An Open-Label, Multiple Dose Study to Evaluate the Pharmacology, Safety, and Tolerability of Patiromer in Participants on Hemodialysis
- Registration Number
- NCT02033317
- Lead Sponsor
- Relypsa, Inc.
- Brief 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.
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- All
- Target Recruitment
- 6
Inclusion Criteria
- Participants on hemodialysis between the ages of 18 and 70 years, with serum potassium levels of at least 5.5 mmol/L
- Adequately dialyzed (Kt/V ≥ 1.2)
Exclusion Criteria
- History of bowel obstruction, swallowing disorders, severe gastrointestinal disorders or major gastrointestinal surgery.
- Severe constipation or irregular bowel habits.
- Unable to consume or tolerate the study-specific diet.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description patiromer patiromer -
- Primary Outcome Measures
Name Time Method Change in Serum Potassium (Day 1 to Day 8) Day 1 and Day 8 Change From Baseline in Fecal Potassium Excretion (Day -7 Through Day -1) and Treatment (Day 1 Through 7) Day -7 Through Day -1 and Day 1 Through Day 7
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
Investigator Site
🇺🇸Minneapolis, Minnesota, United States