Phase 3TerminatedAge-related condition
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)
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
- Sponsor
- AstraZeneca (Industry)
- Enrollment
- 1,112 enrolled
- Conditions
- Renal Insufficiency, Chronic; Hyperkalemia
- Interventions
- Sodium Zirconium Cyclosilicate (SZC); Placebo; Lisinopril; Valsartan; Irbesartan
- Ages
- adults, older adults
- Registry
- NCT05056727, EUCTR2021-001911-96
Full record on ClinicalTrials.gov
From the registry
The purpose of this study is to evaluate the effect of Sodium Zirconium Cyclosilicate (SZC), as adjunct to ACEi/ARB therapy (lisinopril or valsartan), on slowing CKD progression (assessed as the reduction in participant's glomerular filtration rate \[eGFR\] decline over time) in participants with hyperkalaemia or at high risk of hyperkalaemia.
Primary outcomes
- Total eGFR Slope (Coprimary Analysis #1)
- Chronic eGFR Slope (Coprimary Analysis #2)
History
Results first posted
Last registry update
Primary completion
Started
Registered