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Relypsa For ED Acute Hyperkalemia Control and Reduction (REDUCE)

NCT02933450 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 43

Last updated 2019-05-09

Study results available
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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.

Conditions

  • Kidney Failure, Chronic

Interventions

DRUG

Patiromer 25.2 g

Single dose of Patiromer 25.2 g

Sponsors & Collaborators

  • Relypsa, Inc.

    collaborator INDUSTRY

  • Baylor College of Medicine

    lead OTHER

Principal Investigators

  • Zubaid Rafique, MD · Baylor College of Medicine

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-08-31
Primary Completion
2017-08-31
Completion
2017-08-31

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02933450 on ClinicalTrials.gov