Status:
COMPLETED
A Phase III Clinical Study of MR13A9 in Hemodialysis Patients With Pruritus.
Lead Sponsor:
Kissei Pharmaceutical Co., Ltd.
Conditions:
Uremic Pruritus
Eligibility:
All Genders
20+ years
Phase:
PHASE3
Brief 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 w...
Eligibility Criteria
Inclusion
- 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
- Patient has pruritus cause other than CKD or its complications
- Patients has hepatic cirrhosis
- Patient has a known history of allergic reaction to opiates
Key Trial Info
Start Date :
January 16 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 26 2022
Estimated Enrollment :
178 Patients enrolled
Trial Details
Trial ID
NCT04711603
Start Date
January 16 2021
End Date
September 26 2022
Last Update
September 10 2025
Active Locations (1)
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1
Research Site
Multiple Locations, Japan