drugset / Trial / NCT05885737
Phase 3 Study of Difelikefalin in Haemodialysis Chinese Adult Subjects With Moderate-to-Severe Pruritus
Phase 3
Completed
260 enrolled
Vifor Fresenius Medical Care Renal Pharma
Tigermed Consulting Co., Ltd · collab
RandomizedParallel-groupQuadruple-blindTreatment
Summary
This a multicentre study that consists of a 12-week double-blind period, and an optional 14-week open-label extension period and a 1-week follow-up period.
Timeline
- Start
- 2023-05-18
- Primary completion
- 2024-09-25
- Completion
- 2024-09-25
Outcome
Met primary endpoint
registry analysis (equivalence test); DB Period: Difelikefalin vs DB Period: Placebo; p = 0.0003; Least square mean difference -0.81 (95% CI -1.25 to -0.37); MMRM NCT05885737 ↗
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Difelikefalin | Protein / enzyme biologic | 0.5 ug/kg | Intravenous |
Indications
No indication recorded.