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.