule QD for 42 days.	AKB-6548 630 mg n=16 Participants Participants with anemia secondary to CKD, stages 3 and 4 were administered with an oral dose of AKB-6548 630 mg capsule QD for 42 days.	Placebo Participants with anemia secondary to CKD, stages 3 and 4 were administered with an oral dose of matching Placebo QD for 42 days.
Mean Plasma Vadadustat Acyl-Glucuronide Concentrations on Week 2 and Week 4 Week 2 Pre-Dose	1848.4 μg/mL Standard Deviation 979.73	2708.5 μg/mL Standard Deviation 1879.02	5900.1 μg/mL Standard Deviation 8309.24	6425.0 μg/mL Standard Deviation 7214.67	—
Mean Plasma Vadadustat Acyl-Glucuronide Concentrations on Week 2 and Week 4 Week 4 Pre-Dose	1999.3 μg/mL Standard Deviation 1427.74	2687.5 μg/mL Standard Deviation 2027.63	6866.9 μg/mL Standard Deviation 9247.39	7960.8 μg/mL Standard Deviation 6643.98	—

SECONDARY outcome

Timeframe: Up to Week 8 (Follow-up Visit 2 weeks after last dose)

Population: ITT population.

An adverse event (AE) was defined as any untoward medical occurrence (including a clinically significant abnormal laboratory finding) that occurred in the protocol-specified AE reporting period. A TEAE included medical conditions, signs, and symptoms not previously observed in the participant that emerged during the protocol-specified AE reporting period, including signs or symptoms associated with pre-existing underlying conditions that were not present prior to the AE reporting period. A SAE included AEs that met one or more of the following criteria/outcomes: death, life-threatening, in-patient hospitalization or prolongation of existing hospitalization, persistent or significant disability/incapacity, and congenital anomaly/birth defect.

Outcome measures

Outcome measures
Measure	AKB-6548 240 mg n=18 Participants Participants with anemia secondary to chronic kidney disease (CKD), stages 3 and 4 were administered with an oral dose of AKB-6548 240 milligrams (mg) capsule once daily (QD) for 42 days.	AKB-6548 370 mg n=18 Participants Participants with anemia secondary to CKD, stages 3 and 4 were administered with an oral dose of AKB-6548 370 mg capsule QD for 42 days.	AKB-6548 500 mg n=17 Participants Participants with anemia secondary to CKD, stages 3 and 4 were administered with an oral dose of AKB-6548 500 mg capsule QD for 42 days.	AKB-6548 630 mg n=19 Participants Participants with anemia secondary to CKD, stages 3 and 4 were administered with an oral dose of AKB-6548 630 mg capsule QD for 42 days.	Placebo n=19 Participants Participants with anemia secondary to CKD, stages 3 and 4 were administered with an oral dose of matching Placebo QD for 42 days.
Number of Participants Treatment-emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs) TEAEs	9 Participants	6 Participants	8 Participants	11 Participants	11 Participants
Number of Participants Treatment-emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs) SAEs	2 Participants	3 Participants	1 Participants	1 Participants	1 Participants

SECONDARY outcome

Timeframe: Up to Week 8 (Follow-up Visit 2 weeks after last dose)

Population: ITT population.

Parameters assessed for vital signs included sitting blood pressure, pulse, respiratory rate, and body temperature. The investigator was responsible for reviewing laboratory results for clinically significant changes.

Outcome measures

Outcome measures
Measure	AKB-6548 240 mg n=18 Participants Participants with anemia secondary to chronic kidney disease (CKD), stages 3 and 4 were administered with an oral dose of AKB-6548 240 milligrams (mg) capsule once daily (QD) for 42 days.	AKB-6548 370 mg n=18 Participants Participants with anemia secondary to CKD, stages 3 and 4 were administered with an oral dose of AKB-6548 370 mg capsule QD for 42 days.	AKB-6548 500 mg n=17 Participants Participants with anemia secondary to CKD, stages 3 and 4 were administered with an oral dose of AKB-6548 500 mg capsule QD for 42 days.	AKB-6548 630 mg n=19 Participants Participants with anemia secondary to CKD, stages 3 and 4 were administered with an oral dose of AKB-6548 630 mg capsule QD for 42 days.	Placebo n=19 Participants Participants with anemia secondary to CKD, stages 3 and 4 were administered with an oral dose of matching Placebo QD for 42 days.
Number of Participants With Clinically Significant Changes From Baseline in Vital Signs Parameter	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants

SECONDARY outcome

Timeframe: Up to Week 8 (Follow-up Visit 2 weeks after last dose)

Population: ITT population.

A standard 12-lead ECG was performed following dosing in a supine position for approximately 10 minutes. ECGs were taken prior to blood draws when possible. Clinical significance is determined by the investigator. The investigator was responsible for reviewing laboratory results for clinical significance.

Outcome measures

Outcome measures
Measure	AKB-6548 240 mg n=18 Participants Participants with anemia secondary to chronic kidney disease (CKD), stages 3 and 4 were administered with an oral dose of AKB-6548 240 milligrams (mg) capsule once daily (QD) for 42 days.	AKB-6548 370 mg n=18 Participants Participants with anemia secondary to CKD, stages 3 and 4 were administered with an oral dose of AKB-6548 370 mg capsule QD for 42 days.	AKB-6548 500 mg n=17 Participants Participants with anemia secondary to CKD, stages 3 and 4 were administered with an oral dose of AKB-6548 500 mg capsule QD for 42 days.	AKB-6548 630 mg n=19 Participants Participants with anemia secondary to CKD, stages 3 and 4 were administered with an oral dose of AKB-6548 630 mg capsule QD for 42 days.	Placebo n=19 Participants Participants with anemia secondary to CKD, stages 3 and 4 were administered with an oral dose of matching Placebo QD for 42 days.
Number of Participants With Clinically Significant Abnormal 12-Electrocardiogram (ECG) Findings	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants

SECONDARY outcome

Timeframe: Baseline, Week 6

Population: ITT population.

A standard 12-lead ECG was performed following dosing in a supine position for approximately 10 minutes. ECGs were taken prior to blood draws when possible. The parameters evaluated from the participant ECG trace included PR interval, QT interval, QRS interval, and QTc (corrected).

Outcome measures

Outcome measures
Measure	AKB-6548 240 mg n=18 Participants Participants with anemia secondary to chronic kidney disease (CKD), stages 3 and 4 were administered with an oral dose of AKB-6548 240 milligrams (mg) capsule once daily (QD) for 42 days.	AKB-6548 370 mg n=18 Participants Participants with anemia secondary to CKD, stages 3 and 4 were administered with an oral dose of AKB-6548 370 mg capsule QD for 42 days.	AKB-6548 500 mg n=17 Participants Participants with anemia secondary to CKD, stages 3 and 4 were administered with an oral dose of AKB-6548 500 mg capsule QD for 42 days.	AKB-6548 630 mg n=19 Participants Participants with anemia secondary to CKD, stages 3 and 4 were administered with an oral dose of AKB-6548 630 mg capsule QD for 42 days.	Placebo n=19 Participants Participants with anemia secondary to CKD, stages 3 and 4 were administered with an oral dose of matching Placebo QD for 42 days.
Mean Change From Baseline in PR Interval, QT Interval, QRS Interval, and QT Corrected (QTc) Interval Baseline QT Interval	412.0 Milliseconds Standard Deviation 41.59	421.4 Milliseconds Standard Deviation 46.58	419.0 Milliseconds Standard Deviation 44.97	406.9 Milliseconds Standard Deviation 42.97	419.1 Milliseconds Standard Deviation 40.10
Mean Change From Baseline in PR Interval, QT Interval, QRS Interval, and QT Corrected (QTc) Interval Baseline PR Interval	156.7 Milliseconds Standard Deviation 46.90	174.6 Milliseconds Standard Deviation 40.89	172.8 Milliseconds Standard Deviation 51.06	187.8 Milliseconds Standard Deviation 45.72	175.8 Milliseconds Standard Deviation 31.82
Mean Change From Baseline in PR Interval, QT Interval, QRS Interval, and QT Corrected (QTc) Interval Change from Baseline PR Interval	-0.8 Milliseconds Standard Deviation 22.95	2.2 Milliseconds Standard Deviation 12.37	11.4 Milliseconds Standard Deviation 29.72	-11.7 Milliseconds Standard Deviation 63.75	-0.4 Milliseconds Standard Deviation 13.07
Mean Change From Baseline in PR Interval, QT Interval, QRS Interval, and QT Corrected (QTc) Interval Baseline QRS Duration	94.9 Milliseconds Standard Deviation 21.35	113.8 Milliseconds Standard Deviation 37.57	97.1 Milliseconds Standard Deviation 28.07	94.5 Milliseconds Standard Deviation 12.65	94.6 Milliseconds Standard Deviation 12.52
Mean Change From Baseline in PR Interval, QT Interval, QRS Interval, and QT Corrected (QTc) Interval Change from Baseline QRS Duration	4.1 Milliseconds Standard Deviation 9.52	2.0 Milliseconds Standard Deviation 13.29	-1.3 Milliseconds Standard Deviation 7.23	1.4 Milliseconds Standard Deviation 10.28	-1.6 Milliseconds Standard Deviation 5.33
Mean Change From Baseline in PR Interval, QT Interval, QRS Interval, and QT Corrected (QTc) Interval Change from Baseline QT Interval	3.8 Milliseconds Standard Deviation 24.78	7.8 Milliseconds Standard Deviation 25.33	-1.6 Milliseconds Standard Deviation 19.83	4.5 Milliseconds Standard Deviation 24.10	11.0 Milliseconds Standard Deviation 23.35
Mean Change From Baseline in PR Interval, QT Interval, QRS Interval, and QT Corrected (QTc) Interval Baseline QTC Interval	424.9 Milliseconds Standard Deviation 27.70	436.3 Milliseconds Standard Deviation 37.56	445.1 Milliseconds Standard Deviation 36.10	427.6 Milliseconds Standard Deviation 23.60	435.6 Milliseconds Standard Deviation 17.90
Mean Change From Baseline in PR Interval, QT Interval, QRS Interval, and QT Corrected (QTc) Interval Change from Baseline QTC Interval	5.1 Milliseconds Standard Deviation 14.33	3.6 Milliseconds Standard Deviation 17.65	-5.8 Milliseconds Standard Deviation 20.70	-1.6 Milliseconds Standard Deviation 16.74	3.3 Milliseconds Standard Deviation 21.46

SECONDARY outcome

Timeframe: Up to Week 8 (Follow-up Visit 2 weeks after last dose)

Population: ITT population.

Parameters assessed for laboratory values included hematology, serum chemistry, C-reactive protein, DHEA-S, VEGF, and cystatin C. The investigator was responsible for reviewing laboratory results for clinically significant changes.

Outcome measures

Outcome measures
Measure	AKB-6548 240 mg n=18 Participants Participants with anemia secondary to chronic kidney disease (CKD), stages 3 and 4 were administered with an oral dose of AKB-6548 240 milligrams (mg) capsule once daily (QD) for 42 days.	AKB-6548 370 mg n=18 Participants Participants with anemia secondary to CKD, stages 3 and 4 were administered with an oral dose of AKB-6548 370 mg capsule QD for 42 days.	AKB-6548 500 mg n=17 Participants Participants with anemia secondary to CKD, stages 3 and 4 were administered with an oral dose of AKB-6548 500 mg capsule QD for 42 days.	AKB-6548 630 mg n=19 Participants Participants with anemia secondary to CKD, stages 3 and 4 were administered with an oral dose of AKB-6548 630 mg capsule QD for 42 days.	Placebo n=19 Participants Participants with anemia secondary to CKD, stages 3 and 4 were administered with an oral dose of matching Placebo QD for 42 days.
Number of Participants With Clinically Significant Changes From Baseline in Laboratory Parameter Values	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants

Adverse Events

AKB-6548 240 mg

Serious events: 2 serious events

Other events: 9 other events

Deaths: 0 deaths

AKB-6548 370 mg

Serious events: 3 serious events

Other events: 5 other events

Deaths: 1 deaths

AKB-6548 500 mg

Serious events: 1 serious events

Other events: 8 other events

Deaths: 0 deaths

AKB-6548 630 mg

Serious events: 1 serious events

Other events: 11 other events

Deaths: 0 deaths

Placebo

Serious events: 1 serious events

Other events: 11 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	AKB-6548 240 mg n=18 participants at risk Participants with anemia secondary to chronic kidney disease (CKD), stages 3 and 4 were administered with an oral dose of AKB-6548 240 milligrams (mg) capsule once daily (QD) for 42 days.	AKB-6548 370 mg n=18 participants at risk Participants with anemia secondary to CKD, stages 3 and 4 were administered with an oral dose of AKB-6548 370 mg capsule QD for 42 days.	AKB-6548 500 mg n=17 participants at risk Participants with anemia secondary to CKD, stages 3 and 4 were administered with an oral dose of AKB-6548 500 mg capsule QD for 42 days.	AKB-6548 630 mg n=19 participants at risk Participants with anemia secondary to CKD, stages 3 and 4 were administered with an oral dose of AKB-6548 630 mg capsule QD for 42 days.	Placebo n=19 participants at risk Participants with anemia secondary to CKD, stages 3 and 4 were administered with an oral dose of matching Placebo QD for 42 days.
Cardiac disorders Coronary artery disease	0.00% 0/18 • Up to Week 8 (Follow-up Visit 2 weeks after last dose) Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported.	5.6% 1/18 • Up to Week 8 (Follow-up Visit 2 weeks after last dose) Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported.	0.00% 0/17 • Up to Week 8 (Follow-up Visit 2 weeks after last dose) Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported.	0.00% 0/19 • Up to Week 8 (Follow-up Visit 2 weeks after last dose) Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported.	0.00% 0/19 • Up to Week 8 (Follow-up Visit 2 weeks after last dose) Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported.
Infections and infestations Gastroenteritis	5.6% 1/18 • Up to Week 8 (Follow-up Visit 2 weeks after last dose) Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported.	0.00% 0/18 • Up to Week 8 (Follow-up Visit 2 weeks after last dose) Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported.	0.00% 0/17 • Up to Week 8 (Follow-up Visit 2 weeks after last dose) Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported.	0.00% 0/19 • Up to Week 8 (Follow-up Visit 2 weeks after last dose) Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported.	0.00% 0/19 • Up to Week 8 (Follow-up Visit 2 weeks after last dose) Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported.
Metabolism and nutrition disorders Fluid overload	0.00% 0/18 • Up to Week 8 (Follow-up Visit 2 weeks after last dose) Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported.	0.00% 0/18 • Up to Week 8 (Follow-up Visit 2 weeks after last dose) Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported.	0.00% 0/17 • Up to Week 8 (Follow-up Visit 2 weeks after last dose) Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported.	0.00% 0/19 • Up to Week 8 (Follow-up Visit 2 weeks after last dose) Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported.	5.3% 1/19 • Up to Week 8 (Follow-up Visit 2 weeks after last dose) Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported.
Metabolism and nutrition disorders Hypoglycaemia	0.00% 0/18 • Up to Week 8 (Follow-up Visit 2 weeks after last dose) Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported.	0.00% 0/18 • Up to Week 8 (Follow-up Visit 2 weeks after last dose) Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported.	0.00% 0/17 • Up to Week 8 (Follow-up Visit 2 weeks after last dose) Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported.	5.3% 1/19 • Up to Week 8 (Follow-up Visit 2 weeks after last dose) Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported.	0.00% 0/19 • Up to Week 8 (Follow-up Visit 2 weeks after last dose) Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported.
Nervous system disorders Dizziness	0.00% 0/18 • Up to Week 8 (Follow-up Visit 2 weeks after last dose) Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported.	0.00% 0/18 • Up to Week 8 (Follow-up Visit 2 weeks after last dose) Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported.	5.9% 1/17 • Up to Week 8 (Follow-up Visit 2 weeks after last dose) Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported.	0.00% 0/19 • Up to Week 8 (Follow-up Visit 2 weeks after last dose) Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported.	0.00% 0/19 • Up to Week 8 (Follow-up Visit 2 weeks after last dose) Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported.
Renal and urinary disorders Azotaemia	0.00% 0/18 • Up to Week 8 (Follow-up Visit 2 weeks after last dose) Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported.	5.6% 1/18 • Up to Week 8 (Follow-up Visit 2 weeks after last dose) Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported.	0.00% 0/17 • Up to Week 8 (Follow-up Visit 2 weeks after last dose) Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported.	0.00% 0/19 • Up to Week 8 (Follow-up Visit 2 weeks after last dose) Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported.	0.00% 0/19 • Up to Week 8 (Follow-up Visit 2 weeks after last dose) Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported.
Cardiac disorders Cardiac pacemaker replacement	5.6% 1/18 • Up to Week 8 (Follow-up Visit 2 weeks after last dose) Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported.	0.00% 0/18 • Up to Week 8 (Follow-up Visit 2 weeks after last dose) Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported.	0.00% 0/17 • Up to Week 8 (Follow-up Visit 2 weeks after last dose) Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported.	0.00% 0/19 • Up to Week 8 (Follow-up Visit 2 weeks after last dose) Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported.	0.00% 0/19 • Up to Week 8 (Follow-up Visit 2 weeks after last dose) Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported.
Vascular disorders Hypertensive crisis	0.00% 0/18 • Up to Week 8 (Follow-up Visit 2 weeks after last dose) Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported.	5.6% 1/18 • Up to Week 8 (Follow-up Visit 2 weeks after last dose) Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported.	0.00% 0/17 • Up to Week 8 (Follow-up Visit 2 weeks after last dose) Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported.	0.00% 0/19 • Up to Week 8 (Follow-up Visit 2 weeks after last dose) Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported.	0.00% 0/19 • Up to Week 8 (Follow-up Visit 2 weeks after last dose) Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported.

Other adverse events

Other adverse events
Measure	AKB-6548 240 mg n=18 participants at risk Participants with anemia secondary to chronic kidney disease (CKD), stages 3 and 4 were administered with an oral dose of AKB-6548 240 milligrams (mg) capsule once daily (QD) for 42 days.	AKB-6548 370 mg n=18 participants at risk Participants with anemia secondary to CKD, stages 3 and 4 were administered with an oral dose of AKB-6548 370 mg capsule QD for 42 days.	AKB-6548 500 mg n=17 participants at risk Participants with anemia secondary to CKD, stages 3 and 4 were administered with an oral dose of AKB-6548 500 mg capsule QD for 42 days.	AKB-6548 630 mg n=19 participants at risk Participants with anemia secondary to CKD, stages 3 and 4 were administered with an oral dose of AKB-6548 630 mg capsule QD for 42 days.	Placebo n=19 participants at risk Participants with anemia secondary to CKD, stages 3 and 4 were administered with an oral dose of matching Placebo QD for 42 days.
Blood and lymphatic system disorders Anaemia	0.00% 0/18 • Up to Week 8 (Follow-up Visit 2 weeks after last dose) Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported.	0.00% 0/18 • Up to Week 8 (Follow-up Visit 2 weeks after last dose) Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported.	0.00% 0/17 • Up to Week 8 (Follow-up Visit 2 weeks after last dose) Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported.	0.00% 0/19 • Up to Week 8 (Follow-up Visit 2 weeks after last dose) Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported.	10.5% 2/19 • Up to Week 8 (Follow-up Visit 2 weeks after last dose) Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported.
Blood and lymphatic system disorders Neutropenia	0.00% 0/18 • Up to Week 8 (Follow-up Visit 2 weeks after last dose) Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported.	0.00% 0/18 • Up to Week 8 (Follow-up Visit 2 weeks after last dose) Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported.	0.00% 0/17 • Up to Week 8 (Follow-up Visit 2 weeks after last dose) Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported.	5.3% 1/19 • Up to Week 8 (Follow-up Visit 2 weeks after last dose) Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported.	0.00% 0/19 • Up to Week 8 (Follow-up Visit 2 weeks after last dose) Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported.
Cardiac disorders Palpitations	0.00% 0/18 • Up to Week 8 (Follow-up Visit 2 weeks after last dose) Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported.	0.00% 0/18 • Up to Week 8 (Follow-up Visit 2 weeks after last dose) Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported.	0.00% 0/17 • Up to Week 8 (Follow-up Visit 2 weeks after last dose) Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported.	5.3% 1/19 • Up to Week 8 (Follow-up Visit 2 weeks after last dose) Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported.	0.00% 0/19 • Up to Week 8 (Follow-up Visit 2 weeks after last dose) Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported.
Ear and labyrinth disorders Ear haemorrhage	0.00% 0/18 • Up to Week 8 (Follow-up Visit 2 weeks after last dose) Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported.	0.00% 0/18 • Up to Week 8 (Follow-up Visit 2 weeks after last dose) Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported.	0.00% 0/17 • Up to Week 8 (Follow-up Visit 2 weeks after last dose) Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported.	5.3% 1/19 • Up to Week 8 (Follow-up Visit 2 weeks after last dose) Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported.	0.00% 0/19 • Up to Week 8 (Follow-up Visit 2 weeks after last dose) Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported.
Eye disorders Vision blurred	0.00% 0/18 • Up to Week 8 (Follow-up Visit 2 weeks after last dose) Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported.	0.00% 0/18 • Up to Week 8 (Follow-up Visit 2 weeks after last dose) Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported.	0.00% 0/17 • Up to Week 8 (Follow-up Visit 2 weeks after last dose) Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported.	0.00% 0/19 • Up to Week 8 (Follow-up Visit 2 weeks after last dose) Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported.	5.3% 1/19 • Up to Week 8 (Follow-up Visit 2 weeks after last dose) Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported.
Gastrointestinal disorders Abdominal discomfort	0.00% 0/18 • Up to Week 8 (Follow-up Visit 2 weeks after last dose) Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported.	5.6% 1/18 • Up to Week 8 (Follow-up Visit 2 weeks after last dose) Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported.	0.00% 0/17 • Up to Week 8 (Follow-up Visit 2 weeks after last dose) Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported.	0.00% 0/19 • Up to Week 8 (Follow-up Visit 2 weeks after last dose) Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported.	0.00% 0/19 • Up to Week 8 (Follow-up Visit 2 weeks after last dose) Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported.
Gastrointestinal disorders Abdominal pain	0.00% 0/18 • Up to Week 8 (Follow-up Visit 2 weeks after last dose) Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported.	0.00% 0/18 • Up to Week 8 (Follow-up Visit 2 weeks after last dose) Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported.	0.00% 0/17 • Up to Week 8 (Follow-up Visit 2 weeks after last dose) Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported.	5.3% 1/19 • Up to Week 8 (Follow-up Visit 2 weeks after last dose) Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported.	0.00% 0/19 • Up to Week 8 (Follow-up Visit 2 weeks after last dose) Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported.
Gastrointestinal disorders Abdominal pain upper	0.00% 0/18 • Up to Week 8 (Follow-up Visit 2 weeks after last dose) Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported.	5.6% 1/18 • Up to Week 8 (Follow-up Visit 2 weeks after last dose) Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported.	0.00% 0/17 • Up to Week 8 (Follow-up Visit 2 weeks after last dose) Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported.	0.00% 0/19 • Up to Week 8 (Follow-up Visit 2 weeks after last dose) Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported.	0.00% 0/19 • Up to Week 8 (Follow-up Visit 2 weeks after last dose) Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported.
Gastrointestinal disorders Constipation	5.6% 1/18 • Up to Week 8 (Follow-up Visit 2 weeks after last dose) Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported.	5.6% 1/18 • Up to Week 8 (Follow-up Visit 2 weeks after last dose) Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported.	5.9% 1/17 • Up to Week 8 (Follow-up Visit 2 weeks after last dose) Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported.	5.3% 1/19 • Up to Week 8 (Follow-up Visit 2 weeks after last dose) Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported.	0.00% 0/19 • Up to Week 8 (Follow-up Visit 2 weeks after last dose) Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported.
Gastrointestinal disorders Diarrhoea	0.00% 0/18 • Up to Week 8 (Follow-up Visit 2 weeks after last dose) Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported.	5.6% 1/18 • Up to Week 8 (Follow-up Visit 2 weeks after last dose) Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported.	5.9% 1/17 • Up to Week 8 (Follow-up Visit 2 weeks after last dose) Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported.	0.00% 0/19 • Up to Week 8 (Follow-up Visit 2 weeks after last dose) Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported.	0.00% 0/19 • Up to Week 8 (Follow-up Visit 2 weeks after last dose) Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported.
Gastrointestinal disorders Dyspepsia	0.00% 0/18 • Up to Week 8 (Follow-up Visit 2 weeks after last dose) Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported.	0.00% 0/18 • Up to Week 8 (Follow-up Visit 2 weeks after last dose) Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported.	0.00% 0/17 • Up to Week 8 (Follow-up Visit 2 weeks after last dose) Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported.	0.00% 0/19 • Up to Week 8 (Follow-up Visit 2 weeks after last dose) Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported.	5.3% 1/19 • Up to Week 8 (Follow-up Visit 2 weeks after last dose) Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported.
Gastrointestinal disorders Frequent bowel movements	0.00% 0/18 • Up to Week 8 (Follow-up Visit 2 weeks after last dose) Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported.	0.00% 0/18 • Up to Week 8 (Follow-up Visit 2 weeks after last dose) Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported.	5.9% 1/17 • Up to Week 8 (Follow-up Visit 2 weeks after last dose) Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported.	0.00% 0/19 • Up to Week 8 (Follow-up Visit 2 weeks after last dose) Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported.	0.00% 0/19 • Up to Week 8 (Follow-up Visit 2 weeks after last dose) Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported.
Gastrointestinal disorders Nausea	5.6% 1/18 • Up to Week 8 (Follow-up Visit 2 weeks after last dose) Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported.	5.6% 1/18 • Up to Week 8 (Follow-up Visit 2 weeks after last dose) Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported.	11.8% 2/17 • Up to Week 8 (Follow-up Visit 2 weeks after last dose) Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported.	5.3% 1/19 • Up to Week 8 (Follow-up Visit 2 weeks after last dose) Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported.	10.5% 2/19 • Up to Week 8 (Follow-up Visit 2 weeks after last dose) Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported.
Gastrointestinal disorders Vomiting	0.00% 0/18 • Up to Week 8 (Follow-up Visit 2 weeks after last dose) Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported.	5.6% 1/18 • Up to Week 8 (Follow-up Visit 2 weeks after last dose) Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported.	0.00% 0/17 • Up to Week 8 (Follow-up Visit 2 weeks after last dose) Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported.	0.00% 0/19 • Up to Week 8 (Follow-up Visit 2 weeks after last dose) Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported.	0.00% 0/19 • Up to Week 8 (Follow-up Visit 2 weeks after last dose) Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported.
General disorders Adverse drug reaction	0.00% 0/18 • Up to Week 8 (Follow-up Visit 2 weeks after last dose) Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported.	0.00% 0/18 • Up to Week 8 (Follow-up Visit 2 weeks after last dose) Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported.	0.00% 0/17 • Up to Week 8 (Follow-up Visit 2 weeks after last dose) Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported.	5.3% 1/19 • Up to Week 8 (Follow-up Visit 2 weeks after last dose) Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported.	0.00% 0/19 • Up to Week 8 (Follow-up Visit 2 weeks after last dose) Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported.
General disorders Fatigue	5.6% 1/18 • Up to Week 8 (Follow-up Visit 2 weeks after last dose) Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported.	5.6% 1/18 • Up to Week 8 (Follow-up Visit 2 weeks after last dose) Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported.	0.00% 0/17 • Up to Week 8 (Follow-up Visit 2 weeks after last dose) Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported.	0.00% 0/19 • Up to Week 8 (Follow-up Visit 2 weeks after last dose) Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported.	0.00% 0/19 • Up to Week 8 (Follow-up Visit 2 weeks after last dose) Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported.
General disorders Oedema	0.00% 0/18 • Up to Week 8 (Follow-up Visit 2 weeks after last dose) Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported.	0.00% 0/18 • Up to Week 8 (Follow-up Visit 2 weeks after last dose) Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported.	5.9% 1/17 • Up to Week 8 (Follow-up Visit 2 weeks after last dose) Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported.	0.00% 0/19 • Up to Week 8 (Follow-up Visit 2 weeks after last dose) Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported.	5.3% 1/19 • Up to Week 8 (Follow-up Visit 2 weeks after last dose) Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported.
General disorders Pain	0.00% 0/18 • Up to Week 8 (Follow-up Visit 2 weeks after last dose) Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported.	0.00% 0/18 • Up to Week 8 (Follow-up Visit 2 weeks after last dose) Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported.	0.00% 0/17 • Up to Week 8 (Follow-up Visit 2 weeks after last dose) Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported.	0.00% 0/19 • Up to Week 8 (Follow-up Visit 2 weeks after last dose) Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported.	5.3% 1/19 • Up to Week 8 (Follow-up Visit 2 weeks after last dose) Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported.
Infections and infestations Bronchitis	0.00% 0/18 • Up to Week 8 (Follow-up Visit 2 weeks after last dose) Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported.	0.00% 0/18 • Up to Week 8 (Follow-up Visit 2 weeks after last dose) Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported.	0.00% 0/17 • Up to Week 8 (Follow-up Visit 2 weeks after last dose) Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported.	0.00% 0/19 • Up to Week 8 (Follow-up Visit 2 weeks after last dose) Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported.	5.3% 1/19 • Up to Week 8 (Follow-up Visit 2 weeks after last dose) Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported.
Infections and infestations Ear infection	0.00% 0/18 • Up to Week 8 (Follow-up Visit 2 weeks after last dose) Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported.	0.00% 0/18 • Up to Week 8 (Follow-up Visit 2 weeks after last dose) Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported.	0.00% 0/17 • Up to Week 8 (Follow-up Visit 2 weeks after last dose) Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported.	0.00% 0/19 • Up to Week 8 (Follow-up Visit 2 weeks after last dose) Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported.	5.3% 1/19 • Up to Week 8 (Follow-up Visit 2 weeks after last dose) Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported.
Infections and infestations Gastroenteritis viral	0.00% 0/18 • Up to Week 8 (Follow-up Visit 2 weeks after last dose) Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported.	0.00% 0/18 • Up to Week 8 (Follow-up Visit 2 weeks after last dose) Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported.	0.00% 0/17 • Up to Week 8 (Follow-up Visit 2 weeks after last dose) Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported.	0.00% 0/19 • Up to Week 8 (Follow-up Visit 2 weeks after last dose) Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported.	5.3% 1/19 • Up to Week 8 (Follow-up Visit 2 weeks after last dose) Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported.
Infections and infestations Nasopharyngitis	5.6% 1/18 • Up to Week 8 (Follow-up Visit 2 weeks after last dose) Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported.	0.00% 0/18 • Up to Week 8 (Follow-up Visit 2 weeks after last dose) Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported.	0.00% 0/17 • Up to Week 8 (Follow-up Visit 2 weeks after last dose) Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported.	0.00% 0/19 • Up to Week 8 (Follow-up Visit 2 weeks after last dose) Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported.	0.00% 0/19 • Up to Week 8 (Follow-up Visit 2 weeks after last dose) Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported.
Infections and infestations Pharyngitis streptococcal	0.00% 0/18 • Up to Week 8 (Follow-up Visit 2 weeks after last dose) Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported.	0.00% 0/18 • Up to Week 8 (Follow-up Visit 2 weeks after last dose) Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported.	0.00% 0/17 • Up to Week 8 (Follow-up Visit 2 weeks after last dose) Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported.	5.3% 1/19 • Up to Week 8 (Follow-up Visit 2 weeks after last dose) Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported.	0.00% 0/19 • Up to Week 8 (Follow-up Visit 2 weeks after last dose) Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported.
Infections and infestations Pneumonia	0.00% 0/18 • Up to Week 8 (Follow-up Visit 2 weeks after last dose) Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported.	5.6% 1/18 • Up to Week 8 (Follow-up Visit 2 weeks after last dose) Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported.	0.00% 0/17 • Up to Week 8 (Follow-up Visit 2 weeks after last dose) Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported.	0.00% 0/19 • Up to Week 8 (Follow-up Visit 2 weeks after last dose) Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported.	0.00% 0/19 • Up to Week 8 (Follow-up Visit 2 weeks after last dose) Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported.
Infections and infestations Urinary tract infection	11.1% 2/18 • Up to Week 8 (Follow-up Visit 2 weeks after last dose) Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported.	0.00% 0/18 • Up to Week 8 (Follow-up Visit 2 weeks after last dose) Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported.	5.9% 1/17 • Up to Week 8 (Follow-up Visit 2 weeks after last dose) Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported.	5.3% 1/19 • Up to Week 8 (Follow-up Visit 2 weeks after last dose) Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported.	0.00% 0/19 • Up to Week 8 (Follow-up Visit 2 weeks after last dose) Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported.
Infections and infestations Viral infection	0.00% 0/18 • Up to Week 8 (Follow-up Visit 2 weeks after last dose) Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported.	0.00% 0/18 • Up to Week 8 (Follow-up Visit 2 weeks after last dose) Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported.	0.00% 0/17 • Up to Week 8 (Follow-up Visit 2 weeks after last dose) Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported.	5.3% 1/19 • Up to Week 8 (Follow-up Visit 2 weeks after last dose) Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported.	0.00% 0/19 • Up to Week 8 (Follow-up Visit 2 weeks after last dose) Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported.
Infections and infestations Wound infection pseudomonas	0.00% 0/18 • Up to Week 8 (Follow-up Visit 2 weeks after last dose) Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported.	0.00% 0/18 • Up to Week 8 (Follow-up Visit 2 weeks after last dose) Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported.	0.00% 0/17 • Up to Week 8 (Follow-up Visit 2 weeks after last dose) Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported.	5.3% 1/19 • Up to Week 8 (Follow-up Visit 2 weeks after last dose) Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported.	0.00% 0/19 • Up to Week 8 (Follow-up Visit 2 weeks after last dose) Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported.
Injury, poisoning and procedural complications Joint sprain	0.00% 0/18 • Up to Week 8 (Follow-up Visit 2 weeks after last dose) Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported.	0.00% 0/18 • Up to Week 8 (Follow-up Visit 2 weeks after last dose) Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported.	0.00% 0/17 • Up to Week 8 (Follow-up Visit 2 weeks after last dose) Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported.	5.3% 1/19 • Up to Week 8 (Follow-up Visit 2 weeks after last dose) Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported.	0.00% 0/19 • Up to Week 8 (Follow-up Visit 2 weeks after last dose) Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported.
Injury, poisoning and procedural complications Muscle strain	0.00% 0/18 • Up to Week 8 (Follow-up Visit 2 weeks after last dose) Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported.	0.00% 0/18 • Up to Week 8 (Follow-up Visit 2 weeks after last dose) Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported.	5.9% 1/17 • Up to Week 8 (Follow-up Visit 2 weeks after last dose) Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported.	0.00% 0/19 • Up to Week 8 (Follow-up Visit 2 weeks after last dose) Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported.	0.00% 0/19 • Up to Week 8 (Follow-up Visit 2 weeks after last dose) Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported.
Injury, poisoning and procedural complications Skin laceration	0.00% 0/18 • Up to Week 8 (Follow-up Visit 2 weeks after last dose) Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported.	0.00% 0/18 • Up to Week 8 (Follow-up Visit 2 weeks after last dose) Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported.	0.00% 0/17 • Up to Week 8 (Follow-up Visit 2 weeks after last dose) Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported.	5.3% 1/19 • Up to Week 8 (Follow-up Visit 2 weeks after last dose) Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported.	0.00% 0/19 • Up to Week 8 (Follow-up Visit 2 weeks after last dose) Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported.
Investigations Blood bicarbonate decreased	0.00% 0/18 • Up to Week 8 (Follow-up Visit 2 weeks after last dose) Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported.	0.00% 0/18 • Up to Week 8 (Follow-up Visit 2 weeks after last dose) Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported.	5.9% 1/17 • Up to Week 8 (Follow-up Visit 2 weeks after last dose) Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported.	0.00% 0/19 • Up to Week 8 (Follow-up Visit 2 weeks after last dose) Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported.	0.00% 0/19 • Up to Week 8 (Follow-up Visit 2 weeks after last dose) Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported.
Investigations Blood glucose decreased	0.00% 0/18 • Up to Week 8 (Follow-up Visit 2 weeks after last dose) Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported.	0.00% 0/18 • Up to Week 8 (Follow-up Visit 2 weeks after last dose) Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported.	5.9% 1/17 • Up to Week 8 (Follow-up Visit 2 weeks after last dose) Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported.	0.00% 0/19 • Up to Week 8 (Follow-up Visit 2 weeks after last dose) Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported.	0.00% 0/19 • Up to Week 8 (Follow-up Visit 2 weeks after last dose) Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported.
Investigations Blood uric acid increased	0.00% 0/18 • Up to Week 8 (Follow-up Visit 2 weeks after last dose) Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported.	5.6% 1/18 • Up to Week 8 (Follow-up Visit 2 weeks after last dose) Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported.	0.00% 0/17 • Up to Week 8 (Follow-up Visit 2 weeks after last dose) Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported.	0.00% 0/19 • Up to Week 8 (Follow-up Visit 2 weeks after last dose) Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported.	0.00% 0/19 • Up to Week 8 (Follow-up Visit 2 weeks after last dose) Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported.
Investigations Transferrin saturation decreased	0.00% 0/18 • Up to Week 8 (Follow-up Visit 2 weeks after last dose) Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported.	0.00% 0/18 • Up to Week 8 (Follow-up Visit 2 weeks after last dose) Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported.	0.00% 0/17 • Up to Week 8 (Follow-up Visit 2 weeks after last dose) Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported.	5.3% 1/19 • Up to Week 8 (Follow-up Visit 2 weeks after last dose) Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported.	0.00% 0/19 • Up to Week 8 (Follow-up Visit 2 weeks after last dose) Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported.
Metabolism and nutrition disorders Gout	0.00% 0/18 • Up to Week 8 (Follow-up Visit 2 weeks after last dose) Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported.	0.00% 0/18 • Up to Week 8 (Follow-up Visit 2 weeks after last dose) Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported.	0.00% 0/17 • Up to Week 8 (Follow-up Visit 2 weeks after last dose) Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported.	5.3% 1/19 • Up to Week 8 (Follow-up Visit 2 weeks after last dose) Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported.	0.00% 0/19 • Up to Week 8 (Follow-up Visit 2 weeks after last dose) Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported.
Metabolism and nutrition disorders Hypercalcaemia	0.00% 0/18 • Up to Week 8 (Follow-up Visit 2 weeks after last dose) Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported.	0.00% 0/18 • Up to Week 8 (Follow-up Visit 2 weeks after last dose) Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported.	0.00% 0/17 • Up to Week 8 (Follow-up Visit 2 weeks after last dose) Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported.	5.3% 1/19 • Up to Week 8 (Follow-up Visit 2 weeks after last dose) Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported.	0.00% 0/19 • Up to Week 8 (Follow-up Visit 2 weeks after last dose) Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported.
Metabolism and nutrition disorders Hyperglycaemia	0.00% 0/18 • Up to Week 8 (Follow-up Visit 2 weeks after last dose) Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported.	0.00% 0/18 • Up to Week 8 (Follow-up Visit 2 weeks after last dose) Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported.	0.00% 0/17 • Up to Week 8 (Follow-up Visit 2 weeks after last dose) Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported.	0.00% 0/19 • Up to Week 8 (Follow-up Visit 2 weeks after last dose) Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported.	5.3% 1/19 • Up to Week 8 (Follow-up Visit 2 weeks after last dose) Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported.
Metabolism and nutrition disorders Hyperkalaemia	5.6% 1/18 • Up to Week 8 (Follow-up Visit 2 weeks after last dose) Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported.	0.00% 0/18 • Up to Week 8 (Follow-up Visit 2 weeks after last dose) Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported.	17.6% 3/17 • Up to Week 8 (Follow-up Visit 2 weeks after last dose) Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported.	0.00% 0/19 • Up to Week 8 (Follow-up Visit 2 weeks after last dose) Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported.	5.3% 1/19 • Up to Week 8 (Follow-up Visit 2 weeks after last dose) Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported.
Metabolism and nutrition disorders Hyperlipidaemia	0.00% 0/18 • Up to Week 8 (Follow-up Visit 2 weeks after last dose) Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported.	0.00% 0/18 • Up to Week 8 (Follow-up Visit 2 weeks after last dose) Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported.	0.00% 0/17 • Up to Week 8 (Follow-up Visit 2 weeks after last dose) Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported.	5.3% 1/19 • Up to Week 8 (Follow-up Visit 2 weeks after last dose) Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported.	0.00% 0/19 • Up to Week 8 (Follow-up Visit 2 weeks after last dose) Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported.
Metabolism and nutrition disorders Hypoglycaemia	0.00% 0/18 • Up to Week 8 (Follow-up Visit 2 weeks after last dose) Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported.	5.6% 1/18 • Up to Week 8 (Follow-up Visit 2 weeks after last dose) Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported.	0.00% 0/17 • Up to Week 8 (Follow-up Visit 2 weeks after last dose) Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported.	5.3% 1/19 • Up to Week 8 (Follow-up Visit 2 weeks after last dose) Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported.	0.00% 0/19 • Up to Week 8 (Follow-up Visit 2 weeks after last dose) Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported.
Metabolism and nutrition disorders Hyponatraemia	0.00% 0/18 • Up to Week 8 (Follow-up Visit 2 weeks after last dose) Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported.	0.00% 0/18 • Up to Week 8 (Follow-up Visit 2 weeks after last dose) Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported.	0.00% 0/17 • Up to Week 8 (Follow-up Visit 2 weeks after last dose) Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported.	0.00% 0/19 • Up to Week 8 (Follow-up Visit 2 weeks after last dose) Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported.	5.3% 1/19 • Up to Week 8 (Follow-up Visit 2 weeks after last dose) Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported.
Metabolism and nutrition disorders Vitamin d deficiency	0.00% 0/18 • Up to Week 8 (Follow-up Visit 2 weeks after last dose) Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported.	0.00% 0/18 • Up to Week 8 (Follow-up Visit 2 weeks after last dose) Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported.	5.9% 1/17 • Up to Week 8 (Follow-up Visit 2 weeks after last dose) Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported.	0.00% 0/19 • Up to Week 8 (Follow-up Visit 2 weeks after last dose) Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported.	0.00% 0/19 • Up to Week 8 (Follow-up Visit 2 weeks after last dose) Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported.
Musculoskeletal and connective tissue disorders Arthralgia	0.00% 0/18 • Up to Week 8 (Follow-up Visit 2 weeks after last dose) Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported.	0.00% 0/18 • Up to Week 8 (Follow-up Visit 2 weeks after last dose) Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported.	0.00% 0/17 • Up to Week 8 (Follow-up Visit 2 weeks after last dose) Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported.	5.3% 1/19 • Up to Week 8 (Follow-up Visit 2 weeks after last dose) Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported.	0.00% 0/19 • Up to Week 8 (Follow-up Visit 2 weeks after last dose) Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported.
Musculoskeletal and connective tissue disorders Muscle spasms	0.00% 0/18 • Up to Week 8 (Follow-up Visit 2 weeks after last dose) Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported.	0.00% 0/18 • Up to Week 8 (Follow-up Visit 2 weeks after last dose) Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported.	5.9% 1/17 • Up to Week 8 (Follow-up Visit 2 weeks after last dose) Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported.	0.00% 0/19 • Up to Week 8 (Follow-up Visit 2 weeks after last dose) Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported.	5.3% 1/19 • Up to Week 8 (Follow-up Visit 2 weeks after last dose) Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported.
Nervous system disorders Dizziness	5.6% 1/18 • Up to Week 8 (Follow-up Visit 2 weeks after last dose) Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported.	0.00% 0/18 • Up to Week 8 (Follow-up Visit 2 weeks after last dose) Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported.	0.00% 0/17 • Up to Week 8 (Follow-up Visit 2 weeks after last dose) Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported.	0.00% 0/19 • Up to Week 8 (Follow-up Visit 2 weeks after last dose) Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported.	5.3% 1/19 • Up to Week 8 (Follow-up Visit 2 weeks after last dose) Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported.
Nervous system disorders Headache	11.1% 2/18 • Up to Week 8 (Follow-up Visit 2 weeks after last dose) Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported.	0.00% 0/18 • Up to Week 8 (Follow-up Visit 2 weeks after last dose) Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported.	0.00% 0/17 • Up to Week 8 (Follow-up Visit 2 weeks after last dose) Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported.	0.00% 0/19 • Up to Week 8 (Follow-up Visit 2 weeks after last dose) Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported.	0.00% 0/19 • Up to Week 8 (Follow-up Visit 2 weeks after last dose) Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported.
Nervous system disorders Presyncope	0.00% 0/18 • Up to Week 8 (Follow-up Visit 2 weeks after last dose) Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported.	0.00% 0/18 • Up to Week 8 (Follow-up Visit 2 weeks after last dose) Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported.	0.00% 0/17 • Up to Week 8 (Follow-up Visit 2 weeks after last dose) Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported.	0.00% 0/19 • Up to Week 8 (Follow-up Visit 2 weeks after last dose) Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported.	5.3% 1/19 • Up to Week 8 (Follow-up Visit 2 weeks after last dose) Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported.
Renal and urinary disorders Nocturia	0.00% 0/18 • Up to Week 8 (Follow-up Visit 2 weeks after last dose) Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported.	0.00% 0/18 • Up to Week 8 (Follow-up Visit 2 weeks after last dose) Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported.	0.00% 0/17 • Up to Week 8 (Follow-up Visit 2 weeks after last dose) Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported.	5.3% 1/19 • Up to Week 8 (Follow-up Visit 2 weeks after last dose) Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported.	0.00% 0/19 • Up to Week 8 (Follow-up Visit 2 weeks after last dose) Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported.
Renal and urinary disorders Pollakiuria	5.6% 1/18 • Up to Week 8 (Follow-up Visit 2 weeks after last dose) Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported.	0.00% 0/18 • Up to Week 8 (Follow-up Visit 2 weeks after last dose) Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported.	0.00% 0/17 • Up to Week 8 (Follow-up Visit 2 weeks after last dose) Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported.	5.3% 1/19 • Up to Week 8 (Follow-up Visit 2 weeks after last dose) Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported.	0.00% 0/19 • Up to Week 8 (Follow-up Visit 2 weeks after last dose) Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported.
Renal and urinary disorders Renal impairment	0.00% 0/18 • Up to Week 8 (Follow-up Visit 2 weeks after last dose) Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported.	0.00% 0/18 • Up to Week 8 (Follow-up Visit 2 weeks after last dose) Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported.	0.00% 0/17 • Up to Week 8 (Follow-up Visit 2 weeks after last dose) Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported.	5.3% 1/19 • Up to Week 8 (Follow-up Visit 2 weeks after last dose) Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported.	0.00% 0/19 • Up to Week 8 (Follow-up Visit 2 weeks after last dose) Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported.
Respiratory, thoracic and mediastinal disorders Cough	0.00% 0/18 • Up to Week 8 (Follow-up Visit 2 weeks after last dose) Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported.	0.00% 0/18 • Up to Week 8 (Follow-up Visit 2 weeks after last dose) Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported.	0.00% 0/17 • Up to Week 8 (Follow-up Visit 2 weeks after last dose) Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported.	0.00% 0/19 • Up to Week 8 (Follow-up Visit 2 weeks after last dose) Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported.	5.3% 1/19 • Up to Week 8 (Follow-up Visit 2 weeks after last dose) Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported.
Respiratory, thoracic and mediastinal disorders Rhinorrhoea	0.00% 0/18 • Up to Week 8 (Follow-up Visit 2 weeks after last dose) Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported.	0.00% 0/18 • Up to Week 8 (Follow-up Visit 2 weeks after last dose) Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported.	0.00% 0/17 • Up to Week 8 (Follow-up Visit 2 weeks after last dose) Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported.	0.00% 0/19 • Up to Week 8 (Follow-up Visit 2 weeks after last dose) Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported.	5.3% 1/19 • Up to Week 8 (Follow-up Visit 2 weeks after last dose) Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported.
Skin and subcutaneous tissue disorders Eczema asteatotic	5.6% 1/18 • Up to Week 8 (Follow-up Visit 2 weeks after last dose) Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported.	0.00% 0/18 • Up to Week 8 (Follow-up Visit 2 weeks after last dose) Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported.	0.00% 0/17 • Up to Week 8 (Follow-up Visit 2 weeks after last dose) Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported.	0.00% 0/19 • Up to Week 8 (Follow-up Visit 2 weeks after last dose) Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported.	0.00% 0/19 • Up to Week 8 (Follow-up Visit 2 weeks after last dose) Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported.
Skin and subcutaneous tissue disorders Hair texture abnormal	0.00% 0/18 • Up to Week 8 (Follow-up Visit 2 weeks after last dose) Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported.	0.00% 0/18 • Up to Week 8 (Follow-up Visit 2 weeks after last dose) Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported.	0.00% 0/17 • Up to Week 8 (Follow-up Visit 2 weeks after last dose) Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported.	5.3% 1/19 • Up to Week 8 (Follow-up Visit 2 weeks after last dose) Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported.	0.00% 0/19 • Up to Week 8 (Follow-up Visit 2 weeks after last dose) Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported.
Skin and subcutaneous tissue disorders Pruritus	0.00% 0/18 • Up to Week 8 (Follow-up Visit 2 weeks after last dose) Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported.	0.00% 0/18 • Up to Week 8 (Follow-up Visit 2 weeks after last dose) Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported.	5.9% 1/17 • Up to Week 8 (Follow-up Visit 2 weeks after last dose) Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported.	0.00% 0/19 • Up to Week 8 (Follow-up Visit 2 weeks after last dose) Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported.	0.00% 0/19 • Up to Week 8 (Follow-up Visit 2 weeks after last dose) Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported.
Skin and subcutaneous tissue disorders Seborrhoeic dermatitis	0.00% 0/18 • Up to Week 8 (Follow-up Visit 2 weeks after last dose) Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported.	5.6% 1/18 • Up to Week 8 (Follow-up Visit 2 weeks after last dose) Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported.	0.00% 0/17 • Up to Week 8 (Follow-up Visit 2 weeks after last dose) Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported.	0.00% 0/19 • Up to Week 8 (Follow-up Visit 2 weeks after last dose) Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported.	0.00% 0/19 • Up to Week 8 (Follow-up Visit 2 weeks after last dose) Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported.
Vascular disorders Hypertension	0.00% 0/18 • Up to Week 8 (Follow-up Visit 2 weeks after last dose) Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported.	0.00% 0/18 • Up to Week 8 (Follow-up Visit 2 weeks after last dose) Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported.	0.00% 0/17 • Up to Week 8 (Follow-up Visit 2 weeks after last dose) Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported.	10.5% 2/19 • Up to Week 8 (Follow-up Visit 2 weeks after last dose) Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported.	15.8% 3/19 • Up to Week 8 (Follow-up Visit 2 weeks after last dose) Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported.
Vascular disorders Hypotension	0.00% 0/18 • Up to Week 8 (Follow-up Visit 2 weeks after last dose) Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported.	0.00% 0/18 • Up to Week 8 (Follow-up Visit 2 weeks after last dose) Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported.	0.00% 0/17 • Up to Week 8 (Follow-up Visit 2 weeks after last dose) Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported.	0.00% 0/19 • Up to Week 8 (Follow-up Visit 2 weeks after last dose) Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported.	10.5% 2/19 • Up to Week 8 (Follow-up Visit 2 weeks after last dose) Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported.

Additional Information

Akebia Therapeutics, Inc.

Phone: +1 617-844-6128

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place