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Completed

NCT Number: NCT04711603

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

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.

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Key information

Conditions

Uremic Pruritus

Age range

20 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Research Site

Multiple Locations, Japan

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

MR13A9

Drug

Intravenous administration

Placebo

Drug

Intravenous administration

Primary outcomes

  1. Change From Baseline in the Mean NRS Score at Week 4

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Kissei Pharmaceutical Co., Ltd.

Industry

Registry information

Official study title

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

Important dates

Study start
2021
Primary completion
2022
Study completion
2022
First posted
Jan 15, 2021
Registry last updated
Sep 10, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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