Relypsa For ED Acute Hyperkalemia Control and Reduction (REDUCE)
| Status: | Completed |
|---|---|
| Conditions: | Renal Impairment / Chronic Kidney Disease, Renal Impairment / Chronic Kidney Disease |
| Therapuetic Areas: | Nephrology / Urology |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 1/20/2018 |
| Start Date: | August 2016 |
| End Date: | August 2017 |
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.
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.
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.
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.
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
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