Phase 2
N=63
Evaluation of Patiromer Titration in Heart Failure Patients With Chronic Kidney Disease
Heart Failure
Bottom Line
View on ClinicalTrials.gov: NCT01130597 ↗Enrolled (actual)
63
Serious AEs
9.5%
Results posted
Jan 2016
Primary outcome: Primary: 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
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- patiromer (Drug); spironolactone (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Relypsa, Inc.
- Primary completion
- Sep 2010
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Participants With Serum Potassium in the Range of 3.5 - 5.5 mEq/L at the End of Treatment |
90.5 | — |
| SECONDARY Percentage of Participants With Serum Potassium in the Range of 3.5 - 5.5 mEq/L at Week 4 |
96.7 | — |
| SECONDARY Percentage of Participants With Serum Potassium in the Range of 3.5 - 5.5 mEq/L at Week 8 |
93.0 | — |
| SECONDARY Percentage of Participants With Serum Potassium in the Range of 4.0 - 5.1 mEq/L at Week 4 |
78.7 | — |
| SECONDARY Percentage of Participants With Serum Potassium in the Range of 4.0 - 5.1 mEq/L at Week 8 |
86.0 | — |
| SECONDARY Percentage of Participants With Serum Potassium in the Range of 4.0 - 5.1 mEq/L at the End of Treatment |
84.1 | — |
| SECONDARY Mean Dose of Patiromer at End of Treatment |
22.5 | — |
| SECONDARY Percentage of Participants Requiring Patiromer Uptitration |
33.3 | — |
| SECONDARY Percentage of Participants Requiring Patiromer Downtitration |
12.7 | — |
| SECONDARY Median Time to First Patiromer Dose Titration |
21 | — |
| SECONDARY Mean Number of Patiromer Titrations |
1.3 | — |
| SECONDARY Mean Patiromer Dose at Week 1 |
20.0 | — |
| SECONDARY Mean Patiromer Dose at Week 4 |
21.9 | — |
| SECONDARY Mean Patiromer Dose at Week 8 |
23.0 | — |
| SECONDARY Mean Change From Baseline in Serum Potassium to End of Treatment |
-0.13 | — |
| SECONDARY Percentage of Participants Discontinuing Due to Hyperkalemia (Serum Potassium > 5.5 mEq/L) |
1.6 | — |
| SECONDARY Percentage of Patients Whose Spironolactone Dose Was Increased Up to 50 mg/Day |
100 | — |
| SECONDARY Change in Urine Albumin to Creatinine Ratio (ACR) From Baseline to Week 4 Among Participants With ACR ≥ 30 mg/g at Baseline |
-291.01 | — |
| SECONDARY Change in ACR From Baseline to Week 8 Among Participants With Urine ACR ≥ 30 mg/g at Baseline |
-291.06 | — |
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).
Eligibility Criteria
Inclusion Criteria
- Chronic HF clinically indicated to receive spironolactone therapy
- Age 18 years or older
- Local laboratory serum potassium values of 4.3 - 5.1 mEq/L at screening and baseline
- CKD (estimated glomerular filtration rate [eGFR] 180 or 3 times upper limit of normal
- 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
- Use of any intravenous cardiac medications within 21 days prior to baseline, or their anticipated need during study participation
- 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
- Use of potassium sparing medication including aldosterone antagonists or potassium supplements in the last 21 days prior to baseline
- Use of any investigational medication within 30 days or 5 half-lives, whichever is longer, prior to baseline
- Participants who have taken investigational product in this study, or a previous patiromer study
- Inability to consume the study medication, or, in the opinion of the Investigator, inability to comply with the protocol
- 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
Data sourced from ClinicalTrials.gov (NCT01130597). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.