drugset / Trial / NCT03326583

The Effects of Patiromer on Serum Potassium Level and Gut Microbiome of ESRD Patients With Hyperkalemia

NCT03326583

Phase 2 Completed 27 enrolled Dominic Raj
NaSequentialOpen-labelTreatment

Summary

The Effects of Patiromer on Serum Potassium Level and Gut Microbiome of ESRD Patients With Hyperkalemia (potassium greater than 5 milliequivalents per liter) is a non-randomized, crossover study. This is an open-label, pilot clinical trial with 3 sequential phases of (a) 2 weeks of no intervention, (b) 12 weeks of Patiromer treatment, and (c) 6 weeks of no intervention. Treatment with Patiromer will be initiated at a dose of 8.4 grams, once daily and observed for a week, then uptitrated to 16.8 grams once daily. Eligible study subjects will collect stool samples and provide blood and urine samples.

Timeline

Start
2017-11-01
Primary completion
2020-12-31
Completion
2020-12-31

Drugs

EvaluationDrugModalityDoseRoute
Subject Patiromer Other / unclassified 16.8 g Oral