CI

At a glance

ClinicalIndex Comparison Record
Phase 4Completed· 43 enrolled
Drug / intervention
Patiromer 25.2 gdrug
Likely dose
Patiromer 25.2 gfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT02933450
NCT02933450Phase 4Completed

Relypsa For ED Acute Hyperkalemia Control and Reduction (REDUCE)

Baylor College of Medicine·interventional·Posted Oct 14, 2016·Updated May 9, 2019

In Brief

A Phase 4 clinical trial evaluating Patiromer 25.2 g for Kidney Failure, Chronic. Completed, enrolled 43 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited States
CollaboratorsRelypsa, Inc.

Timeline

Phase 4CompletedFinished
2017201820192020202120222023202420252026
First PostedOct 14, 2016
Enrollment StartAug 1, 2016
Primary CompletionAug 1, 2017
TodayJul 2, 2026
Enrollment to primary: 1 yearPosted 9.7 years ago

Interventions

Patiromer 25.2 gdrug

Single dose of Patiromer 25.2 g