Patiromer With or Without Food for the Treatment of Hyperkalemia

• Status: Completed
• Trial end date: 2016-08-01
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to evaluate the efficacy and safety of patiromer administered once daily (QD) when given with food compared to without food (experimental treatment group) for the treatment of hyperkalemia (high potassium in the blood).

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Relypsa, Inc.

Criteria

Key Inclusion Criteria:

• Potassium concentration > 5.0 mEq/L from two blood draws at Screening

• Stable RAASi medication, if taking

• Medications taken on a chronic basis are given once daily or twice daily

• Informed consent given

Key Exclusion Criteria:

• Expected need for dialysis

• Major organ transplant

• History of conditions associated with pseudohyperkalemia

• History of swallowing disorder, gastroparesis, bariatric surgery, bowel obstruction or severe gastrointestinal disorders or major gastrointestinal surgery

• Cancer or unstable medical condition