Relypsa For ED Acute Hyperkalemia Control and Reduction (REDUCE)

Kidney Failure, Chronic Clinical Trial

Official title:

Relypsa For ED Acute Hyperkalemia Control and Reduction (REDUCE)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02933450
• Other study ID #: H-39340
• Status: Completed
• Phase: Phase 4
• Start date: August 2016
• Est. completion date: August 2017

Study information

• Verified date: May 2019
• Source: Baylor College of Medicine
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 43
• Est. completion date: August 2017
• Est. primary completion date: August 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Hyperkalemia
• Kidney Failure, Chronic
• Renal Insufficiency

Intervention

Drug:
• Patiromer 25.2 g
Single dose of Patiromer 25.2 g

Locations

Country	Name	City	State
United States	Ben Taub Hospital	Houston	Texas

Sponsors (2)

Lead Sponsor	Collaborator
Baylor College of Medicine	Relypsa, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Efficacy of Patiromer in Reducing Serum Potassium	serial serum potassium levels will be graphed and compared between the 2 groups	6 hours
Secondary	Tolerability of High Dose Patiromer in ESRD Patients on Hemodialysis in the Acute Setting.	adverse events will be recorded and compared between the 2 groups	6 hours