Trial Outcomes & Findings for Trial Evaluating the Efficacy and Safety of Oral Vadadustat Once Daily (QD) and Three Times Weekly (TIW) for the Maintenance Treatment of Anemia in Hemodialysis Subjects Converting From Erythropoiesis-Stimulating Agents (ESAs) (NCT NCT04313153)

Last Updated: 2025-05-22

Results Overview

The Baseline Hb was defined as the average of the last 2 central laboratory Hb values taken on or prior to the first dose date. The average for the PEP was calculated as the average of all Hb measurements from the central laboratory within the three visit windows during Weeks 20 through 26, regardless of intercurrent events. Analysis was conducted using an analysis of covariance (ANCOVA) model with multiple imputation for missing data with randomization stratification factors and Baseline Hb as covariates. Change from Baseline was calculated as PEP value minus the Baseline value.

Recruitment status

COMPLETED

Study phase

PHASE3

Target enrollment

319 participants

Primary outcome timeframe

Baseline; Weeks 20 to 26

Results posted on

2025-05-22

Participant Flow

This was a randomized, open-label, active-controlled study of vadadustat versus darbepoetin alfa for the maintenance treatment of anemia in hemodialysis participants, after conversion from erythropoiesis-stimulating agent (ESA therapy).

A total of 319 participants were enrolled in the study. Data was collected by the arm to which participants were randomized and not by dose received in vadadustat QD or vadadustat TIW arms.

Participant milestones

Participant milestones
Measure	Vadadustat QD Participants were randomized to receive vadadustat QD orally. Vadadustat starting daily dose was determined by pre-Baseline mean weekly darbepoetin alfa dose (or ESA equivalent). In the low darbepoetin alfa dose group (less than or equal to \[\<=\] 0.45 micrograms per kilograms per week \[mcg/kg/week\]), participants received an initial vadadustat daily dose of 300 milligrams (mg) daily. In the high darbepoetin alfa dose group (\> 0.45 and \<= 1.5 mcg/kg/week), participants received an initial vadadustat daily dose of 450 mg daily. Vadadustat was titrated to achieve and maintain target hemoglobin (Hb) levels. The dose range for titration was 150 to 900 mg vadadustat QD.	Vadadustat TIW Participants were randomized to receive vadadustat TIW orally. Vadadustat starting daily dose was determined by pre-Baseline mean weekly darbepoetin alfa dose (or ESA equivalent). In the low darbepoetin alfa dose group (\<= 0.45 mcg/kg/week), participants received an initial vadadustat dose of 600 mg TIW. In the high darbepoetin alfa dose group (\> 0.45 and \<= 1.5 mcg/kg/week), participants received an initial vadadustat dose of 750 mg TIW. Vadadustat was titrated to achieve and maintain target Hb levels. The dose range for titration was 150 to 1200 mg vadadustat TIW.	Darbepoetin Alfa Participants were randomized to receive darbepoetin alfa as a solution in single-dose prefilled syringes via intravenous (IV) injection through dialysis vascular access. For participants who had received darbepoetin alfa during screening, the initial dosing regimen was approximately the same weekly dose that they were receiving prior to randomization. For participants who had received darbepoetin alfa for the first time, the initial dosing regimen was determined by the United States Package Insert (USPI) or European Union Summary of product characteristics (EU SmPC), per the medical judgment of the investigator.
Overall Study STARTED	105	106	108
Overall Study COMPLETED	54	50	67
Overall Study NOT COMPLETED	51	56	41

Reasons for withdrawal

Reasons for withdrawal
Measure	Vadadustat QD Participants were randomized to receive vadadustat QD orally. Vadadustat starting daily dose was determined by pre-Baseline mean weekly darbepoetin alfa dose (or ESA equivalent). In the low darbepoetin alfa dose group (less than or equal to \[\<=\] 0.45 micrograms per kilograms per week \[mcg/kg/week\]), participants received an initial vadadustat daily dose of 300 milligrams (mg) daily. In the high darbepoetin alfa dose group (\> 0.45 and \<= 1.5 mcg/kg/week), participants received an initial vadadustat daily dose of 450 mg daily. Vadadustat was titrated to achieve and maintain target hemoglobin (Hb) levels. The dose range for titration was 150 to 900 mg vadadustat QD.	Vadadustat TIW Participants were randomized to receive vadadustat TIW orally. Vadadustat starting daily dose was determined by pre-Baseline mean weekly darbepoetin alfa dose (or ESA equivalent). In the low darbepoetin alfa dose group (\<= 0.45 mcg/kg/week), participants received an initial vadadustat dose of 600 mg TIW. In the high darbepoetin alfa dose group (\> 0.45 and \<= 1.5 mcg/kg/week), participants received an initial vadadustat dose of 750 mg TIW. Vadadustat was titrated to achieve and maintain target Hb levels. The dose range for titration was 150 to 1200 mg vadadustat TIW.	Darbepoetin Alfa Participants were randomized to receive darbepoetin alfa as a solution in single-dose prefilled syringes via intravenous (IV) injection through dialysis vascular access. For participants who had received darbepoetin alfa during screening, the initial dosing regimen was approximately the same weekly dose that they were receiving prior to randomization. For participants who had received darbepoetin alfa for the first time, the initial dosing regimen was determined by the United States Package Insert (USPI) or European Union Summary of product characteristics (EU SmPC), per the medical judgment of the investigator.
Overall Study Adverse Event (includes Death)	14	19	10
Overall Study Physician Decision	4	2	1
Overall Study Withdrawal by Subject	7	6	2
Overall Study Lack of Efficacy	3	3	0
Overall Study Lost to Follow-up	1	0	2
Overall Study Receipt of a Solid Organ, Hematopoietic Stem Cell, or Bone Marrow Transplantation	0	2	3
Overall Study Meeting Criteria for Trial Medication Stopping Rules	16	20	19
Overall Study Change in Dialysis Modality	0	1	2
Overall Study Permanent Change in Frequency of In-center Hemodialysis from TIW	1	0	0
Overall Study Other	5	3	2

Baseline Characteristics

Trial Evaluating the Efficacy and Safety of Oral Vadadustat Once Daily (QD) and Three Times Weekly (TIW) for the Maintenance Treatment of Anemia in Hemodialysis Subjects Converting From Erythropoiesis-Stimulating Agents (ESAs)

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Vadadustat QD n=105 Participants Participants were randomized to receive vadadustat QD orally. Vadadustat starting daily dose was determined by pre-Baseline mean weekly darbepoetin alfa dose (or ESA equivalent). In the low darbepoetin alfa dose group (less than or equal to \[\<=\] 0.45 micrograms per kilograms per week \[mcg/kg/week\]), participants received an initial vadadustat daily dose of 300 milligrams (mg) daily. In the high darbepoetin alfa dose group (\> 0.45 and \<= 1.5 mcg/kg/week), participants received an initial vadadustat daily dose of 450 mg daily. Vadadustat was titrated to achieve and maintain target hemoglobin (Hb) levels. The dose range for titration was 150 to 900 mg vadadustat QD.	Vadadustat TIW n=106 Participants Participants were randomized to receive vadadustat TIW orally. Vadadustat starting daily dose was determined by pre-Baseline mean weekly darbepoetin alfa dose (or ESA equivalent). In the low darbepoetin alfa dose group (\<= 0.45 mcg/kg/week), participants received an initial vadadustat dose of 600 mg TIW. In the high darbepoetin alfa dose group (\> 0.45 and \<= 1.5 mcg/kg/week), participants received an initial vadadustat dose of 750 mg TIW. Vadadustat was titrated to achieve and maintain target Hb levels. The dose range for titration was 150 to 1200 mg vadadustat TIW.	Darbepoetin Alfa n=108 Participants Participants were randomized to receive darbepoetin alfa as a solution in single-dose prefilled syringes via intravenous (IV) injection through dialysis vascular access. For participants who had received darbepoetin alfa during screening, the initial dosing regimen was approximately the same weekly dose that they were receiving prior to randomization. For participants who had received darbepoetin alfa for the first time, the initial dosing regimen was determined by the United States Package Insert (USPI) or European Union Summary of product characteristics (EU SmPC), per the medical judgment of the investigator.	Total n=319 Participants Total of all reporting groups
Age, Continuous	60.9 years STANDARD_DEVIATION 13.4 • n=93 Participants	61.2 years STANDARD_DEVIATION 12.5 • n=4 Participants	60.8 years STANDARD_DEVIATION 12.8 • n=27 Participants	61.0 years STANDARD_DEVIATION 12.9 • n=483 Participants
Sex: Female, Male Female	47 Participants n=93 Participants	46 Participants n=4 Participants	43 Participants n=27 Participants	136 Participants n=483 Participants
Sex: Female, Male Male	58 Participants n=93 Participants	60 Participants n=4 Participants	65 Participants n=27 Participants	183 Participants n=483 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	23 Participants n=93 Participants	36 Participants n=4 Participants	26 Participants n=27 Participants	85 Participants n=483 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	82 Participants n=93 Participants	70 Participants n=4 Participants	82 Participants n=27 Participants	234 Participants n=483 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
Race/Ethnicity, Customized American Indian or Alaska Native	1 Participants n=93 Participants	2 Participants n=4 Participants	0 Participants n=27 Participants	3 Participants n=483 Participants
Race/Ethnicity, Customized Asian	4 Participants n=93 Participants	1 Participants n=4 Participants	3 Participants n=27 Participants	8 Participants n=483 Participants
Race/Ethnicity, Customized Black Or African American	31 Participants n=93 Participants	30 Participants n=4 Participants	33 Participants n=27 Participants	94 Participants n=483 Participants
Race/Ethnicity, Customized Native Hawaiian or Other Pacific Islander	0 Participants n=93 Participants	2 Participants n=4 Participants	1 Participants n=27 Participants	3 Participants n=483 Participants
Race/Ethnicity, Customized White	68 Participants n=93 Participants	67 Participants n=4 Participants	71 Participants n=27 Participants	206 Participants n=483 Participants
Race/Ethnicity, Customized Not Reported	1 Participants n=93 Participants	3 Participants n=4 Participants	0 Participants n=27 Participants	4 Participants n=483 Participants
Race/Ethnicity, Customized Reported as Other	0 Participants n=93 Participants	1 Participants n=4 Participants	0 Participants n=27 Participants	1 Participants n=483 Participants

PRIMARY outcome

Timeframe: Baseline; Weeks 20 to 26

Population: Randomized Population

Outcome measures

Outcome measures
Measure	Vadadustat QD n=105 Participants Participants were randomized to receive vadadustat QD orally. Vadadustat starting daily dose was determined by pre-Baseline mean weekly darbepoetin alfa dose (or ESA equivalent). In the low darbepoetin alfa dose group (less than or equal to \[\<=\] 0.45 micrograms per kilograms per week \[mcg/kg/week\]), participants received an initial vadadustat daily dose of 300 milligrams (mg) daily. In the high darbepoetin alfa dose group (\> 0.45 and \<= 1.5 mcg/kg/week), participants received an initial vadadustat daily dose of 450 mg daily. Vadadustat was titrated to achieve and maintain target hemoglobin (Hb) levels. The dose range for titration was 150 to 900 mg vadadustat QD.	Vadadustat TIW n=106 Participants Participants were randomized to receive vadadustat TIW orally. Vadadustat starting daily dose was determined by pre-Baseline mean weekly darbepoetin alfa dose (or ESA equivalent). In the low darbepoetin alfa dose group (\<= 0.45 mcg/kg/week), participants received an initial vadadustat dose of 600 mg TIW. In the high darbepoetin alfa dose group (\> 0.45 and \<= 1.5 mcg/kg/week), participants received an initial vadadustat dose of 750 mg TIW. Vadadustat was titrated to achieve and maintain target Hb levels. The dose range for titration was 150 to 1200 mg vadadustat TIW.	Darbepoetin Alfa n=108 Participants Participants were randomized to receive darbepoetin alfa as a solution in single-dose prefilled syringes via intravenous (IV) injection through dialysis vascular access. For participants who had received darbepoetin alfa during screening, the initial dosing regimen was approximately the same weekly dose that they were receiving prior to randomization. For participants who had received darbepoetin alfa for the first time, the initial dosing regimen was determined by the United States Package Insert (USPI) or European Union Summary of product characteristics (EU SmPC), per the medical judgment of the investigator.
Change From Baseline in Hb to the Average Over the Primary Evaluation Period (PEP) (Weeks 20 to 26)	0.07 Grams per deciliter (g/dL) Standard Error 0.12	-0.19 Grams per deciliter (g/dL) Standard Error 0.12	0.34 Grams per deciliter (g/dL) Standard Error 0.12

SECONDARY outcome

Timeframe: Baseline; Weeks 46 to 52

Population: Randomized Population

The Baseline Hb was defined as the average of the last 2 central laboratory Hb values taken on or prior to the first dose date. The average for the SEP was calculated as the average of all Hb measurements from the central laboratory within the three visit windows during Weeks 46 through 52, regardless of intercurrent events. Analysis was conducted using an ANCOVA model with multiple imputation for missing data with randomization stratification factors and Baseline Hb as covariates. Change from Baseline was calculated as SEP value minus the Baseline value.

Outcome measures

Outcome measures
Measure	Vadadustat QD n=105 Participants Participants were randomized to receive vadadustat QD orally. Vadadustat starting daily dose was determined by pre-Baseline mean weekly darbepoetin alfa dose (or ESA equivalent). In the low darbepoetin alfa dose group (less than or equal to \[\<=\] 0.45 micrograms per kilograms per week \[mcg/kg/week\]), participants received an initial vadadustat daily dose of 300 milligrams (mg) daily. In the high darbepoetin alfa dose group (\> 0.45 and \<= 1.5 mcg/kg/week), participants received an initial vadadustat daily dose of 450 mg daily. Vadadustat was titrated to achieve and maintain target hemoglobin (Hb) levels. The dose range for titration was 150 to 900 mg vadadustat QD.	Vadadustat TIW n=106 Participants Participants were randomized to receive vadadustat TIW orally. Vadadustat starting daily dose was determined by pre-Baseline mean weekly darbepoetin alfa dose (or ESA equivalent). In the low darbepoetin alfa dose group (\<= 0.45 mcg/kg/week), participants received an initial vadadustat dose of 600 mg TIW. In the high darbepoetin alfa dose group (\> 0.45 and \<= 1.5 mcg/kg/week), participants received an initial vadadustat dose of 750 mg TIW. Vadadustat was titrated to achieve and maintain target Hb levels. The dose range for titration was 150 to 1200 mg vadadustat TIW.	Darbepoetin Alfa n=108 Participants Participants were randomized to receive darbepoetin alfa as a solution in single-dose prefilled syringes via intravenous (IV) injection through dialysis vascular access. For participants who had received darbepoetin alfa during screening, the initial dosing regimen was approximately the same weekly dose that they were receiving prior to randomization. For participants who had received darbepoetin alfa for the first time, the initial dosing regimen was determined by the United States Package Insert (USPI) or European Union Summary of product characteristics (EU SmPC), per the medical judgment of the investigator.
Change From Baseline in Hb to the Average Over the Secondary Evaluation Period (SEP) (Weeks 46 to 52)	0.04 g/dL Standard Error 0.15	0.03 g/dL Standard Error 0.15	0.44 g/dL Standard Error 0.15

Adverse Events

Vadadustat QD

Serious events: 47 serious events

Other events: 46 other events

Deaths: 12 deaths

Vadadustat TIW

Serious events: 47 serious events

Other events: 49 other events

Deaths: 9 deaths

Darbepoetin Alfa

Serious events: 47 serious events

Other events: 46 other events

Deaths: 7 deaths

Serious adverse events

Other adverse events

Other adverse events
Measure	Vadadustat QD n=105 participants at risk Participants were randomized to receive vadadustat QD orally. Vadadustat starting daily dose was determined by pre-Baseline mean weekly darbepoetin alfa dose (or ESA equivalent). In the low darbepoetin alfa dose group (less than or equal to \[\<=\] 0.45 micrograms per kilograms per week \[mcg/kg/week\]), participants received an initial vadadustat daily dose of 300 milligrams (mg) daily. In the high darbepoetin alfa dose group (\> 0.45 and \<= 1.5 mcg/kg/week), participants received an initial vadadustat daily dose of 450 mg daily. Vadadustat was titrated to achieve and maintain target hemoglobin (Hb) levels. The dose range for titration was 150 to 900 mg vadadustat QD.	Vadadustat TIW n=104 participants at risk Participants were randomized to receive vadadustat TIW orally. Vadadustat starting daily dose was determined by pre-Baseline mean weekly darbepoetin alfa dose (or ESA equivalent). In the low darbepoetin alfa dose group (\<= 0.45 mcg/kg/week), participants received an initial vadadustat dose of 600 mg TIW. In the high darbepoetin alfa dose group (\> 0.45 and \<= 1.5 mcg/kg/week), participants received an initial vadadustat dose of 750 mg TIW. Vadadustat was titrated to achieve and maintain target Hb levels. The dose range for titration was 150 to 1200 mg vadadustat TIW.	Darbepoetin Alfa n=108 participants at risk Participants were randomized to receive darbepoetin alfa as a solution in single-dose prefilled syringes via intravenous (IV) injection through dialysis vascular access. For participants who had received darbepoetin alfa during screening, the initial dosing regimen was approximately the same weekly dose that they were receiving prior to randomization. For participants who had received darbepoetin alfa for the first time, the initial dosing regimen was determined by the United States Package Insert (USPI) or European Union Summary of product characteristics (EU SmPC), per the medical judgment of the investigator.
Blood and lymphatic system disorders Anaemia	4.8% 5/105 • From first dose of study drug (Day 1) up to Week 56 (from first dose of study drug to last dose + 4 weeks of follow-up) All serious and non-serious adverse events were collected in the Safety Population which consisted of all participants in the randomized population who received at least 1 dose of study drug. Participants received treatment per dosing schedule and the data was not collected for each dose level separately.	6.7% 7/104 • From first dose of study drug (Day 1) up to Week 56 (from first dose of study drug to last dose + 4 weeks of follow-up) All serious and non-serious adverse events were collected in the Safety Population which consisted of all participants in the randomized population who received at least 1 dose of study drug. Participants received treatment per dosing schedule and the data was not collected for each dose level separately.	6.5% 7/108 • From first dose of study drug (Day 1) up to Week 56 (from first dose of study drug to last dose + 4 weeks of follow-up) All serious and non-serious adverse events were collected in the Safety Population which consisted of all participants in the randomized population who received at least 1 dose of study drug. Participants received treatment per dosing schedule and the data was not collected for each dose level separately.
Gastrointestinal disorders Abdominal pain	3.8% 4/105 • From first dose of study drug (Day 1) up to Week 56 (from first dose of study drug to last dose + 4 weeks of follow-up) All serious and non-serious adverse events were collected in the Safety Population which consisted of all participants in the randomized population who received at least 1 dose of study drug. Participants received treatment per dosing schedule and the data was not collected for each dose level separately.	3.8% 4/104 • From first dose of study drug (Day 1) up to Week 56 (from first dose of study drug to last dose + 4 weeks of follow-up) All serious and non-serious adverse events were collected in the Safety Population which consisted of all participants in the randomized population who received at least 1 dose of study drug. Participants received treatment per dosing schedule and the data was not collected for each dose level separately.	7.4% 8/108 • From first dose of study drug (Day 1) up to Week 56 (from first dose of study drug to last dose + 4 weeks of follow-up) All serious and non-serious adverse events were collected in the Safety Population which consisted of all participants in the randomized population who received at least 1 dose of study drug. Participants received treatment per dosing schedule and the data was not collected for each dose level separately.
Gastrointestinal disorders Diarrhoea	13.3% 14/105 • From first dose of study drug (Day 1) up to Week 56 (from first dose of study drug to last dose + 4 weeks of follow-up) All serious and non-serious adverse events were collected in the Safety Population which consisted of all participants in the randomized population who received at least 1 dose of study drug. Participants received treatment per dosing schedule and the data was not collected for each dose level separately.	14.4% 15/104 • From first dose of study drug (Day 1) up to Week 56 (from first dose of study drug to last dose + 4 weeks of follow-up) All serious and non-serious adverse events were collected in the Safety Population which consisted of all participants in the randomized population who received at least 1 dose of study drug. Participants received treatment per dosing schedule and the data was not collected for each dose level separately.	5.6% 6/108 • From first dose of study drug (Day 1) up to Week 56 (from first dose of study drug to last dose + 4 weeks of follow-up) All serious and non-serious adverse events were collected in the Safety Population which consisted of all participants in the randomized population who received at least 1 dose of study drug. Participants received treatment per dosing schedule and the data was not collected for each dose level separately.
Gastrointestinal disorders Nausea	11.4% 12/105 • From first dose of study drug (Day 1) up to Week 56 (from first dose of study drug to last dose + 4 weeks of follow-up) All serious and non-serious adverse events were collected in the Safety Population which consisted of all participants in the randomized population who received at least 1 dose of study drug. Participants received treatment per dosing schedule and the data was not collected for each dose level separately.	5.8% 6/104 • From first dose of study drug (Day 1) up to Week 56 (from first dose of study drug to last dose + 4 weeks of follow-up) All serious and non-serious adverse events were collected in the Safety Population which consisted of all participants in the randomized population who received at least 1 dose of study drug. Participants received treatment per dosing schedule and the data was not collected for each dose level separately.	5.6% 6/108 • From first dose of study drug (Day 1) up to Week 56 (from first dose of study drug to last dose + 4 weeks of follow-up) All serious and non-serious adverse events were collected in the Safety Population which consisted of all participants in the randomized population who received at least 1 dose of study drug. Participants received treatment per dosing schedule and the data was not collected for each dose level separately.
Gastrointestinal disorders Vomiting	9.5% 10/105 • From first dose of study drug (Day 1) up to Week 56 (from first dose of study drug to last dose + 4 weeks of follow-up) All serious and non-serious adverse events were collected in the Safety Population which consisted of all participants in the randomized population who received at least 1 dose of study drug. Participants received treatment per dosing schedule and the data was not collected for each dose level separately.	3.8% 4/104 • From first dose of study drug (Day 1) up to Week 56 (from first dose of study drug to last dose + 4 weeks of follow-up) All serious and non-serious adverse events were collected in the Safety Population which consisted of all participants in the randomized population who received at least 1 dose of study drug. Participants received treatment per dosing schedule and the data was not collected for each dose level separately.	5.6% 6/108 • From first dose of study drug (Day 1) up to Week 56 (from first dose of study drug to last dose + 4 weeks of follow-up) All serious and non-serious adverse events were collected in the Safety Population which consisted of all participants in the randomized population who received at least 1 dose of study drug. Participants received treatment per dosing schedule and the data was not collected for each dose level separately.
General disorders Oedema peripheral	5.7% 6/105 • From first dose of study drug (Day 1) up to Week 56 (from first dose of study drug to last dose + 4 weeks of follow-up) All serious and non-serious adverse events were collected in the Safety Population which consisted of all participants in the randomized population who received at least 1 dose of study drug. Participants received treatment per dosing schedule and the data was not collected for each dose level separately.	0.00% 0/104 • From first dose of study drug (Day 1) up to Week 56 (from first dose of study drug to last dose + 4 weeks of follow-up) All serious and non-serious adverse events were collected in the Safety Population which consisted of all participants in the randomized population who received at least 1 dose of study drug. Participants received treatment per dosing schedule and the data was not collected for each dose level separately.	2.8% 3/108 • From first dose of study drug (Day 1) up to Week 56 (from first dose of study drug to last dose + 4 weeks of follow-up) All serious and non-serious adverse events were collected in the Safety Population which consisted of all participants in the randomized population who received at least 1 dose of study drug. Participants received treatment per dosing schedule and the data was not collected for each dose level separately.
Infections and infestations COVID-19	11.4% 12/105 • From first dose of study drug (Day 1) up to Week 56 (from first dose of study drug to last dose + 4 weeks of follow-up) All serious and non-serious adverse events were collected in the Safety Population which consisted of all participants in the randomized population who received at least 1 dose of study drug. Participants received treatment per dosing schedule and the data was not collected for each dose level separately.	10.6% 11/104 • From first dose of study drug (Day 1) up to Week 56 (from first dose of study drug to last dose + 4 weeks of follow-up) All serious and non-serious adverse events were collected in the Safety Population which consisted of all participants in the randomized population who received at least 1 dose of study drug. Participants received treatment per dosing schedule and the data was not collected for each dose level separately.	9.3% 10/108 • From first dose of study drug (Day 1) up to Week 56 (from first dose of study drug to last dose + 4 weeks of follow-up) All serious and non-serious adverse events were collected in the Safety Population which consisted of all participants in the randomized population who received at least 1 dose of study drug. Participants received treatment per dosing schedule and the data was not collected for each dose level separately.
Injury, poisoning and procedural complications Fall	9.5% 10/105 • From first dose of study drug (Day 1) up to Week 56 (from first dose of study drug to last dose + 4 weeks of follow-up) All serious and non-serious adverse events were collected in the Safety Population which consisted of all participants in the randomized population who received at least 1 dose of study drug. Participants received treatment per dosing schedule and the data was not collected for each dose level separately.	5.8% 6/104 • From first dose of study drug (Day 1) up to Week 56 (from first dose of study drug to last dose + 4 weeks of follow-up) All serious and non-serious adverse events were collected in the Safety Population which consisted of all participants in the randomized population who received at least 1 dose of study drug. Participants received treatment per dosing schedule and the data was not collected for each dose level separately.	4.6% 5/108 • From first dose of study drug (Day 1) up to Week 56 (from first dose of study drug to last dose + 4 weeks of follow-up) All serious and non-serious adverse events were collected in the Safety Population which consisted of all participants in the randomized population who received at least 1 dose of study drug. Participants received treatment per dosing schedule and the data was not collected for each dose level separately.
Metabolism and nutrition disorders Hyperkalaemia	3.8% 4/105 • From first dose of study drug (Day 1) up to Week 56 (from first dose of study drug to last dose + 4 weeks of follow-up) All serious and non-serious adverse events were collected in the Safety Population which consisted of all participants in the randomized population who received at least 1 dose of study drug. Participants received treatment per dosing schedule and the data was not collected for each dose level separately.	4.8% 5/104 • From first dose of study drug (Day 1) up to Week 56 (from first dose of study drug to last dose + 4 weeks of follow-up) All serious and non-serious adverse events were collected in the Safety Population which consisted of all participants in the randomized population who received at least 1 dose of study drug. Participants received treatment per dosing schedule and the data was not collected for each dose level separately.	8.3% 9/108 • From first dose of study drug (Day 1) up to Week 56 (from first dose of study drug to last dose + 4 weeks of follow-up) All serious and non-serious adverse events were collected in the Safety Population which consisted of all participants in the randomized population who received at least 1 dose of study drug. Participants received treatment per dosing schedule and the data was not collected for each dose level separately.
Metabolism and nutrition disorders Hypoglycaemia	5.7% 6/105 • From first dose of study drug (Day 1) up to Week 56 (from first dose of study drug to last dose + 4 weeks of follow-up) All serious and non-serious adverse events were collected in the Safety Population which consisted of all participants in the randomized population who received at least 1 dose of study drug. Participants received treatment per dosing schedule and the data was not collected for each dose level separately.	0.96% 1/104 • From first dose of study drug (Day 1) up to Week 56 (from first dose of study drug to last dose + 4 weeks of follow-up) All serious and non-serious adverse events were collected in the Safety Population which consisted of all participants in the randomized population who received at least 1 dose of study drug. Participants received treatment per dosing schedule and the data was not collected for each dose level separately.	2.8% 3/108 • From first dose of study drug (Day 1) up to Week 56 (from first dose of study drug to last dose + 4 weeks of follow-up) All serious and non-serious adverse events were collected in the Safety Population which consisted of all participants in the randomized population who received at least 1 dose of study drug. Participants received treatment per dosing schedule and the data was not collected for each dose level separately.
Musculoskeletal and connective tissue disorders Back pain	1.9% 2/105 • From first dose of study drug (Day 1) up to Week 56 (from first dose of study drug to last dose + 4 weeks of follow-up) All serious and non-serious adverse events were collected in the Safety Population which consisted of all participants in the randomized population who received at least 1 dose of study drug. Participants received treatment per dosing schedule and the data was not collected for each dose level separately.	5.8% 6/104 • From first dose of study drug (Day 1) up to Week 56 (from first dose of study drug to last dose + 4 weeks of follow-up) All serious and non-serious adverse events were collected in the Safety Population which consisted of all participants in the randomized population who received at least 1 dose of study drug. Participants received treatment per dosing schedule and the data was not collected for each dose level separately.	1.9% 2/108 • From first dose of study drug (Day 1) up to Week 56 (from first dose of study drug to last dose + 4 weeks of follow-up) All serious and non-serious adverse events were collected in the Safety Population which consisted of all participants in the randomized population who received at least 1 dose of study drug. Participants received treatment per dosing schedule and the data was not collected for each dose level separately.
Vascular disorders Hypertension	5.7% 6/105 • From first dose of study drug (Day 1) up to Week 56 (from first dose of study drug to last dose + 4 weeks of follow-up) All serious and non-serious adverse events were collected in the Safety Population which consisted of all participants in the randomized population who received at least 1 dose of study drug. Participants received treatment per dosing schedule and the data was not collected for each dose level separately.	10.6% 11/104 • From first dose of study drug (Day 1) up to Week 56 (from first dose of study drug to last dose + 4 weeks of follow-up) All serious and non-serious adverse events were collected in the Safety Population which consisted of all participants in the randomized population who received at least 1 dose of study drug. Participants received treatment per dosing schedule and the data was not collected for each dose level separately.	9.3% 10/108 • From first dose of study drug (Day 1) up to Week 56 (from first dose of study drug to last dose + 4 weeks of follow-up) All serious and non-serious adverse events were collected in the Safety Population which consisted of all participants in the randomized population who received at least 1 dose of study drug. Participants received treatment per dosing schedule and the data was not collected for each dose level separately.

Additional Information

Akebia Therapeutics, Inc.

Phone: 6178446128

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place