drugset / Trial / NCT03303521
A Study to Test Whether ZS (Sodium Zirconium Cyclosilicate) Can Reduce the Incidence of Increased Blood Potassium Levels Among Dialized Patients.
RandomizedParallel-groupTriple-blindTreatment
Summary
The purpose of this study is to evaluate the efficacy of ZS in the treatment of hyperkalemia in patients on hemodialysis.
Timeline
- Start
- 2017-12-14
- Primary completion
- 2018-11-07
- Completion
- 2018-11-07
Outcome
Met primary endpoint
registry analysis (superiority test); Sodium Zirconium Cyclosilicate (SZC) vs Placebo; p <0.001; Odds Ratio (OR) 68.77 (95% CI 10.85 to 2810.85); Fisher Exact NCT03303521 ↗
registry analysis (superiority test); Sodium Zirconium Cyclosilicate (SZC) vs Placebo; p <0.001; Odds Ratio (OR) 35.51 (95% CI 8.53 to 309.48); Fisher Exact NCT03303521 ↗
release “In Phase IIIb DIALIZE trial , 41.2% of Lokelma patients maintained normal potassium levels pre-dialysis compared to 1% receiving placebo” astrazeneca.com ↗
Publications
- Fishbane S, Ford M, Fukagawa M, McCafferty K, Rastogi A, Spinowitz B, Staroselskiy K, Vishnevskiy K, Lisovskaja V, Al-Shurbaji A, Guzman N, Bhandari S. Potassium responses to sodium zirconium cyclosilicate in hyperkalemic hemodialysis patients: post-hoc analysis of DIALIZE. BMC Nephrol. 2022 Feb 8;23(1):59. doi: 10.1186/s12882-021-02569-7.
- Natale P, Palmer SC, Ruospo M, Saglimbene VM, Strippoli GF. Potassium binders for chronic hyperkalaemia in people with chronic kidney disease. Cochrane Database Syst Rev. 2020 Jun 26;6(6):CD013165. doi: 10.1002/14651858.CD013165.pub2.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| 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 |
Indications
No indication recorded.