Relypsa For ED Acute Hyperkalemia Control and Reduction (REDUCE)
Primary Purpose
Kidney Failure, Chronic
Status
Completed
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Patiromer 25.2 g
Sponsored by
About this trial
This is an interventional treatment trial for Kidney Failure, Chronic
Eligibility Criteria
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
Sites / Locations
- Ben Taub Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
No Intervention
Arm Label
Patiromer group
Standard of Care group
Arm Description
Patiromer 25.2 g dose
Standard of Care
Outcomes
Primary Outcome Measures
Efficacy of Patiromer in Reducing Serum Potassium
serial serum potassium levels will be graphed and compared between the 2 groups
Secondary Outcome Measures
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
Full Information
NCT ID
NCT02933450
First Posted
August 25, 2016
Last Updated
May 7, 2019
Sponsor
Baylor College of Medicine
Collaborators
Relypsa, Inc.
1. Study Identification
Unique Protocol Identification Number
NCT02933450
Brief Title
Relypsa For ED Acute Hyperkalemia Control and Reduction (REDUCE)
Official Title
Relypsa For ED Acute Hyperkalemia Control and Reduction (REDUCE)
Study Type
Interventional
2. Study Status
Record Verification Date
May 2019
Overall Recruitment Status
Completed
Study Start Date
August 2016 (undefined)
Primary Completion Date
August 2017 (Actual)
Study Completion Date
August 2017 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Baylor College of Medicine
Collaborators
Relypsa, Inc.
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief 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.
Detailed 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Kidney Failure, Chronic
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
43 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Patiromer group
Arm Type
Active Comparator
Arm Description
Patiromer 25.2 g dose
Arm Title
Standard of Care group
Arm Type
No Intervention
Arm Description
Standard of Care
Intervention Type
Drug
Intervention Name(s)
Patiromer 25.2 g
Intervention Description
Single dose of Patiromer 25.2 g
Primary Outcome Measure Information:
Title
Efficacy of Patiromer in Reducing Serum Potassium
Description
serial serum potassium levels will be graphed and compared between the 2 groups
Time Frame
6 hours
Secondary Outcome Measure Information:
Title
Tolerability of High Dose Patiromer in ESRD Patients on Hemodialysis in the Acute Setting.
Description
adverse events will be recorded and compared between the 2 groups
Time Frame
6 hours
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Zubaid Rafique, MD
Organizational Affiliation
Baylor College of Medicine
Official's Role
Principal Investigator
Facility Information:
Facility Name
Ben Taub Hospital
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing Plan Description
Data will be coded and shared with the sponsor
Learn more about this trial
Relypsa For ED Acute Hyperkalemia Control and Reduction (REDUCE)
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