Efficacy and safety of patiromer for non-dialysis and dialysis patients with hyperkalemia: the randomized, placebo-controlled and long-term study.

ABSTRACT:

Background

The objectives of this phase two study are to investigate the efficacy of two starting doses of 8.4 g and 16.8 g and evaluate the long-term safety of patiromer in Japanese patients with hyperkalemia.

Methods

This study comprised three cohorts; non-dialysis patients with baseline serum potassium (sK) level of 5.1 to < 6.0 mmol/L (NDC1); 6.0 to < 6.5 mmol/L (NDC2); dialysis patients with baseline sK level of 5.5 to < 6.5 mmol/L (DC). The study design was one-week, randomized, double-blind, placebo-controlled, and open label extension for one year in NDC1, open label during the study in NDC2 and DC. Patients were randomly assigned to patiromer 8.4 g, 16.8 g or placebo in NDC1, 8.4 g or 16.8 g in NDC2 and DC. Dose was adjusted up to 25.2 g according to the titration a

SUBMITTER: Kashihara N 

PROVIDER: S-EPMC12049377 | biostudies-literature | 2025 May

REPOSITORIES: biostudies-literature