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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01371747
Recruitment Status : Completed
First Posted : June 13, 2011
Results First Posted : December 17, 2015
Last Update Posted : April 26, 2017
Sponsor:
Information provided by (Responsible Party):
Relypsa, Inc.

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Conditions Chronic Kidney Disease
Hypertension
Hyperkalemia
Interventions Drug: patiromer
Drug: losartan
Drug: spironolactone
Enrollment 324
Recruitment Details 324 participants were enrolled in the study; 306 participants were randomized to receive study drug.
Pre-assignment Details 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.
Arm/Group Title Stratum 1: 8.4 g/d Patiromer Stratum 1: 16.8 g/d Patiromer Stratum 1: 25.2 g/d Patiromer Stratum 2: 16.8 g/d Patiromer Stratum 2: 25.2 g/d Patiromer Stratum 2: 33.6 g/d Patiromer
Hide Arm/Group Description 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. 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. 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. 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. 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. 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.
Period Title: Overall Study
Started 74 74 74 26 28 30
Completed 56 51 50 17 21 16
Not Completed 18 23 24 9 7 14
Reason Not Completed
Adverse Event             4             2             7             2             2             2
Death             1             0             4             1             2             0
Abnormal Renal Function             0             2             0             1             0             1
High Serum Potassium Results             1             1             1             2             0             2
Low Serum Potassium Results             1             1             1             1             0             3
Protocol Violation             0             0             1             0             0             0
Non-Compliance             3             4             3             0             0             1
Physician Decision             0             0             0             0             1             0
Withdrawal by Subject             6             12             5             2             2             4
Other Reasons             2             1             2             0             0             1
Arm/Group Title Stratum 1: 8.4 g/d Patiromer Stratum 1: 16.8 g/d Patiromer Stratum 1: 25.2 g/d Patiromer Stratum 2: 16.8 g/d Patiromer Stratum 2: 25.2 g/d Patiromer Stratum 2: 33.6 g/d Patiromer Total
Hide Arm/Group Description 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. 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. 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. 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. 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 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 of all reporting groups
Overall Number of Baseline Participants 74 73 73 26 28 30 304
Hide Baseline Analysis Population Description
306 participants were randomized and stratified by baseline serum potassium (2 randomized participants in Stratum 1 did not receive any study drug: 1 participant withdrew consent and 1 participant was randomized in error and was withdrawn from the study); 304 participants were analyzed for safety.
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 74 participants 73 participants 73 participants 26 participants 28 participants 30 participants 304 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
28
  37.8%
29
  39.7%
28
  38.4%
12
  46.2%
12
  42.9%
13
  43.3%
122
  40.1%
>=65 years
46
  62.2%
44
  60.3%
45
  61.6%
14
  53.8%
16
  57.1%
17
  56.7%
182
  59.9%
Age, Continuous  
Median (Full Range)
Unit of measure:  Years
Number Analyzed 74 participants 73 participants 73 participants 26 participants 28 participants 30 participants 304 participants
67
(46 to 80)
70
(37 to 79)
68
(40 to 79)
66.5
(56 to 76)
68.5
(39 to 80)
65
(44 to 78)
67.5
(37 to 80)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 74 participants 73 participants 73 participants 26 participants 28 participants 30 participants 304 participants
Female
29
  39.2%
26
  35.6%
26
  35.6%
8
  30.8%
13
  46.4%
10
  33.3%
112
  36.8%
Male
45
  60.8%
47
  64.4%
47
  64.4%
18
  69.2%
15
  53.6%
20
  66.7%
192
  63.2%
1.Primary Outcome
Title Least Squares Mean Change in Serum Potassium From Baseline to Week 4 or Time of First Titration for Each Individual Starting Dose Group
Hide Description 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.
Time Frame Baseline to Week 4 or First Titration which could occur at any scheduled study visit after patiromer initiation.
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Stratum 1: 8.4 g/d Patiromer Stratum 1: 16.8 g/d Patiromer Stratum 1: 25.2 g/d Patiromer Stratum 2: 16.8 g/d Patiromer Stratum 2: 25.2 g/d Patiromer Stratum 2: 33.6 g/d Patiromer
Hide Arm/Group Description:
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.
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.
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.
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.
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.
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 Number of Participants Analyzed 73 72 72 26 27 30
Least Squares Mean (Standard Error)
Unit of Measure: mEq/L
-0.35  (0.066) -0.51  (0.067) -0.55  (0.067) -0.87  (0.134) -0.97  (0.132) -0.92  (0.125)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Stratum 1: 8.4 g/d Patiromer
Comments Each starting dose group was compared to its baseline.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments P-value <0.001
Method ANCOVA
Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Stratum 1: 16.8 g/d Patiromer
Comments Each starting dose group was compared to its baseline.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments P-Value <0.001
Method ANCOVA
Comments [Not Specified]
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Stratum 1: 25.2 g/d Patiromer
Comments Each starting dose group was compared to its baseline.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments P-value <0.001
Method ANCOVA
Comments [Not Specified]
Show Statistical Analysis 4 Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection Stratum 2: 16.8 g/d Patiromer
Comments Each starting dose group was compared to its baseline.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments P-value <0.001
Method ANCOVA
Comments [Not Specified]
Show Statistical Analysis 5 Hide Statistical Analysis 5
Statistical Analysis Overview Comparison Group Selection Stratum 2: 25.2 g/d Patiromer
Comments Each starting dose group was compared to its baseline.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments P-value <0.001
Method ANCOVA
Comments [Not Specified]
Show Statistical Analysis 6 Hide Statistical Analysis 6
Statistical Analysis Overview Comparison Group Selection Stratum 2: 33.6 g/d Patiromer
Comments Each starting dose group was compared to its baseline.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments P-value <0.001
Method ANCOVA
Comments [Not Specified]
2.Secondary Outcome
Title Least Squares Mean Change in Serum Potassium From Baseline to Week 8 or Time of First Titration for Each Individual Starting Dose Group
Hide Description 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.
Time Frame Baseline to Week 8 or First Titration which could occur at any scheduled study visit after patiromer initiation.
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Stratum 1: 8.4 g/d Patiromer Stratum 1: 16.8 g/d Patiromer Stratum 1: 25.2 g/d Patiromer Stratum 2: 16.8 g/d Patiromer Stratum 2: 25.2 g/d Patiromer Stratum 2: 33.6 g/d Patiromer
Hide Arm/Group Description:
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.
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.
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.
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.
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.
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 Number of Participants Analyzed 73 72 72 26 27 30
Least Squares Mean (Standard Error)
Unit of Measure: mEq/L
-0.35  (0.070) -0.47  (0.070) -0.54  (0.070) -0.88  (0.142) -0.95  (0.139) -0.91  (0.132)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Stratum 1: 8.4 g/d Patiromer
Comments Each starting dose group was compared to its baseline.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments P-Value <0.001
Method ANCOVA
Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Stratum 1: 16.8 g/d Patiromer
Comments Each starting dose group was compared to its baseline.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments P-Value <0.001
Method ANCOVA
Comments [Not Specified]
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Stratum 1: 25.2 g/d Patiromer
Comments Each starting dose group was compared to its baseline.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments P-value <0.001
Method ANCOVA
Comments [Not Specified]
Show Statistical Analysis 4 Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection Stratum 2: 16.8 g/d Patiromer
Comments Each starting dose group was compared to its baseline.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments P-value <0.001
Method ANCOVA
Comments [Not Specified]
Show Statistical Analysis 5 Hide Statistical Analysis 5
Statistical Analysis Overview Comparison Group Selection Stratum 2: 25.2 g/d Patiromer
Comments Each starting dose group was compared to its baseline.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments P-value <0.001
Method ANCOVA
Comments [Not Specified]
Show Statistical Analysis 6 Hide Statistical Analysis 6
Statistical Analysis Overview Comparison Group Selection Stratum 2: 33.6 g/d Patiromer
Comments Each starting dose group was compared to its baseline.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments P-value <0.001
Method ANCOVA
Comments [Not Specified]
3.Secondary Outcome
Title Least Squares Mean Change in Serum Potassium From Baseline to Day 3 During the Treatment Initiation Period for Each Individual Starting Dose Group
Hide Description 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.
Time Frame Baseline to Day 3
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Stratum 1: 8.4 g/d Patiromer Stratum 1: 16.8 g/d Patiromer Stratum 1: 25.2 g/d Patiromer Stratum 2: 16.8 g/d Patiromer Stratum 2: 25.2 g/d Patiromer Stratum 2: 33.6 g/d Patiromer
Hide Arm/Group Description:
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.
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.
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.
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.
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.
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 Number of Participants Analyzed 68 63 69 25 26 30
Least Squares Mean (Standard Error)
Unit of Measure: mEq/L
-0.26  (0.048) -0.28  (0.050) -0.31  (0.047) -0.65  (0.086) -0.59  (0.084) -0.53  (0.079)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Stratum 1: 8.4 g/d Patiromer
Comments Each starting dose group was compared to its baseline.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments P-Value <0.001
Method ANCOVA
Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Stratum 1: 16.8 g/d Patiromer
Comments Each starting dose group was compared to its baseline.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments P-Value <0.001
Method ANCOVA
Comments [Not Specified]
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Stratum 1: 25.2 g/d Patiromer
Comments Each starting dose group was compared to its baseline.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments P-value <0.001
Method ANCOVA
Comments [Not Specified]
Show Statistical Analysis 4 Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection Stratum 2: 16.8 g/d Patiromer
Comments Each starting dose group was compared to its baseline.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments P-value <0.001
Method ANCOVA
Comments [Not Specified]
Show Statistical Analysis 5 Hide Statistical Analysis 5
Statistical Analysis Overview Comparison Group Selection Stratum 2: 25.2 g/d Patiromer
Comments Each starting dose group was compared to its baseline.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments P-value <0.001
Method ANCOVA
Comments [Not Specified]
Show Statistical Analysis 6 Hide Statistical Analysis 6
Statistical Analysis Overview Comparison Group Selection Stratum 2: 33.6 g/d Patiromer
Comments Each starting dose group was compared to its baseline.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments P-value <0.001
Method ANCOVA
Comments [Not Specified]
4.Secondary Outcome
Title Mean Change in Serum Potassium From Baseline to Week 52 During the Long-term Maintenance Period for Each Individual Starting Dose Group
Hide Description [Not Specified]
Time Frame Baseline to Week 52
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Stratum 1: 8.4 g/d Patiromer Stratum 1: 16.8 g/d Patiromer Stratum 1: 25.2 g/d Patiromer Stratum 2: 16.8 g/d Patiromer Stratum 2: 25.2 g/d Patiromer Stratum 2: 33.6 g/d Patiromer
Hide Arm/Group Description:
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.
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.
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.
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.
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.
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 Number of Participants Analyzed 50 49 44 15 19 15
Mean (Standard Deviation)
Unit of Measure: mEq/L
-0.54  (0.465) -0.44  (0.440) -0.50  (0.417) -1.00  (0.466) -0.96  (0.414) -1.17  (0.569)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Stratum 1: 8.4 g/d Patiromer
Comments Each starting dose group was compared to its baseline.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value -0.54
Estimation Comments Estimated values were based on summary statistics.
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Stratum 1: 16.8 g/d Patiromer
Comments Each starting dose group was compared to its baseline.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value -0.44
Estimation Comments Estimated values were based on summary statistics.
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Stratum 1: 25.2 g/d Patiromer
Comments Each starting dose group was compared to its baseline.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value -0.50
Estimation Comments Estimated values were based on summary statistics.
Show Statistical Analysis 4 Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection Stratum 2: 16.8 g/d Patiromer
Comments Each starting dose group was compared to its baseline.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value -1.00
Estimation Comments Estimated values were based on summary statistics.
Show Statistical Analysis 5 Hide Statistical Analysis 5
Statistical Analysis Overview Comparison Group Selection Stratum 2: 25.2 g/d Patiromer
Comments Each starting dose group was compared to its baseline.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value -0.96
Estimation Comments Estimated values were based on summary statistics.
Show Statistical Analysis 6 Hide Statistical Analysis 6
Statistical Analysis Overview Comparison Group Selection Stratum 2: 33.6 g/d Patiromer
Comments Each starting dose group was compared to its baseline.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value -1.17
Estimation Comments Estimated values were based on summary statistics.
5.Secondary Outcome
Title Mean Change in Serum Potassium From Week 52 or Last Patiromer Dose (if Occurred Before Week 52) to Follow-up Visits Plus 7 Days
Hide Description [Not Specified]
Time Frame Week 52 or Last Patiromer Dose (if Occurred before Week 52) to Following up Visit Plus 7 Days
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Stratum 1: 8.4 g/d Patiromer Stratum 1: 16.8 g/d Patiromer Stratum 1: 25.2 g/d Patiromer Stratum 2: 16.8 g/d Patiromer Stratum 2: 25.2 g/d Patiromer Stratum 2: 33.6 g/d Patiromer
Hide Arm/Group Description:
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.
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.
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.
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.
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.
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 Number of Participants Analyzed 52 52 50 20 17 20
Mean (Standard Deviation)
Unit of Measure: mEq/L
0.36  (0.567) 0.22  (0.424) 0.30  (0.508) 0.41  (0.660) 0.39  (0.331) 0.58  (0.557)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Stratum 1: 8.4 g/d Patiromer
Comments Each starting dose group was compared to its baseline.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value 0.36
Estimation Comments Estimated values were based on summary statistics.
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Stratum 1: 16.8 g/d Patiromer
Comments Each starting dose group was compared to its baseline.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value 0.22
Estimation Comments Estimated values were based on summary statistics.
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Stratum 1: 25.2 g/d Patiromer
Comments Each starting dose group was compared to its baseline.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value 0.30
Estimation Comments Estimated values were based on summary statistics.
Show Statistical Analysis 4 Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection Stratum 2: 16.8 g/d Patiromer
Comments Each starting dose group was compared to its baseline.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value 0.41
Estimation Comments Estimated values were based on summary statistics.
Show Statistical Analysis 5 Hide Statistical Analysis 5
Statistical Analysis Overview Comparison Group Selection Stratum 2: 25.2 g/d Patiromer
Comments Each starting dose group was compared to its baseline.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value 0.39
Estimation Comments Estimated values were based on summary statistics.
Show Statistical Analysis 6 Hide Statistical Analysis 6
Statistical Analysis Overview Comparison Group Selection Stratum 2: 33.6 g/d Patiromer
Comments Each starting dose group was compared to its baseline.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value 0.58
Estimation Comments Estimated values were based on summary statistics.
6.Secondary Outcome
Title Proportion of Participants Achieving Serum Potassium Levels Within 3.5 to 5.5 mEq/L at Week 8 for Each Individual Starting Dose Group
Hide Description [Not Specified]
Time Frame Baseline to Week 8
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Stratum 1: 8.4 g/d Patiromer Stratum 1: 16.8 g/d Patiromer Stratum 1: 25.2 g/d Patiromer Stratum 2: 16.8 g/d Patiromer Stratum 2: 25.2 g/d Patiromer Stratum 2: 33.6 g/d Patiromer
Hide Arm/Group Description:
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.
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.
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.
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.
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.
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 Number of Participants Analyzed 63 65 64 24 24 22
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
100
(94.3 to 100.0)
100
(94.5 to 100)
98.4
(91.6 to 100)
91.7
(73.0 to 99.0)
95.8
(78.9 to 99.9)
95.5
(77.2 to 99.9)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Stratum 1: 8.4 g/d Patiromer
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Percentage of Participants
Estimated Value 100
Confidence Interval (2-Sided) 95%
94.3 to 100.0
Estimation Comments 2-sided 95% exact binomial CI
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Stratum 1: 16.8 g/d Patiromer
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Percentage of Participants
Estimated Value 100
Confidence Interval (2-Sided) 95%
94.5 to 100
Estimation Comments 2-sided 95% exact binomial CI
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Stratum 1: 25.2 g/d Patiromer
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Percentage of Participants
Estimated Value 98.4
Confidence Interval (2-Sided) 95%
91.6 to 100
Estimation Comments 2-sided 95% exact binomial CI
Show Statistical Analysis 4 Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection Stratum 2: 16.8 g/d Patiromer
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Percentage of Participants
Estimated Value 91.7
Confidence Interval (2-Sided) 95%
73 to 99
Estimation Comments 2-sided 95% exact binomial CI
Show Statistical Analysis 5 Hide Statistical Analysis 5
Statistical Analysis Overview Comparison Group Selection Stratum 2: 25.2 g/d Patiromer
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Percentage of Participants
Estimated Value 95.8
Confidence Interval (2-Sided) 95%
78.9 to 99.9
Estimation Comments 2-sided 95% exact binomial CI
Show Statistical Analysis 6 Hide Statistical Analysis 6
Statistical Analysis Overview Comparison Group Selection Stratum 2: 33.6 g/d Patiromer
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Percentage of Participants
Estimated Value 95.5
Confidence Interval (2-Sided) 95%
77.2 to 99.9
Estimation Comments 2-sided 95% exact binomial CI
7.Secondary Outcome
Title Proportion of Participants Achieving Serum Potassium Levels Within 4.0 to 5.0 mEq/L at Week 8 for Each Individual Starting Dose Group
Hide Description [Not Specified]
Time Frame Baseline to Week 8
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Stratum 1: 8.4 g/d Patiromer Stratum 1: 16.8 g/d Patiromer Stratum 1: 25.2 g/d Patiromer Stratum 2: 16.8 g/d Patiromer Stratum 2: 25.2 g/d Patiromer Stratum 2: 33.6 g/d Patiromer
Hide Arm/Group Description:
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.
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.
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.
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.
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.
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 Number of Participants Analyzed 63 65 64 24 24 22
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
95.2
(86.7 to 99.0)
90.8
(81.0 to 96.5)
81.3
(69.5 to 89.9)
79.2
(57.8 to 92.9)
91.7
(73.0 to 99.0)
77.3
(54.6 to 92.2)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Stratum 1: 8.4 g/d Patiromer
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Percentage of Participants
Estimated Value 95.2
Confidence Interval (2-Sided) 95%
86.7 to 99.0
Estimation Comments 2-sided 95% exact binomial CI
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Stratum 1: 16.8 g/d Patiromer
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Percentage of Participants
Estimated Value 90.8
Confidence Interval (2-Sided) 95%
81.0 to 96.5
Estimation Comments 2-sided 95% exact binomial CI
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Stratum 1: 25.2 g/d Patiromer
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Percentage of Participants
Estimated Value 81.3
Confidence Interval (2-Sided) 95%
69.5 to 89.9
Estimation Comments 2-sided 95% exact binomial CI
Show Statistical Analysis 4 Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection Stratum 2: 16.8 g/d Patiromer
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Percentage of Participants
Estimated Value 79.2
Confidence Interval (2-Sided) 95%
57.8 to 92.9
Estimation Comments 2-sided 95% exact binomial CI
Show Statistical Analysis 5 Hide Statistical Analysis 5
Statistical Analysis Overview Comparison Group Selection Stratum 2: 25.2 g/d Patiromer
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Percentage of Participants
Estimated Value 91.7
Confidence Interval (2-Sided) 95%
73 to 99
Estimation Comments 2-sided 95% exact binomial CI
Show Statistical Analysis 6 Hide Statistical Analysis 6
Statistical Analysis Overview Comparison Group Selection Stratum 2: 33.6 g/d Patiromer
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Percentage of Participants
Estimated Value 77.3
Confidence Interval (2-Sided) 95%
54.6 to 92.2
Estimation Comments 2-sided 95% exact binomial CI
8.Secondary Outcome
Title Time to First Serum Potassium Measurement of 4.0 - 5.0 mEq/L During Treatment Initiation Period for Each Individual Starting Dose Group
Hide Description [Not Specified]
Time Frame Baseline to Week 8
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Stratum 1: 8.4 g/d Patiromer Stratum 1: 16.8 g/d Patiromer Stratum 1: 25.2 g/d Patiromer Stratum 2: 16.8 g/d Patiromer Stratum 2: 25.2 g/d Patiromer Stratum 2: 33.6 g/d Patiromer
Hide Arm/Group Description:
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
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.
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.
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.
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.
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 Number of Participants Analyzed 72 72 73 26 28 30
Median (95% Confidence Interval)
Unit of Measure: Days
4
(4 to 5)
4
(4 to 6)
4
(4 to 5)
8
(4 to 9)
7.5
(4 to 8)
8
(4 to 8)
9.Secondary Outcome
Title Proportions of Participants Achieving Serum Potassium Levels Within 3.8 to 5.0 mEq/L at Week 52 for Each Individual Starting Dose Group
Hide Description [Not Specified]
Time Frame Baseline to Week 52
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Stratum 1: 8.4 g/d Patiromer Stratum 1: 16.8 g/d Patiromer Stratum 1: 25.2 g/d Patiromer Stratum 2: 16.8 g/d Patiromer Stratum 2: 25.2 g/d Patiromer Stratum 2: 33.6 g/d Patiromer
Hide Arm/Group Description:
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.
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.
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.
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.
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.
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 Number of Participants Analyzed 58 63 59 22 24 20
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
86.3
(73.7 to 94.3)
81.6
(68.0 to 91.2)
88.9
(75.9 to 96.3)
86.7
(59.5 to 98.3)
89.5
(66.9 to 98.7)
93.3
(68.1 to 99.8)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Stratum 1: 8.4 g/d Patiromer
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Percentage of Participants
Estimated Value 86.3
Confidence Interval (2-Sided) 95%
73.7 to 94.3
Estimation Comments 2-sided 95% exact binomial CI
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Stratum 1: 16.8 g/d Patiromer
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Percentage of Participants
Estimated Value 81.6
Confidence Interval (2-Sided) 95%
68.0 to 91.2
Estimation Comments 2-sided 95% exact binomial CI
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Stratum 1: 25.2 g/d Patiromer
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Percentage of Participants
Estimated Value 88.9
Confidence Interval (2-Sided) 95%
75.9 to 96.3
Estimation Comments 2-sided 95% exact binomial CI
Show Statistical Analysis 4 Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection Stratum 2: 16.8 g/d Patiromer
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Percentage of Participants
Estimated Value 86.7
Confidence Interval (2-Sided) 95%
59.5 to 98.3
Estimation Comments 2-sided 95% exact binomial CI
Show Statistical Analysis 5 Hide Statistical Analysis 5
Statistical Analysis Overview Comparison Group Selection Stratum 2: 25.2 g/d Patiromer
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Percentage of Participants
Estimated Value 89.5
Confidence Interval (2-Sided) 95%
66.9 to 98.7
Estimation Comments 2-sided 95% exact binomial CI
Show Statistical Analysis 6 Hide Statistical Analysis 6
Statistical Analysis Overview Comparison Group Selection Stratum 2: 33.6 g/d Patiromer
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Percentage of Participants
Estimated Value 93.3
Confidence Interval (2-Sided) 95%
68.1 to 99.8
Estimation Comments 2-sided 95% exact binomial CI
Time Frame Up to 28 days after Week 52 or last patiromer dose, whichever was earlier
Adverse Event Reporting Description Randomized participants who received at least one dose of trial medication
 
Arm/Group Title Stratum 1: 8.4 g/d Patiromer Stratum 1: 16.8 g/d Patiromer Stratum 1: 25.2 g/d Patiromer Stratum 2: 16.8 g/d Patiromer Stratum 2: 25.2 g/d Patiromer Stratum 2: 33.6 g/d Patiromer
Hide Arm/Group Description 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. 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. 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. 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. 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. 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.
All-Cause Mortality
Stratum 1: 8.4 g/d Patiromer Stratum 1: 16.8 g/d Patiromer Stratum 1: 25.2 g/d Patiromer Stratum 2: 16.8 g/d Patiromer Stratum 2: 25.2 g/d Patiromer Stratum 2: 33.6 g/d Patiromer
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/--   --/--   --/--   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Stratum 1: 8.4 g/d Patiromer Stratum 1: 16.8 g/d Patiromer Stratum 1: 25.2 g/d Patiromer Stratum 2: 16.8 g/d Patiromer Stratum 2: 25.2 g/d Patiromer Stratum 2: 33.6 g/d Patiromer
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   9/74 (12.16%)   10/73 (13.70%)   10/73 (13.70%)   6/26 (23.08%)   5/28 (17.86%)   4/30 (13.33%) 
Cardiac disorders             
Acute left ventricular failure  1  1/74 (1.35%)  0/73 (0.00%)  0/73 (0.00%)  0/26 (0.00%)  0/28 (0.00%)  0/30 (0.00%) 
Acute myocardial infarction  1  0/74 (0.00%)  0/73 (0.00%)  0/73 (0.00%)  1/26 (3.85%)  0/28 (0.00%)  1/30 (3.33%) 
Angina pectoris  1  0/74 (0.00%)  0/73 (0.00%)  0/73 (0.00%)  0/26 (0.00%)  1/28 (3.57%)  0/30 (0.00%) 
Atrial fibrillation  1  0/74 (0.00%)  1/73 (1.37%)  0/73 (0.00%)  0/26 (0.00%)  0/28 (0.00%)  0/30 (0.00%) 
Atrioventricular block complete  1  0/74 (0.00%)  0/73 (0.00%)  0/73 (0.00%)  1/26 (3.85%)  0/28 (0.00%)  0/30 (0.00%) 
Cardiac failure  1  0/74 (0.00%)  0/73 (0.00%)  0/73 (0.00%)  1/26 (3.85%)  1/28 (3.57%)  1/30 (3.33%) 
Cardiac failure chronic  1  0/74 (0.00%)  1/73 (1.37%)  0/73 (0.00%)  1/26 (3.85%)  0/28 (0.00%)  0/30 (0.00%) 
Myocardial infarction  1  0/74 (0.00%)  1/73 (1.37%)  1/73 (1.37%)  0/26 (0.00%)  1/28 (3.57%)  0/30 (0.00%) 
Eye disorders             
Diabetic retinopathy  1  0/74 (0.00%)  1/73 (1.37%)  0/73 (0.00%)  0/26 (0.00%)  0/28 (0.00%)  0/30 (0.00%) 
Gastrointestinal disorders             
Gastric ulcer  1  0/74 (0.00%)  0/73 (0.00%)  0/73 (0.00%)  0/26 (0.00%)  0/28 (0.00%)  1/30 (3.33%) 
Gastric ulcer haemorrhage  1  0/74 (0.00%)  1/73 (1.37%)  0/73 (0.00%)  0/26 (0.00%)  0/28 (0.00%)  0/30 (0.00%) 
Mesenteric artery thrombosis  1  0/74 (0.00%)  0/73 (0.00%)  0/73 (0.00%)  0/26 (0.00%)  1/28 (3.57%)  0/30 (0.00%) 
General disorders             
Brain death  1  0/74 (0.00%)  0/73 (0.00%)  1/73 (1.37%)  0/26 (0.00%)  0/28 (0.00%)  0/30 (0.00%) 
Sudden cardiac death  1  0/74 (0.00%)  0/73 (0.00%)  3/73 (4.11%)  0/26 (0.00%)  0/28 (0.00%)  0/30 (0.00%) 
Sudden death  1  0/74 (0.00%)  0/73 (0.00%)  1/73 (1.37%)  1/26 (3.85%)  2/28 (7.14%)  1/30 (3.33%) 
Hepatobiliary disorders             
Cholecystitis  1  0/74 (0.00%)  1/73 (1.37%)  0/73 (0.00%)  0/26 (0.00%)  0/28 (0.00%)  0/30 (0.00%) 
Infections and infestations             
Appendicitis  1  1/74 (1.35%)  0/73 (0.00%)  0/73 (0.00%)  0/26 (0.00%)  0/28 (0.00%)  0/30 (0.00%) 
Arteriosclerotic gangrene  1  1/74 (1.35%)  0/73 (0.00%)  0/73 (0.00%)  0/26 (0.00%)  0/28 (0.00%)  0/30 (0.00%) 
Gastrointestinal infection  1  0/74 (0.00%)  1/73 (1.37%)  0/73 (0.00%)  0/26 (0.00%)  0/28 (0.00%)  0/30 (0.00%) 
Pneumonia  1  0/74 (0.00%)  0/73 (0.00%)  1/73 (1.37%)  0/26 (0.00%)  0/28 (0.00%)  0/30 (0.00%) 
Urinary tract infection  1  0/74 (0.00%)  0/73 (0.00%)  0/73 (0.00%)  1/26 (3.85%)  0/28 (0.00%)  0/30 (0.00%) 
Investigations             
Intraocular pressure increased  1  0/74 (0.00%)  0/73 (0.00%)  0/73 (0.00%)  0/26 (0.00%)  0/28 (0.00%)  1/30 (3.33%) 
Metabolism and nutrition disorders             
Diabetes mellitus inadequate control  1  0/74 (0.00%)  1/73 (1.37%)  0/73 (0.00%)  0/26 (0.00%)  0/28 (0.00%)  0/30 (0.00%) 
Gout  1  1/74 (1.35%)  0/73 (0.00%)  0/73 (0.00%)  0/26 (0.00%)  0/28 (0.00%)  0/30 (0.00%) 
Hypoglycaemia  1  0/74 (0.00%)  1/73 (1.37%)  0/73 (0.00%)  0/26 (0.00%)  0/28 (0.00%)  0/30 (0.00%) 
Hypovolaemia  1  1/74 (1.35%)  0/73 (0.00%)  0/73 (0.00%)  0/26 (0.00%)  0/28 (0.00%)  0/30 (0.00%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)             
Colon cancer  1  0/74 (0.00%)  0/73 (0.00%)  1/73 (1.37%)  0/26 (0.00%)  0/28 (0.00%)  0/30 (0.00%) 
Nervous system disorders             
Cerebrovascular accident  1  1/74 (1.35%)  1/73 (1.37%)  0/73 (0.00%)  0/26 (0.00%)  0/28 (0.00%)  0/30 (0.00%) 
Ischaemic stroke  1  1/74 (1.35%)  0/73 (0.00%)  1/73 (1.37%)  0/26 (0.00%)  0/28 (0.00%)  0/30 (0.00%) 
Transient ischaemic attack  1  1/74 (1.35%)  0/73 (0.00%)  0/73 (0.00%)  0/26 (0.00%)  0/28 (0.00%)  0/30 (0.00%) 
Renal and urinary disorders             
Nephropathy toxic  1  0/74 (0.00%)  0/73 (0.00%)  0/73 (0.00%)  0/26 (0.00%)  0/28 (0.00%)  1/30 (3.33%) 
Renal failure chronic  1  0/74 (0.00%)  2/73 (2.74%)  1/73 (1.37%)  1/26 (3.85%)  1/28 (3.57%)  1/30 (3.33%) 
Tubulointerstitial nephritis  1  0/74 (0.00%)  0/73 (0.00%)  0/73 (0.00%)  1/26 (3.85%)  0/28 (0.00%)  0/30 (0.00%) 
Vascular disorders             
Diabetic vascular disorder  1  2/74 (2.70%)  0/73 (0.00%)  0/73 (0.00%)  0/26 (0.00%)  0/28 (0.00%)  0/30 (0.00%) 
Femoral artery occlusion  1  1/74 (1.35%)  0/73 (0.00%)  0/73 (0.00%)  0/26 (0.00%)  0/28 (0.00%)  0/30 (0.00%) 
Hypertensive crisis  1  0/74 (0.00%)  0/73 (0.00%)  1/73 (1.37%)  0/26 (0.00%)  0/28 (0.00%)  0/30 (0.00%) 
Hypotension  1  1/74 (1.35%)  0/73 (0.00%)  0/73 (0.00%)  0/26 (0.00%)  0/28 (0.00%)  0/30 (0.00%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA (12.0)
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Stratum 1: 8.4 g/d Patiromer Stratum 1: 16.8 g/d Patiromer Stratum 1: 25.2 g/d Patiromer Stratum 2: 16.8 g/d Patiromer Stratum 2: 25.2 g/d Patiromer Stratum 2: 33.6 g/d Patiromer
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   28/74 (37.84%)   29/73 (39.73%)   29/73 (39.73%)   14/26 (53.85%)   14/28 (50.00%)   22/30 (73.33%) 
Blood and lymphatic system disorders             
Anaemia  1  2/74 (2.70%)  2/73 (2.74%)  4/73 (5.48%)  0/26 (0.00%)  1/28 (3.57%)  2/30 (6.67%) 
Cardiac disorders             
Angina pectoris  1  0/74 (0.00%)  1/73 (1.37%)  2/73 (2.74%)  1/26 (3.85%)  2/28 (7.14%)  0/30 (0.00%) 
Cardiac failure chronic  1  0/74 (0.00%)  0/73 (0.00%)  1/73 (1.37%)  2/26 (7.69%)  0/28 (0.00%)  0/30 (0.00%) 
Ventricular extrasystoles  1  2/74 (2.70%)  4/73 (5.48%)  2/73 (2.74%)  0/26 (0.00%)  1/28 (3.57%)  2/30 (6.67%) 
Gastrointestinal disorders             
Constipation  1  4/74 (5.41%)  3/73 (4.11%)  4/73 (5.48%)  2/26 (7.69%)  1/28 (3.57%)  5/30 (16.67%) 
Diarrhoea  1  6/74 (8.11%)  5/73 (6.85%)  1/73 (1.37%)  3/26 (11.54%)  1/28 (3.57%)  1/30 (3.33%) 
Infections and infestations             
Influenza  1  3/74 (4.05%)  0/73 (0.00%)  4/73 (5.48%)  1/26 (3.85%)  1/28 (3.57%)  0/30 (0.00%) 
Nasopharyngitis  1  0/74 (0.00%)  1/73 (1.37%)  2/73 (2.74%)  1/26 (3.85%)  1/28 (3.57%)  2/30 (6.67%) 
Urinary tract infection  1  3/74 (4.05%)  3/73 (4.11%)  2/73 (2.74%)  0/26 (0.00%)  2/28 (7.14%)  0/30 (0.00%) 
Metabolism and nutrition disorders             
Hypercholesterolaemia  1  1/74 (1.35%)  2/73 (2.74%)  1/73 (1.37%)  0/26 (0.00%)  2/28 (7.14%)  0/30 (0.00%) 
Hypoglycaemia  1  1/74 (1.35%)  1/73 (1.37%)  1/73 (1.37%)  2/26 (7.69%)  1/28 (3.57%)  3/30 (10.00%) 
Hypokalaemia  1  2/74 (2.70%)  1/73 (1.37%)  0/73 (0.00%)  1/26 (3.85%)  0/28 (0.00%)  3/30 (10.00%) 
Hypomagnesaemia  1  4/74 (5.41%)  5/73 (6.85%)  6/73 (8.22%)  2/26 (7.69%)  4/28 (14.29%)  5/30 (16.67%) 
Nervous system disorders             
Headache  1  3/74 (4.05%)  2/73 (2.74%)  1/73 (1.37%)  0/26 (0.00%)  0/28 (0.00%)  2/30 (6.67%) 
Renal and urinary disorders             
Renal failure chronic  1  5/74 (6.76%)  4/73 (5.48%)  2/73 (2.74%)  2/26 (7.69%)  3/28 (10.71%)  6/30 (20.00%) 
Vascular disorders             
Hypertension  1  5/74 (6.76%)  7/73 (9.59%)  2/73 (2.74%)  4/26 (15.38%)  2/28 (7.14%)  4/30 (13.33%) 
Hypotension  1  0/74 (0.00%)  1/73 (1.37%)  1/73 (1.37%)  0/26 (0.00%)  0/28 (0.00%)  2/30 (6.67%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA (12.0)
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
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.
Results Point of Contact
Name/Title: Medical Information
Organization: Relypsa, Inc.
Phone: 1-844-relypsa
Responsible Party: Relypsa, Inc.
ClinicalTrials.gov Identifier: NCT01371747     History of Changes
Other Study ID Numbers: RLY5016-205
2011-000165-12 ( EudraCT Number )
First Submitted: June 9, 2011
First Posted: June 13, 2011
Results First Submitted: November 11, 2015
Results First Posted: December 17, 2015
Last Update Posted: April 26, 2017