Correction of serum potassium with sodium zirconium cyclosilicate in Japanese patients with hyperkalemia: a randomized, dose-response, phase 2/3 study.

ABSTRACT:

Background

Sodium zirconium cyclosilicate (SZC) is an oral potassium binder approved to treat hyperkalemia in adults in a number of countries, including Japan.

Methods

This phase 2/3, randomized, double-blind, placebo-controlled, dose-response study (ClinicalTrials.gov: NCT03127644) was designed to determine the efficacy and safety of SZC in Japanese adults with hyperkalemia. Patients with serum potassium (sK⁺) concentrations ≥ 5.1- ≤ 6.5 mmol/L were randomized 1:1:1 to SZC 5 g, SZC 10 g, or placebo three times daily for 48 h (six doses total). The primary efficacy endpoint was the exponential rate of change in sK⁺ over 48 h. The proportion of patients with normokalemia (sK⁺ 3.5-5.0 mmol/L) at 48 h and adverse events (AEs) were also evaluated

SUBMITTER: Kashihara N 

PROVIDER: S-EPMC7599176 | biostudies-literature | 2020 Dec

REPOSITORIES: biostudies-literature