Overview

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

Status:
Terminated
Trial end date:
2008-12-01
Target enrollment:
0
Participant gender:
All
Summary
This study assessed the pharmacodynamic effects of patiromer on serum potassium in participants on hemodialysis.
Phase:
Phase 2
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Relypsa, Inc.
Criteria
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.