Back to resultsA Clinical Study of MR13A9 in Hemodialysis Patients With Pruritus.
Primary Purpose
Uremic Pruritus
Status
Completed
Phase
Phase 2
Locations
Japan
Study Type
Interventional
Intervention
MR13A9
Placebo
Sponsored by
About this trial
This is an interventional treatment trial for Uremic Pruritus
Eligibility Criteria
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
Sites / Locations
- Research Site
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm Type
Experimental
Experimental
Experimental
Placebo Comparator
Arm Label
MR13A9 low dose
MR13A9 medium dose
MR13A9 high dose
Placebo
Arm Description
Outcomes
Primary Outcome Measures
Change in Numerical Rating Scale (NRS) score of itch
Change from baseline in average NRS score of itch at week 8
Secondary Outcome Measures
Change in itching scores of Shiratori severity criteria
Change from baseline in average itching scores of Shiratori severity criteria at week 8
Full Information
NCT ID
NCT03802617
First Posted
January 10, 2019
Last Updated
February 16, 2021
Sponsor
Kissei Pharmaceutical Co., Ltd.
Collaborators
Maruishi Pharmaceutical
1. Study Identification
Unique Protocol Identification Number
NCT03802617
Brief Title
A Clinical Study of MR13A9 in Hemodialysis Patients With Pruritus.
Official Title
A Phase II Clinical Study of MR13A9 in Hemodialysis Patients With Pruritus.
Study Type
Interventional
2. Study Status
Record Verification Date
February 2021
Overall Recruitment Status
Completed
Study Start Date
February 1, 2019 (Actual)
Primary Completion Date
October 22, 2019 (Actual)
Study Completion Date
October 22, 2019 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Kissei Pharmaceutical Co., Ltd.
Collaborators
Maruishi Pharmaceutical
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Uremic Pruritus
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
247 (Actual)
8. Arms, Groups, and Interventions
Arm Title
MR13A9 low dose
Arm Type
Experimental
Arm Title
MR13A9 medium dose
Arm Type
Experimental
Arm Title
MR13A9 high dose
Arm Type
Experimental
Arm Title
Placebo
Arm Type
Placebo Comparator
Intervention Type
Drug
Intervention Name(s)
MR13A9
Intervention Description
Intravenous administration
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Intravenous administration
Primary Outcome Measure Information:
Title
Change in Numerical Rating Scale (NRS) score of itch
Description
Change from baseline in average NRS score of itch at week 8
Time Frame
8 weeks
Secondary Outcome Measure Information:
Title
Change in itching scores of Shiratori severity criteria
Description
Change from baseline in average itching scores of Shiratori severity criteria at week 8
Time Frame
8 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
20 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Naomi Koshihara
Organizational Affiliation
Clinical Development Div.
Official's Role
Study Director
Facility Information:
Facility Name
Research Site
City
Multiple Locations
Country
Japan
12. IPD Sharing Statement
Citations:
PubMed Identifier
35511180
Citation
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.
Results Reference
derived
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A Clinical Study of MR13A9 in Hemodialysis Patients With Pruritus.
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