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
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
Outcome
Missed primary endpoint
Stopped (Enrollment): “The study started enrollment in Sep 2021 and despite huge efforts the rate of patient enrollment continued to be below target such that the completion of the study within a reasonable timeframe was deemed very unlikely.”
registry Treatment difference in mean slope -0.7354 (95% CI -2.7311 to 1.2604); Mixed Models Analysis; note: Test of no treatment difference in mean total eGFR-slope NCT05056727 ↗
registry Maintenance Phase: SZC vs Maintenance Phase: Placebo; p = 0.4691 NCT05056727 ↗
registry Maintenance Phase: SZC vs Maintenance Phase: Placebo; p = 0.1338; Treatment difference in mean slope -2.0421 (95% CI -4.7156 to 0.6314) NCT05056727 ↗
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Sodium Zirconium Cyclosilicate (SZC) | Unknown | 5 g | Oral |
| Subject | Sodium Zirconium Cyclosilicate (SZC) | Unknown | 10 g | Oral |
| Subject | Sodium Zirconium Cyclosilicate (SZC) | Unknown | 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 | Unknown | 40 mg | Oral |
| Background | Valsartan | Unknown | 80 mg | Oral |
| Background | Valsartan | Unknown | 160 mg | Oral |
| Background | Valsartan | Unknown | 320 mg | Oral |