Phase 4 N=43 Randomized Treatment

Relypsa For ED Acute Hyperkalemia Control and Reduction (REDUCE)

Kidney Failure, Chronic

Bottom Line

View on ClinicalTrials.gov: NCT02933450 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

May 2019

Primary outcome: Primary: Efficacy of Patiromer in Reducing Serum Potassium — 6.17; 6.6; 5.9; 6.47 mEq/L

Study Design & Population

Study type: Interventional
Phase: Phase 4
Interventions: Patiromer 25.2 g (Drug)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: Baylor College of Medicine
Primary completion: Aug 2017

Outcome Measures

Outcome	Result	p-value
PRIMARY Efficacy of Patiromer in Reducing Serum Potassium	6.17; 6.6; 5.9; 6.47; 5.73; 6.04	—
SECONDARY Tolerability of High Dose Patiromer in ESRD Patients on Hemodialysis in the Acute Setting.	4; 5; 1; 2; 3; 3	—

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.

Eligibility 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

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT02933450). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.