drugset / Trial / NCT04217590
Reduce Incidence of Pre-Dialysis Hyperkalaemia With Sodium Zirconium Cyclosilicate in Chinese Subjects
RandomizedParallel-groupQuadruple-blindTreatment
Summary
The purpose of this study is to evaluate the efficacy and safety of Sodium Zirconium Cyclosilicate (SZC), as well as the appropriateness of the dosing mechanism, in Chinese end-stage renal disease (ESRD) patients on chronic haemodialysis.
Timeline
- Start
- 2020-11-16
- Primary completion
- 2022-01-03
- Completion
- 2022-01-03
Publications
- Ni Z, Lu R, Xu X, Bian X, Zhou Z, Yang J, Luo Q, Chen M, Chen C, Sun X, Yu L, He Q, Jiang H, Yuan W, Li Y, Zhou R, Wang J, Zhang X, Zuo L, Meng X, Chang Z, Zhao J, Wessman P, Xiang P; DIALIZE China Study Group. DIALIZE China: A Phase IIIb, Randomized, Placebo-Controlled Study to Reduce Predialysis Hyperkalemia With Sodium Zirconium Cyclosilicate in Chinese Patients. Clin Ther. 2023 Jul;45(7):633-642. doi: 10.1016/j.clinthera.2023.04.014. Epub 2023 Jun 27.
- 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.