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

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

Outcome

Missed primary endpoint

registry analysis (superiority test); Pre-Treatment vs Treatment vs Post-Treatment; p = .05; Fisher Exact NCT03326583 ↗

registry analysis (superiority test); Pre-Treatment vs Intervention: Treatment vs Post-Treatment; p = .05; Mixed Models Analysis NCT03326583 ↗

registry analysis (superiority test); Pre-Treatment vs Treatment vs Post-Treatment; p = .05; Mixed Models Analysis NCT03326583 ↗

Publications

• Results Amdur RL, Paul R, Barrows ED, Kincaid D, Muralidharan J, Nobakht E, Centron-Vinales P, Siddiqi M, Patel SS, Raj DS. The potassium regulator patiromer affects serum and stool electrolytes in patients receiving hemodialysis. Kidney Int. 2020 Nov;98(5):1331-1340. doi: 10.1016/j.kint.2020.06.042. Epub 2020 Aug 1.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Patiromer	Other / unclassified	16.8 g	Oral

Indications