Phase 2
N=105
Evaluation of Patiromer in Heart Failure Patients
Hyperkalemia · Heart Failure
Bottom Line
View on ClinicalTrials.gov: NCT00868439 ↗Enrolled (actual)
105
Serious AEs
3.8%
Results posted
Dec 2015
Primary outcome: Primary: Change From Baseline in Serum Potassium to the End of the 28-day Treatment Period. — -0.21; 0.23 mEq/L — p=< 0.001
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- patiromer (Drug); placebo (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Relypsa, Inc.
- Primary completion
- Nov 2009
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change From Baseline in Serum Potassium to the End of the 28-day Treatment Period. |
-0.21; 0.23 | < 0.001 sig |
| SECONDARY Proportion of Participants With a Serum Potassium Level During the 28-day Treatment Period That Was > 5.5 mEq/L. |
7.3; 24.5 | = 0.027 sig |
| SECONDARY Proportion of Participants Discontinuing the Study Due to Serum Potassium Elevation (Serum K+ > 5.5 mEq/L). |
0; 6.1 | = 0.101 |
| SECONDARY Proportion of Participants Whose Spironolactone Dose Was Increased. |
90.9; 73.5 | 0.022 sig |
| SECONDARY Proportion of Participants With an Increase in Serum Potassium Level From Baseline to the End of the 28-day Treatment Period That Was ≥ 0.5 mEq/L |
12.7; 24.5 | = 0.136 |
| SECONDARY Time to First Elevated Serum K+ > 5.5 mEq/L. |
NA; NA | = 0.015 sig |
Summary
The purpose of this study was to assess the effects of patiromer on serum potassium participants with heart failure. This study also assessed the safety and tolerability of patiromer in participants with heart failure.
Eligibility Criteria
Inclusion Criteria
- Participants with chronic heart failure clinically indicated to receive spironolactone therapy, aged 18 years or older with serum potassium level of 4.3 - 5.1 mEq/L at screening and baseline, AND (1) chronic kidney disease (GFR 500 msec (Bazett's correction formula)
- Sustained systolic blood pressure > 170 or 3 times upper limit of normal
- Use of oral cardiac medications (including loop and thiazide diuretics) that have not been stable for at least 21 days prior to baseline and are not anticipated to remain stable during study participation
- Use of any IV cardiac medications within 21 days prior to baseline, or their anticipated need during study participation.
- Current use of polymer-based drugs (e.g. Renagel, Kayexalate, Welchol, Colestid), other phosphate binders or potassium binders, calcium supplements, antacids (eg TUMS, Maalox), or their anticipated need during study participation
- Use of aldosterone antagonist in the last 30 days prior to baseline, unless was discontinued due to hyperkalemia
- Use of potassium sparing medication and/or potassium supplements in the last 30 days prior to baseline
- Use of any investigational medication, 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 (NCT00868439). 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.