Relypsa For ED Acute Hyperkalemia Control and Reduction (REDUCE)

Baylor College of Medicine

Status and phase: Completed; Phase 4

Conditions: Kidney Failure, Chronic

Treatments: Drug: Patiromer 25.2 g

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT02933450

H-39340

Details and patient eligibility

About

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.

Full description

This is an open label pilot study. Thirty patients with ESRD who qualify for emergent dialysis on the basis of serum potassium greater than 6mEq/L will be randomly assigned, using a random number generator in blocks of sixes, to standard-of-care (standard care) or patiromer group. Patients in the patiromer group will be given a single dose of 25.2g of patiromer in addition to standard-of-care treatment after randomization. Standard-of-care is defined as intervention or care provided by clinical provider according to individual practice pattern or hospital protocol. Each group of 15 patients will be observed with telemetry monitoring for 10 hours or till hemodialysis units become available for treatment (whichever comes first). Blood draws and electrocardiograms (ECGs) will be performed at enrollment and at 1, 2, 4, 6, 8 and 10hrs thereafter. Serum will be analyzed for basic metabolic panel and magnesium. Medications, including potassium lowering agents, administered during this period will be documented.

1. Informed consent will be obtained. 2. Subject will be randomized. 3. A. Randomized to Standard of Care (SOC): data will be collected on SOC treatment. 3. B. Randomized to patiromer group: subjects will receive a single dose of 25.2g of patiromer. SOC data will be collected. 4. all subjects will have blood drawn and ECGs (1 12 lead ECG and 1 Lead I Rhythm strip) done at baseline, 1, 2, 4, 6, 8 and 10 hours. Blood will be analyzed for basic metabolic panel and magnesium. 5. CRF completion-SOC data will be recorded in addition to current medications. 6. After subjects have received hemodialysis or reach the 10 hour study period, whichever comes first, the subject will be completed on the study.

Enrollment: 43 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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43 participants in 2 patient groups

Patiromer group

Active Comparator group

Description:

Patiromer 25.2 g dose

Treatment:

Drug: Patiromer 25.2 g

Standard of Care group

No Intervention group

Description:

Standard of Care