drugset
drugset / Trial / NCT05056727

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

NCT05056727 ↗

Phase 3 Terminated 1112 enrolled AstraZeneca
RandomizedParallel-groupQuadruple-blindTreatment

Summary

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.

Timeline

Start
2021-09-30
Primary completion
2024-02-07
Completion
2024-02-07

Drugs

EvaluationDrugModalityDoseRoute
Subject Sodium Zirconium Cyclosilicate Other / unclassified 5 g Oral
Subject Sodium Zirconium Cyclosilicate Other / unclassified 10 g Oral
Subject Sodium Zirconium Cyclosilicate Other / unclassified 15 g Oral
Background Irbesartan Small molecule 75 mg Oral
Background Irbesartan Small molecule 150 mg Oral
Background Irbesartan Small molecule 300 mg Oral
Background LISINOPRIL ANHYDROUS Small molecule 5 mg Oral
Background LISINOPRIL ANHYDROUS Small molecule 10 mg Oral
Background LISINOPRIL ANHYDROUS Small molecule 20 mg Oral
Background LISINOPRIL ANHYDROUS Small molecule 40 mg Oral
Background Valsartan Small molecule 40 mg Oral
Background Valsartan Small molecule 80 mg Oral
Background Valsartan Small molecule 160 mg Oral
Background Valsartan Small molecule 320 mg Oral

Indications

chronic kidney disease