Phase 4
Completed N=43
Relypsa For ED Acute Hyperkalemia Control and Reduction (REDUCE)
Kidney Failure, Chronic
Source: ClinicalTrials.gov NCT02933450 ↗
Enrolled (actual)
43
Serious AEs
0.0%
Results posted
May 2019
Primary outcomePrimary: Efficacy of Patiromer in Reducing Serum Potassium — 6.17; 6.6; 5.9; 6.47 mEq/L
◆ Published Evidence
No publication linked
No peer-reviewed publication reporting this trial's results has been linked yet. This can indicate results are unpublished — a known publication-bias signal. We re-check periodically.
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Efficacy of Patiromer in Reducing Serum Potassium |
6.17; 6.6; 5.9; 6.47; 5.73; 6.04 | — |
| SECONDARY Tolerability of High Dose Patiromer in ESRD Patients on Hemodialysis in the Acute Setting. |
4; 5; 1; 2; 3; 3 | — |
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
Data sourced from ClinicalTrials.gov (NCT02933450). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.