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NCT03802617 Clinical Trial

A Clinical Study of MR13A9 in Hemodialysis Patients With Pruritus.

Uremic Pruritus Clinical Trial

Official title:
A Phase II Clinical Study of MR13A9 in Hemodialysis Patients With Pruritus.

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT03802617
Other study ID # MR13A9-4
Secondary ID
Status Completed
Phase Phase 2
First received
Last updated
Start date February 1, 2019
Est. completion date October 22, 2019

Study information
Verified date February 2021
Source Kissei Pharmaceutical Co., Ltd.
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

Double-blind, Placebo-controlled study to evaluate the dose-response relationship of safety, efficacy and pharmacokinetics of MA13A9 in hemodialysis patients with pruritus.

Recruitment information / eligibility
Status Completed
Enrollment 247
Est. completion date October 22, 2019
Est. primary completion date October 22, 2019
Accepts healthy volunteers No
Gender All
Age group 20 Years and older
Eligibility 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

Study Design

Related Conditions & MeSH terms

Intervention

Drug:
• MR13A9
Intravenous administration
• Placebo
Intravenous administration

Locations
Country Name City State
Japan Research Site Multiple Locations

Sponsors (2)
Lead Sponsor Collaborator
Kissei Pharmaceutical Co., Ltd. Maruishi Pharmaceutical

Country where clinical trial is conducted

Japan, 

Outcome
Type Measure Description Time frame Safety issue
Primary Change in Numerical Rating Scale (NRS) score of itch Change from baseline in average NRS score of itch at week 8 8 weeks
Secondary Change in itching scores of Shiratori severity criteria Change from baseline in average itching scores of Shiratori severity criteria at week 8 8 weeks
See also
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Terminated NCT01660243 - Efficacy and Safety of MT-9938 for Treatment of Uremic Pruritus in Subjects With End-stage Renal Disease Receiving Hemodialysis Phase 2
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Completed NCT02143648 - Study of Nalbuphine HCl ER Tablets in Hemodialysis Patients With Uremic Pruritus Phase 2/Phase 3
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Completed NCT04711603 - A Phase III Clinical Study of MR13A9 in Hemodialysis Patients With Pruritus. Phase 3
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