drugset / Trial / NCT07251309
A Two-Part, Phase 3 Study Evaluating the Efficacy and Safety of WS016 for the Treatment of Hyperkalemia
RandomizedParallel-groupQuadruple-blindTreatment
Summary
This clinical trial consists of 2 parts, Part A and Part B. Part A consists of a 2-day randomized, double-blind, placebo-controlled corrective phase (CP) and a 28-day randomized, double-blind, placebo-controlled maintenance phase (MP). Part B (open-label extension, OLE) is an open-label, 11-month extension study carried out in participants who come from Part A and meet certain inclusion criteria.
Timeline
- Start
- 2024-12-23
- Primary completion
- 2026-11
- Completion
- 2026-11
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | WS016 | Unknown | 6 g | Oral |
| Subject | WS016 | Unknown | 12 g | Oral |
| Subject | WS016 | Unknown | 18 g | Oral |
Indications
No indication recorded.