drugset / Trial / NCT07098351
Efficacy and Safety of Nalfurafine Hydrochloride ODT for Moderate-to-Severe Pruritus in Patients on Peritoneal Dialysis
NaSingle-groupOpen-labelTreatment
Summary
Moderate to severe pruritus significantly impairs the quality of life in peritoneal dialysis patients, and effective treatment options remain limited. κ-opioid receptor agonists may alleviate itching by modulating neural signaling pathways. This study is a multicenter, prospective, single-arm clinical trial, planning to enroll 93 patients. It aims to test the hypothesis that nalfurafine hydrochloride orally disintegrating tablets compared to baseline, with acceptable safety.
Timeline
- Start
- 2025-08-07
- Primary completion
- 2026-06-30
- Completion
- 2026-06-30
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Nalfurafine | Small molecule | 2.5 ug | Oral |
| Subject | Nalfurafine | Small molecule | 5 ug | Oral |