A Phase III Clinical Study of MR13A9 in Hemodialysis Patients With Pruritus.
- Registration Number
- NCT04711603
- Lead Sponsor
- Kissei Pharmaceutical Co., Ltd.
- 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 with pruritus.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 178
- 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
- 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/MR13A9 MR13A9 Patients are administered MR13A9 for 6 weeks (double-blind period), followed by MR13A9 for 52 weeks (open-label period). Placebo/MR13A9 MR13A9 Patients are administered Placebo for 6 weeks (double-blind period), followed by MR13A9 for 52 weeks (open-label period). Placebo/MR13A9 Placebo Patients are administered Placebo for 6 weeks (double-blind period), followed by MR13A9 for 52 weeks (open-label period).
- Primary Outcome Measures
Name Time Method Change from baseline in mean itch Numerical Rating Scale (NRS) score at week 4 Up to 58 weeks The most severe itching within the day will be recorded in integers on a scale ranging from 0 to 10, where 0 represents no itching and 10 represents worst itching imaginable.
- Secondary Outcome Measures
Name Time Method Change from baseline in 5-D itch scale score Week 4, 10, 18, 26, 34, 46, 58 Five components of condition of itching (duration, degree, direction, disability, distribution) will be recorded based on scale ranging from 5 to 25, with higher scores indicating worse itch-related QOL.
Change from baseline in mean itch scores based on the Shiratori severity criteria Up to 58 weeks The symptoms during the day and the night will be recorded on a scale ranging from 0 to 4, where 0 represents no symptoms and 4 represents severe itching.
Percentage of subjects with 4-point improvement in mean itch NRS score Up to 58 weeks Percentage of subjects with 4-point improvement whose change from baseline in mean itch NRS score is ≤ -4
Percentage of subjects with global symptoms in Patient Global Impression of Change (PGIC) Week 4, 10, 18, 26, 34, 46, 58 Subjects will record the overall symptom of itching from the screening period based on a 7-level scale consisting of very much improved, much improved, minimally improved, no change, minimally worsened, much worsened, and very much worsened.
Change from baseline in mean itch NRS score Up to 58 weeks The most severe itching within the day will be recorded in integers on a scale ranging from 0 to 10, where 0 represents no itching and 10 represents worst itching imaginable.
Percentage of subjects with 3-point improvement in mean itch NRS score Up to 58 weeks Percentage of subjects with 3-point improvement whose change from baseline in mean itch NRS score is ≤ -3
Change from baseline in Skindex-16 score Week 4, 10, 18, 26, 34, 46, 58 The frequency of bothered by itching will be recorded based on scale ranging from 0 to 6, where 0 represents never bothered and 6 represents always bothered.
Trial Locations
- Locations (1)
Research Site
🇯🇵Multiple Locations, Japan