Relypsa For ED Acute Hyperkalemia Control and Reduction (REDUCE)

Part of paid clinical trials in Houston, Texas.

Sponsor
Baylor College of Medicine
Study ID
NCT02933450
Phase
PHASE4
Status
Completed

Conditions

  • Kidney Failure, Chronic

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

Study Details

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 Dates

Start date
Aug 31, 2016
Status verified
May 2019
Primary completion
Aug 31, 2017
Completion
Aug 31, 2017

Study Design

Enrollment
43 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Active Comparator: Patiromer group
    Patiromer 25.2 g dose
  • No Intervention: Standard of Care group
    Standard of Care

Primary Outcome Measure

Efficacy of Patiromer in Reducing Serum Potassium [ Time Frame: 6 hours ]

Locations (1)

FacilityCityStateZIPSite coordinators
Ben Taub HospitalHoustonTexas77030-

Find similar trials in Houston, TX

By research site
Ben Taub Hospital· Houston, TX

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