- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04711603
A Phase III Clinical Study of MR13A9 in Hemodialysis Patients With Pruritus.
July 13, 2023 updated by: Kissei Pharmaceutical Co., Ltd.
A Phase III Clinical Study of MR13A9 in Hemodialysis Patients With Pruritus
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.
Study Overview
Study Type
Interventional
Enrollment (Actual)
178
Phase
- Phase 3
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Multiple Locations, Japan
- Research Site
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
20 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Quadruple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: MR13A9/MR13A9
Patients are administered MR13A9 for 6 weeks (double-blind period), followed by MR13A9 for 52 weeks (open-label period).
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Intravenous administration
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Placebo Comparator: Placebo/MR13A9
Patients are administered Placebo for 6 weeks (double-blind period), followed by MR13A9 for 52 weeks (open-label period).
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Intravenous administration
Intravenous administration
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change from baseline in mean itch Numerical Rating Scale (NRS) score at week 4
Time Frame: Up to 58 weeks
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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.
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Up to 58 weeks
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change from baseline in mean itch NRS score
Time Frame: 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.
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Up to 58 weeks
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Change from baseline in mean itch scores based on the Shiratori severity criteria
Time Frame: Up to 58 weeks
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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.
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Up to 58 weeks
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Percentage of subjects with 3-point improvement in mean itch NRS score
Time Frame: Up to 58 weeks
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Percentage of subjects with 3-point improvement whose change from baseline in mean itch NRS score is ≤ -3
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Up to 58 weeks
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Percentage of subjects with 4-point improvement in mean itch NRS score
Time Frame: Up to 58 weeks
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Percentage of subjects with 4-point improvement whose change from baseline in mean itch NRS score is ≤ -4
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Up to 58 weeks
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Change from baseline in Skindex-16 score
Time Frame: Week 4, 10, 18, 26, 34, 46, 58
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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.
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Week 4, 10, 18, 26, 34, 46, 58
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Change from baseline in 5-D itch scale score
Time Frame: Week 4, 10, 18, 26, 34, 46, 58
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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.
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Week 4, 10, 18, 26, 34, 46, 58
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Percentage of subjects with global symptoms in Patient Global Impression of Change (PGIC)
Time Frame: Week 4, 10, 18, 26, 34, 46, 58
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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.
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Week 4, 10, 18, 26, 34, 46, 58
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Study Director: Yoshitaka Shimizu, Kissei Pharmaceutical Co., Ltd.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
January 16, 2021
Primary Completion (Actual)
January 25, 2022
Study Completion (Actual)
September 26, 2022
Study Registration Dates
First Submitted
January 13, 2021
First Submitted That Met QC Criteria
January 13, 2021
First Posted (Actual)
January 15, 2021
Study Record Updates
Last Update Posted (Actual)
July 17, 2023
Last Update Submitted That Met QC Criteria
July 13, 2023
Last Verified
April 1, 2023
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- MR13A9-5
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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