Trial Outcomes & Findings for Patiromer With or Without Food for the Treatment of Hyperkalemia (NCT NCT02694744)

NCT ID: NCT02694744

Last Updated: 2021-05-12

Results Overview

• Recruitment status: COMPLETED
• Study phase: PHASE4
• Target enrollment: 114 participants
• Primary outcome timeframe: 21 to 28 Days
• Results posted on: 2021-05-12

Participant Flow

Participant milestones

Measure	Group 1 - Dosing Without Food Patiromer dosing without food patiromer: 8.4 g/day starting dose, administered orally	Group 2 - Dosing With Food Patiromer dosing with food patiromer: 8.4 g/day starting dose, administered orally
Overall Study STARTED	57	57
Overall Study Safety Population	57	56
Overall Study ITT	57	55
Overall Study COMPLETED	51	52
Overall Study NOT COMPLETED	6	5

Reasons for withdrawal

Measure	Group 1 - Dosing Without Food Patiromer dosing without food patiromer: 8.4 g/day starting dose, administered orally	Group 2 - Dosing With Food Patiromer dosing with food patiromer: 8.4 g/day starting dose, administered orally
Overall Study Adverse Event	2	1
Overall Study Withdrawal by Subject	2	1
Overall Study Physician Decision	1	2
Overall Study Lost to Follow-up	1	0
Overall Study Taking potassium supplement: exclusion 6	0	1

Baseline Characteristics

Patiromer With or Without Food for the Treatment of Hyperkalemia

Baseline characteristics by cohort

Measure	Group 1 - Dosing Without Food n=57 Participants Patiromer dosing without food patiromer: 8.4 g/day starting dose, administered orally	Group 2 - Dosing With Food n=55 Participants Patiromer dosing with food patiromer: 8.4 g/day starting dose, administered orally \*Note: Two randomized participants in Group 2 -Dosing With Food were excluded from the analyses for the intent-to-treat (ITT) population. One participant who did not receive any patiromer dose. Another participant had an important protocol violation and had no post-baseline serum K+, and was excluded from ITT prior to unblinding.	Total n=112 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	19 Participants n=5 Participants	20 Participants n=7 Participants	39 Participants n=5 Participants
Age, Categorical >=65 years	38 Participants n=5 Participants	35 Participants n=7 Participants	73 Participants n=5 Participants
Age, Continuous	69 years n=5 Participants	66 years n=7 Participants	67 years n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Sex: Female, Male Female	17 Participants n=5 Participants	22 Participants n=7 Participants	39 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Sex: Female, Male Male	40 Participants n=5 Participants	33 Participants n=7 Participants	73 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	33 Participants n=5 Participants	30 Participants n=7 Participants	63 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	24 Participants n=5 Participants	25 Participants n=7 Participants	49 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants	2 Participants n=7 Participants	2 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	6 Participants n=5 Participants	8 Participants n=7 Participants	14 Participants n=5 Participants
Race (NIH/OMB) White	48 Participants n=5 Participants	44 Participants n=7 Participants	92 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	3 Participants n=5 Participants	1 Participants n=7 Participants	4 Participants n=5 Participants
Region of Enrollment United States	57 participants n=5 Participants	55 participants n=7 Participants	112 participants n=5 Participants

PRIMARY outcome

Timeframe: 21 to 28 Days

Population: The intent-to-treat (ITT) population for efficacy analyses includes all subjects who have been randomized and have taken at least one dose of patiromer.

Outcome measures

Measure	Group 1 - Dosing Without Food n=57 Participants Patiromer dosing without food patiromer: 8.4 g/day starting dose, administered orally	Group 2 - Dosing With Food n=55 Participants Patiromer dosing with food patiromer: 8.4 g/day starting dose, administered orally
Percentage of Subjects With Serum Potassium in the Target Range (3.8 - 5.0 mEq/L) at Either Week 3 or Week 4	82.5 percentage of participants Interval 70.1 to 91.3	87.3 percentage of participants Interval 75.5 to 94.7

SECONDARY outcome

Timeframe: Baseline to Day 28

Population: Only intent-to-treat subjects who were available at both Baseline and Week 4 visits.

An ANCOVA model was used to estimate the mean serum potassium change from Baseline to Week 4 with baseline serum potassium as a covariate and treatment group, race (white vs all others), and history of Type 1 or 2 diabetes mellitus (yes or no) as factors in the model.

Outcome measures

Measure	Group 1 - Dosing Without Food n=51 Participants Patiromer dosing without food patiromer: 8.4 g/day starting dose, administered orally	Group 2 - Dosing With Food n=49 Participants Patiromer dosing with food patiromer: 8.4 g/day starting dose, administered orally
Mean Change in Serum Potassium From Baseline to Week 4	-0.62 mEq/L Standard Error 0.094	-0.65 mEq/L Standard Error 0.088

Adverse Events

Group 1 - Dosing Without Food

Serious events: 4 serious events

Other events: 4 other events

Deaths: 1 deaths

Group 2 - Dosing With Food

Serious events: 1 serious events

Other events: 8 other events

Deaths: 0 deaths

Serious adverse events

Measure	Group 1 - Dosing Without Food n=57 participants at risk Patiromer dosing without food patiromer: 8.4 g/day starting dose, administered orally	Group 2 - Dosing With Food n=56 participants at risk Patiromer dosing with food patiromer: 8.4 g/day starting dose, administered orally \*Note - One randomized participant was excluded from the analysis as this participant did not receive any patiromer dose.
Cardiac disorders Angina pectoris	0.00% 0/57 • Beginning from the time the subject signs the informed consent form until the subject's last study visit, up to 6 weeks. Treatment emergets AEs (TEAEs) and SAEs were coded in accordance with MedDRA version (18.1). A TEAE is defined as any AE that newly appeared or worsened in severity following initiation of study drug administration.	1.8% 1/56 • Beginning from the time the subject signs the informed consent form until the subject's last study visit, up to 6 weeks. Treatment emergets AEs (TEAEs) and SAEs were coded in accordance with MedDRA version (18.1). A TEAE is defined as any AE that newly appeared or worsened in severity following initiation of study drug administration.
Cardiac disorders Cardio-respiratory arrest	1.8% 1/57 • Beginning from the time the subject signs the informed consent form until the subject's last study visit, up to 6 weeks. Treatment emergets AEs (TEAEs) and SAEs were coded in accordance with MedDRA version (18.1). A TEAE is defined as any AE that newly appeared or worsened in severity following initiation of study drug administration.	0.00% 0/56 • Beginning from the time the subject signs the informed consent form until the subject's last study visit, up to 6 weeks. Treatment emergets AEs (TEAEs) and SAEs were coded in accordance with MedDRA version (18.1). A TEAE is defined as any AE that newly appeared or worsened in severity following initiation of study drug administration.
Blood and lymphatic system disorders Anaemia	1.8% 1/57 • Beginning from the time the subject signs the informed consent form until the subject's last study visit, up to 6 weeks. Treatment emergets AEs (TEAEs) and SAEs were coded in accordance with MedDRA version (18.1). A TEAE is defined as any AE that newly appeared or worsened in severity following initiation of study drug administration.	0.00% 0/56 • Beginning from the time the subject signs the informed consent form until the subject's last study visit, up to 6 weeks. Treatment emergets AEs (TEAEs) and SAEs were coded in accordance with MedDRA version (18.1). A TEAE is defined as any AE that newly appeared or worsened in severity following initiation of study drug administration.
Renal and urinary disorders Acute kidney injury	1.8% 1/57 • Beginning from the time the subject signs the informed consent form until the subject's last study visit, up to 6 weeks. Treatment emergets AEs (TEAEs) and SAEs were coded in accordance with MedDRA version (18.1). A TEAE is defined as any AE that newly appeared or worsened in severity following initiation of study drug administration.	0.00% 0/56 • Beginning from the time the subject signs the informed consent form until the subject's last study visit, up to 6 weeks. Treatment emergets AEs (TEAEs) and SAEs were coded in accordance with MedDRA version (18.1). A TEAE is defined as any AE that newly appeared or worsened in severity following initiation of study drug administration.
Vascular disorders Intermittent claudication	1.8% 1/57 • Beginning from the time the subject signs the informed consent form until the subject's last study visit, up to 6 weeks. Treatment emergets AEs (TEAEs) and SAEs were coded in accordance with MedDRA version (18.1). A TEAE is defined as any AE that newly appeared or worsened in severity following initiation of study drug administration.	0.00% 0/56 • Beginning from the time the subject signs the informed consent form until the subject's last study visit, up to 6 weeks. Treatment emergets AEs (TEAEs) and SAEs were coded in accordance with MedDRA version (18.1). A TEAE is defined as any AE that newly appeared or worsened in severity following initiation of study drug administration.

Other adverse events

Measure	Group 1 - Dosing Without Food n=57 participants at risk Patiromer dosing without food patiromer: 8.4 g/day starting dose, administered orally	Group 2 - Dosing With Food n=56 participants at risk Patiromer dosing with food patiromer: 8.4 g/day starting dose, administered orally \*Note - One randomized participant was excluded from the analysis as this participant did not receive any patiromer dose.
Gastrointestinal disorders Diarrhoea	5.3% 3/57 • Beginning from the time the subject signs the informed consent form until the subject's last study visit, up to 6 weeks. Treatment emergets AEs (TEAEs) and SAEs were coded in accordance with MedDRA version (18.1). A TEAE is defined as any AE that newly appeared or worsened in severity following initiation of study drug administration.	5.4% 3/56 • Beginning from the time the subject signs the informed consent form until the subject's last study visit, up to 6 weeks. Treatment emergets AEs (TEAEs) and SAEs were coded in accordance with MedDRA version (18.1). A TEAE is defined as any AE that newly appeared or worsened in severity following initiation of study drug administration.
Nervous system disorders Headache	0.00% 0/57 • Beginning from the time the subject signs the informed consent form until the subject's last study visit, up to 6 weeks. Treatment emergets AEs (TEAEs) and SAEs were coded in accordance with MedDRA version (18.1). A TEAE is defined as any AE that newly appeared or worsened in severity following initiation of study drug administration.	5.4% 3/56 • Beginning from the time the subject signs the informed consent form until the subject's last study visit, up to 6 weeks. Treatment emergets AEs (TEAEs) and SAEs were coded in accordance with MedDRA version (18.1). A TEAE is defined as any AE that newly appeared or worsened in severity following initiation of study drug administration.
Investigations Blood Creatine Phosphokinase Increased	1.8% 1/57 • Beginning from the time the subject signs the informed consent form until the subject's last study visit, up to 6 weeks. Treatment emergets AEs (TEAEs) and SAEs were coded in accordance with MedDRA version (18.1). A TEAE is defined as any AE that newly appeared or worsened in severity following initiation of study drug administration.	5.4% 3/56 • Beginning from the time the subject signs the informed consent form until the subject's last study visit, up to 6 weeks. Treatment emergets AEs (TEAEs) and SAEs were coded in accordance with MedDRA version (18.1). A TEAE is defined as any AE that newly appeared or worsened in severity following initiation of study drug administration.

Additional Information

Medical Information

Relypsa, Inc.

Phone: 1-844-relypsa

Email: medinfo@relypsa.com

Results disclosure agreements

• Principal investigator is a sponsor employee Our agreements generally provide that PI cannot publish single site data before publication of the multi-site publication, unless 1 year has elapsed since completion of the study at all sites. Thereafter, PI may publish provided that PI shall: provide a copy of the publication to sponsor at least 60 days in advance of submission for publication; delete sponsor's confidential information as requested; and delay publication up to an additional 90 days to permit protection of intellectual property.
• Publication restrictions are in place

Restriction type: OTHER