Relypsa For ED Acute Hyperkalemia Control and Reduction (REDUCE)

Completed · Phase 4

Conditions studied: Kidney Failure, Chronic

In brief

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.

Key facts

Study ID

NCT02933450

Run by

Baylor College of Medicine

People needed

43

Starts

2016-08-01

Expected to finish

2017-08-01

Last updated by the study team

2019-05-09

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• ESRD patients with serum potassium greater than or equal to 6.0 mEq/L
• Emergent dialysis not expected to be available for 6 hours

You may not qualify if…

• new clinically significant arrhythmia on initial ECG
• patiromer is contraindicated
• have received SPS

Where it is running

• Ben Taub Hospital — Houston, Texas, United States

Full record on ClinicalTrials.gov

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