A Phase 2 interventional study of patiromer and spironolactone in Heart Failure, sponsored by Relypsa, Inc.. Completed at 13 sites in 2 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2021-05-12.
Sponsored by Relypsa, Inc. · Phase 2, Interventional, and Prevention
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).
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 5.5 mEq/L on two consecutive scheduled study visits, despite titration of patiromer or spironolactone, were withdrawn from the study, permanently discontinued patiromer and spironolactone, and returned for a follow-up visit within 7 days.
3,840 studies on the registry are indexed under Kidney Diseases; 500 are open to participants now.
This study's enrollment of 63 is close to the median of 70 across 2,640 interventional studies indexed under Kidney Diseases.
Browse Kidney Diseases studies →Relypsa, Inc. is the lead sponsor of 7 studies on the registry; none are open to participants now.
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Exclusion Criteria:
spironolactone + patiromer
Drug: patiromer · Drug: spironolactone
Active investigational drug
Also known as: RLY5016, Veltassa
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
Percentage of Participants With Serum Potassium in the Range of 3.5 - 5.5 mEq/L at Week 4
Time frame: 28 Days
Percentage of Participants With Serum Potassium in the Range of 3.5 - 5.5 mEq/L at Week 8
Time frame: 56 Days
Percentage of Participants With Serum Potassium in the Range of 4.0 - 5.1 mEq/L at Week 4
Time frame: 28 Days
Percentage of Participants With Serum Potassium in the Range of 4.0 - 5.1 mEq/L at Week 8
Time frame: 56 Days
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
Mean Dose of Patiromer at End of Treatment
Time frame: 56 Days
Percentage of Participants Requiring Patiromer Uptitration
Time frame: 56 Days
Percentage of Participants Requiring Patiromer Downtitration
Time frame: 56 Days
Median Time to First Patiromer Dose Titration
Time frame: 56 Days
Mean Number of Patiromer Titrations
Time frame: 56 Days
Mean Patiromer Dose at Week 1
Time frame: Up to Week 1
Mean Patiromer Dose at Week 4
Time frame: Up to Week 4
Mean Patiromer Dose at Week 8
Time frame: Up to Week 8
Mean Change From Baseline in Serum Potassium to End of Treatment
Time frame: 56 Days
Percentage of Participants Discontinuing Due to Hyperkalemia (Serum Potassium > 5.5 mEq/L)
Time frame: 56 Days
Percentage of Patients Whose Spironolactone Dose Was Increased Up to 50 mg/Day
Time frame: 56 Days
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
Change in ACR From Baseline to Week 8 Among Participants With Urine ACR ≥ 30 mg/g at Baseline
Time frame: Baseline and Day 56
| Milestone | Patiromer |
|---|---|
| Started | 63 |
| Completed | 56 |
| Not completed | 7 |
| Withdrew: Protocol-specified (high k+) | 1 |
| Withdrew: Adverse event | 4 |
| Withdrew: Death | 1 |
| Withdrew: Protocol violation | 1 |
| percentage of participants | Patiromer |
|---|---|
| Percentage of Participants With Serum Potassium in the Range of 3.5 - 5.5 mEq/L at the End of Treatment | 90.5 |
| percentage of participants | Patiromer |
|---|---|
| Percentage of Participants With Serum Potassium in the Range of 3.5 - 5.5 mEq/L at Week 4 | 96.7 |
| percentage of participants | Patiromer |
|---|---|
| Percentage of Participants With Serum Potassium in the Range of 3.5 - 5.5 mEq/L at Week 8 | 93.0 |
| percentage of participants | Patiromer |
|---|---|
| Percentage of Participants With Serum Potassium in the Range of 4.0 - 5.1 mEq/L at Week 4 | 78.7 |
| percentage of participants | Patiromer |
|---|---|
| Percentage of Participants With Serum Potassium in the Range of 4.0 - 5.1 mEq/L at Week 8 | 86.0 |
| percentage of participants | Patiromer |
|---|---|
| Percentage of Participants With Serum Potassium in the Range of 4.0 - 5.1 mEq/L at the End of Treatment | 84.1 |
| grams | Patiromer |
|---|---|
| Mean Dose of Patiromer at End of Treatment | 22.5 ± 7.8 |
| percentage of participants | Patiromer |
|---|---|
| Percentage of Participants Requiring Patiromer Uptitration | 33.3 |
| percentage of participants | Patiromer |
|---|---|
| Percentage of Participants Requiring Patiromer Downtitration | 12.7 |
| days | Patiromer |
|---|---|
| Median Time to First Patiromer Dose Titration | 21 (14.0 to 36.0) |
| patiromer titrations | Patiromer |
|---|---|
| Mean Number of Patiromer Titrations | 1.3 ± 1.1 |
| grams | Patiromer |
|---|---|
| Mean Patiromer Dose at Week 1 | 20.0 ± 0.0 |
| grams | Patiromer |
|---|---|
| Mean Patiromer Dose at Week 4 | 21.9 ± 8.5 |
| grams | Patiromer |
|---|---|
| Mean Patiromer Dose at Week 8 | 23.0 ± 12.4 |
| mEq/L | Patiromer |
|---|---|
| Mean Change From Baseline in Serum Potassium to End of Treatment | -0.13 ± 0.686 |
| percentage of participants | Patiromer |
|---|---|
| Percentage of Participants Discontinuing Due to Hyperkalemia (Serum Potassium > 5.5 mEq/L) | 1.6 |
| percentage of participants | Patiromer |
|---|---|
| Percentage of Patients Whose Spironolactone Dose Was Increased Up to 50 mg/Day | 100 |
| mg/g | Patiromer |
|---|---|
| Change in Urine Albumin to Creatinine Ratio (ACR) From Baseline to Week 4 Among Participants With ACR ≥ 30 mg/g at Baseline | -291.01 ± 130.7973 |
| mg/g | Patiromer |
|---|---|
| Change in ACR From Baseline to Week 8 Among Participants With Urine ACR ≥ 30 mg/g at Baseline | -291.06 ± 141.5644 |
Collected over Up to 7 days after Day 56 or last patiromer dose, whichever was earlier.. Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Patiromer | — | 6/63 (9.5%) | 4/63 (6.3%) |
| Event | Patiromer |
|---|---|
| Renal failure acuteRenal and urinary disorders | 3/63 |
| Acute myocardial infarctionCardiac disorders | 1/63 |
| Sudden cardiac deathGeneral disorders | 1/63 |
| Sudden deathGeneral disorders | 1/63 |
| PneumoniaInfections and infestations | 1/63 |
| Staphylococcal sepsisInfections and infestations | 1/63 |
| Subcutaneous abscessInfections and infestations | 1/63 |
| Diabetes mellitusMetabolism and nutrition disorders | 1/63 |
| AzotaemiaRenal and urinary disorders | 1/63 |
| Event | Patiromer |
|---|---|
| Abdominal discomfortGastrointestinal disorders | 4/63 |
| Age, Categorical(Participants) | Patiromer |
|---|---|
| <=18 years | 0 |
| Between 18 and 65 years | 17 |
| >=65 years | 46 |
| Age, Continuous(years) | Patiromer |
|---|---|
| Mean | 70.8 (53 to 86) |
| Sex: Female, Male(Participants) | Patiromer |
|---|---|
| Female | 24 |
| Male | 39 |
This study is completed, as verified in Dec 2015. You cannot join it, but the record below documents what was studied.
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Relypsa, Inc.