Status:
COMPLETED
A Clinical Study of MR13A9 in Hemodialysis Patients With Pruritus.
Lead Sponsor:
Kissei Pharmaceutical Co., Ltd.
Collaborating Sponsors:
Maruishi Pharmaceutical
Conditions:
Uremic Pruritus
Eligibility:
All Genders
20+ years
Phase:
PHASE2
Brief Summary
Double-blind, Placebo-controlled study to evaluate the dose-response relationship of safety, efficacy and pharmacokinetics of MA13A9 in hemodialysis patients with pruritus.
Eligibility Criteria
Inclusion
- Japanese with male or female aged ≥ 20
- 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 :
February 1 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 22 2019
Estimated Enrollment :
247 Patients enrolled
Trial Details
Trial ID
NCT03802617
Start Date
February 1 2019
End Date
October 22 2019
Last Update
December 5 2025
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Research Site
Multiple Locations, Japan