Relypsa For ED Acute Hyperkalemia Control and Reduction (REDUCE)

• Status: Completed
• Trial end date: 2017-08-01
• Target enrollment: 0
• Participant gender: All

Summary

The Investigator hypothesize that a single dose of patiromer will lower serum potassium levels in less than 6hrs. Since a dosage of 30g/day for a period of 4 weeks has been studied in at least two multicenter randomized controlled trials, the Investigator further hypothesize that a single dose of 25.2g of patiromer will be well tolerated in hyperkalemic patients in the Emergency Department setting. The FDA approved dosage of 25.2g is appropriate for this study because the research staff will enroll patients with moderate (K greater than 6 mEq/L) to severe hyperkalemia, and the higher dosage has typically been used in this population for more effective control.

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

Details

• Lead Sponsor: Baylor College of Medicine
• Collaborator: Relypsa, Inc.

Criteria

Inclusion Criteria:

• ESRD patients with serum potassium greater than or equal to 6.0 mEq/L

• Emergent dialysis not expected to be available for 6 hours

Exclusion Criteria:

• new clinically significant arrhythmia on initial ECG

• patiromer is contraindicated

• have received SPS