Hyperkalemia, Resistant Hypertension
Conditions
Keywords
Treatment of Hyperkalemia, Hyperkalemia, Potassium, Chronic Kidney Disease, Hypertension, Resistant Hypertension, Spironolactone
Brief summary
The purpose of this study is to determine if patiromer treatment in chronic kidney disease (CKD) subjects receiving spironolactone for the treatment of resistant hypertension will result in more persistent use of spironolactone through prevention of hyperkalemia and lead to improved blood pressure control compared with treatment with spironolactone alone (placebo).
Detailed description
Approximately 290 eligible participants with \[chronic kidney disease (CKD) on stable doses of medication\] will be randomly assigned to receive a patiromer or placebo starting dose of two packets a day, once a day. All eligible participants will undergo a screening/run-in period (up to 4 weeks) to determine eligibility for study entry. Eligible participants will be randomized and treated for 12 weeks (Treatment Period) and followed for 2 weeks after completing the patiromer or placebo treatment. There are 8 planned clinic visits during the Treatment Period and one planned visit two weeks after the last dose of patiromer or placebo (Follow-up Period). The dose of patiromer or placebo may be increased or decreased (titrated) based on participants' individual potassium response.
Interventions
DRUGPatiromer
2 packets/day starting dose, administered orally
DRUGPlacebo
2 packets/day starting dose, administered orally
DRUGSpironolactone
25 mg tablet/day starting dose, administered orally
Sponsors
Relypsa, Inc.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Age ≥ 18 years * Taking at least three medications for blood pressure (one a diuretic) * Uncontrolled high blood pressure * Abnormal kidney function (with-eGFR, a measure of kidney function, of 25 - ≤ 45 mL/min/1.73m2 * Normal Blood serum Potassium in a specific range (4.3 - 5.1 mEq/L)
Exclusion criteria
* History of untreated known causes of high blood pressure, excluding kidney disease (not CKD) * Inability to measure BP * Not taking high blood pressure medications as prescribed medications * Recent change in renal function (in the past 3 months) which has required hospitalization or dialysis * Renal transplant * History of cancer within past 12 months * Recent cardiovascular event with last 3 months * Clinically significant abnormalities of heart rhythm (ventricular arrhythmia or atrial fibrillation with uncontrolled heart rate) * Inability to take study medication * Alcoholism
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants Remaining on Spironolactone at Week 12 | At week 12 | The proportion of subjects remaining on spironolactone at Week 12 will be compared between treatment groups (spironolactone/patiromer versus spironolactone/placebo). Subjects who discontinued from the study early or discontinued study spironolactone prior to Week 12, for any reason, were considered as not having remained on spironolactone until Week 12. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in AOBP SBP From Baseline to Week 12 or Last Available AOBP SBP Prior to Addition of Any New BP Medications or Increase From Any Baseline BP Medications | From baseline to Week 12 | AOBP: Automated Office Blood Pressure SBP: Systolic Blood Pressure BP: Blood Pressure |
Other
| Measure | Time frame | Description |
|---|---|---|
| Central Serum Potassium Change From Baseline to Week 12 by Baseline Serum Potassium Category | From baseline to Week 12 | The two baseline potassium subgroups, 4.3-\<4.7 mEq/L versus 4.7-5.1 mEq/L, are based on central laboratory data. If a participant's serum potassium result at baseline was not in one of the two subgroups reported below, the participant's potassium stratum at randomization was used. Therefore, participants with BCSP \<4.3 mEq/L or \>5.1 mEq/L at baseline (Day 0) have been classified according to their serum potassium values at the Screening period. |
| Participants With Central Serum Potassium <5.5 mEq/L Over Time | From baseline to Week 12 | Baseline Central Serum Potassium: BCSP. The symbols \> and ≤ included in the row titles are used to indicate the time interval \[\>Week1 and ≤Week2 meaning from day 8 until day 14 (included)\]. If a participant's serum potassium result at baseline was not in one of the two subgroups reported below, the participant's potassium stratum at randomization was used. Therefore, participants with BCSP \<4.3 mEq/L or \>5.1 mEq/L at baseline (Day 0) have been classified according to their serum potassium values at the Screening period. |
| Spironolactone Dose Level at End of 12 Weeks of Study Treatment | 12 Weeks of Study Treatment | Row title: Participants not completing 12W of study treatment: Participants who had not completed 12 weeks of study treatment. |
| Number of Participants by Spironolactone Dose Prescribed at Each Visit | From baseline to Week 10 | QD: Once daily QOD: Once every other day |
| Shifts in Selected Laboratory Tests From Baseline to End of Treatment | From Baseline to End of Treatment, up to 12 weeks. | The end of treatment value is defined as the last non-missing value on or prior to the last spironolactone dose date (from End of Treatment - Case report form) + 3 days LLN=Lower limit of the normal range. ULN=Upper limit of the normal range. EoT=End of Treatment |
| Participants Having Spironolactone Titrations Over Time | From baseline to Week 12 | The titration was performed according to the following criteria: Spironolactone was increased in cases of hypertension, decreased or stopped in cases of hypotension and maintained if the blood pressure results were adequate The symbols \> and ≤ included in the row titles are used to indicate the time interval \[\>Week1 and ≤Week2 meaning from day 8 until day 14 (included)\]. |
| Change in AOBP SBP From Baseline to Week 12 Regardless of Increase in Antihypertensives | From baseline to Week 12 | AOBP SBP: Automated Office Systolic Blood Pressure |
Countries
Bulgaria, Croatia, Georgia, Germany, Hungary, South Africa, Ukraine, United Kingdom, United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Group 1 - Patiromer Spironolactone + blinded patiromer
Patiromer: 2 packets/day starting dose, administered orally
Spironolactone: 25 mg tablet/day starting dose, administered orally | 147 |
| Group 2 - Placebo Spironolactone + blinded placebo
Placebo: 2 packets/day starting dose, administered orally
Spironolactone: 25 mg tablet/day starting dose, administered orally | 148 |
| Total | 295 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Adverse Event | 1 | 3 |
| Overall Study | Participant moved to another city | 0 | 1 |
| Overall Study | Physician Decision | 1 | 0 |
| Overall Study | Withdrawal by Subject | 1 | 3 |
Baseline characteristics
| Characteristic | Group 2 - Placebo | Group 1 - Patiromer | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 104 Participants | 98 Participants | 202 Participants |
| Age, Categorical Between 18 and 65 years | 44 Participants | 49 Participants | 93 Participants |
| Age, Continuous | 68.5 years STANDARD_DEVIATION 11.13 | 67.8 years STANDARD_DEVIATION 12.24 | 68.1 years STANDARD_DEVIATION 11.69 |
| Antihypertensive Medications at Baseline Amlodipine | 86 Participants | 74 Participants | 160 Participants |
| Antihypertensive Medications at Baseline Bisoprolol | 43 Participants | 34 Participants | 77 Participants |
| Antihypertensive Medications at Baseline Furosemide | 17 Participants | 26 Participants | 43 Participants |
| Antihypertensive Medications at Baseline Hydrochlorothiazide | 60 Participants | 52 Participants | 112 Participants |
| Antihypertensive Medications at Baseline Indapamide | 58 Participants | 62 Participants | 120 Participants |
| Antihypertensive Medications at Baseline Lercanidipine | 15 Participants | 18 Participants | 33 Participants |
| Antihypertensive Medications at Baseline Losartan | 26 Participants | 20 Participants | 46 Participants |
| Antihypertensive Medications at Baseline Nebivolol | 19 Participants | 26 Participants | 45 Participants |
| Antihypertensive Medications at Baseline Other antihypertensives | 31 Participants | 40 Participants | 71 Participants |
| Antihypertensive Medications at Baseline Perindopril | 51 Participants | 54 Participants | 105 Participants |
| Antihypertensive Medications at Baseline Torasemide | 17 Participants | 15 Participants | 32 Participants |
| Antihypertensive Medications at Baseline Valsartan | 27 Participants | 38 Participants | 65 Participants |
| Baseline central laboratory serum potassium Baseline serum potassium 4.3-<4.7 mEq/L | 52 Participants | 55 Participants | 107 Participants |
| Baseline central laboratory serum potassium Baseline serum potassium <4.3 mEq/L | 17 Participants | 7 Participants | 24 Participants |
| Baseline central laboratory serum potassium Baseline serum potassium 4.7-5.1 mEq/L | 65 Participants | 65 Participants | 130 Participants |
| Baseline central laboratory serum potassium Baseline serum potassium >5.1 mEq/L | 14 Participants | 20 Participants | 34 Participants |
| Baseline eGFR | 36.08 mL/min/1.73m^2 STANDARD_DEVIATION 7.597 | 35.37 mL/min/1.73m^2 STANDARD_DEVIATION 7.274 | 35.73 mL/min/1.73m^2 STANDARD_DEVIATION 7.434 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 16 Participants | 7 Participants | 23 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 131 Participants | 140 Participants | 271 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 1 Participants | 0 Participants | 1 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 2 Participants | 2 Participants | 4 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 1 Participants | 0 Participants | 1 Participants |
| Race (NIH/OMB) White | 145 Participants | 145 Participants | 290 Participants |
| Sex: Female, Male Female | 71 Participants | 71 Participants | 142 Participants |
| Sex: Female, Male Male | 77 Participants | 76 Participants | 153 Participants |
| Systolic blood pressure as measured using automated office blood pressure device (AOBP SBP) | 144.9 mmHg STANDARD_DEVIATION 7.01 | 143.3 mmHg STANDARD_DEVIATION 6.48 | 144.1 mmHg STANDARD_DEVIATION 6.79 |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 147 | 1 / 148 |
| other Total, other adverse events | 47 / 147 | 48 / 148 |
| serious Total, serious adverse events | 1 / 147 | 4 / 148 |
Outcome results
Primary
Number of Participants Remaining on Spironolactone at Week 12
The proportion of subjects remaining on spironolactone at Week 12 will be compared between treatment groups (spironolactone/patiromer versus spironolactone/placebo). Subjects who discontinued from the study early or discontinued study spironolactone prior to Week 12, for any reason, were considered as not having remained on spironolactone until Week 12.
Time frame: At week 12
Population: Intent-to-Treat population (ITT): The ITT population included all participants who were randomized and who took at least 1 dose of spironolactone and at least 1 dose of patiromer/placebo.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Group 1 - Patiromer | Number of Participants Remaining on Spironolactone at Week 12 | 126 Participants |
| Group 2 - Placebo | Number of Participants Remaining on Spironolactone at Week 12 | 98 Participants |
Comparison: A sample size of 280 subjects has 90% power to detect a difference between treatment groups of 20% or more in the proportion of subjects remaining on spironolactone at Week 12, at α = 0.05.p-value: <0.0001Cochran-Mantel-Haenszel
Secondary
Change in AOBP SBP From Baseline to Week 12 or Last Available AOBP SBP Prior to Addition of Any New BP Medications or Increase From Any Baseline BP Medications
AOBP: Automated Office Blood Pressure SBP: Systolic Blood Pressure BP: Blood Pressure
Time frame: From baseline to Week 12
Population: Intent-to-Treat population (ITT): The ITT population included all participants who were randomized and who took at least 1 dose of spironolactone and at least 1 dose of patiromer/placebo.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Group 1 - Patiromer | Change in AOBP SBP From Baseline to Week 12 or Last Available AOBP SBP Prior to Addition of Any New BP Medications or Increase From Any Baseline BP Medications | -11.3 mmHg | Standard Deviation 14.11 |
| Group 2 - Placebo | Change in AOBP SBP From Baseline to Week 12 or Last Available AOBP SBP Prior to Addition of Any New BP Medications or Increase From Any Baseline BP Medications | -11.0 mmHg | Standard Deviation 15.34 |
p-value: 0.5757ANCOVA
Other Pre-specified
Central Serum Potassium Change From Baseline to Week 12 by Baseline Serum Potassium Category
The two baseline potassium subgroups, 4.3-\<4.7 mEq/L versus 4.7-5.1 mEq/L, are based on central laboratory data. If a participant's serum potassium result at baseline was not in one of the two subgroups reported below, the participant's potassium stratum at randomization was used. Therefore, participants with BCSP \<4.3 mEq/L or \>5.1 mEq/L at baseline (Day 0) have been classified according to their serum potassium values at the Screening period.
Time frame: From baseline to Week 12
Population: Intent-to-Treat population (ITT): The ITT population included all participants who were randomized and who took at least 1 dose of spironolactone and at least 1 dose of patiromer/placebo.~Table depicts those participants with values at Baseline and Week 12. Those participants with no available results at W12 were not included in the table below.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Group 1 - Patiromer | Central Serum Potassium Change From Baseline to Week 12 by Baseline Serum Potassium Category | Baseline Central Serum Potassium 4.3-<4.7 mEq/L | 0.16 mEq/L | Standard Deviation 0.468 |
| Group 1 - Patiromer | Central Serum Potassium Change From Baseline to Week 12 by Baseline Serum Potassium Category | Baseline Central Serum Potassium 4.7-<5.1 mEq/L | -0.09 mEq/L | Standard Deviation 0.442 |
| Group 1 - Patiromer | Central Serum Potassium Change From Baseline to Week 12 by Baseline Serum Potassium Category | Overall | 0.02 mEq/L | Standard Deviation 0.469 |
| Group 2 - Placebo | Central Serum Potassium Change From Baseline to Week 12 by Baseline Serum Potassium Category | Baseline Central Serum Potassium 4.3-<4.7 mEq/L | 0.40 mEq/L | Standard Deviation 0.494 |
| Group 2 - Placebo | Central Serum Potassium Change From Baseline to Week 12 by Baseline Serum Potassium Category | Baseline Central Serum Potassium 4.7-<5.1 mEq/L | 0.03 mEq/L | Standard Deviation 0.468 |
| Group 2 - Placebo | Central Serum Potassium Change From Baseline to Week 12 by Baseline Serum Potassium Category | Overall | 0.20 mEq/L | Standard Deviation 0.514 |
Other Pre-specified
Change in AOBP SBP From Baseline to Week 12 Regardless of Increase in Antihypertensives
AOBP SBP: Automated Office Systolic Blood Pressure
Time frame: From baseline to Week 12
Population: Intent-to-Treat population (ITT): The ITT population included all participants who were randomized and who took at least 1 dose of spironolactone and at least 1 dose of patiromer/placebo.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Group 1 - Patiromer | Change in AOBP SBP From Baseline to Week 12 Regardless of Increase in Antihypertensives | -11.3 mmHg | Standard Deviation 14.11 |
| Group 2 - Placebo | Change in AOBP SBP From Baseline to Week 12 Regardless of Increase in Antihypertensives | -11.2 mmHg | Standard Deviation 15.04 |
Comparison: The p-value is from a test comparing the difference between two groups in the mean change in AOBP SBP from baseline.p-value: 0.6367ANCOVA
Other Pre-specified
Number of Participants by Spironolactone Dose Prescribed at Each Visit
QD: Once daily QOD: Once every other day
Time frame: From baseline to Week 10
Population: Intent-to-Treat population (ITT): The ITT population included all participants who were randomized and who took at least 1 dose of spironolactone and at least 1 dose of patiromer/placebo.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Group 1 - Patiromer | Number of Participants by Spironolactone Dose Prescribed at Each Visit | 50 mg QD : Week 8 | 106 Participants |
| Group 1 - Patiromer | Number of Participants by Spironolactone Dose Prescribed at Each Visit | 50 mg QD : Week 1 | 0 Participants |
| Group 1 - Patiromer | Number of Participants by Spironolactone Dose Prescribed at Each Visit | 50 mg QD : Week 2 | 0 Participants |
| Group 1 - Patiromer | Number of Participants by Spironolactone Dose Prescribed at Each Visit | 50 mg QD : Week 3 | 86 Participants |
| Group 1 - Patiromer | Number of Participants by Spironolactone Dose Prescribed at Each Visit | 50 mg QD : Week 4 | 105 Participants |
| Group 1 - Patiromer | Number of Participants by Spironolactone Dose Prescribed at Each Visit | 50 mg QD : Week 6 | 106 Participants |
| Group 1 - Patiromer | Number of Participants by Spironolactone Dose Prescribed at Each Visit | 50 mg QD : Baseline | 0 Participants |
| Group 1 - Patiromer | Number of Participants by Spironolactone Dose Prescribed at Each Visit | 50 mg QD : Week 10 | 106 Participants |
| Group 1 - Patiromer | Number of Participants by Spironolactone Dose Prescribed at Each Visit | 25 mg QD : Baseline | 147 Participants |
| Group 1 - Patiromer | Number of Participants by Spironolactone Dose Prescribed at Each Visit | 25 mg QD : Week 1 | 145 Participants |
| Group 1 - Patiromer | Number of Participants by Spironolactone Dose Prescribed at Each Visit | 25 mg QD : Week 2 | 140 Participants |
| Group 1 - Patiromer | Number of Participants by Spironolactone Dose Prescribed at Each Visit | 25 mg QD : Week 3 | 49 Participants |
| Group 1 - Patiromer | Number of Participants by Spironolactone Dose Prescribed at Each Visit | 25 mg QD : Week 4 | 27 Participants |
| Group 1 - Patiromer | Number of Participants by Spironolactone Dose Prescribed at Each Visit | 25 mg QD : Week 6 | 25 Participants |
| Group 1 - Patiromer | Number of Participants by Spironolactone Dose Prescribed at Each Visit | 25 mg QD : Week 8 | 26 Participants |
| Group 1 - Patiromer | Number of Participants by Spironolactone Dose Prescribed at Each Visit | 25 mg QD : Week 10 | 19 Participants |
| Group 1 - Patiromer | Number of Participants by Spironolactone Dose Prescribed at Each Visit | 25 mg QOD : Baseline | 0 Participants |
| Group 1 - Patiromer | Number of Participants by Spironolactone Dose Prescribed at Each Visit | 25 mg QOD : Week 1 | 1 Participants |
| Group 1 - Patiromer | Number of Participants by Spironolactone Dose Prescribed at Each Visit | 25 mg QOD : Week 2 | 3 Participants |
| Group 1 - Patiromer | Number of Participants by Spironolactone Dose Prescribed at Each Visit | 25 mg QOD : Week 3 | 3 Participants |
| Group 1 - Patiromer | Number of Participants by Spironolactone Dose Prescribed at Each Visit | 25 mg QOD : Week 4 | 3 Participants |
| Group 1 - Patiromer | Number of Participants by Spironolactone Dose Prescribed at Each Visit | 25 mg QOD : Week 6 | 2 Participants |
| Group 1 - Patiromer | Number of Participants by Spironolactone Dose Prescribed at Each Visit | 25 mg QOD : Week 8 | 1 Participants |
| Group 1 - Patiromer | Number of Participants by Spironolactone Dose Prescribed at Each Visit | 25 mg QOD : Week 10 | 2 Participants |
| Group 2 - Placebo | Number of Participants by Spironolactone Dose Prescribed at Each Visit | 25 mg QOD : Week 8 | 4 Participants |
| Group 2 - Placebo | Number of Participants by Spironolactone Dose Prescribed at Each Visit | 50 mg QD : Baseline | 0 Participants |
| Group 2 - Placebo | Number of Participants by Spironolactone Dose Prescribed at Each Visit | 25 mg QD : Week 4 | 34 Participants |
| Group 2 - Placebo | Number of Participants by Spironolactone Dose Prescribed at Each Visit | 50 mg QD : Week 1 | 0 Participants |
| Group 2 - Placebo | Number of Participants by Spironolactone Dose Prescribed at Each Visit | 25 mg QOD : Week 2 | 1 Participants |
| Group 2 - Placebo | Number of Participants by Spironolactone Dose Prescribed at Each Visit | 50 mg QD : Week 2 | 0 Participants |
| Group 2 - Placebo | Number of Participants by Spironolactone Dose Prescribed at Each Visit | 25 mg QD : Week 6 | 28 Participants |
| Group 2 - Placebo | Number of Participants by Spironolactone Dose Prescribed at Each Visit | 50 mg QD : Week 3 | 76 Participants |
| Group 2 - Placebo | Number of Participants by Spironolactone Dose Prescribed at Each Visit | 25 mg QOD : Week 6 | 2 Participants |
| Group 2 - Placebo | Number of Participants by Spironolactone Dose Prescribed at Each Visit | 50 mg QD : Week 4 | 94 Participants |
| Group 2 - Placebo | Number of Participants by Spironolactone Dose Prescribed at Each Visit | 25 mg QD : Week 8 | 24 Participants |
| Group 2 - Placebo | Number of Participants by Spironolactone Dose Prescribed at Each Visit | 50 mg QD : Week 6 | 96 Participants |
| Group 2 - Placebo | Number of Participants by Spironolactone Dose Prescribed at Each Visit | 25 mg QOD : Week 3 | 2 Participants |
| Group 2 - Placebo | Number of Participants by Spironolactone Dose Prescribed at Each Visit | 50 mg QD : Week 8 | 85 Participants |
| Group 2 - Placebo | Number of Participants by Spironolactone Dose Prescribed at Each Visit | 25 mg QD : Week 10 | 20 Participants |
| Group 2 - Placebo | Number of Participants by Spironolactone Dose Prescribed at Each Visit | 50 mg QD : Week 10 | 80 Participants |
| Group 2 - Placebo | Number of Participants by Spironolactone Dose Prescribed at Each Visit | 25 mg QOD : Week 10 | 4 Participants |
| Group 2 - Placebo | Number of Participants by Spironolactone Dose Prescribed at Each Visit | 25 mg QD : Baseline | 148 Participants |
| Group 2 - Placebo | Number of Participants by Spironolactone Dose Prescribed at Each Visit | 25 mg QOD : Baseline | 0 Participants |
| Group 2 - Placebo | Number of Participants by Spironolactone Dose Prescribed at Each Visit | 25 mg QD : Week 1 | 144 Participants |
| Group 2 - Placebo | Number of Participants by Spironolactone Dose Prescribed at Each Visit | 25 mg QOD : Week 4 | 3 Participants |
| Group 2 - Placebo | Number of Participants by Spironolactone Dose Prescribed at Each Visit | 25 mg QD : Week 2 | 142 Participants |
| Group 2 - Placebo | Number of Participants by Spironolactone Dose Prescribed at Each Visit | 25 mg QOD : Week 1 | 2 Participants |
| Group 2 - Placebo | Number of Participants by Spironolactone Dose Prescribed at Each Visit | 25 mg QD : Week 3 | 57 Participants |
Post Hoc
Number of Participants Requiring Additional New Antihypertensive Medications or Increases to Baseline Antihypertensive Medications
Row Titles: * AM: Antihypertensive Medication(s) * New AM: Participants who required additional new antihypertensive medication(s) * Increases to baseline AM: Participants who required increases to baseline antihypertensive medication(s) * Addition new (or increase) AM: Participants who required addition of new antihypertensive medication(s) and/or increases to baseline antihypertensive medications * At any time during the study: During study * While on study medication: On medication
Time frame: From baseline to Week 12/Early Termination visit
Population: Intent-to-Treat population (ITT): The ITT population included all participants who were randomized and who took at least 1 dose of spironolactone and at least 1 dose of patiromer/placebo.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Group 1 - Patiromer | Number of Participants Requiring Additional New Antihypertensive Medications or Increases to Baseline Antihypertensive Medications | New AM : At any time during the study | 0 participants |
| Group 1 - Patiromer | Number of Participants Requiring Additional New Antihypertensive Medications or Increases to Baseline Antihypertensive Medications | New AM : On medication | 0 participants |
| Group 1 - Patiromer | Number of Participants Requiring Additional New Antihypertensive Medications or Increases to Baseline Antihypertensive Medications | Increases to baseline AM: During study | 0 participants |
| Group 1 - Patiromer | Number of Participants Requiring Additional New Antihypertensive Medications or Increases to Baseline Antihypertensive Medications | Increases to baseline AM: On medication | 0 participants |
| Group 1 - Patiromer | Number of Participants Requiring Additional New Antihypertensive Medications or Increases to Baseline Antihypertensive Medications | Addition new (or increases) AM: During study | 0 participants |
| Group 1 - Patiromer | Number of Participants Requiring Additional New Antihypertensive Medications or Increases to Baseline Antihypertensive Medications | Addition new (or increases) AM : On medication | 0 participants |
| Group 2 - Placebo | Number of Participants Requiring Additional New Antihypertensive Medications or Increases to Baseline Antihypertensive Medications | Addition new (or increases) AM: During study | 4 participants |
| Group 2 - Placebo | Number of Participants Requiring Additional New Antihypertensive Medications or Increases to Baseline Antihypertensive Medications | New AM : At any time during the study | 3 participants |
| Group 2 - Placebo | Number of Participants Requiring Additional New Antihypertensive Medications or Increases to Baseline Antihypertensive Medications | Increases to baseline AM: On medication | 1 participants |
| Group 2 - Placebo | Number of Participants Requiring Additional New Antihypertensive Medications or Increases to Baseline Antihypertensive Medications | New AM : On medication | 1 participants |
| Group 2 - Placebo | Number of Participants Requiring Additional New Antihypertensive Medications or Increases to Baseline Antihypertensive Medications | Addition new (or increases) AM : On medication | 2 participants |
| Group 2 - Placebo | Number of Participants Requiring Additional New Antihypertensive Medications or Increases to Baseline Antihypertensive Medications | Increases to baseline AM: During study | 2 participants |
Other Pre-specified
Participants Having Spironolactone Titrations Over Time
The titration was performed according to the following criteria: Spironolactone was increased in cases of hypertension, decreased or stopped in cases of hypotension and maintained if the blood pressure results were adequate The symbols \> and ≤ included in the row titles are used to indicate the time interval \[\>Week1 and ≤Week2 meaning from day 8 until day 14 (included)\].
Time frame: From baseline to Week 12
Population: Intent-to-Treat population (ITT): The ITT population included all participants who were randomized and who took at least 1 dose of spironolactone and at least 1 dose of patiromer/placebo.~Reported results only include the number of participants having spironolactone titrations over time according to the classification defined below.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Group 1 - Patiromer | Participants Having Spironolactone Titrations Over Time | Up : ≤Week 1 | 0 Participants |
| Group 1 - Patiromer | Participants Having Spironolactone Titrations Over Time | Up : >Week 1 and ≤Week 2 | 0 Participants |
| Group 1 - Patiromer | Participants Having Spironolactone Titrations Over Time | Up : >Week 2 and ≤Week 3 | 88 Participants |
| Group 1 - Patiromer | Participants Having Spironolactone Titrations Over Time | Up : >Week 3 and ≤Week 4 | 27 Participants |
| Group 1 - Patiromer | Participants Having Spironolactone Titrations Over Time | Up : >Week 4 and ≤Week 6 | 10 Participants |
| Group 1 - Patiromer | Participants Having Spironolactone Titrations Over Time | Up : >Week 6 and ≤Week 8 | 6 Participants |
| Group 1 - Patiromer | Participants Having Spironolactone Titrations Over Time | Up : >Week 8 and ≤Week 10 | 6 Participants |
| Group 1 - Patiromer | Participants Having Spironolactone Titrations Over Time | Up : >Week 10 and ≤Week 12 | 1 Participants |
| Group 1 - Patiromer | Participants Having Spironolactone Titrations Over Time | Down : ≤Week 1 | 1 Participants |
| Group 1 - Patiromer | Participants Having Spironolactone Titrations Over Time | Down : >Week 1 and ≤Week 2 | 2 Participants |
| Group 1 - Patiromer | Participants Having Spironolactone Titrations Over Time | Down : >Week 2 and ≤Week 3 | 2 Participants |
| Group 1 - Patiromer | Participants Having Spironolactone Titrations Over Time | Down : >Week 3 and ≤Week 4 | 6 Participants |
| Group 1 - Patiromer | Participants Having Spironolactone Titrations Over Time | Down : >Week 4 and ≤Week 6 | 8 Participants |
| Group 1 - Patiromer | Participants Having Spironolactone Titrations Over Time | Down : >Week 6 and ≤Week 8 | 5 Participants |
| Group 1 - Patiromer | Participants Having Spironolactone Titrations Over Time | Down : >Week 8 and ≤Week 10 | 4 Participants |
| Group 1 - Patiromer | Participants Having Spironolactone Titrations Over Time | Down : >Week 10 and ≤Week 12 | 3 Participants |
| Group 2 - Placebo | Participants Having Spironolactone Titrations Over Time | Down : >Week 10 and ≤Week 12 | 1 Participants |
| Group 2 - Placebo | Participants Having Spironolactone Titrations Over Time | Up : ≤Week 1 | 0 Participants |
| Group 2 - Placebo | Participants Having Spironolactone Titrations Over Time | Down : ≤Week 1 | 2 Participants |
| Group 2 - Placebo | Participants Having Spironolactone Titrations Over Time | Up : >Week 1 and ≤Week 2 | 0 Participants |
| Group 2 - Placebo | Participants Having Spironolactone Titrations Over Time | Down : >Week 4 and ≤Week 6 | 7 Participants |
| Group 2 - Placebo | Participants Having Spironolactone Titrations Over Time | Up : >Week 2 and ≤Week 3 | 77 Participants |
| Group 2 - Placebo | Participants Having Spironolactone Titrations Over Time | Down : >Week 1 and ≤Week 2 | 0 Participants |
| Group 2 - Placebo | Participants Having Spironolactone Titrations Over Time | Up : >Week 3 and ≤Week 4 | 21 Participants |
| Group 2 - Placebo | Participants Having Spironolactone Titrations Over Time | Down : >Week 8 and ≤Week 10 | 7 Participants |
| Group 2 - Placebo | Participants Having Spironolactone Titrations Over Time | Up : >Week 4 and ≤Week 6 | 11 Participants |
| Group 2 - Placebo | Participants Having Spironolactone Titrations Over Time | Down : >Week 2 and ≤Week 3 | 2 Participants |
| Group 2 - Placebo | Participants Having Spironolactone Titrations Over Time | Up : >Week 6 and ≤Week 8 | 6 Participants |
| Group 2 - Placebo | Participants Having Spironolactone Titrations Over Time | Down : >Week 6 and ≤Week 8 | 8 Participants |
| Group 2 - Placebo | Participants Having Spironolactone Titrations Over Time | Up : >Week 8 and ≤Week 10 | 7 Participants |
| Group 2 - Placebo | Participants Having Spironolactone Titrations Over Time | Down : >Week 3 and ≤Week 4 | 5 Participants |
| Group 2 - Placebo | Participants Having Spironolactone Titrations Over Time | Up : >Week 10 and ≤Week 12 | 0 Participants |
Other Pre-specified
Participants With Central Serum Potassium <5.5 mEq/L Over Time
Baseline Central Serum Potassium: BCSP. The symbols \> and ≤ included in the row titles are used to indicate the time interval \[\>Week1 and ≤Week2 meaning from day 8 until day 14 (included)\]. If a participant's serum potassium result at baseline was not in one of the two subgroups reported below, the participant's potassium stratum at randomization was used. Therefore, participants with BCSP \<4.3 mEq/L or \>5.1 mEq/L at baseline (Day 0) have been classified according to their serum potassium values at the Screening period.
Time frame: From baseline to Week 12
Population: Intent-to-Treat population (ITT): The ITT population included all participants who were randomized and who took at least 1 dose of spironolactone and at least 1 dose of patiromer/placebo.~Table depicts those participants with values at mentioned time frame. Those participants with no available results were not included in the table below.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Group 1 - Patiromer | Participants With Central Serum Potassium <5.5 mEq/L Over Time | BCSP 4.3-<4.7mEq/L: >Week 6 and ≤Week 8 | 61 Participants |
| Group 1 - Patiromer | Participants With Central Serum Potassium <5.5 mEq/L Over Time | BCSP 4.3-<4.7mEq/L: >Week 3 and ≤Week 4 | 61 Participants |
| Group 1 - Patiromer | Participants With Central Serum Potassium <5.5 mEq/L Over Time | BCSP 4.7-<5.1mEq/L: >Week 6 and ≤Week 8 | 74 Participants |
| Group 1 - Patiromer | Participants With Central Serum Potassium <5.5 mEq/L Over Time | BCSP 4.3-<4.7mEq/L: >Week 2 and ≤Week 3 | 59 Participants |
| Group 1 - Patiromer | Participants With Central Serum Potassium <5.5 mEq/L Over Time | BCSP 4.7-<5.1mEq/L: >Week 8 and ≤Week 10 | 72 Participants |
| Group 1 - Patiromer | Participants With Central Serum Potassium <5.5 mEq/L Over Time | BCSP 4.3-<4.7mEq/L: > Week 10 and ≤ Week 12 | 61 Participants |
| Group 1 - Patiromer | Participants With Central Serum Potassium <5.5 mEq/L Over Time | BCSP 4.7-<5.1mEq/L: >Week 10 and ≤Week 12 | 80 Participants |
| Group 1 - Patiromer | Participants With Central Serum Potassium <5.5 mEq/L Over Time | BCSP 4.3-<4.7mEq/L: >Week 4 and ≤Week 6 | 61 Participants |
| Group 1 - Patiromer | Participants With Central Serum Potassium <5.5 mEq/L Over Time | Overall : ≤Week 1 | 135 Participants |
| Group 1 - Patiromer | Participants With Central Serum Potassium <5.5 mEq/L Over Time | BCSP 4.7-<5.1 mEq/L: ≤Week 1 | 75 Participants |
| Group 1 - Patiromer | Participants With Central Serum Potassium <5.5 mEq/L Over Time | Overall : > Week 1 and ≤Week 2 | 131 Participants |
| Group 1 - Patiromer | Participants With Central Serum Potassium <5.5 mEq/L Over Time | BCSP 4.3-<4.7mEq/L: >Week 8 and ≤Week 10 | 58 Participants |
| Group 1 - Patiromer | Participants With Central Serum Potassium <5.5 mEq/L Over Time | Overall : >Week 2 and ≤Week 3 | 133 Participants |
| Group 1 - Patiromer | Participants With Central Serum Potassium <5.5 mEq/L Over Time | BCSP 4.7-<5.1mEq/L: >Week 1 and ≤Week 2 | 74 Participants |
| Group 1 - Patiromer | Participants With Central Serum Potassium <5.5 mEq/L Over Time | Overall : >Week 3 and ≤Week 4 | 135 Participants |
| Group 1 - Patiromer | Participants With Central Serum Potassium <5.5 mEq/L Over Time | BCSP 4.7-<5.1 mEq/L: >Week 4 and ≤Week 6 | 79 Participants |
| Group 1 - Patiromer | Participants With Central Serum Potassium <5.5 mEq/L Over Time | Overall : >Week 4 and ≤Week 6 | 140 Participants |
| Group 1 - Patiromer | Participants With Central Serum Potassium <5.5 mEq/L Over Time | BCSP 4.7-<5.1mEq/L: >Week 2 and ≤Week 3 | 74 Participants |
| Group 1 - Patiromer | Participants With Central Serum Potassium <5.5 mEq/L Over Time | Overall : >Week 6 and ≤Week 8 | 135 Participants |
| Group 1 - Patiromer | Participants With Central Serum Potassium <5.5 mEq/L Over Time | BCSP 4.3-<4.7mEq/L: >Week1 and ≤Week2 | 57 Participants |
| Group 1 - Patiromer | Participants With Central Serum Potassium <5.5 mEq/L Over Time | Overall : >Week 8 and ≤Week 10 | 130 Participants |
| Group 1 - Patiromer | Participants With Central Serum Potassium <5.5 mEq/L Over Time | BCSP 4.7-<5.1mEq/L: >Week 3 and ≤Week 4 | 74 Participants |
| Group 1 - Patiromer | Participants With Central Serum Potassium <5.5 mEq/L Over Time | Overall : >Week 10 and ≤Week 12 | 141 Participants |
| Group 1 - Patiromer | Participants With Central Serum Potassium <5.5 mEq/L Over Time | BCSP 4.3-<4.7mEq/L: ≤Week1 | 60 Participants |
| Group 2 - Placebo | Participants With Central Serum Potassium <5.5 mEq/L Over Time | Overall : >Week 10 and ≤Week 12 | 126 Participants |
| Group 2 - Placebo | Participants With Central Serum Potassium <5.5 mEq/L Over Time | BCSP 4.3-<4.7mEq/L: ≤Week1 | 62 Participants |
| Group 2 - Placebo | Participants With Central Serum Potassium <5.5 mEq/L Over Time | BCSP 4.3-<4.7mEq/L: >Week1 and ≤Week2 | 57 Participants |
| Group 2 - Placebo | Participants With Central Serum Potassium <5.5 mEq/L Over Time | BCSP 4.3-<4.7mEq/L: >Week 2 and ≤Week 3 | 63 Participants |
| Group 2 - Placebo | Participants With Central Serum Potassium <5.5 mEq/L Over Time | BCSP 4.3-<4.7mEq/L: >Week 3 and ≤Week 4 | 60 Participants |
| Group 2 - Placebo | Participants With Central Serum Potassium <5.5 mEq/L Over Time | BCSP 4.3-<4.7mEq/L: >Week 4 and ≤Week 6 | 61 Participants |
| Group 2 - Placebo | Participants With Central Serum Potassium <5.5 mEq/L Over Time | BCSP 4.3-<4.7mEq/L: >Week 6 and ≤Week 8 | 58 Participants |
| Group 2 - Placebo | Participants With Central Serum Potassium <5.5 mEq/L Over Time | BCSP 4.3-<4.7mEq/L: >Week 8 and ≤Week 10 | 58 Participants |
| Group 2 - Placebo | Participants With Central Serum Potassium <5.5 mEq/L Over Time | BCSP 4.3-<4.7mEq/L: > Week 10 and ≤ Week 12 | 61 Participants |
| Group 2 - Placebo | Participants With Central Serum Potassium <5.5 mEq/L Over Time | BCSP 4.7-<5.1 mEq/L: ≤Week 1 | 66 Participants |
| Group 2 - Placebo | Participants With Central Serum Potassium <5.5 mEq/L Over Time | BCSP 4.7-<5.1mEq/L: >Week 1 and ≤Week 2 | 65 Participants |
| Group 2 - Placebo | Participants With Central Serum Potassium <5.5 mEq/L Over Time | BCSP 4.7-<5.1mEq/L: >Week 2 and ≤Week 3 | 65 Participants |
| Group 2 - Placebo | Participants With Central Serum Potassium <5.5 mEq/L Over Time | BCSP 4.7-<5.1mEq/L: >Week 3 and ≤Week 4 | 61 Participants |
| Group 2 - Placebo | Participants With Central Serum Potassium <5.5 mEq/L Over Time | BCSP 4.7-<5.1 mEq/L: >Week 4 and ≤Week 6 | 64 Participants |
| Group 2 - Placebo | Participants With Central Serum Potassium <5.5 mEq/L Over Time | BCSP 4.7-<5.1mEq/L: >Week 6 and ≤Week 8 | 66 Participants |
| Group 2 - Placebo | Participants With Central Serum Potassium <5.5 mEq/L Over Time | BCSP 4.7-<5.1mEq/L: >Week 8 and ≤Week 10 | 66 Participants |
| Group 2 - Placebo | Participants With Central Serum Potassium <5.5 mEq/L Over Time | BCSP 4.7-<5.1mEq/L: >Week 10 and ≤Week 12 | 65 Participants |
| Group 2 - Placebo | Participants With Central Serum Potassium <5.5 mEq/L Over Time | Overall : ≤Week 1 | 128 Participants |
| Group 2 - Placebo | Participants With Central Serum Potassium <5.5 mEq/L Over Time | Overall : > Week 1 and ≤Week 2 | 122 Participants |
| Group 2 - Placebo | Participants With Central Serum Potassium <5.5 mEq/L Over Time | Overall : >Week 2 and ≤Week 3 | 128 Participants |
| Group 2 - Placebo | Participants With Central Serum Potassium <5.5 mEq/L Over Time | Overall : >Week 3 and ≤Week 4 | 121 Participants |
| Group 2 - Placebo | Participants With Central Serum Potassium <5.5 mEq/L Over Time | Overall : >Week 4 and ≤Week 6 | 125 Participants |
| Group 2 - Placebo | Participants With Central Serum Potassium <5.5 mEq/L Over Time | Overall : >Week 6 and ≤Week 8 | 124 Participants |
| Group 2 - Placebo | Participants With Central Serum Potassium <5.5 mEq/L Over Time | Overall : >Week 8 and ≤Week 10 | 124 Participants |
Other Pre-specified
Shifts in Selected Laboratory Tests From Baseline to End of Treatment
The end of treatment value is defined as the last non-missing value on or prior to the last spironolactone dose date (from End of Treatment - Case report form) + 3 days LLN=Lower limit of the normal range. ULN=Upper limit of the normal range. EoT=End of Treatment
Time frame: From Baseline to End of Treatment, up to 12 weeks.
Population: Safety Population
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Group 1 - Patiromer | Shifts in Selected Laboratory Tests From Baseline to End of Treatment | Magnesium - Baseline Value >ULN : EoT Value Normal | 10 participants |
| Group 1 - Patiromer | Shifts in Selected Laboratory Tests From Baseline to End of Treatment | Phosphate - Baseline Value Normal : EoT Value >ULN | 2 participants |
| Group 1 - Patiromer | Shifts in Selected Laboratory Tests From Baseline to End of Treatment | Magnesium- Baseline Value Normal: EoT Value Normal | 103 participants |
| Group 1 - Patiromer | Shifts in Selected Laboratory Tests From Baseline to End of Treatment | Phosphate - Baseline Value >ULN : EoT Value <LLN | 0 participants |
| Group 1 - Patiromer | Shifts in Selected Laboratory Tests From Baseline to End of Treatment | Magnesium - Baseline Value >ULN : EoT Value >ULN | 3 participants |
| Group 1 - Patiromer | Shifts in Selected Laboratory Tests From Baseline to End of Treatment | Phosphate - Baseline Value >ULN : EoT Value Normal | 5 participants |
| Group 1 - Patiromer | Shifts in Selected Laboratory Tests From Baseline to End of Treatment | Magnesium - Baseline Value <LLN : EoT Value Normal | 3 participants |
| Group 1 - Patiromer | Shifts in Selected Laboratory Tests From Baseline to End of Treatment | Phosphate - Baseline Value >ULN : EoT Value >ULN | 2 participants |
| Group 1 - Patiromer | Shifts in Selected Laboratory Tests From Baseline to End of Treatment | Phosphate - Baseline Value <LLN : EoT Value <LLN | 0 participants |
| Group 1 - Patiromer | Shifts in Selected Laboratory Tests From Baseline to End of Treatment | Calcium - Baseline Value <LLN : EoT Value <LLN | 2 participants |
| Group 1 - Patiromer | Shifts in Selected Laboratory Tests From Baseline to End of Treatment | Magnesium - Baseline Value Normal : EoT Value >ULN | 6 participants |
| Group 1 - Patiromer | Shifts in Selected Laboratory Tests From Baseline to End of Treatment | Calcium - Baseline Value <LLN : EoT Value Normal | 5 participants |
| Group 1 - Patiromer | Shifts in Selected Laboratory Tests From Baseline to End of Treatment | Phosphate - Baseline Value <LLN : EoT Value Normal | 1 participants |
| Group 1 - Patiromer | Shifts in Selected Laboratory Tests From Baseline to End of Treatment | Calcium - Baseline Value <LLN : EoT Value >ULN | 0 participants |
| Group 1 - Patiromer | Shifts in Selected Laboratory Tests From Baseline to End of Treatment | Magnesium - Baseline Value Normal : EoT Value <LLN | 12 participants |
| Group 1 - Patiromer | Shifts in Selected Laboratory Tests From Baseline to End of Treatment | Calcium - Baseline Value Normal : EoT Value <LLN | 4 participants |
| Group 1 - Patiromer | Shifts in Selected Laboratory Tests From Baseline to End of Treatment | Phosphate - Baseline Value <LLN : EoT Value >ULN | 0 participants |
| Group 1 - Patiromer | Shifts in Selected Laboratory Tests From Baseline to End of Treatment | Calcium - Baseline Value Normal : EoT Value Normal | 133 participants |
| Group 1 - Patiromer | Shifts in Selected Laboratory Tests From Baseline to End of Treatment | Magnesium - Baseline Value >ULN : EoT Value <LLN | 0 participants |
| Group 1 - Patiromer | Shifts in Selected Laboratory Tests From Baseline to End of Treatment | Calcium - Baseline Value Normal : EoT Value >ULN | 0 participants |
| Group 1 - Patiromer | Shifts in Selected Laboratory Tests From Baseline to End of Treatment | Phosphate - Baseline Value Normal : EoT Value <LLN | 0 participants |
| Group 1 - Patiromer | Shifts in Selected Laboratory Tests From Baseline to End of Treatment | Calcium - Baseline Value >ULN : EoT Value <LLN | 0 participants |
| Group 1 - Patiromer | Shifts in Selected Laboratory Tests From Baseline to End of Treatment | Magnesium - Baseline Value <LLN : EoT Value >ULN | 0 participants |
| Group 1 - Patiromer | Shifts in Selected Laboratory Tests From Baseline to End of Treatment | Calcium - Baseline Value >ULN : EoT Value Normal | 2 participants |
| Group 1 - Patiromer | Shifts in Selected Laboratory Tests From Baseline to End of Treatment | Phosphate- Baseline Value Normal: EoT Value Normal | 136 participants |
| Group 1 - Patiromer | Shifts in Selected Laboratory Tests From Baseline to End of Treatment | Calcium - Baseline Value >ULN : EoT Value >ULN | 0 participants |
| Group 1 - Patiromer | Shifts in Selected Laboratory Tests From Baseline to End of Treatment | Magnesium - Baseline Value <LLN : EoT Value<LLN | 9 participants |
| Group 2 - Placebo | Shifts in Selected Laboratory Tests From Baseline to End of Treatment | Calcium - Baseline Value >ULN : EoT Value >ULN | 2 participants |
| Group 2 - Placebo | Shifts in Selected Laboratory Tests From Baseline to End of Treatment | Magnesium - Baseline Value <LLN : EoT Value<LLN | 4 participants |
| Group 2 - Placebo | Shifts in Selected Laboratory Tests From Baseline to End of Treatment | Magnesium - Baseline Value <LLN : EoT Value Normal | 8 participants |
| Group 2 - Placebo | Shifts in Selected Laboratory Tests From Baseline to End of Treatment | Magnesium - Baseline Value <LLN : EoT Value >ULN | 0 participants |
| Group 2 - Placebo | Shifts in Selected Laboratory Tests From Baseline to End of Treatment | Magnesium - Baseline Value Normal : EoT Value <LLN | 7 participants |
| Group 2 - Placebo | Shifts in Selected Laboratory Tests From Baseline to End of Treatment | Magnesium- Baseline Value Normal: EoT Value Normal | 109 participants |
| Group 2 - Placebo | Shifts in Selected Laboratory Tests From Baseline to End of Treatment | Magnesium - Baseline Value Normal : EoT Value >ULN | 10 participants |
| Group 2 - Placebo | Shifts in Selected Laboratory Tests From Baseline to End of Treatment | Magnesium - Baseline Value >ULN : EoT Value <LLN | 0 participants |
| Group 2 - Placebo | Shifts in Selected Laboratory Tests From Baseline to End of Treatment | Magnesium - Baseline Value >ULN : EoT Value Normal | 6 participants |
| Group 2 - Placebo | Shifts in Selected Laboratory Tests From Baseline to End of Treatment | Magnesium - Baseline Value >ULN : EoT Value >ULN | 3 participants |
| Group 2 - Placebo | Shifts in Selected Laboratory Tests From Baseline to End of Treatment | Phosphate - Baseline Value <LLN : EoT Value <LLN | 1 participants |
| Group 2 - Placebo | Shifts in Selected Laboratory Tests From Baseline to End of Treatment | Phosphate - Baseline Value <LLN : EoT Value Normal | 3 participants |
| Group 2 - Placebo | Shifts in Selected Laboratory Tests From Baseline to End of Treatment | Phosphate - Baseline Value <LLN : EoT Value >ULN | 0 participants |
| Group 2 - Placebo | Shifts in Selected Laboratory Tests From Baseline to End of Treatment | Phosphate - Baseline Value Normal : EoT Value <LLN | 1 participants |
| Group 2 - Placebo | Shifts in Selected Laboratory Tests From Baseline to End of Treatment | Phosphate- Baseline Value Normal: EoT Value Normal | 125 participants |
| Group 2 - Placebo | Shifts in Selected Laboratory Tests From Baseline to End of Treatment | Phosphate - Baseline Value Normal : EoT Value >ULN | 8 participants |
| Group 2 - Placebo | Shifts in Selected Laboratory Tests From Baseline to End of Treatment | Phosphate - Baseline Value >ULN : EoT Value <LLN | 0 participants |
| Group 2 - Placebo | Shifts in Selected Laboratory Tests From Baseline to End of Treatment | Phosphate - Baseline Value >ULN : EoT Value Normal | 4 participants |
| Group 2 - Placebo | Shifts in Selected Laboratory Tests From Baseline to End of Treatment | Phosphate - Baseline Value >ULN : EoT Value >ULN | 5 participants |
| Group 2 - Placebo | Shifts in Selected Laboratory Tests From Baseline to End of Treatment | Calcium - Baseline Value <LLN : EoT Value <LLN | 4 participants |
| Group 2 - Placebo | Shifts in Selected Laboratory Tests From Baseline to End of Treatment | Calcium - Baseline Value <LLN : EoT Value Normal | 1 participants |
| Group 2 - Placebo | Shifts in Selected Laboratory Tests From Baseline to End of Treatment | Calcium - Baseline Value <LLN : EoT Value >ULN | 0 participants |
| Group 2 - Placebo | Shifts in Selected Laboratory Tests From Baseline to End of Treatment | Calcium - Baseline Value Normal : EoT Value <LLN | 6 participants |
| Group 2 - Placebo | Shifts in Selected Laboratory Tests From Baseline to End of Treatment | Calcium - Baseline Value Normal : EoT Value Normal | 133 participants |
| Group 2 - Placebo | Shifts in Selected Laboratory Tests From Baseline to End of Treatment | Calcium - Baseline Value Normal : EoT Value >ULN | 0 participants |
| Group 2 - Placebo | Shifts in Selected Laboratory Tests From Baseline to End of Treatment | Calcium - Baseline Value >ULN : EoT Value <LLN | 0 participants |
| Group 2 - Placebo | Shifts in Selected Laboratory Tests From Baseline to End of Treatment | Calcium - Baseline Value >ULN : EoT Value Normal | 1 participants |
Other Pre-specified
Spironolactone Dose Level at End of 12 Weeks of Study Treatment
Row title: Participants not completing 12W of study treatment: Participants who had not completed 12 weeks of study treatment.
Time frame: 12 Weeks of Study Treatment
Population: Intent-to-Treat population (ITT): The ITT population included all participants who were randomized and who took at least 1 dose of spironolactone and at least 1 dose of patiromer/placebo.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Group 1 - Patiromer | Spironolactone Dose Level at End of 12 Weeks of Study Treatment | 50 mg QD | 102 Participants |
| Group 1 - Patiromer | Spironolactone Dose Level at End of 12 Weeks of Study Treatment | 25 mg QD | 22 Participants |
| Group 1 - Patiromer | Spironolactone Dose Level at End of 12 Weeks of Study Treatment | 25 mg QOD | 2 Participants |
| Group 1 - Patiromer | Spironolactone Dose Level at End of 12 Weeks of Study Treatment | Participants not completing 12W of study treatment | 21 Participants |
| Group 2 - Placebo | Spironolactone Dose Level at End of 12 Weeks of Study Treatment | Participants not completing 12W of study treatment | 50 Participants |
| Group 2 - Placebo | Spironolactone Dose Level at End of 12 Weeks of Study Treatment | 50 mg QD | 76 Participants |
| Group 2 - Placebo | Spironolactone Dose Level at End of 12 Weeks of Study Treatment | 25 mg QOD | 3 Participants |
| Group 2 - Placebo | Spironolactone Dose Level at End of 12 Weeks of Study Treatment | 25 mg QD | 19 Participants |