A Clinical Study of MR13A9 in Hemodialysis Patients With Pruritus.
- Registration Number
- NCT03802617
- Lead Sponsor
- Kissei Pharmaceutical Co., Ltd.
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 247
Inclusion Criteria
- 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 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description MR13A9 low dose MR13A9 - MR13A9 medium dose MR13A9 - MR13A9 high dose MR13A9 - Placebo Placebo -
- Primary Outcome Measures
Name Time Method Change in Numerical Rating Scale (NRS) score of itch 8 weeks Change from baseline in average NRS score of itch at week 8
- Secondary Outcome Measures
Name Time Method Change in itching scores of Shiratori severity criteria 8 weeks Change from baseline in average itching scores of Shiratori severity criteria at week 8
Trial Locations
- Locations (1)
Research Site
🇯🇵Multiple Locations, Japan