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

Last updated: August 21, 2025
Sponsor: Kissei Pharmaceutical Co., Ltd.
Overall Status: Completed

Phase

3

Condition

Skin Wounds

Hives (Urticaria)

Rash

Treatment

MR13A9

Placebo

Clinical Study ID

NCT04711603
MR13A9-5
  • Ages > 20
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

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

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

Total Participants: 178
Treatment Group(s): 2
Primary Treatment: MR13A9
Phase: 3
Study Start date:
January 16, 2021
Estimated Completion Date:
September 26, 2022

Connect with a study center

  • Research Site

    Multiple Locations,
    Japan

    Site Not Available

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