A Study to Evaluate the Effect of Sodium Zirconium Cyclosilicate on Chronic Kidney Disease (CKD) Progression in Participants with CKD and Hyperkalaemia or at Risk of Hyperkalaemia - STABILIZE-CKD

Study identifier:D9488C00001

ClinicalTrials.gov identifier:NCT05056727

EudraCT identifier:2021-001911-96

CTIS identifier:N/A

Terminated/Withdrawn

Official Title

A Phase 3, International, Randomised, Double-blind, Placebo-controlled Study to Evaluate the Effect of Sodium Zirconium Cyclosilicate on CKD Progression in Participants with CKD and Hyperkalaemia or at Risk of Hyperkalaemia

Medical condition

Renal Insufficiency, Chronic

Phase

Phase 3

Healthy volunteers

No

Study drug

Sodium Zirconium Cyclosilicate (SZC), Placebo, Lisinopril, Valsartan, Irbesartan

Sex

All

Actual Enrollment

716

Study type

Interventional

Age

18 Years - 130 Years

Date

Study Start Date: 30 Sept 2021
Primary Completion Date: 07 Feb 2024
Study Completion Date: 07 Feb 2024

Study design

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

Verification:

Verified 01 Jun 2024 by AstraZeneca

Sponsors

AstraZeneca

Collaborators

-

Inclusion and exclusion criteria