Evaluation of Patiromer Titration in Heart Failure Patients With Chronic Kidney Disease

• Sponsor: Relypsa, Inc. (Industry)
• Overall Status: Completed
• CT.gov ID: NCT01130597
• Collaborator: (none)
• Enrollment: 63
• Locations: 13
• Arm: 1
• Duration (Months): 4
• Patients Per Site: 4.8
• Patients Per Site Per Month: 1.2

Study Details

Study Description

Brief Summary

The purpose of this study was to evaluate the feasibility of individualized titration of patiromer according to serum potassium. This study also assessed the safety and tolerability of patiromer and the effects of patiromer on serum potassium in heart failure (HF) participants with chronic kidney disease (CKD).

Condition or Disease	Intervention/Treatment	Phase
Heart Failure	Drug: patiromer; Drug: spironolactone	Phase 2

Detailed Description

This was an open-label, single-arm study to evaluate a titration regimen for patiromer in approximately 63 HF participants with CKD receiving one or more of the following: angiotensin-converting enzyme inhibitors (ACEIs), angiotensin II receptor blockers (ARBs), or beta blockers (BBs). This study was considered to be exploratory.

Upon successful completion of screening evaluations (-10 to -5 days prior to enrollment), all eligible participants were assigned at Baseline (Day 0 visit) to an initial dose of patiromer (20 g/day) and spironolactone (25 mg/day).

Study visits for enrolled participants were scheduled for Days 3, 7, 14, 21, 28, 35, 42, 49 and 56. A follow-up visit occurred on Day 63.

At selected study visits, patiromer or spironolactone doses may have been titrated. The study dosing algorithm was designed to maintain an individual's serum potassium value in the range of 4.0 - 5.1 mEq/L (based on local lab data).

Any participant with a local laboratory serum potassium value < 3.5 or > 5.5 mEq/L on two consecutive scheduled study visits, despite titration of patiromer or spironolactone, were withdrawn from the study, permanently discontinued patiromer and spironolactone, and returned for a follow-up visit within 7 days.

Study Design

• Study Type: Interventional
• Actual Enrollment: 63 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Prevention
• Official Title: A Multicenter, Open-Label, Single-Arm Study to Evaluate a Titration Regimen for Patiromer in Heart Failure Patients With Chronic Kidney Disease
• Study Start Date: May 1, 2010
• Actual Primary Completion Date: Sep 1, 2010
• Actual Study Completion Date: Sep 1, 2010

Arms and Interventions

Arm	Intervention/Treatment
Experimental: patiromer spironolactone + patiromer	Drug: patiromer; Active investigational drug; Other Names: RLY5016 Veltassa ; Drug: spironolactone

Outcome Measures

Primary Outcome Measures

1. Percentage of Participants With Serum Potassium in the Range of 3.5 - 5.5 mEq/L at the End of Treatment [56 days]

Secondary Outcome Measures

1. Percentage of Participants With Serum Potassium in the Range of 3.5 - 5.5 mEq/L at Week 4 [28 Days]

2. Percentage of Participants With Serum Potassium in the Range of 3.5 - 5.5 mEq/L at Week 8 [56 Days]

3. Percentage of Participants With Serum Potassium in the Range of 4.0 - 5.1 mEq/L at Week 4 [28 Days]

4. Percentage of Participants With Serum Potassium in the Range of 4.0 - 5.1 mEq/L at Week 8 [56 Days]

5. Percentage of Participants With Serum Potassium in the Range of 4.0 - 5.1 mEq/L at the End of Treatment [56 Days]

6. Mean Dose of Patiromer at End of Treatment [56 Days]

7. Percentage of Participants Requiring Patiromer Uptitration [56 Days]

8. Percentage of Participants Requiring Patiromer Downtitration [56 Days]

9. Median Time to First Patiromer Dose Titration [56 Days]

10. Mean Number of Patiromer Titrations [56 Days]

11. Mean Patiromer Dose at Week 1 [Up to Week 1]

12. Mean Patiromer Dose at Week 4 [Up to Week 4]

13. Mean Patiromer Dose at Week 8 [Up to Week 8]

14. Mean Change From Baseline in Serum Potassium to End of Treatment [56 Days]

15. Percentage of Participants Discontinuing Due to Hyperkalemia (Serum Potassium > 5.5 mEq/L) [56 Days]

16. Percentage of Patients Whose Spironolactone Dose Was Increased Up to 50 mg/Day [56 Days]

17. Change in Urine Albumin to Creatinine Ratio (ACR) From Baseline to Week 4 Among Participants With ACR ≥ 30 mg/g at Baseline [Baseline and Day 28]

18. Change in ACR From Baseline to Week 8 Among Participants With Urine ACR ≥ 30 mg/g at Baseline [Baseline and Day 56]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

1. Chronic HF clinically indicated to receive spironolactone therapy

2. Age 18 years or older

3. Local laboratory serum potassium values of 4.3 - 5.1 mEq/L at screening and baseline

4. CKD (estimated glomerular filtration rate [eGFR] < 60 mL/min/1.73m2 at screening based on central lab creatinine measurement)

5. On at least one of the following HF therapies: ACEI, ARB, or BB

6. Females of child-bearing potential must be non-lactating, must have a negative serum pregnancy test at screening, and must have used a highly effective form of contraception for at least 3 months before study drug administration, during the study, and for one month after study completion

7. Male participants and/or their female partners of child-bearing potential must use a highly effective form of contraception during the study and for 3 months after study completion

8. Provide their written informed consent prior to participation in the study

Exclusion Criteria:

1. History of bowel obstruction, swallowing disorders, severe gastrointestinal disorders or major gastrointestinal surgery

2. Uncorrected primary severe valvular disease, known obstructive or restrictive cardiomyopathy, uncontrolled or hemodynamically unstable arrhythmia

3. Coronary-artery bypass graft, percutaneous intervention (e.g., cardiac, cerebrovascular, aortic), or major surgery including thoracic and cardiac, within 3 months prior to baseline or anticipated need during study participation

4. Heart transplant recipient, or anticipated need for transplant during study participation

5. Any of the following events having occurred within 2 months prior to baseline: unstable angina as judged by the Investigator, unresolved acute coronary syndrome, transient ischemic attack or stroke

6. Current dialysis participant, or anticipated need for dialysis during study participation

7. Prior kidney transplant, or anticipated need for transplant during study participation

8. Metastatic, late-stage or end-stage cancer with < 12 months life expectancy or at risk for tumor lysis syndrome

9. History of alcoholism or drug/chemical abuse within 1 year

10. Sustained systolic blood pressure > 180 or < 90 mmHg

11. Liver enzymes [alanine aminotransferase (ALT), aspartate aminotransferase (AST)] > 3 times upper limit of normal

12. Loop and thiazide diuretics that have not been stable for at least 21 days prior to baseline or not anticipated to remain stable during study participation

13. Use of any intravenous cardiac medications within 21 days prior to baseline, or their anticipated need during study participation

14. Current use of polymer-based drugs (e.g., sevelamer, sodium polystyrene sulfonate, colesevelam, colestipol), phosphate binders (e.g., lanthanum carbonate), or other potassium binders, or their anticipated need during study participation

15. Use of potassium sparing medication including aldosterone antagonists or potassium supplements in the last 21 days prior to baseline

16. Use of any investigational medication within 30 days or 5 half-lives, whichever is longer, prior to baseline

17. Participants who have taken investigational product in this study, or a previous patiromer study

18. Inability to consume the study medication, or, in the opinion of the Investigator, inability to comply with the protocol

19. In the opinion of the Investigator, any medical condition, uncontrolled systemic disease, serious intercurrent illness, or extenuating circumstance occurring or persisting, within 30 days prior to baseline, that would significantly decrease study compliance or jeopardize the safety of the participant or affect the validity of the trial results

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Investigator Site 11	Tbilisi		Georgia
2	Investigator Site 12	Tbilisi		Georgia
3	Investigator Site 13	Tbilisi		Georgia
4	Investigator Site 14	Tbilisi		Georgia
5	Investigator Site 15	Tbilisi		Georgia
6	Investigator Site 16	Tbilisi		Georgia
7	Investigator Site 17	Tbilisi		Georgia
8	Investigator Site 18	Tbilisi		Georgia
9	Investigator Site 25	Golnik		Slovenia
10	Investigator Site 27	Izola		Slovenia
11	Investigator Site 21	Ljubljana		Slovenia
12	Investigator Site 22	Maribor		Slovenia
13	Investigator Site 26	Slovenj Gradec		Slovenia

Sponsors and Collaborators

• Relypsa, Inc.

Investigators

• Study Director: Director Clinical Operations, Relypsa, Inc.

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

• Related Info

Publications

None provided.

• Responsible Party: Relypsa, Inc.
• ClinicalTrials.gov Identifier: NCT01130597
• Other Study ID Numbers: RLY5016-204
• First Posted: May 26, 2010
• Last Update Posted: May 12, 2021
• Last Verified: Dec 1, 2015

• Keywords provided by Relypsa, Inc.: HF; Heart failure; hyperkalemia; chronic kidney disease; prevention of hyperkalemia in heart failure participants
• Additional relevant MeSH terms: Kidney Diseases; Renal Insufficiency, Chronic; Heart Failure; Spironolactone

Study Results

Participant Flow

Pre-assignment Detail	Eligible participants were ≥ 18 years old, had a history of chronic HF, were clinically indicated to initiate spironolactone therapy, had a serum potassium measurement of 4.3 - 5.1 mEq/L at screening and baseline, had CKD (eGFR < 60 mL/min/1.73 m2 at screening), and were taking one or more HF therapies (ACEIs, ARBs, or BBs).

Arm/Group Title	Patiromer
Arm/Group Description	Spironolactone + Patiromer Participants received patiromer (20 g/day, administered as a divided dose of 10 g in the morning and 10 g in the evening) and spironolactone (25 mg/day, administered once daily), orally. After Day 3, at the first occurrence of a serum potassium value of ≤ 5.1 mEq/L, the spironolactone dose was increased once to 50 mg/day; dose reductions were not allowed.
Period Title: Overall Study
STARTED	63
COMPLETED	56
NOT COMPLETED	7

Baseline Characteristics

Arm/Group Title	Patiromer
Arm/Group Description	Spironolactone + Patiromer Participants received patiromer (20 g/day, administered as a divided dose of 10 g in the morning and 10 g in the evening) and spironolactone (25 mg/day, administered once daily), orally. After Day 3, at the first occurrence of a serum potassium value of ≤ 5.1 mEq/L, the spironolactone dose was increased once to 50 mg/day; dose reductions were not allowed.
Overall Participants	63
Age (Count of Participants)
<=18 years	0 0%
Between 18 and 65 years	17 27%
>=65 years	46 73%
Age (years) [Mean (Full Range) ]
Mean (Full Range) [years]	70.8
Sex: Female, Male (Count of Participants)
Female	24 38.1%
Male	39 61.9%

Outcome Measures

1. Primary Outcome

Title	Percentage of Participants With Serum Potassium in the Range of 3.5 - 5.5 mEq/L at the End of Treatment
Time Frame	56 days

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Patiromer
Arm/Group Description	Spironolactone + Patiromer Participants received patiromer (20 g/day, administered as a divided dose of 10 g in the morning and 10 g in the evening) and spironolactone (25 mg/day, administered once daily), orally. After Day 3, at the first occurrence of a serum potassium value of ≤ 5.1 mEq/L, the spironolactone dose was increased once to 50 mg/day; dose reductions were not allowed.
Measure Participants	63
Number [percentage of participants]	90.5 143.7%

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Patiromer
	Comments
	Type of Statistical Test	Superiority or Other (legacy)
	Comments
Statistical Test of Hypothesis	p-Value
	Comments
	Method
	Comments
Method of Estimation	Estimation Parameter	Percentage of Participants
	Estimated Value	90.5
	Confidence Interval	(2-Sided) 95%; 80.4 to 96.4
	Parameter Dispersion	Type: Value:
	Estimation Comments	Clopper-Pearson was used to arrive at the 95% Confidence Interval

2. Secondary Outcome

Title	Percentage of Participants With Serum Potassium in the Range of 3.5 - 5.5 mEq/L at Week 4
Time Frame	28 Days

Outcome Measure Data

Analysis Population Description

Participants with available data at Week 4.

Arm/Group Title	Patiromer
Arm/Group Description	Spironolactone + Patiromer Participants received patiromer (20 g/day, administered as a divided dose of 10 g in the morning and 10 g in the evening) and spironolactone (25 mg/day, administered once daily), orally. After Day 3, at the first occurrence of a serum potassium value of ≤ 5.1 mEq/L, the spironolactone dose was increased once to 50 mg/day; dose reductions were not allowed.
Measure Participants	61
Number [percentage of participants]	96.7 153.5%

3. Secondary Outcome

Title	Percentage of Participants With Serum Potassium in the Range of 3.5 - 5.5 mEq/L at Week 8
Time Frame	56 Days

Outcome Measure Data

Analysis Population Description

Participants with available data at Week 8.

Arm/Group Title	Patiromer
Arm/Group Description	Spironolactone + Patiromer Participants received patiromer (20 g/day, administered as a divided dose of 10 g in the morning and 10 g in the evening) and spironolactone (25 mg/day, administered once daily), orally. After Day 3, at the first occurrence of a serum potassium value of ≤ 5.1 mEq/L, the spironolactone dose was increased once to 50 mg/day; dose reductions were not allowed.
Measure Participants	57
Number [percentage of participants]	93.0 147.6%

4. Secondary Outcome

Title	Percentage of Participants With Serum Potassium in the Range of 4.0 - 5.1 mEq/L at Week 4
Time Frame	28 Days

Outcome Measure Data

Analysis Population Description

Participants with available data at Week 4.

Arm/Group Title	Patiromer
Arm/Group Description	Spironolactone + Patiromer Participants received patiromer (20 g/day, administered as a divided dose of 10 g in the morning and 10 g in the evening) and spironolactone (25 mg/day, administered once daily), orally. After Day 3, at the first occurrence of a serum potassium value of ≤ 5.1 mEq/L, the spironolactone dose was increased once to 50 mg/day; dose reductions were not allowed.
Measure Participants	61
Number [percentage of participants]	78.7 124.9%

5. Secondary Outcome

Title	Percentage of Participants With Serum Potassium in the Range of 4.0 - 5.1 mEq/L at Week 8
Time Frame	56 Days

Outcome Measure Data

Analysis Population Description

Participants with available data at Week 8.

Arm/Group Title	Patiromer
Arm/Group Description	Spironolactone + Patiromer Participants received patiromer (20 g/day, administered as a divided dose of 10 g in the morning and 10 g in the evening) and spironolactone (25 mg/day, administered once daily), orally. After Day 3, at the first occurrence of a serum potassium value of ≤ 5.1 mEq/L, the spironolactone dose was increased once to 50 mg/day; dose reductions were not allowed.
Measure Participants	57
Number [percentage of participants]	86.0 136.5%

6. Secondary Outcome

Title	Percentage of Participants With Serum Potassium in the Range of 4.0 - 5.1 mEq/L at the End of Treatment
Time Frame	56 Days

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Patiromer
Arm/Group Description	Spironolactone + Patiromer Participants received patiromer (20 g/day, administered as a divided dose of 10 g in the morning and 10 g in the evening) and spironolactone (25 mg/day, administered once daily), orally. After Day 3, at the first occurrence of a serum potassium value of ≤ 5.1 mEq/L, the spironolactone dose was increased once to 50 mg/day; dose reductions were not allowed.
Measure Participants	63
Number [percentage of participants]	84.1 133.5%

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Patiromer
	Comments
	Type of Statistical Test	Superiority or Other (legacy)
	Comments
Statistical Test of Hypothesis	p-Value
	Comments
	Method
	Comments
Method of Estimation	Estimation Parameter	Percentage of Participants
	Estimated Value	84.1
	Confidence Interval	(2-Sided) 95%; 72.7 to 92.1
	Parameter Dispersion	Type: Value:
	Estimation Comments	Clopper-Pearson was used to arrive at the 95% Confidence Interval

7. Secondary Outcome

Title	Mean Dose of Patiromer at End of Treatment
Time Frame	56 Days

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Patiromer
Arm/Group Description	Spironolactone + Patiromer Participants received patiromer (20 g/day, administered as a divided dose of 10 g in the morning and 10 g in the evening) and spironolactone (25 mg/day, administered once daily), orally. After Day 3, at the first occurrence of a serum potassium value of ≤ 5.1 mEq/L, the spironolactone dose was increased once to 50 mg/day; dose reductions were not allowed.
Measure Participants	63
Mean (Standard Deviation) [grams]	22.5 (7.8)

8. Secondary Outcome

Title	Percentage of Participants Requiring Patiromer Uptitration
Time Frame	56 Days

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Patiromer
Arm/Group Description	Spironolactone + Patiromer Participants received patiromer (20 g/day, administered as a divided dose of 10 g in the morning and 10 g in the evening) and spironolactone (25 mg/day, administered once daily), orally. After Day 3, at the first occurrence of a serum potassium value of ≤ 5.1 mEq/L, the spironolactone dose was increased once to 50 mg/day; dose reductions were not allowed.
Measure Participants	63
Number [percentage of participants]	33.3 52.9%

9. Secondary Outcome

Title	Percentage of Participants Requiring Patiromer Downtitration
Time Frame	56 Days

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Patiromer
Arm/Group Description	Spironolactone + Patiromer Participants received patiromer (20 g/day, administered as a divided dose of 10 g in the morning and 10 g in the evening) and spironolactone (25 mg/day, administered once daily), orally. After Day 3, at the first occurrence of a serum potassium value of ≤ 5.1 mEq/L, the spironolactone dose was increased once to 50 mg/day; dose reductions were not allowed.
Measure Participants	63
Number [percentage of participants]	12.7 20.2%

10. Secondary Outcome

Title	Median Time to First Patiromer Dose Titration
Time Frame	56 Days

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Patiromer
Arm/Group Description	Spironolactone + Patiromer Participants received patiromer (20 g/day, administered as a divided dose of 10 g in the morning and 10 g in the evening) and spironolactone (25 mg/day, administered once daily), orally. After Day 3, at the first occurrence of a serum potassium value of ≤ 5.1 mEq/L, the spironolactone dose was increased once to 50 mg/day; dose reductions were not allowed.
Measure Participants	63
Median (95% Confidence Interval) [days]	21

11. Secondary Outcome

Title	Mean Number of Patiromer Titrations
Time Frame	56 Days

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Patiromer
Arm/Group Description	Spironolactone + Patiromer Participants received patiromer (20 g/day, administered as a divided dose of 10 g in the morning and 10 g in the evening) and spironolactone (25 mg/day, administered once daily), orally. After Day 3, at the first occurrence of a serum potassium value of ≤ 5.1 mEq/L, the spironolactone dose was increased once to 50 mg/day; dose reductions were not allowed.
Measure Participants	63
Mean (Standard Deviation) [patiromer titrations]	1.3 (1.1)

12. Secondary Outcome

Title	Mean Patiromer Dose at Week 1
Time Frame	Up to Week 1

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Patiromer
Arm/Group Description	Spironolactone + Patiromer Participants received patiromer (20 g/day, administered as a divided dose of 10 g in the morning and 10 g in the evening) and spironolactone (25 mg/day, administered once daily), orally. After Day 3, at the first occurrence of a serum potassium value of ≤ 5.1 mEq/L, the spironolactone dose was increased once to 50 mg/day; dose reductions were not allowed.
Measure Participants	63
Mean (Standard Deviation) [grams]	20.0 (0.0)

13. Secondary Outcome

Title	Mean Patiromer Dose at Week 4
Time Frame	Up to Week 4

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Patiromer
Arm/Group Description	Spironolactone + Patiromer Participants received patiromer (20 g/day, administered as a divided dose of 10 g in the morning and 10 g in the evening) and spironolactone (25 mg/day, administered once daily), orally. After Day 3, at the first occurrence of a serum potassium value of ≤ 5.1 mEq/L, the spironolactone dose was increased once to 50 mg/day; dose reductions were not allowed.
Measure Participants	63
Mean (Standard Deviation) [grams]	21.9 (8.5)

14. Secondary Outcome

Title	Mean Patiromer Dose at Week 8
Time Frame	Up to Week 8

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Patiromer
Arm/Group Description	Spironolactone + Patiromer Participants received patiromer (20 g/day, administered as a divided dose of 10 g in the morning and 10 g in the evening) and spironolactone (25 mg/day, administered once daily), orally. After Day 3, at the first occurrence of a serum potassium value of ≤ 5.1 mEq/L, the spironolactone dose was increased once to 50 mg/day; dose reductions were not allowed.
Measure Participants	63
Mean (Standard Deviation) [grams]	23.0 (12.4)

15. Secondary Outcome

Title	Mean Change From Baseline in Serum Potassium to End of Treatment
Time Frame	56 Days

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Patiromer
Arm/Group Description	Spironolactone + Patiromer Participants received patiromer (20 g/day, administered as a divided dose of 10 g in the morning and 10 g in the evening) and spironolactone (25 mg/day, administered once daily), orally. After Day 3, at the first occurrence of a serum potassium value of ≤ 5.1 mEq/L, the spironolactone dose was increased once to 50 mg/day; dose reductions were not allowed.
Measure Participants	63
Mean (Standard Deviation) [mEq/L]	-0.13 (0.686)

16. Secondary Outcome

Title	Percentage of Participants Discontinuing Due to Hyperkalemia (Serum Potassium > 5.5 mEq/L)
Time Frame	56 Days

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Patiromer
Arm/Group Description	Spironolactone + Patiromer Participants received patiromer (20 g/day, administered as a divided dose of 10 g in the morning and 10 g in the evening) and spironolactone (25 mg/day, administered once daily), orally. After Day 3, at the first occurrence of a serum potassium value of ≤ 5.1 mEq/L, the spironolactone dose was increased once to 50 mg/day; dose reductions were not allowed.
Measure Participants	63
Number [percentage of participants]	1.6 2.5%

17. Secondary Outcome

Title	Percentage of Patients Whose Spironolactone Dose Was Increased Up to 50 mg/Day
Time Frame	56 Days

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Patiromer
Arm/Group Description	Spironolactone + Patiromer Participants received patiromer (20 g/day, administered as a divided dose of 10 g in the morning and 10 g in the evening) and spironolactone (25 mg/day, administered once daily), orally. After Day 3, at the first occurrence of a serum potassium value of ≤ 5.1 mEq/L, the spironolactone dose was increased once to 50 mg/day; dose reductions were not allowed.
Measure Participants	63
Number [percentage of participants]	100 158.7%

18. Secondary Outcome

Title	Change in Urine Albumin to Creatinine Ratio (ACR) From Baseline to Week 4 Among Participants With ACR ≥ 30 mg/g at Baseline
Time Frame	Baseline and Day 28

Outcome Measure Data

Analysis Population Description

Participants with urine ACR ≥ 30 mg/g at baseline and available data at Week 4

Arm/Group Title	Patiromer
Arm/Group Description	Spironolactone + Patiromer Participants received patiromer (20 g/day, administered as a divided dose of 10 g in the morning and 10 g in the evening) and spironolactone (25 mg/day, administered once daily), orally. After Day 3, at the first occurrence of a serum potassium value of ≤ 5.1 mEq/L, the spironolactone dose was increased once to 50 mg/day; dose reductions were not allowed.
Measure Participants	31
Mean (Standard Error) [mg/g]	-291.01 (130.7973)

19. Secondary Outcome

Title	Change in ACR From Baseline to Week 8 Among Participants With Urine ACR ≥ 30 mg/g at Baseline
Time Frame	Baseline and Day 56

Outcome Measure Data

Analysis Population Description

Participants with urine ACR ≥ 30 mg/g at baseline and available data at Week 8

Arm/Group Title	Patiromer
Arm/Group Description	Spironolactone + Patiromer Participants received patiromer (20 g/day, administered as a divided dose of 10 g in the morning and 10 g in the evening) and spironolactone (25 mg/day, administered once daily), orally. After Day 3, at the first occurrence of a serum potassium value of ≤ 5.1 mEq/L, the spironolactone dose was increased once to 50 mg/day; dose reductions were not allowed.
Measure Participants	30
Mean (Standard Error) [mg/g]	-291.06 (141.5644)

Adverse Events

Time Frame	Up to 7 days after Day 56 or last patiromer dose, whichever was earlier.
Adverse Event Reporting Description	Participants who received at least one dose of trial medication.
Arm/Group Title	Patiromer
Arm/Group Description	Spironolactone + Patiromer Participants received patiromer (20 g/day, administered as a divided dose of 10 g in the morning and 10 g in the evening) and spironolactone (25 mg/day, administered once daily), orally. After Day 3, at the first occurrence of a serum potassium value of ≤ 5.1 mEq/L, the spironolactone dose was increased once to 50 mg/day; dose reductions were not allowed.
All Cause Mortality
	Patiromer
	Affected / at Risk (%)	# Events
Total	/ (NaN)
Serious Adverse Events
	Patiromer
	Affected / at Risk (%)	# Events
Total	6/63 (9.5%)
Cardiac disorders
Acute myocardial infarction	1/63 (1.6%)
General disorders
Sudden cardiac death	1/63 (1.6%)
Sudden death	1/63 (1.6%)
Infections and infestations
Pneumonia	1/63 (1.6%)
Staphylococcal sepsis	1/63 (1.6%)
Subcutaneous abscess	1/63 (1.6%)
Metabolism and nutrition disorders
Diabetes mellitus	1/63 (1.6%)
Renal and urinary disorders
Azotaemia	1/63 (1.6%)
Renal failure acute	3/63 (4.8%)
Other (Not Including Serious) Adverse Events
	Patiromer
	Affected / at Risk (%)	# Events
Total	4/63 (6.3%)
Gastrointestinal disorders
Abdominal discomfort	4/63 (6.3%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

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.