A Clinical Study of MR13A9 in Hemodialysis Patients With Pruritus.

NCT03802617 | Completed Phase 2 Results

• 1 other identifier: MR13A9-4
• Study Type: interventional
• Target: 247
• Locations: 1 country
• Sites: 1

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.

Conditions

Uremic Pruritus

Outcome Measures

Primary Outcomes (1)

• Change From Baseline in the Mean NRS Score at Week 8 of the Treatment Period

  The primary analysis was performed using an MMRM with change from baseline in the mean NRS score at each time point as an objective variable; treatment group, time point, and treatment group-by-time point interaction as fixed effects; baseline mean NRS score and dynamic allocation factors, presence of prior treatment with nalfurafine hydrochloride, and presence of specific signs or symptoms to be confirmed in the screening period, as covariates; and subject as a random effect. 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.

  8 weeks

Study Arms (4)

MR13A9 low dose

EXPERIMENTAL

Drug: MR13A9

MR13A9 medium dose

EXPERIMENTAL

Drug: MR13A9

MR13A9 high dose

EXPERIMENTAL

Drug: MR13A9

Placebo

PLACEBO COMPARATOR

Drug: Placebo

Interventions

MR13A9 DRUG

Intravenous administration

MR13A9 high dose; MR13A9 low dose; MR13A9 medium dose

Placebo DRUG

Intravenous administration

Placebo

Eligibility Criteria

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

You may qualify if:

• 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

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
• Maruishi Pharmaceutical: collaborator

Study Sites (1)

Research Site

Multiple Locations, Japan

Location

Related Publications (1)

• 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.

  PMID: 35511180 DERIVED

Results Point of Contact

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

rinsyousiken@pharm.kissei.co.jp

Email olly

Study Officials

• Naomi Koshihara

  Clinical Development Div.

  STUDY DIRECTOR

Publication Agreements

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

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 10, 2019
• First Posted: January 14, 2019
• Study Start: February 1, 2019
• Primary Completion: October 22, 2019
• Study Completion: October 22, 2019
• Last Updated: December 5, 2025
• Results First Posted: December 5, 2025

Record last verified: 2021-02

Locations

JP (1)