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

NCT04711603 | Completed Phase 3 Results

• 1 other identifier: MR13A9-5
• Study Type: interventional
• Target: 178
• Locations: 1 country
• Sites: 1

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.

Conditions

Uremic Pruritus

Outcome Measures

Primary Outcomes (1)

• Change From Baseline in the Mean NRS Score at Week 4

  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.

  4 weeks

Study Arms (2)

MR13A9/MR13A9

EXPERIMENTAL

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

Drug: MR13A9

Placebo/MR13A9

PLACEBO COMPARATOR

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

Drug: MR13A9; Drug: Placebo

Interventions

MR13A9 DRUG

Intravenous administration

MR13A9/MR13A9; Placebo/MR13A9

Placebo DRUG

Intravenous administration

Placebo/MR13A9

Eligibility Criteria

• Age: 20 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Patient has pruritus cause other than CKD or its complications
• Patients has hepatic cirrhosis
• Patient has a known history of allergic reaction to opiates

Sponsors & Collaborators

• Kissei Pharmaceutical Co., Ltd.: lead

Study Sites (1)

Research Site

Multiple Locations, Japan

Location

Related Publications (1)

• Narita I, Tsubakihara Y, Takahashi N, Ebata T, Uchiyama T, Marumo M, Okamura S, Gejyo F; MR13A9-5 Trial Investigators. Difelikefalin for Hemodialysis Patients with Pruritus in Japan. NEJM Evid. 2023 Nov;2(11):EVIDoa2300094. doi: 10.1056/EVIDoa2300094. Epub 2023 Oct 17.

  PMID: 38320524 DERIVED

Results Point of Contact

• Title: Clinical Development Division
• Organization: Kissei Pharmaceutical Co., Ltd

rinsyousiken@pharm.kissei.co.jp

Email olly

Study Officials

• Yoshitaka Shimizu

  Kissei Pharmaceutical Co., Ltd.

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 13, 2021
• First Posted: January 15, 2021
• Study Start: January 16, 2021
• Primary Completion: January 25, 2022
• Study Completion: September 26, 2022
• Last Updated: September 10, 2025
• Results First Posted: September 10, 2025

Record last verified: 2023-04

Data Sharing

• IPD Sharing: Will not share

Locations

JP (1)