A Phase III Clinical Study of MR13A9 in Hemodialysis Patients With Pruritus.

Study Overview
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Brief Summary
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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.

Official Title
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A Phase III Clinical Study of MR13A9 in Hemodialysis Patients With Pruritus

Conditions
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Uremic Pruritus

Intervention / Treatment
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* Drug: MR13A9
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 20 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: MR13A9/MR13A9<br>Patients are administered MR13A9 for 6 weeks (double-blind period), followed by MR13A9 for 52 weeks (open-label period). | Drug: MR13A9<br>* Intravenous administration<br>|
| Placebo Comparator: Placebo/MR13A9<br>Patients are administered Placebo for 6 weeks (double-blind period), followed by MR13A9 for 52 weeks (open-label period). | Drug: MR13A9<br>* Intravenous administration<br>Drug: Placebo<br>* Intravenous administration<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from baseline in mean itch Numerical Rating Scale (NRS) score at week 4 | 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. | Up to 58 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from baseline in mean itch NRS score | 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. | Up to 58 weeks | 
| Change from baseline in mean itch scores based on the Shiratori severity criteria | 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. | Up to 58 weeks | 
| Percentage of subjects with 3-point improvement in mean itch NRS score | Percentage of subjects with 3-point improvement whose change from baseline in mean itch NRS score is ≤ -3 | Up to 58 weeks | 
| Percentage of subjects with 4-point improvement in mean itch NRS score | Percentage of subjects with 4-point improvement whose change from baseline in mean itch NRS score is ≤ -4 | Up to 58 weeks | 
| Change from baseline in Skindex-16 score | 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. | Week 4, 10, 18, 26, 34, 46, 58 | 
| Change from baseline in 5-D itch scale score | 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. | Week 4, 10, 18, 26, 34, 46, 58 | 
| Percentage of subjects with global symptoms in Patient Global Impression of Change (PGIC) | 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. | Week 4, 10, 18, 26, 34, 46, 58 |