A study to investigate the safety and efficacy of ZS in patients with hyperkalemia. - HARMONIZE Asia

Study identifier:D9480C00001

ClinicalTrials.gov identifier:NCT03528681

EudraCT identifier:N/A

CTIS identifier:N/A

Study Complete

Official Title

A phase 3 multicenter, prospective, randomized, double-blind, placebo-controlled study to investigate the safety and efficacy of ZS (sodium zirconium cyclosilicate), in patients with hyperkalemia-HARMONIZE Asia

Medical condition

Hyperkalemia

Phase

Phase 3

Healthy volunteers

No

Study drug

Sodium Zirconium Cyclosilicate 5g, Sodium Zirconium Cyclosilicate 10g, Placebo

Sex

All

Actual Enrollment

250

Study type

Interventional

Age

18 Years - 90 Years

Date

Study Start Date: 06 May 2021
Primary Completion Date: 15 Sept 2022
Study Completion Date: 15 Sept 2022

Study design

Allocation: Randomized
Endpoint Classification: -
Intervention Model: Parallel Assignment
Masking: Double Blind
Primary Purpose: Treatment

Verification:

Verified 01 Sept 2023 by AstraZeneca

Sponsors

AstraZeneca

Collaborators

-

Inclusion and exclusion criteria