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

Phase 3

Completed

• Conditions: Uremic Pruritus
• Interventions: Drug: MR13A9; Drug: Placebo

• Registration Number: NCT04711603
• Lead Sponsor: Kissei Pharmaceutical Co., Ltd.

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2021-01-13
• Study First Submitted QC: 2021-01-13
• Study First Posted: 2021-01-15
• Study Start: 2021-01-16
• Primary Completion: 2022-01-25
• Study Completion: 2022-09-26
• Status Verified: 2023-04
• Results First Submitted: 2025-06-09
• Results First Submitted QC: 2025-08-21
• Last Update Submitted: 2025-08-21
• Results First Posted: 2025-09-10
• Last Update Posted: 2025-09-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 178

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
MR13A9/MR13A9	MR13A9	Patients are administered MR13A9 for 6 weeks (double-blind period), followed by MR13A9 for 52 weeks (open-label period).
Placebo/MR13A9	MR13A9	Patients are administered Placebo for 6 weeks (double-blind period), followed by MR13A9 for 52 weeks (open-label period).
Placebo/MR13A9	Placebo	Patients are administered Placebo for 6 weeks (double-blind period), followed by MR13A9 for 52 weeks (open-label period).

Primary Outcome Measures

Name	Time	Method
Change From Baseline in the Mean NRS Score at Week 4	4 weeks	The change from baseline in the mean NRS score at each time point was calculated using an MMRM with the change from baseline in the mean NRS score at each time point as an objective variable, group, time point, and group-by-time point interaction as fixed effects, mean NRS score at baseline and presence or absence of prior treatment with nalfurafine hydrochloride as dynamic allocation factors as a covariate, and subjects as a random effect for data up to Week 4 of the double-blind period in FAS.; Looking back on the period between the time of awakening on the previous day of assessment and the time of awakening on the day of assessment (including sleeping hours) once daily, subjects will assess the NRS score for the most severe itching by themselves. The most severe itching within the day will be assessed in integer on a scale ranging from 0 to 10, where 0 represents no itching and 10 represents worst itching imaginable.

Trial Locations

Locations (1)

Research Site; 🇯🇵 Multiple Locations, Japan

Research Site

🇯🇵Multiple Locations, Japan