NCT00868439

Evaluation of Patiromer in Heart Failure Patients

A Multicenter, Randomized, Double-blind, Placebo-Controlled, Parallel-Group, Multiple-Dose Study to Evaluate the Effects of Patiromer in Heart Failure Patients

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 120 (actual)
• Sponsor: Relypsa, Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed description

This was a double-blind, randomized, placebo-controlled, parallel-group, multiple-dose study in congestive heart failure participants. Depending on the outcome from the initial cohort of 100 participants (Part 1), a second cohort of 170 participants could have been enrolled (Part 2). Based on the results of Part 1 of the study, Part 2 was not conducted. Participants were randomly assigned to and received patiromer (30 g/day) or placebo for up to 28 days. All participants also received spironolactone; the initial spironolactone dose was 25 mg daily and was increased to 50 mg daily for participants who had a serum potassium ≤ 5.1 mEq/L on treatment Day 14. Study visits occurred on treatment Days 3, 7, 14, 17, 21 and 28. A safety follow-up contact was made 7 days after administration of last dose of study drug.

Conditions

• Hyperkalemia
• Heart Failure

Interventions

Type	Name	Description
DRUG	patiromer	Active investigational drug
DRUG	placebo	placebo

Timeline

• Start date: 2009-04-01
• Primary completion: 2009-11-01
• Completion: 2009-12-01
• First posted: 2009-03-25
• Last updated: 2021-06-02
• Results posted: 2015-12-15

Locations

33 sites across 7 countries: United States, Czechia, Georgia, Germany, Poland, Russia, Ukraine