Overview
A Phase III Clinical Study of MR13A9 in Hemodialysis Patients With Pruritus.
Status:
Active, not recruiting
Active, not recruiting
Trial end date:
2023-01-01
2023-01-01
Target enrollment:
0
0
Participant gender:
All
All
Summary
Double-blind, Placebo-controlled study to confirm the superiority of MR13A9 to placebo, and followed by extension, open-label treatment to confirm long-term safety of MA13A9 in hemodialysis patients with pruritus.Phase:
Phase 3Accepts Healthy Volunteers?
NoDetails
Lead Sponsor:
Kissei Pharmaceutical Co., Ltd.
Criteria
Inclusion Criteria:- Patient with Chronic Kidney Disease (CKD) has been on hemodialysis 3 times per week
- Patient receiving treatment for itch
- Patient has a baseline NRS score > 4
Exclusion Criteria:
- Patient has pruritus cause other than CKD or its complications
- Patients has hepatic cirrhosis
- Patient has a known history of allergic reaction to opiates