Clinical Trial: An Open-Label, Multiple Dose Study to Evaluate the Pharmacology, Safety, and Tolerability of Patiromer in Participants on Hemodialysis
Study Status: Terminated
Recruit Status: Terminated
Study Type: Interventional
Official Title: An Open-Label, Multiple Dose Study to Evaluate the Pharmacology, Safety, and Tolerability of Patiromer in Hemodialysis Patients
Brief Summary: This study assessed the pharmacodynamic effects of patiromer on serum potassium in participants on hemodialysis.
Detailed Summary:
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.
Sponsor: Relypsa, Inc.
Current Primary Outcome:
- Change in Serum Potassium (Day 1 to Day 8) [ Time Frame: Day 1 and Day 8 ]
- Change From Baseline in Fecal Potassium Excretion (Day -7 Through Day -1) and Treatment (Day 1 Through 7) [ Time Frame: Day -7 Through Day -1 and Day 1 Through Day 7 ]
Original Primary Outcome: Change from baseline in serum potassium [ Time Frame: 8 Days ]
Current Secondary Outcome:
Original Secondary Outcome: Change from baseline in fecal potassium excretion [ Time Frame: 8 Days ]
Information By: Relypsa, Inc.
Dates:
Date Received: January 9, 2014
Date Started: August 2008
Date Completion:
Last Updated: January 25, 2016
Last Verified: January 2016
