A Clinical Study of MR13A9 in Hemodialysis Patients With Pruritus.
NCT ID: NCT03802617
Last Updated: 2025-12-05
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE2
247 participants
INTERVENTIONAL
2019-02-01
2019-10-22
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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MR13A9 low dose
MR13A9
Intravenous administration
MR13A9 medium dose
MR13A9
Intravenous administration
MR13A9 high dose
MR13A9
Intravenous administration
Placebo
Placebo
Intravenous administration
Interventions
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MR13A9
Intravenous administration
Placebo
Intravenous administration
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
* Patients has hepatic cirrhosis
* Patient has a known history of allergic reaction to opiates
20 Years
ALL
No
Sponsors
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Maruishi Pharmaceutical
INDUSTRY
Kissei Pharmaceutical Co., Ltd.
INDUSTRY
Responsible Party
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Principal Investigators
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Naomi Koshihara
Role: STUDY_DIRECTOR
Clinical Development Div.
Locations
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Research Site
Multiple Locations, , Japan
Countries
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References
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Narita I, Tsubakihara Y, Uchiyama T, Okamura S, Oya N, Takahashi N, Gejyo F; MR13A9-4 Trial Investigators. Efficacy and Safety of Difelikefalin in Japanese Patients With Moderate to Severe Pruritus Receiving Hemodialysis: A Randomized Clinical Trial. JAMA Netw Open. 2022 May 2;5(5):e2210339. doi: 10.1001/jamanetworkopen.2022.10339.
Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Other Identifiers
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MR13A9-4
Identifier Type: -
Identifier Source: org_study_id
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