Trial Outcomes & Findings for Patiromer in the Treatment of Hyperkalemia in Patients With Hypertension and Diabetic Nephropathy (AMETHYST-DN) (NCT NCT01371747)

Last Updated: 2021-06-03

Results Overview

Least square mean changes from Baseline to Week 4/first titration were derived from parallel lines ANCOVA model with randomized starting dose and baseline serum potassium value as covariates.

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

324 participants

Primary outcome timeframe

Baseline to Week 4 or First Titration which could occur at any scheduled study visit after patiromer initiation.

Results posted on

2021-06-03

Participant Flow

324 participants were enrolled in the study; 306 participants were randomized to receive study drug.

Screening serum potassium ≤ 5 mEq/L (milliequivalent) entered Run-in: Cohort 1 stopped ACEI/ARB (angiotensin-converting enzyme inhibitor/angiotensin receptor blockers), started losartan; Cohort 2 started spironolactone; Run-in (Cohorts 1 and 2) or screening (Cohort 3) \> 5 mEq/L entered study.

Participant milestones

Participant milestones
Measure	Stratum 1: 8.4 g/d Patiromer Participants with baseline serum potassium \> 5.0 - 5.5 mEq/L randomized to 8.4 g/day patiromer starting dose, orally, as a divided dose twice a day.	Stratum 1: 16.8 g/d Patiromer Participants with baseline serum potassium \> 5.0 - 5.5 mEq/L randomized to 16.8 g/day patiromer starting dose, orally, as a divided dose twice a day.	Stratum 1: 25.2 g/d Patiromer Participants with baseline serum potassium \> 5.0 - 5.5 mEq/L randomized to 25.2 g/day patiromer starting dose, orally, as a divided dose twice a day.	Stratum 2: 16.8 g/d Patiromer Participants with baseline serum potassium \> 5.5 to \< 6.0 mEq/L randomized to 16.8 g/day patiromer starting dose, orally, as a divided dose twice a day.	Stratum 2: 25.2 g/d Patiromer Participants with baseline serum potassium \> 5.5 to \< 6.0 mEq/L randomized to 25.2 g/day patiromer starting dose, orally, as a divided dose twice a day.	Stratum 2: 33.6 g/d Patiromer Participants with baseline serum potassium \> 5.5 to \< 6.0 mEq/L randomized to 33.6 g/day patiromer starting dose, orally, as a divided dose twice a day.
Overall Study STARTED	74	74	74	26	28	30
Overall Study COMPLETED	56	51	50	17	21	16
Overall Study NOT COMPLETED	18	23	24	9	7	14

Reasons for withdrawal

Reasons for withdrawal
Measure	Stratum 1: 8.4 g/d Patiromer Participants with baseline serum potassium \> 5.0 - 5.5 mEq/L randomized to 8.4 g/day patiromer starting dose, orally, as a divided dose twice a day.	Stratum 1: 16.8 g/d Patiromer Participants with baseline serum potassium \> 5.0 - 5.5 mEq/L randomized to 16.8 g/day patiromer starting dose, orally, as a divided dose twice a day.	Stratum 1: 25.2 g/d Patiromer Participants with baseline serum potassium \> 5.0 - 5.5 mEq/L randomized to 25.2 g/day patiromer starting dose, orally, as a divided dose twice a day.	Stratum 2: 16.8 g/d Patiromer Participants with baseline serum potassium \> 5.5 to \< 6.0 mEq/L randomized to 16.8 g/day patiromer starting dose, orally, as a divided dose twice a day.	Stratum 2: 25.2 g/d Patiromer Participants with baseline serum potassium \> 5.5 to \< 6.0 mEq/L randomized to 25.2 g/day patiromer starting dose, orally, as a divided dose twice a day.	Stratum 2: 33.6 g/d Patiromer Participants with baseline serum potassium \> 5.5 to \< 6.0 mEq/L randomized to 33.6 g/day patiromer starting dose, orally, as a divided dose twice a day.
Overall Study Adverse Event	4	2	7	2	2	2
Overall Study Death	1	0	4	1	2	0
Overall Study Abnormal Renal Function	0	2	0	1	0	1
Overall Study High Serum Potassium Results	1	1	1	2	0	2
Overall Study Low Serum Potassium Results	1	1	1	1	0	3
Overall Study Protocol Violation	0	0	1	0	0	0
Overall Study Non-Compliance	3	4	3	0	0	1
Overall Study Physician Decision	0	0	0	0	1	0
Overall Study Withdrawal by Subject	6	12	5	2	2	4
Overall Study Other Reasons	2	1	2	0	0	1

Baseline Characteristics

Patiromer in the Treatment of Hyperkalemia in Patients With Hypertension and Diabetic Nephropathy (AMETHYST-DN)

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Stratum 1: 8.4 g/d Patiromer n=74 Participants Participants with baseline serum potassium \> 5.0 - 5.5 mEq/L randomized to 8.4 g/day patiromer starting dose, orally, as a divided dose twice a day.	Stratum 1: 16.8 g/d Patiromer n=73 Participants Participants with baseline serum potassium \> 5.0 - 5.5 mEq/L randomized to 16.8 g/day patiromer starting dose, orally, as a divided dose twice a day.	Stratum 1: 25.2 g/d Patiromer n=73 Participants Participants with baseline serum potassium \> 5.0 - 5.5 mEq/L randomized to 25.2 g/day patiromer starting dose, orally, as a divided dose twice a day.	Stratum 2: 16.8 g/d Patiromer n=26 Participants Participants with baseline serum potassium \> 5.5 to \< 6.0 mEq/L randomized to 16.8 g/day patiromer starting dose, orally, as a divided dose twice a day.	Stratum 2: 25.2 g/d Patiromer n=28 Participants Participants with baseline serum potassium \> 5.5 to \< 6.0 mEq/L randomized to 25.2 g/day patiromer starting dose, orally, as a divided dose twice a day	Stratum 2: 33.6 g/d Patiromer n=30 Participants Participants with baseline serum potassium \> 5.5 to \< 6.0 mEq/L randomized to 33.6 g/day patiromer starting dose, orally, as a divided dose twice a day.	Total n=304 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	0 Participants n=4 Participants	0 Participants n=21 Participants	0 Participants n=10 Participants	0 Participants n=115 Participants
Age, Categorical Between 18 and 65 years	28 Participants n=5 Participants	29 Participants n=7 Participants	28 Participants n=5 Participants	12 Participants n=4 Participants	12 Participants n=21 Participants	13 Participants n=10 Participants	122 Participants n=115 Participants
Age, Categorical >=65 years	46 Participants n=5 Participants	44 Participants n=7 Participants	45 Participants n=5 Participants	14 Participants n=4 Participants	16 Participants n=21 Participants	17 Participants n=10 Participants	182 Participants n=115 Participants
Age, Continuous	67 years n=5 Participants	70 years n=7 Participants	68 years n=5 Participants	66.5 years n=4 Participants	68.5 years n=21 Participants	65 years n=10 Participants	67.5 years n=115 Participants
Sex: Female, Male Female	29 Participants n=5 Participants	26 Participants n=7 Participants	26 Participants n=5 Participants	8 Participants n=4 Participants	13 Participants n=21 Participants	10 Participants n=10 Participants	112 Participants n=115 Participants
Sex: Female, Male Male	45 Participants n=5 Participants	47 Participants n=7 Participants	47 Participants n=5 Participants	18 Participants n=4 Participants	15 Participants n=21 Participants	20 Participants n=10 Participants	192 Participants n=115 Participants

PRIMARY outcome

Timeframe: Baseline to Week 4 or First Titration which could occur at any scheduled study visit after patiromer initiation.

Population: Included all randomized participants who received at least 1 dose of patiromer. Analyses of endpoints included participants with available central laboratory potassium values at the time point of interest.

Least square mean changes from Baseline to Week 4/first titration were derived from parallel lines ANCOVA model with randomized starting dose and baseline serum potassium value as covariates.

Outcome measures

Outcome measures
Measure	Stratum 1: 8.4 g/d Patiromer n=73 Participants Participants with baseline serum potassium \> 5.0 - 5.5 mEq/L randomized to 8.4 g/day patiromer starting dose, orally, as a divided dose twice a day.	Stratum 1: 16.8 g/d Patiromer n=72 Participants Participants with baseline serum potassium \> 5.0 - 5.5 mEq/L randomized to 16.8 g/day patiromer starting dose, orally, as a divided dose twice a day.	Stratum 1: 25.2 g/d Patiromer n=72 Participants Participants with baseline serum potassium \> 5.0 - 5.5 mEq/L randomized to 25.2 g/day patiromer starting dose, orally, as a divided dose twice a day.	Stratum 2: 16.8 g/d Patiromer n=26 Participants Participants with baseline serum potassium \> 5.5 to \< 6.0 mEq/L randomized to 16.8 g/day patiromer starting dose, orally, as a divided dose twice a day.	Stratum 2: 25.2 g/d Patiromer n=27 Participants Participants with baseline serum potassium \> 5.5 to \< 6.0 mEq/L randomized to 25.2 g/day patiromer starting dose, orally, as a divided dose twice a day.	Stratum 2: 33.6 g/d Patiromer n=30 Participants Participants with baseline serum potassium \> 5.5 to \< 6.0 mEq/L randomized to 33.6 g/day patiromer starting dose, orally, as a divided dose twice a day.
Least Squares Mean Change in Serum Potassium From Baseline to Week 4 or Time of First Titration for Each Individual Starting Dose Group	-0.35 mEq/L Standard Error 0.066	-0.51 mEq/L Standard Error 0.067	-0.55 mEq/L Standard Error 0.067	-0.87 mEq/L Standard Error 0.134	-0.97 mEq/L Standard Error 0.132	-0.92 mEq/L Standard Error 0.125

SECONDARY outcome

Timeframe: Baseline to Week 8 or First Titration which could occur at any scheduled study visit after patiromer initiation.

Least squares mean changes from Baseline to Week 8/first titration were derived from parallel lines ANCOVA model with randomized starting dose and baseline serum potassium value as covariates.

Outcome measures

Outcome measures
Measure	Stratum 1: 8.4 g/d Patiromer n=73 Participants Participants with baseline serum potassium \> 5.0 - 5.5 mEq/L randomized to 8.4 g/day patiromer starting dose, orally, as a divided dose twice a day.	Stratum 1: 16.8 g/d Patiromer n=72 Participants Participants with baseline serum potassium \> 5.0 - 5.5 mEq/L randomized to 16.8 g/day patiromer starting dose, orally, as a divided dose twice a day.	Stratum 1: 25.2 g/d Patiromer n=72 Participants Participants with baseline serum potassium \> 5.0 - 5.5 mEq/L randomized to 25.2 g/day patiromer starting dose, orally, as a divided dose twice a day.	Stratum 2: 16.8 g/d Patiromer n=26 Participants Participants with baseline serum potassium \> 5.5 to \< 6.0 mEq/L randomized to 16.8 g/day patiromer starting dose, orally, as a divided dose twice a day.	Stratum 2: 25.2 g/d Patiromer n=27 Participants Participants with baseline serum potassium \> 5.5 to \< 6.0 mEq/L randomized to 25.2 g/day patiromer starting dose, orally, as a divided dose twice a day.	Stratum 2: 33.6 g/d Patiromer n=30 Participants Participants with baseline serum potassium \> 5.5 to \< 6.0 mEq/L randomized to 33.6 g/day patiromer starting dose, orally, as a divided dose twice a day.
Least Squares Mean Change in Serum Potassium From Baseline to Week 8 or Time of First Titration for Each Individual Starting Dose Group	-0.35 mEq/L Standard Error 0.070	-0.47 mEq/L Standard Error 0.070	-0.54 mEq/L Standard Error 0.070	-0.88 mEq/L Standard Error 0.142	-0.95 mEq/L Standard Error 0.139	-0.91 mEq/L Standard Error 0.132

SECONDARY outcome

Timeframe: Baseline to Day 3

Least squares mean changes from Baseline to Day 3 were derived from parallel lines ANCOVA model with randomized starting dose and baseline serum potassium value as covariates.

Outcome measures

Outcome measures
Measure	Stratum 1: 8.4 g/d Patiromer n=68 Participants Participants with baseline serum potassium \> 5.0 - 5.5 mEq/L randomized to 8.4 g/day patiromer starting dose, orally, as a divided dose twice a day.	Stratum 1: 16.8 g/d Patiromer n=63 Participants Participants with baseline serum potassium \> 5.0 - 5.5 mEq/L randomized to 16.8 g/day patiromer starting dose, orally, as a divided dose twice a day.	Stratum 1: 25.2 g/d Patiromer n=69 Participants Participants with baseline serum potassium \> 5.0 - 5.5 mEq/L randomized to 25.2 g/day patiromer starting dose, orally, as a divided dose twice a day.	Stratum 2: 16.8 g/d Patiromer n=25 Participants Participants with baseline serum potassium \> 5.5 to \< 6.0 mEq/L randomized to 16.8 g/day patiromer starting dose, orally, as a divided dose twice a day.	Stratum 2: 25.2 g/d Patiromer n=26 Participants Participants with baseline serum potassium \> 5.5 to \< 6.0 mEq/L randomized to 25.2 g/day patiromer starting dose, orally, as a divided dose twice a day.	Stratum 2: 33.6 g/d Patiromer n=30 Participants Participants with baseline serum potassium \> 5.5 to \< 6.0 mEq/L randomized to 33.6 g/day patiromer starting dose, orally, as a divided dose twice a day.
Least Squares Mean Change in Serum Potassium From Baseline to Day 3 During the Treatment Initiation Period for Each Individual Starting Dose Group	-0.26 mEq/L Standard Error 0.048	-0.28 mEq/L Standard Error 0.050	-0.31 mEq/L Standard Error 0.047	-0.65 mEq/L Standard Error 0.086	-0.59 mEq/L Standard Error 0.084	-0.53 mEq/L Standard Error 0.079

SECONDARY outcome

Timeframe: Baseline to Week 52

Outcome measures

Outcome measures
Measure	Stratum 1: 8.4 g/d Patiromer n=50 Participants Participants with baseline serum potassium \> 5.0 - 5.5 mEq/L randomized to 8.4 g/day patiromer starting dose, orally, as a divided dose twice a day.	Stratum 1: 16.8 g/d Patiromer n=49 Participants Participants with baseline serum potassium \> 5.0 - 5.5 mEq/L randomized to 16.8 g/day patiromer starting dose, orally, as a divided dose twice a day.	Stratum 1: 25.2 g/d Patiromer n=44 Participants Participants with baseline serum potassium \> 5.0 - 5.5 mEq/L randomized to 25.2 g/day patiromer starting dose, orally, as a divided dose twice a day.	Stratum 2: 16.8 g/d Patiromer n=15 Participants Participants with baseline serum potassium \> 5.5 to \< 6.0 mEq/L randomized to 16.8 g/day patiromer starting dose, orally, as a divided dose twice a day.	Stratum 2: 25.2 g/d Patiromer n=19 Participants Participants with baseline serum potassium \> 5.5 to \< 6.0 mEq/L randomized to 25.2 g/day patiromer starting dose, orally, as a divided dose twice a day.	Stratum 2: 33.6 g/d Patiromer n=15 Participants Participants with baseline serum potassium \> 5.5 to \< 6.0 mEq/L randomized to 33.6 g/day patiromer starting dose, orally, as a divided dose twice a day.
Mean Change in Serum Potassium From Baseline to Week 52 During the Long-term Maintenance Period for Each Individual Starting Dose Group	-0.54 mEq/L Standard Deviation 0.465	-0.44 mEq/L Standard Deviation 0.440	-0.50 mEq/L Standard Deviation 0.417	-1.00 mEq/L Standard Deviation 0.466	-0.96 mEq/L Standard Deviation 0.414	-1.17 mEq/L Standard Deviation 0.569

SECONDARY outcome

Timeframe: Week 52 or Last Patiromer Dose (if Occurred before Week 52) to Following up Visit Plus 7 Days

Outcome measures

Outcome measures
Measure	Stratum 1: 8.4 g/d Patiromer n=52 Participants Participants with baseline serum potassium \> 5.0 - 5.5 mEq/L randomized to 8.4 g/day patiromer starting dose, orally, as a divided dose twice a day.	Stratum 1: 16.8 g/d Patiromer n=52 Participants Participants with baseline serum potassium \> 5.0 - 5.5 mEq/L randomized to 16.8 g/day patiromer starting dose, orally, as a divided dose twice a day.	Stratum 1: 25.2 g/d Patiromer n=50 Participants Participants with baseline serum potassium \> 5.0 - 5.5 mEq/L randomized to 25.2 g/day patiromer starting dose, orally, as a divided dose twice a day.	Stratum 2: 16.8 g/d Patiromer n=20 Participants Participants with baseline serum potassium \> 5.5 to \< 6.0 mEq/L randomized to 16.8 g/day patiromer starting dose, orally, as a divided dose twice a day.	Stratum 2: 25.2 g/d Patiromer n=17 Participants Participants with baseline serum potassium \> 5.5 to \< 6.0 mEq/L randomized to 25.2 g/day patiromer starting dose, orally, as a divided dose twice a day.	Stratum 2: 33.6 g/d Patiromer n=20 Participants Participants with baseline serum potassium \> 5.5 to \< 6.0 mEq/L randomized to 33.6 g/day patiromer starting dose, orally, as a divided dose twice a day.
Mean Change in Serum Potassium From Week 52 or Last Patiromer Dose (if Occurred Before Week 52) to Follow-up Visits Plus 7 Days	0.36 mEq/L Standard Deviation 0.567	0.22 mEq/L Standard Deviation 0.424	0.30 mEq/L Standard Deviation 0.508	0.41 mEq/L Standard Deviation 0.660	0.39 mEq/L Standard Deviation 0.331	0.58 mEq/L Standard Deviation 0.557

SECONDARY outcome

Timeframe: Baseline to Week 8

Outcome measures

Outcome measures
Measure	Stratum 1: 8.4 g/d Patiromer n=63 Participants Participants with baseline serum potassium \> 5.0 - 5.5 mEq/L randomized to 8.4 g/day patiromer starting dose, orally, as a divided dose twice a day.	Stratum 1: 16.8 g/d Patiromer n=65 Participants Participants with baseline serum potassium \> 5.0 - 5.5 mEq/L randomized to 16.8 g/day patiromer starting dose, orally, as a divided dose twice a day.	Stratum 1: 25.2 g/d Patiromer n=64 Participants Participants with baseline serum potassium \> 5.0 - 5.5 mEq/L randomized to 25.2 g/day patiromer starting dose, orally, as a divided dose twice a day.	Stratum 2: 16.8 g/d Patiromer n=24 Participants Participants with baseline serum potassium \> 5.5 to \< 6.0 mEq/L randomized to 16.8 g/day patiromer starting dose, orally, as a divided dose twice a day.	Stratum 2: 25.2 g/d Patiromer n=24 Participants Participants with baseline serum potassium \> 5.5 to \< 6.0 mEq/L randomized to 25.2 g/day patiromer starting dose, orally, as a divided dose twice a day.	Stratum 2: 33.6 g/d Patiromer n=22 Participants Participants with baseline serum potassium \> 5.5 to \< 6.0 mEq/L randomized to 33.6 g/day patiromer starting dose, orally, as a divided dose twice a day.
Proportion of Participants Achieving Serum Potassium Levels Within 3.5 to 5.5 mEq/L at Week 8 for Each Individual Starting Dose Group	100 percentage of participants Interval 94.3 to 100.0	100 percentage of participants Interval 94.5 to 100.0	98.4 percentage of participants Interval 91.6 to 100.0	91.7 percentage of participants Interval 73.0 to 99.0	95.8 percentage of participants Interval 78.9 to 99.9	95.5 percentage of participants Interval 77.2 to 99.9

SECONDARY outcome

Timeframe: Baseline to Week 8

Outcome measures

Outcome measures
Measure	Stratum 1: 8.4 g/d Patiromer n=63 Participants Participants with baseline serum potassium \> 5.0 - 5.5 mEq/L randomized to 8.4 g/day patiromer starting dose, orally, as a divided dose twice a day.	Stratum 1: 16.8 g/d Patiromer n=65 Participants Participants with baseline serum potassium \> 5.0 - 5.5 mEq/L randomized to 16.8 g/day patiromer starting dose, orally, as a divided dose twice a day.	Stratum 1: 25.2 g/d Patiromer n=64 Participants Participants with baseline serum potassium \> 5.0 - 5.5 mEq/L randomized to 25.2 g/day patiromer starting dose, orally, as a divided dose twice a day.	Stratum 2: 16.8 g/d Patiromer n=24 Participants Participants with baseline serum potassium \> 5.5 to \< 6.0 mEq/L randomized to 16.8 g/day patiromer starting dose, orally, as a divided dose twice a day.	Stratum 2: 25.2 g/d Patiromer n=24 Participants Participants with baseline serum potassium \> 5.5 to \< 6.0 mEq/L randomized to 25.2 g/day patiromer starting dose, orally, as a divided dose twice a day.	Stratum 2: 33.6 g/d Patiromer n=22 Participants Participants with baseline serum potassium \> 5.5 to \< 6.0 mEq/L randomized to 33.6 g/day patiromer starting dose, orally, as a divided dose twice a day.
Proportion of Participants Achieving Serum Potassium Levels Within 4.0 to 5.0 mEq/L at Week 8 for Each Individual Starting Dose Group	95.2 percentage of participants Interval 86.7 to 99.0	90.8 percentage of participants Interval 81.0 to 96.5	81.3 percentage of participants Interval 69.5 to 89.9	79.2 percentage of participants Interval 57.8 to 92.9	91.7 percentage of participants Interval 73.0 to 99.0	77.3 percentage of participants Interval 54.6 to 92.2

SECONDARY outcome

Timeframe: Baseline to Week 8

Outcome measures

Outcome measures
Measure	Stratum 1: 8.4 g/d Patiromer n=72 Participants Participants with baseline serum potassium \> 5.0 - 5.5 mEq/L randomized to 8.4 g/day patiromer starting dose, orally, as a divided dose twice a day.	Stratum 1: 16.8 g/d Patiromer n=72 Participants Participants with baseline serum potassium \> 5.0 - 5.5 mEq/L randomized to 16.8 g/day patiromer starting dose, orally, as a divided dose twice a day.	Stratum 1: 25.2 g/d Patiromer n=73 Participants Participants with baseline serum potassium \> 5.0 - 5.5 mEq/L randomized to 25.2 g/day patiromer starting dose, orally, as a divided dose twice a day.	Stratum 2: 16.8 g/d Patiromer n=26 Participants Participants with baseline serum potassium \> 5.5 to \< 6.0 mEq/L randomized to 16.8 g/day patiromer starting dose, orally, as a divided dose twice a day.	Stratum 2: 25.2 g/d Patiromer n=28 Participants Participants with baseline serum potassium \> 5.5 to \< 6.0 mEq/L randomized to 25.2 g/day patiromer starting dose, orally, as a divided dose twice a day.	Stratum 2: 33.6 g/d Patiromer n=30 Participants Participants with baseline serum potassium \> 5.5 to \< 6.0 mEq/L randomized to 33.6 g/day patiromer starting dose, orally, as a divided dose twice a day.
Time to First Serum Potassium Measurement of 4.0 - 5.0 mEq/L During Treatment Initiation Period for Each Individual Starting Dose Group	4 Days Interval 4.0 to 5.0	4 Days Interval 4.0 to 6.0	4 Days Interval 4.0 to 5.0	8 Days Interval 4.0 to 9.0	7.5 Days Interval 4.0 to 8.0	8 Days Interval 4.0 to 8.0

SECONDARY outcome

Timeframe: Baseline to Week 52

Outcome measures

Outcome measures
Measure	Stratum 1: 8.4 g/d Patiromer n=58 Participants Participants with baseline serum potassium \> 5.0 - 5.5 mEq/L randomized to 8.4 g/day patiromer starting dose, orally, as a divided dose twice a day.	Stratum 1: 16.8 g/d Patiromer n=63 Participants Participants with baseline serum potassium \> 5.0 - 5.5 mEq/L randomized to 16.8 g/day patiromer starting dose, orally, as a divided dose twice a day.	Stratum 1: 25.2 g/d Patiromer n=59 Participants Participants with baseline serum potassium \> 5.0 - 5.5 mEq/L randomized to 25.2 g/day patiromer starting dose, orally, as a divided dose twice a day.	Stratum 2: 16.8 g/d Patiromer n=22 Participants Participants with baseline serum potassium \> 5.5 to \< 6.0 mEq/L randomized to 16.8 g/day patiromer starting dose, orally, as a divided dose twice a day.	Stratum 2: 25.2 g/d Patiromer n=24 Participants Participants with baseline serum potassium \> 5.5 to \< 6.0 mEq/L randomized to 25.2 g/day patiromer starting dose, orally, as a divided dose twice a day.	Stratum 2: 33.6 g/d Patiromer n=20 Participants Participants with baseline serum potassium \> 5.5 to \< 6.0 mEq/L randomized to 33.6 g/day patiromer starting dose, orally, as a divided dose twice a day.
Proportions of Participants Achieving Serum Potassium Levels Within 3.8 to 5.0 mEq/L at Week 52 for Each Individual Starting Dose Group	86.3 percentage of participants Interval 73.7 to 94.3	81.6 percentage of participants Interval 68.0 to 91.2	88.9 percentage of participants Interval 75.9 to 96.3	86.7 percentage of participants Interval 59.5 to 98.3	89.5 percentage of participants Interval 66.9 to 98.7	93.3 percentage of participants Interval 68.1 to 99.8

Adverse Events

Stratum 1: 8.4 g/d Patiromer

Serious events: 9 serious events

Other events: 28 other events

Deaths: 0 deaths

Stratum 1: 16.8 g/d Patiromer

Serious events: 10 serious events

Other events: 29 other events

Deaths: 0 deaths

Stratum 1: 25.2 g/d Patiromer

Serious events: 10 serious events

Other events: 29 other events

Deaths: 0 deaths

Stratum 2: 16.8 g/d Patiromer

Serious events: 6 serious events

Other events: 14 other events

Deaths: 0 deaths

Stratum 2: 25.2 g/d Patiromer

Serious events: 5 serious events

Other events: 14 other events

Deaths: 0 deaths

Stratum 2: 33.6 g/d Patiromer

Serious events: 4 serious events

Other events: 22 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Stratum 1: 8.4 g/d Patiromer n=74 participants at risk Participants with baseline serum potassium \> 5.0 - 5.5 mEq/L randomized to 8.4 g/day patiromer starting dose, orally, as a divided dose twice a day.	Stratum 1: 16.8 g/d Patiromer n=73 participants at risk Participants with baseline serum potassium \> 5.0 - 5.5 mEq/L randomized to 16.8 g/day patiromer starting dose, orally, as a divided dose twice a day.	Stratum 1: 25.2 g/d Patiromer n=73 participants at risk Participants with baseline serum potassium \> 5.0 - 5.5 mEq/L randomized to 25.2 g/day patiromer starting dose, orally, as a divided dose twice a day.	Stratum 2: 16.8 g/d Patiromer n=26 participants at risk Participants with baseline serum potassium \> 5.5 to \< 6.0 mEq/L randomized to 16.8 g/day patiromer starting dose, orally, as a divided dose twice a day.	Stratum 2: 25.2 g/d Patiromer n=28 participants at risk Participants with baseline serum potassium \> 5.5 to \< 6.0 mEq/L randomized to 25.2 g/day patiromer starting dose, orally, as a divided dose twice a day.	Stratum 2: 33.6 g/d Patiromer n=30 participants at risk Participants with baseline serum potassium \> 5.5 to \< 6.0 mEq/L randomized to 33.6 g/day patiromer starting dose, orally, as a divided dose twice a day.
Cardiac disorders Acute left ventricular failure	1.4% 1/74 • Up to 28 days after Week 52 or last patiromer dose, whichever was earlier Randomized participants who received at least one dose of trial medication	0.00% 0/73 • Up to 28 days after Week 52 or last patiromer dose, whichever was earlier Randomized participants who received at least one dose of trial medication	0.00% 0/73 • Up to 28 days after Week 52 or last patiromer dose, whichever was earlier Randomized participants who received at least one dose of trial medication	0.00% 0/26 • Up to 28 days after Week 52 or last patiromer dose, whichever was earlier Randomized participants who received at least one dose of trial medication	0.00% 0/28 • Up to 28 days after Week 52 or last patiromer dose, whichever was earlier Randomized participants who received at least one dose of trial medication	0.00% 0/30 • Up to 28 days after Week 52 or last patiromer dose, whichever was earlier Randomized participants who received at least one dose of trial medication
Cardiac disorders Acute myocardial infarction	0.00% 0/74 • Up to 28 days after Week 52 or last patiromer dose, whichever was earlier Randomized participants who received at least one dose of trial medication	0.00% 0/73 • Up to 28 days after Week 52 or last patiromer dose, whichever was earlier Randomized participants who received at least one dose of trial medication	0.00% 0/73 • Up to 28 days after Week 52 or last patiromer dose, whichever was earlier Randomized participants who received at least one dose of trial medication	3.8% 1/26 • Up to 28 days after Week 52 or last patiromer dose, whichever was earlier Randomized participants who received at least one dose of trial medication	0.00% 0/28 • Up to 28 days after Week 52 or last patiromer dose, whichever was earlier Randomized participants who received at least one dose of trial medication	3.3% 1/30 • Up to 28 days after Week 52 or last patiromer dose, whichever was earlier Randomized participants who received at least one dose of trial medication
Cardiac disorders Angina pectoris	0.00% 0/74 • Up to 28 days after Week 52 or last patiromer dose, whichever was earlier Randomized participants who received at least one dose of trial medication	0.00% 0/73 • Up to 28 days after Week 52 or last patiromer dose, whichever was earlier Randomized participants who received at least one dose of trial medication	0.00% 0/73 • Up to 28 days after Week 52 or last patiromer dose, whichever was earlier Randomized participants who received at least one dose of trial medication	0.00% 0/26 • Up to 28 days after Week 52 or last patiromer dose, whichever was earlier Randomized participants who received at least one dose of trial medication	3.6% 1/28 • Up to 28 days after Week 52 or last patiromer dose, whichever was earlier Randomized participants who received at least one dose of trial medication	0.00% 0/30 • Up to 28 days after Week 52 or last patiromer dose, whichever was earlier Randomized participants who received at least one dose of trial medication
Cardiac disorders Atrial fibrillation	0.00% 0/74 • Up to 28 days after Week 52 or last patiromer dose, whichever was earlier Randomized participants who received at least one dose of trial medication	1.4% 1/73 • Up to 28 days after Week 52 or last patiromer dose, whichever was earlier Randomized participants who received at least one dose of trial medication	0.00% 0/73 • Up to 28 days after Week 52 or last patiromer dose, whichever was earlier Randomized participants who received at least one dose of trial medication	0.00% 0/26 • Up to 28 days after Week 52 or last patiromer dose, whichever was earlier Randomized participants who received at least one dose of trial medication	0.00% 0/28 • Up to 28 days after Week 52 or last patiromer dose, whichever was earlier Randomized participants who received at least one dose of trial medication	0.00% 0/30 • Up to 28 days after Week 52 or last patiromer dose, whichever was earlier Randomized participants who received at least one dose of trial medication
Cardiac disorders Atrioventricular block complete	0.00% 0/74 • Up to 28 days after Week 52 or last patiromer dose, whichever was earlier Randomized participants who received at least one dose of trial medication	0.00% 0/73 • Up to 28 days after Week 52 or last patiromer dose, whichever was earlier Randomized participants who received at least one dose of trial medication	0.00% 0/73 • Up to 28 days after Week 52 or last patiromer dose, whichever was earlier Randomized participants who received at least one dose of trial medication	3.8% 1/26 • Up to 28 days after Week 52 or last patiromer dose, whichever was earlier Randomized participants who received at least one dose of trial medication	0.00% 0/28 • Up to 28 days after Week 52 or last patiromer dose, whichever was earlier Randomized participants who received at least one dose of trial medication	0.00% 0/30 • Up to 28 days after Week 52 or last patiromer dose, whichever was earlier Randomized participants who received at least one dose of trial medication
Cardiac disorders Cardiac failure	0.00% 0/74 • Up to 28 days after Week 52 or last patiromer dose, whichever was earlier Randomized participants who received at least one dose of trial medication	0.00% 0/73 • Up to 28 days after Week 52 or last patiromer dose, whichever was earlier Randomized participants who received at least one dose of trial medication	0.00% 0/73 • Up to 28 days after Week 52 or last patiromer dose, whichever was earlier Randomized participants who received at least one dose of trial medication	3.8% 1/26 • Up to 28 days after Week 52 or last patiromer dose, whichever was earlier Randomized participants who received at least one dose of trial medication	3.6% 1/28 • Up to 28 days after Week 52 or last patiromer dose, whichever was earlier Randomized participants who received at least one dose of trial medication	3.3% 1/30 • Up to 28 days after Week 52 or last patiromer dose, whichever was earlier Randomized participants who received at least one dose of trial medication
Cardiac disorders Cardiac failure chronic	0.00% 0/74 • Up to 28 days after Week 52 or last patiromer dose, whichever was earlier Randomized participants who received at least one dose of trial medication	1.4% 1/73 • Up to 28 days after Week 52 or last patiromer dose, whichever was earlier Randomized participants who received at least one dose of trial medication	0.00% 0/73 • Up to 28 days after Week 52 or last patiromer dose, whichever was earlier Randomized participants who received at least one dose of trial medication	3.8% 1/26 • Up to 28 days after Week 52 or last patiromer dose, whichever was earlier Randomized participants who received at least one dose of trial medication	0.00% 0/28 • Up to 28 days after Week 52 or last patiromer dose, whichever was earlier Randomized participants who received at least one dose of trial medication	0.00% 0/30 • Up to 28 days after Week 52 or last patiromer dose, whichever was earlier Randomized participants who received at least one dose of trial medication
Cardiac disorders Myocardial infarction	0.00% 0/74 • Up to 28 days after Week 52 or last patiromer dose, whichever was earlier Randomized participants who received at least one dose of trial medication	1.4% 1/73 • Up to 28 days after Week 52 or last patiromer dose, whichever was earlier Randomized participants who received at least one dose of trial medication	1.4% 1/73 • Up to 28 days after Week 52 or last patiromer dose, whichever was earlier Randomized participants who received at least one dose of trial medication	0.00% 0/26 • Up to 28 days after Week 52 or last patiromer dose, whichever was earlier Randomized participants who received at least one dose of trial medication	3.6% 1/28 • Up to 28 days after Week 52 or last patiromer dose, whichever was earlier Randomized participants who received at least one dose of trial medication	0.00% 0/30 • Up to 28 days after Week 52 or last patiromer dose, whichever was earlier Randomized participants who received at least one dose of trial medication
Eye disorders Diabetic retinopathy	0.00% 0/74 • Up to 28 days after Week 52 or last patiromer dose, whichever was earlier Randomized participants who received at least one dose of trial medication	1.4% 1/73 • Up to 28 days after Week 52 or last patiromer dose, whichever was earlier Randomized participants who received at least one dose of trial medication	0.00% 0/73 • Up to 28 days after Week 52 or last patiromer dose, whichever was earlier Randomized participants who received at least one dose of trial medication	0.00% 0/26 • Up to 28 days after Week 52 or last patiromer dose, whichever was earlier Randomized participants who received at least one dose of trial medication	0.00% 0/28 • Up to 28 days after Week 52 or last patiromer dose, whichever was earlier Randomized participants who received at least one dose of trial medication	0.00% 0/30 • Up to 28 days after Week 52 or last patiromer dose, whichever was earlier Randomized participants who received at least one dose of trial medication
Gastrointestinal disorders Gastric ulcer	0.00% 0/74 • Up to 28 days after Week 52 or last patiromer dose, whichever was earlier Randomized participants who received at least one dose of trial medication	0.00% 0/73 • Up to 28 days after Week 52 or last patiromer dose, whichever was earlier Randomized participants who received at least one dose of trial medication	0.00% 0/73 • Up to 28 days after Week 52 or last patiromer dose, whichever was earlier Randomized participants who received at least one dose of trial medication	0.00% 0/26 • Up to 28 days after Week 52 or last patiromer dose, whichever was earlier Randomized participants who received at least one dose of trial medication	0.00% 0/28 • Up to 28 days after Week 52 or last patiromer dose, whichever was earlier Randomized participants who received at least one dose of trial medication	3.3% 1/30 • Up to 28 days after Week 52 or last patiromer dose, whichever was earlier Randomized participants who received at least one dose of trial medication
Gastrointestinal disorders Gastric ulcer haemorrhage	0.00% 0/74 • Up to 28 days after Week 52 or last patiromer dose, whichever was earlier Randomized participants who received at least one dose of trial medication	1.4% 1/73 • Up to 28 days after Week 52 or last patiromer dose, whichever was earlier Randomized participants who received at least one dose of trial medication	0.00% 0/73 • Up to 28 days after Week 52 or last patiromer dose, whichever was earlier Randomized participants who received at least one dose of trial medication	0.00% 0/26 • Up to 28 days after Week 52 or last patiromer dose, whichever was earlier Randomized participants who received at least one dose of trial medication	0.00% 0/28 • Up to 28 days after Week 52 or last patiromer dose, whichever was earlier Randomized participants who received at least one dose of trial medication	0.00% 0/30 • Up to 28 days after Week 52 or last patiromer dose, whichever was earlier Randomized participants who received at least one dose of trial medication
Gastrointestinal disorders Mesenteric artery thrombosis	0.00% 0/74 • Up to 28 days after Week 52 or last patiromer dose, whichever was earlier Randomized participants who received at least one dose of trial medication	0.00% 0/73 • Up to 28 days after Week 52 or last patiromer dose, whichever was earlier Randomized participants who received at least one dose of trial medication	0.00% 0/73 • Up to 28 days after Week 52 or last patiromer dose, whichever was earlier Randomized participants who received at least one dose of trial medication	0.00% 0/26 • Up to 28 days after Week 52 or last patiromer dose, whichever was earlier Randomized participants who received at least one dose of trial medication	3.6% 1/28 • Up to 28 days after Week 52 or last patiromer dose, whichever was earlier Randomized participants who received at least one dose of trial medication	0.00% 0/30 • Up to 28 days after Week 52 or last patiromer dose, whichever was earlier Randomized participants who received at least one dose of trial medication
General disorders Brain death	0.00% 0/74 • Up to 28 days after Week 52 or last patiromer dose, whichever was earlier Randomized participants who received at least one dose of trial medication	0.00% 0/73 • Up to 28 days after Week 52 or last patiromer dose, whichever was earlier Randomized participants who received at least one dose of trial medication	1.4% 1/73 • Up to 28 days after Week 52 or last patiromer dose, whichever was earlier Randomized participants who received at least one dose of trial medication	0.00% 0/26 • Up to 28 days after Week 52 or last patiromer dose, whichever was earlier Randomized participants who received at least one dose of trial medication	0.00% 0/28 • Up to 28 days after Week 52 or last patiromer dose, whichever was earlier Randomized participants who received at least one dose of trial medication	0.00% 0/30 • Up to 28 days after Week 52 or last patiromer dose, whichever was earlier Randomized participants who received at least one dose of trial medication
General disorders Sudden cardiac death	0.00% 0/74 • Up to 28 days after Week 52 or last patiromer dose, whichever was earlier Randomized participants who received at least one dose of trial medication	0.00% 0/73 • Up to 28 days after Week 52 or last patiromer dose, whichever was earlier Randomized participants who received at least one dose of trial medication	4.1% 3/73 • Up to 28 days after Week 52 or last patiromer dose, whichever was earlier Randomized participants who received at least one dose of trial medication	0.00% 0/26 • Up to 28 days after Week 52 or last patiromer dose, whichever was earlier Randomized participants who received at least one dose of trial medication	0.00% 0/28 • Up to 28 days after Week 52 or last patiromer dose, whichever was earlier Randomized participants who received at least one dose of trial medication	0.00% 0/30 • Up to 28 days after Week 52 or last patiromer dose, whichever was earlier Randomized participants who received at least one dose of trial medication
Hepatobiliary disorders Cholecystitis	0.00% 0/74 • Up to 28 days after Week 52 or last patiromer dose, whichever was earlier Randomized participants who received at least one dose of trial medication	1.4% 1/73 • Up to 28 days after Week 52 or last patiromer dose, whichever was earlier Randomized participants who received at least one dose of trial medication	0.00% 0/73 • Up to 28 days after Week 52 or last patiromer dose, whichever was earlier Randomized participants who received at least one dose of trial medication	0.00% 0/26 • Up to 28 days after Week 52 or last patiromer dose, whichever was earlier Randomized participants who received at least one dose of trial medication	0.00% 0/28 • Up to 28 days after Week 52 or last patiromer dose, whichever was earlier Randomized participants who received at least one dose of trial medication	0.00% 0/30 • Up to 28 days after Week 52 or last patiromer dose, whichever was earlier Randomized participants who received at least one dose of trial medication
Infections and infestations Appendicitis	1.4% 1/74 • Up to 28 days after Week 52 or last patiromer dose, whichever was earlier Randomized participants who received at least one dose of trial medication	0.00% 0/73 • Up to 28 days after Week 52 or last patiromer dose, whichever was earlier Randomized participants who received at least one dose of trial medication	0.00% 0/73 • Up to 28 days after Week 52 or last patiromer dose, whichever was earlier Randomized participants who received at least one dose of trial medication	0.00% 0/26 • Up to 28 days after Week 52 or last patiromer dose, whichever was earlier Randomized participants who received at least one dose of trial medication	0.00% 0/28 • Up to 28 days after Week 52 or last patiromer dose, whichever was earlier Randomized participants who received at least one dose of trial medication	0.00% 0/30 • Up to 28 days after Week 52 or last patiromer dose, whichever was earlier Randomized participants who received at least one dose of trial medication
Infections and infestations Arteriosclerotic gangrene	1.4% 1/74 • Up to 28 days after Week 52 or last patiromer dose, whichever was earlier Randomized participants who received at least one dose of trial medication	0.00% 0/73 • Up to 28 days after Week 52 or last patiromer dose, whichever was earlier Randomized participants who received at least one dose of trial medication	0.00% 0/73 • Up to 28 days after Week 52 or last patiromer dose, whichever was earlier Randomized participants who received at least one dose of trial medication	0.00% 0/26 • Up to 28 days after Week 52 or last patiromer dose, whichever was earlier Randomized participants who received at least one dose of trial medication	0.00% 0/28 • Up to 28 days after Week 52 or last patiromer dose, whichever was earlier Randomized participants who received at least one dose of trial medication	0.00% 0/30 • Up to 28 days after Week 52 or last patiromer dose, whichever was earlier Randomized participants who received at least one dose of trial medication
Infections and infestations Gastrointestinal infection	0.00% 0/74 • Up to 28 days after Week 52 or last patiromer dose, whichever was earlier Randomized participants who received at least one dose of trial medication	1.4% 1/73 • Up to 28 days after Week 52 or last patiromer dose, whichever was earlier Randomized participants who received at least one dose of trial medication	0.00% 0/73 • Up to 28 days after Week 52 or last patiromer dose, whichever was earlier Randomized participants who received at least one dose of trial medication	0.00% 0/26 • Up to 28 days after Week 52 or last patiromer dose, whichever was earlier Randomized participants who received at least one dose of trial medication	0.00% 0/28 • Up to 28 days after Week 52 or last patiromer dose, whichever was earlier Randomized participants who received at least one dose of trial medication	0.00% 0/30 • Up to 28 days after Week 52 or last patiromer dose, whichever was earlier Randomized participants who received at least one dose of trial medication
Infections and infestations Pneumonia	0.00% 0/74 • Up to 28 days after Week 52 or last patiromer dose, whichever was earlier Randomized participants who received at least one dose of trial medication	0.00% 0/73 • Up to 28 days after Week 52 or last patiromer dose, whichever was earlier Randomized participants who received at least one dose of trial medication	1.4% 1/73 • Up to 28 days after Week 52 or last patiromer dose, whichever was earlier Randomized participants who received at least one dose of trial medication	0.00% 0/26 • Up to 28 days after Week 52 or last patiromer dose, whichever was earlier Randomized participants who received at least one dose of trial medication	0.00% 0/28 • Up to 28 days after Week 52 or last patiromer dose, whichever was earlier Randomized participants who received at least one dose of trial medication	0.00% 0/30 • Up to 28 days after Week 52 or last patiromer dose, whichever was earlier Randomized participants who received at least one dose of trial medication
Infections and infestations Urinary tract infection	0.00% 0/74 • Up to 28 days after Week 52 or last patiromer dose, whichever was earlier Randomized participants who received at least one dose of trial medication	0.00% 0/73 • Up to 28 days after Week 52 or last patiromer dose, whichever was earlier Randomized participants who received at least one dose of trial medication	0.00% 0/73 • Up to 28 days after Week 52 or last patiromer dose, whichever was earlier Randomized participants who received at least one dose of trial medication	3.8% 1/26 • Up to 28 days after Week 52 or last patiromer dose, whichever was earlier Randomized participants who received at least one dose of trial medication	0.00% 0/28 • Up to 28 days after Week 52 or last patiromer dose, whichever was earlier Randomized participants who received at least one dose of trial medication	0.00% 0/30 • Up to 28 days after Week 52 or last patiromer dose, whichever was earlier Randomized participants who received at least one dose of trial medication
Investigations Intraocular pressure increased	0.00% 0/74 • Up to 28 days after Week 52 or last patiromer dose, whichever was earlier Randomized participants who received at least one dose of trial medication	0.00% 0/73 • Up to 28 days after Week 52 or last patiromer dose, whichever was earlier Randomized participants who received at least one dose of trial medication	0.00% 0/73 • Up to 28 days after Week 52 or last patiromer dose, whichever was earlier Randomized participants who received at least one dose of trial medication	0.00% 0/26 • Up to 28 days after Week 52 or last patiromer dose, whichever was earlier Randomized participants who received at least one dose of trial medication	0.00% 0/28 • Up to 28 days after Week 52 or last patiromer dose, whichever was earlier Randomized participants who received at least one dose of trial medication	3.3% 1/30 • Up to 28 days after Week 52 or last patiromer dose, whichever was earlier Randomized participants who received at least one dose of trial medication
Metabolism and nutrition disorders Diabetes mellitus inadequate control	0.00% 0/74 • Up to 28 days after Week 52 or last patiromer dose, whichever was earlier Randomized participants who received at least one dose of trial medication	1.4% 1/73 • Up to 28 days after Week 52 or last patiromer dose, whichever was earlier Randomized participants who received at least one dose of trial medication	0.00% 0/73 • Up to 28 days after Week 52 or last patiromer dose, whichever was earlier Randomized participants who received at least one dose of trial medication	0.00% 0/26 • Up to 28 days after Week 52 or last patiromer dose, whichever was earlier Randomized participants who received at least one dose of trial medication	0.00% 0/28 • Up to 28 days after Week 52 or last patiromer dose, whichever was earlier Randomized participants who received at least one dose of trial medication	0.00% 0/30 • Up to 28 days after Week 52 or last patiromer dose, whichever was earlier Randomized participants who received at least one dose of trial medication
Metabolism and nutrition disorders Gout	1.4% 1/74 • Up to 28 days after Week 52 or last patiromer dose, whichever was earlier Randomized participants who received at least one dose of trial medication	0.00% 0/73 • Up to 28 days after Week 52 or last patiromer dose, whichever was earlier Randomized participants who received at least one dose of trial medication	0.00% 0/73 • Up to 28 days after Week 52 or last patiromer dose, whichever was earlier Randomized participants who received at least one dose of trial medication	0.00% 0/26 • Up to 28 days after Week 52 or last patiromer dose, whichever was earlier Randomized participants who received at least one dose of trial medication	0.00% 0/28 • Up to 28 days after Week 52 or last patiromer dose, whichever was earlier Randomized participants who received at least one dose of trial medication	0.00% 0/30 • Up to 28 days after Week 52 or last patiromer dose, whichever was earlier Randomized participants who received at least one dose of trial medication
Metabolism and nutrition disorders Hypoglycaemia	0.00% 0/74 • Up to 28 days after Week 52 or last patiromer dose, whichever was earlier Randomized participants who received at least one dose of trial medication	1.4% 1/73 • Up to 28 days after Week 52 or last patiromer dose, whichever was earlier Randomized participants who received at least one dose of trial medication	0.00% 0/73 • Up to 28 days after Week 52 or last patiromer dose, whichever was earlier Randomized participants who received at least one dose of trial medication	0.00% 0/26 • Up to 28 days after Week 52 or last patiromer dose, whichever was earlier Randomized participants who received at least one dose of trial medication	0.00% 0/28 • Up to 28 days after Week 52 or last patiromer dose, whichever was earlier Randomized participants who received at least one dose of trial medication	0.00% 0/30 • Up to 28 days after Week 52 or last patiromer dose, whichever was earlier Randomized participants who received at least one dose of trial medication
Metabolism and nutrition disorders Hypovolaemia	1.4% 1/74 • Up to 28 days after Week 52 or last patiromer dose, whichever was earlier Randomized participants who received at least one dose of trial medication	0.00% 0/73 • Up to 28 days after Week 52 or last patiromer dose, whichever was earlier Randomized participants who received at least one dose of trial medication	0.00% 0/73 • Up to 28 days after Week 52 or last patiromer dose, whichever was earlier Randomized participants who received at least one dose of trial medication	0.00% 0/26 • Up to 28 days after Week 52 or last patiromer dose, whichever was earlier Randomized participants who received at least one dose of trial medication	0.00% 0/28 • Up to 28 days after Week 52 or last patiromer dose, whichever was earlier Randomized participants who received at least one dose of trial medication	0.00% 0/30 • Up to 28 days after Week 52 or last patiromer dose, whichever was earlier Randomized participants who received at least one dose of trial medication
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Colon cancer	0.00% 0/74 • Up to 28 days after Week 52 or last patiromer dose, whichever was earlier Randomized participants who received at least one dose of trial medication	0.00% 0/73 • Up to 28 days after Week 52 or last patiromer dose, whichever was earlier Randomized participants who received at least one dose of trial medication	1.4% 1/73 • Up to 28 days after Week 52 or last patiromer dose, whichever was earlier Randomized participants who received at least one dose of trial medication	0.00% 0/26 • Up to 28 days after Week 52 or last patiromer dose, whichever was earlier Randomized participants who received at least one dose of trial medication	0.00% 0/28 • Up to 28 days after Week 52 or last patiromer dose, whichever was earlier Randomized participants who received at least one dose of trial medication	0.00% 0/30 • Up to 28 days after Week 52 or last patiromer dose, whichever was earlier Randomized participants who received at least one dose of trial medication
Nervous system disorders Cerebrovascular accident	1.4% 1/74 • Up to 28 days after Week 52 or last patiromer dose, whichever was earlier Randomized participants who received at least one dose of trial medication	1.4% 1/73 • Up to 28 days after Week 52 or last patiromer dose, whichever was earlier Randomized participants who received at least one dose of trial medication	0.00% 0/73 • Up to 28 days after Week 52 or last patiromer dose, whichever was earlier Randomized participants who received at least one dose of trial medication	0.00% 0/26 • Up to 28 days after Week 52 or last patiromer dose, whichever was earlier Randomized participants who received at least one dose of trial medication	0.00% 0/28 • Up to 28 days after Week 52 or last patiromer dose, whichever was earlier Randomized participants who received at least one dose of trial medication	0.00% 0/30 • Up to 28 days after Week 52 or last patiromer dose, whichever was earlier Randomized participants who received at least one dose of trial medication
General disorders Sudden death	0.00% 0/74 • Up to 28 days after Week 52 or last patiromer dose, whichever was earlier Randomized participants who received at least one dose of trial medication	0.00% 0/73 • Up to 28 days after Week 52 or last patiromer dose, whichever was earlier Randomized participants who received at least one dose of trial medication	1.4% 1/73 • Up to 28 days after Week 52 or last patiromer dose, whichever was earlier Randomized participants who received at least one dose of trial medication	3.8% 1/26 • Up to 28 days after Week 52 or last patiromer dose, whichever was earlier Randomized participants who received at least one dose of trial medication	7.1% 2/28 • Up to 28 days after Week 52 or last patiromer dose, whichever was earlier Randomized participants who received at least one dose of trial medication	3.3% 1/30 • Up to 28 days after Week 52 or last patiromer dose, whichever was earlier Randomized participants who received at least one dose of trial medication
Nervous system disorders Ischaemic stroke	1.4% 1/74 • Up to 28 days after Week 52 or last patiromer dose, whichever was earlier Randomized participants who received at least one dose of trial medication	0.00% 0/73 • Up to 28 days after Week 52 or last patiromer dose, whichever was earlier Randomized participants who received at least one dose of trial medication	1.4% 1/73 • Up to 28 days after Week 52 or last patiromer dose, whichever was earlier Randomized participants who received at least one dose of trial medication	0.00% 0/26 • Up to 28 days after Week 52 or last patiromer dose, whichever was earlier Randomized participants who received at least one dose of trial medication	0.00% 0/28 • Up to 28 days after Week 52 or last patiromer dose, whichever was earlier Randomized participants who received at least one dose of trial medication	0.00% 0/30 • Up to 28 days after Week 52 or last patiromer dose, whichever was earlier Randomized participants who received at least one dose of trial medication
Renal and urinary disorders Nephropathy toxic	0.00% 0/74 • Up to 28 days after Week 52 or last patiromer dose, whichever was earlier Randomized participants who received at least one dose of trial medication	0.00% 0/73 • Up to 28 days after Week 52 or last patiromer dose, whichever was earlier Randomized participants who received at least one dose of trial medication	0.00% 0/73 • Up to 28 days after Week 52 or last patiromer dose, whichever was earlier Randomized participants who received at least one dose of trial medication	0.00% 0/26 • Up to 28 days after Week 52 or last patiromer dose, whichever was earlier Randomized participants who received at least one dose of trial medication	0.00% 0/28 • Up to 28 days after Week 52 or last patiromer dose, whichever was earlier Randomized participants who received at least one dose of trial medication	3.3% 1/30 • Up to 28 days after Week 52 or last patiromer dose, whichever was earlier Randomized participants who received at least one dose of trial medication
Renal and urinary disorders Renal failure chronic	0.00% 0/74 • Up to 28 days after Week 52 or last patiromer dose, whichever was earlier Randomized participants who received at least one dose of trial medication	2.7% 2/73 • Up to 28 days after Week 52 or last patiromer dose, whichever was earlier Randomized participants who received at least one dose of trial medication	1.4% 1/73 • Up to 28 days after Week 52 or last patiromer dose, whichever was earlier Randomized participants who received at least one dose of trial medication	3.8% 1/26 • Up to 28 days after Week 52 or last patiromer dose, whichever was earlier Randomized participants who received at least one dose of trial medication	3.6% 1/28 • Up to 28 days after Week 52 or last patiromer dose, whichever was earlier Randomized participants who received at least one dose of trial medication	3.3% 1/30 • Up to 28 days after Week 52 or last patiromer dose, whichever was earlier Randomized participants who received at least one dose of trial medication
Renal and urinary disorders Tubulointerstitial nephritis	0.00% 0/74 • Up to 28 days after Week 52 or last patiromer dose, whichever was earlier Randomized participants who received at least one dose of trial medication	0.00% 0/73 • Up to 28 days after Week 52 or last patiromer dose, whichever was earlier Randomized participants who received at least one dose of trial medication	0.00% 0/73 • Up to 28 days after Week 52 or last patiromer dose, whichever was earlier Randomized participants who received at least one dose of trial medication	3.8% 1/26 • Up to 28 days after Week 52 or last patiromer dose, whichever was earlier Randomized participants who received at least one dose of trial medication	0.00% 0/28 • Up to 28 days after Week 52 or last patiromer dose, whichever was earlier Randomized participants who received at least one dose of trial medication	0.00% 0/30 • Up to 28 days after Week 52 or last patiromer dose, whichever was earlier Randomized participants who received at least one dose of trial medication
Vascular disorders Diabetic vascular disorder	2.7% 2/74 • Up to 28 days after Week 52 or last patiromer dose, whichever was earlier Randomized participants who received at least one dose of trial medication	0.00% 0/73 • Up to 28 days after Week 52 or last patiromer dose, whichever was earlier Randomized participants who received at least one dose of trial medication	0.00% 0/73 • Up to 28 days after Week 52 or last patiromer dose, whichever was earlier Randomized participants who received at least one dose of trial medication	0.00% 0/26 • Up to 28 days after Week 52 or last patiromer dose, whichever was earlier Randomized participants who received at least one dose of trial medication	0.00% 0/28 • Up to 28 days after Week 52 or last patiromer dose, whichever was earlier Randomized participants who received at least one dose of trial medication	0.00% 0/30 • Up to 28 days after Week 52 or last patiromer dose, whichever was earlier Randomized participants who received at least one dose of trial medication
Vascular disorders Femoral artery occlusion	1.4% 1/74 • Up to 28 days after Week 52 or last patiromer dose, whichever was earlier Randomized participants who received at least one dose of trial medication	0.00% 0/73 • Up to 28 days after Week 52 or last patiromer dose, whichever was earlier Randomized participants who received at least one dose of trial medication	0.00% 0/73 • Up to 28 days after Week 52 or last patiromer dose, whichever was earlier Randomized participants who received at least one dose of trial medication	0.00% 0/26 • Up to 28 days after Week 52 or last patiromer dose, whichever was earlier Randomized participants who received at least one dose of trial medication	0.00% 0/28 • Up to 28 days after Week 52 or last patiromer dose, whichever was earlier Randomized participants who received at least one dose of trial medication	0.00% 0/30 • Up to 28 days after Week 52 or last patiromer dose, whichever was earlier Randomized participants who received at least one dose of trial medication
Vascular disorders Hypertensive crisis	0.00% 0/74 • Up to 28 days after Week 52 or last patiromer dose, whichever was earlier Randomized participants who received at least one dose of trial medication	0.00% 0/73 • Up to 28 days after Week 52 or last patiromer dose, whichever was earlier Randomized participants who received at least one dose of trial medication	1.4% 1/73 • Up to 28 days after Week 52 or last patiromer dose, whichever was earlier Randomized participants who received at least one dose of trial medication	0.00% 0/26 • Up to 28 days after Week 52 or last patiromer dose, whichever was earlier Randomized participants who received at least one dose of trial medication	0.00% 0/28 • Up to 28 days after Week 52 or last patiromer dose, whichever was earlier Randomized participants who received at least one dose of trial medication	0.00% 0/30 • Up to 28 days after Week 52 or last patiromer dose, whichever was earlier Randomized participants who received at least one dose of trial medication
Vascular disorders Hypotension	1.4% 1/74 • Up to 28 days after Week 52 or last patiromer dose, whichever was earlier Randomized participants who received at least one dose of trial medication	0.00% 0/73 • Up to 28 days after Week 52 or last patiromer dose, whichever was earlier Randomized participants who received at least one dose of trial medication	0.00% 0/73 • Up to 28 days after Week 52 or last patiromer dose, whichever was earlier Randomized participants who received at least one dose of trial medication	0.00% 0/26 • Up to 28 days after Week 52 or last patiromer dose, whichever was earlier Randomized participants who received at least one dose of trial medication	0.00% 0/28 • Up to 28 days after Week 52 or last patiromer dose, whichever was earlier Randomized participants who received at least one dose of trial medication	0.00% 0/30 • Up to 28 days after Week 52 or last patiromer dose, whichever was earlier Randomized participants who received at least one dose of trial medication
Nervous system disorders Transient ischaemic attack	1.4% 1/74 • Up to 28 days after Week 52 or last patiromer dose, whichever was earlier Randomized participants who received at least one dose of trial medication	0.00% 0/73 • Up to 28 days after Week 52 or last patiromer dose, whichever was earlier Randomized participants who received at least one dose of trial medication	0.00% 0/73 • Up to 28 days after Week 52 or last patiromer dose, whichever was earlier Randomized participants who received at least one dose of trial medication	0.00% 0/26 • Up to 28 days after Week 52 or last patiromer dose, whichever was earlier Randomized participants who received at least one dose of trial medication	0.00% 0/28 • Up to 28 days after Week 52 or last patiromer dose, whichever was earlier Randomized participants who received at least one dose of trial medication	0.00% 0/30 • Up to 28 days after Week 52 or last patiromer dose, whichever was earlier Randomized participants who received at least one dose of trial medication

Other adverse events

Other adverse events
Measure	Stratum 1: 8.4 g/d Patiromer n=74 participants at risk Participants with baseline serum potassium \> 5.0 - 5.5 mEq/L randomized to 8.4 g/day patiromer starting dose, orally, as a divided dose twice a day.	Stratum 1: 16.8 g/d Patiromer n=73 participants at risk Participants with baseline serum potassium \> 5.0 - 5.5 mEq/L randomized to 16.8 g/day patiromer starting dose, orally, as a divided dose twice a day.	Stratum 1: 25.2 g/d Patiromer n=73 participants at risk Participants with baseline serum potassium \> 5.0 - 5.5 mEq/L randomized to 25.2 g/day patiromer starting dose, orally, as a divided dose twice a day.	Stratum 2: 16.8 g/d Patiromer n=26 participants at risk Participants with baseline serum potassium \> 5.5 to \< 6.0 mEq/L randomized to 16.8 g/day patiromer starting dose, orally, as a divided dose twice a day.	Stratum 2: 25.2 g/d Patiromer n=28 participants at risk Participants with baseline serum potassium \> 5.5 to \< 6.0 mEq/L randomized to 25.2 g/day patiromer starting dose, orally, as a divided dose twice a day.	Stratum 2: 33.6 g/d Patiromer n=30 participants at risk Participants with baseline serum potassium \> 5.5 to \< 6.0 mEq/L randomized to 33.6 g/day patiromer starting dose, orally, as a divided dose twice a day.
Blood and lymphatic system disorders Anaemia	2.7% 2/74 • Up to 28 days after Week 52 or last patiromer dose, whichever was earlier Randomized participants who received at least one dose of trial medication	2.7% 2/73 • Up to 28 days after Week 52 or last patiromer dose, whichever was earlier Randomized participants who received at least one dose of trial medication	5.5% 4/73 • Up to 28 days after Week 52 or last patiromer dose, whichever was earlier Randomized participants who received at least one dose of trial medication	0.00% 0/26 • Up to 28 days after Week 52 or last patiromer dose, whichever was earlier Randomized participants who received at least one dose of trial medication	3.6% 1/28 • Up to 28 days after Week 52 or last patiromer dose, whichever was earlier Randomized participants who received at least one dose of trial medication	6.7% 2/30 • Up to 28 days after Week 52 or last patiromer dose, whichever was earlier Randomized participants who received at least one dose of trial medication
Cardiac disorders Angina pectoris	0.00% 0/74 • Up to 28 days after Week 52 or last patiromer dose, whichever was earlier Randomized participants who received at least one dose of trial medication	1.4% 1/73 • Up to 28 days after Week 52 or last patiromer dose, whichever was earlier Randomized participants who received at least one dose of trial medication	2.7% 2/73 • Up to 28 days after Week 52 or last patiromer dose, whichever was earlier Randomized participants who received at least one dose of trial medication	3.8% 1/26 • Up to 28 days after Week 52 or last patiromer dose, whichever was earlier Randomized participants who received at least one dose of trial medication	7.1% 2/28 • Up to 28 days after Week 52 or last patiromer dose, whichever was earlier Randomized participants who received at least one dose of trial medication	0.00% 0/30 • Up to 28 days after Week 52 or last patiromer dose, whichever was earlier Randomized participants who received at least one dose of trial medication
Cardiac disorders Cardiac failure chronic	0.00% 0/74 • Up to 28 days after Week 52 or last patiromer dose, whichever was earlier Randomized participants who received at least one dose of trial medication	0.00% 0/73 • Up to 28 days after Week 52 or last patiromer dose, whichever was earlier Randomized participants who received at least one dose of trial medication	1.4% 1/73 • Up to 28 days after Week 52 or last patiromer dose, whichever was earlier Randomized participants who received at least one dose of trial medication	7.7% 2/26 • Up to 28 days after Week 52 or last patiromer dose, whichever was earlier Randomized participants who received at least one dose of trial medication	0.00% 0/28 • Up to 28 days after Week 52 or last patiromer dose, whichever was earlier Randomized participants who received at least one dose of trial medication	0.00% 0/30 • Up to 28 days after Week 52 or last patiromer dose, whichever was earlier Randomized participants who received at least one dose of trial medication
Cardiac disorders Ventricular extrasystoles	2.7% 2/74 • Up to 28 days after Week 52 or last patiromer dose, whichever was earlier Randomized participants who received at least one dose of trial medication	5.5% 4/73 • Up to 28 days after Week 52 or last patiromer dose, whichever was earlier Randomized participants who received at least one dose of trial medication	2.7% 2/73 • Up to 28 days after Week 52 or last patiromer dose, whichever was earlier Randomized participants who received at least one dose of trial medication	0.00% 0/26 • Up to 28 days after Week 52 or last patiromer dose, whichever was earlier Randomized participants who received at least one dose of trial medication	3.6% 1/28 • Up to 28 days after Week 52 or last patiromer dose, whichever was earlier Randomized participants who received at least one dose of trial medication	6.7% 2/30 • Up to 28 days after Week 52 or last patiromer dose, whichever was earlier Randomized participants who received at least one dose of trial medication
Gastrointestinal disorders Constipation	5.4% 4/74 • Up to 28 days after Week 52 or last patiromer dose, whichever was earlier Randomized participants who received at least one dose of trial medication	4.1% 3/73 • Up to 28 days after Week 52 or last patiromer dose, whichever was earlier Randomized participants who received at least one dose of trial medication	5.5% 4/73 • Up to 28 days after Week 52 or last patiromer dose, whichever was earlier Randomized participants who received at least one dose of trial medication	7.7% 2/26 • Up to 28 days after Week 52 or last patiromer dose, whichever was earlier Randomized participants who received at least one dose of trial medication	3.6% 1/28 • Up to 28 days after Week 52 or last patiromer dose, whichever was earlier Randomized participants who received at least one dose of trial medication	16.7% 5/30 • Up to 28 days after Week 52 or last patiromer dose, whichever was earlier Randomized participants who received at least one dose of trial medication
Gastrointestinal disorders Diarrhoea	8.1% 6/74 • Up to 28 days after Week 52 or last patiromer dose, whichever was earlier Randomized participants who received at least one dose of trial medication	6.8% 5/73 • Up to 28 days after Week 52 or last patiromer dose, whichever was earlier Randomized participants who received at least one dose of trial medication	1.4% 1/73 • Up to 28 days after Week 52 or last patiromer dose, whichever was earlier Randomized participants who received at least one dose of trial medication	11.5% 3/26 • Up to 28 days after Week 52 or last patiromer dose, whichever was earlier Randomized participants who received at least one dose of trial medication	3.6% 1/28 • Up to 28 days after Week 52 or last patiromer dose, whichever was earlier Randomized participants who received at least one dose of trial medication	3.3% 1/30 • Up to 28 days after Week 52 or last patiromer dose, whichever was earlier Randomized participants who received at least one dose of trial medication
Infections and infestations Influenza	4.1% 3/74 • Up to 28 days after Week 52 or last patiromer dose, whichever was earlier Randomized participants who received at least one dose of trial medication	0.00% 0/73 • Up to 28 days after Week 52 or last patiromer dose, whichever was earlier Randomized participants who received at least one dose of trial medication	5.5% 4/73 • Up to 28 days after Week 52 or last patiromer dose, whichever was earlier Randomized participants who received at least one dose of trial medication	3.8% 1/26 • Up to 28 days after Week 52 or last patiromer dose, whichever was earlier Randomized participants who received at least one dose of trial medication	3.6% 1/28 • Up to 28 days after Week 52 or last patiromer dose, whichever was earlier Randomized participants who received at least one dose of trial medication	0.00% 0/30 • Up to 28 days after Week 52 or last patiromer dose, whichever was earlier Randomized participants who received at least one dose of trial medication
Infections and infestations Nasopharyngitis	0.00% 0/74 • Up to 28 days after Week 52 or last patiromer dose, whichever was earlier Randomized participants who received at least one dose of trial medication	1.4% 1/73 • Up to 28 days after Week 52 or last patiromer dose, whichever was earlier Randomized participants who received at least one dose of trial medication	2.7% 2/73 • Up to 28 days after Week 52 or last patiromer dose, whichever was earlier Randomized participants who received at least one dose of trial medication	3.8% 1/26 • Up to 28 days after Week 52 or last patiromer dose, whichever was earlier Randomized participants who received at least one dose of trial medication	3.6% 1/28 • Up to 28 days after Week 52 or last patiromer dose, whichever was earlier Randomized participants who received at least one dose of trial medication	6.7% 2/30 • Up to 28 days after Week 52 or last patiromer dose, whichever was earlier Randomized participants who received at least one dose of trial medication
Infections and infestations Urinary tract infection	4.1% 3/74 • Up to 28 days after Week 52 or last patiromer dose, whichever was earlier Randomized participants who received at least one dose of trial medication	4.1% 3/73 • Up to 28 days after Week 52 or last patiromer dose, whichever was earlier Randomized participants who received at least one dose of trial medication	2.7% 2/73 • Up to 28 days after Week 52 or last patiromer dose, whichever was earlier Randomized participants who received at least one dose of trial medication	0.00% 0/26 • Up to 28 days after Week 52 or last patiromer dose, whichever was earlier Randomized participants who received at least one dose of trial medication	7.1% 2/28 • Up to 28 days after Week 52 or last patiromer dose, whichever was earlier Randomized participants who received at least one dose of trial medication	0.00% 0/30 • Up to 28 days after Week 52 or last patiromer dose, whichever was earlier Randomized participants who received at least one dose of trial medication
Metabolism and nutrition disorders Hypercholesterolaemia	1.4% 1/74 • Up to 28 days after Week 52 or last patiromer dose, whichever was earlier Randomized participants who received at least one dose of trial medication	2.7% 2/73 • Up to 28 days after Week 52 or last patiromer dose, whichever was earlier Randomized participants who received at least one dose of trial medication	1.4% 1/73 • Up to 28 days after Week 52 or last patiromer dose, whichever was earlier Randomized participants who received at least one dose of trial medication	0.00% 0/26 • Up to 28 days after Week 52 or last patiromer dose, whichever was earlier Randomized participants who received at least one dose of trial medication	7.1% 2/28 • Up to 28 days after Week 52 or last patiromer dose, whichever was earlier Randomized participants who received at least one dose of trial medication	0.00% 0/30 • Up to 28 days after Week 52 or last patiromer dose, whichever was earlier Randomized participants who received at least one dose of trial medication
Metabolism and nutrition disorders Hypoglycaemia	1.4% 1/74 • Up to 28 days after Week 52 or last patiromer dose, whichever was earlier Randomized participants who received at least one dose of trial medication	1.4% 1/73 • Up to 28 days after Week 52 or last patiromer dose, whichever was earlier Randomized participants who received at least one dose of trial medication	1.4% 1/73 • Up to 28 days after Week 52 or last patiromer dose, whichever was earlier Randomized participants who received at least one dose of trial medication	7.7% 2/26 • Up to 28 days after Week 52 or last patiromer dose, whichever was earlier Randomized participants who received at least one dose of trial medication	3.6% 1/28 • Up to 28 days after Week 52 or last patiromer dose, whichever was earlier Randomized participants who received at least one dose of trial medication	10.0% 3/30 • Up to 28 days after Week 52 or last patiromer dose, whichever was earlier Randomized participants who received at least one dose of trial medication
Metabolism and nutrition disorders Hypokalaemia	2.7% 2/74 • Up to 28 days after Week 52 or last patiromer dose, whichever was earlier Randomized participants who received at least one dose of trial medication	1.4% 1/73 • Up to 28 days after Week 52 or last patiromer dose, whichever was earlier Randomized participants who received at least one dose of trial medication	0.00% 0/73 • Up to 28 days after Week 52 or last patiromer dose, whichever was earlier Randomized participants who received at least one dose of trial medication	3.8% 1/26 • Up to 28 days after Week 52 or last patiromer dose, whichever was earlier Randomized participants who received at least one dose of trial medication	0.00% 0/28 • Up to 28 days after Week 52 or last patiromer dose, whichever was earlier Randomized participants who received at least one dose of trial medication	10.0% 3/30 • Up to 28 days after Week 52 or last patiromer dose, whichever was earlier Randomized participants who received at least one dose of trial medication
Metabolism and nutrition disorders Hypomagnesaemia	5.4% 4/74 • Up to 28 days after Week 52 or last patiromer dose, whichever was earlier Randomized participants who received at least one dose of trial medication	6.8% 5/73 • Up to 28 days after Week 52 or last patiromer dose, whichever was earlier Randomized participants who received at least one dose of trial medication	8.2% 6/73 • Up to 28 days after Week 52 or last patiromer dose, whichever was earlier Randomized participants who received at least one dose of trial medication	7.7% 2/26 • Up to 28 days after Week 52 or last patiromer dose, whichever was earlier Randomized participants who received at least one dose of trial medication	14.3% 4/28 • Up to 28 days after Week 52 or last patiromer dose, whichever was earlier Randomized participants who received at least one dose of trial medication	16.7% 5/30 • Up to 28 days after Week 52 or last patiromer dose, whichever was earlier Randomized participants who received at least one dose of trial medication
Nervous system disorders Headache	4.1% 3/74 • Up to 28 days after Week 52 or last patiromer dose, whichever was earlier Randomized participants who received at least one dose of trial medication	2.7% 2/73 • Up to 28 days after Week 52 or last patiromer dose, whichever was earlier Randomized participants who received at least one dose of trial medication	1.4% 1/73 • Up to 28 days after Week 52 or last patiromer dose, whichever was earlier Randomized participants who received at least one dose of trial medication	0.00% 0/26 • Up to 28 days after Week 52 or last patiromer dose, whichever was earlier Randomized participants who received at least one dose of trial medication	0.00% 0/28 • Up to 28 days after Week 52 or last patiromer dose, whichever was earlier Randomized participants who received at least one dose of trial medication	6.7% 2/30 • Up to 28 days after Week 52 or last patiromer dose, whichever was earlier Randomized participants who received at least one dose of trial medication
Renal and urinary disorders Renal failure chronic	6.8% 5/74 • Up to 28 days after Week 52 or last patiromer dose, whichever was earlier Randomized participants who received at least one dose of trial medication	5.5% 4/73 • Up to 28 days after Week 52 or last patiromer dose, whichever was earlier Randomized participants who received at least one dose of trial medication	2.7% 2/73 • Up to 28 days after Week 52 or last patiromer dose, whichever was earlier Randomized participants who received at least one dose of trial medication	7.7% 2/26 • Up to 28 days after Week 52 or last patiromer dose, whichever was earlier Randomized participants who received at least one dose of trial medication	10.7% 3/28 • Up to 28 days after Week 52 or last patiromer dose, whichever was earlier Randomized participants who received at least one dose of trial medication	20.0% 6/30 • Up to 28 days after Week 52 or last patiromer dose, whichever was earlier Randomized participants who received at least one dose of trial medication
Vascular disorders Hypertension	6.8% 5/74 • Up to 28 days after Week 52 or last patiromer dose, whichever was earlier Randomized participants who received at least one dose of trial medication	9.6% 7/73 • Up to 28 days after Week 52 or last patiromer dose, whichever was earlier Randomized participants who received at least one dose of trial medication	2.7% 2/73 • Up to 28 days after Week 52 or last patiromer dose, whichever was earlier Randomized participants who received at least one dose of trial medication	15.4% 4/26 • Up to 28 days after Week 52 or last patiromer dose, whichever was earlier Randomized participants who received at least one dose of trial medication	7.1% 2/28 • Up to 28 days after Week 52 or last patiromer dose, whichever was earlier Randomized participants who received at least one dose of trial medication	13.3% 4/30 • Up to 28 days after Week 52 or last patiromer dose, whichever was earlier Randomized participants who received at least one dose of trial medication
Vascular disorders Hypotension	0.00% 0/74 • Up to 28 days after Week 52 or last patiromer dose, whichever was earlier Randomized participants who received at least one dose of trial medication	1.4% 1/73 • Up to 28 days after Week 52 or last patiromer dose, whichever was earlier Randomized participants who received at least one dose of trial medication	1.4% 1/73 • Up to 28 days after Week 52 or last patiromer dose, whichever was earlier Randomized participants who received at least one dose of trial medication	0.00% 0/26 • Up to 28 days after Week 52 or last patiromer dose, whichever was earlier Randomized participants who received at least one dose of trial medication	0.00% 0/28 • Up to 28 days after Week 52 or last patiromer dose, whichever was earlier Randomized participants who received at least one dose of trial medication	6.7% 2/30 • Up to 28 days after Week 52 or last patiromer dose, whichever was earlier Randomized participants who received at least one dose of trial medication

Additional Information

Medical Information

Relypsa, Inc.

Phone: 1-844-relypsa

Email: [email protected]

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