NCT02033317

An Open-Label, Multiple Dose Study to Evaluate the Pharmacology, Safety, and Tolerability of Patiromer in Participants on Hemodialysis

An Open-Label, Multiple Dose Study to Evaluate the Pharmacology, Safety, and Tolerability of Patiromer in Hemodialysis Patients

• Status: Terminated
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 6 (actual)
• Sponsor: Relypsa, Inc. · Industry
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

Summary

This study assessed the pharmacodynamic effects of patiromer on serum potassium in participants on hemodialysis.

Detailed description

The initial intent was to enroll 12-24 adult male and female participants on hemodialysis into the study. Due to significant recruitment challenges, the study was discontinued after six participants were enrolled in the study. This was an open-label, multiple-dose, adaptive-design study in participants on hemodialysis. Eligible participants on hemodialysis were to remain in the Clinical Research Unit for 2 weeks (Day -7 to Day 8) and were required to consume a potassium, magnesium, calcium and sodium-controlled diet.

Conditions

• Hyperkalemia

Interventions

Type	Name	Description
DRUG	patiromer	15 grams/day (5 grams 3 times daily) administered orally

Timeline

• Start date: 2008-08-01
• Primary completion: 2008-12-01
• Completion: 2008-12-01
• First posted: 2014-01-10
• Last updated: 2021-05-12
• Results posted: 2015-12-15

Locations

2 sites across 1 country: United States