Clinical Study on the Efficacy and Safety of Nalfurafine Hydrochloride Orally Disintegrating Tablets in Treating Pruritus in Patients Undergoing Maintenance Hemodialysis

Summary

This is a randomized, open-label, multi-center clinical study aimed at evaluating the efficacy and safety of 12 weeks of nalfurafine hydrochloride administration in the treatment of pruritus in patients undergoing maintenance hemodialysis.

Conditions

• Chronic Kidney Disease-Associated Pruritus in Hemodialysis

Interventions

DRUG

Nalfurafine Hydrochloride

Nalfurafine hydrochloride orally disintegrating tablets will be took at a dose of 2.5μg (1 tablet) once daily for 12 consecutive weeks.

OTHER

Basic treatment

If any itching treatment medication is being received on the day of the screening period, the itching treatment medication (prescription drugs, over-the-counter drugs, moisturizers, etc. with itching as the indication, see the allowed medication list for details) will continue to be used as the basic treatment during the subsequent itching evaluation period. If no itching treatment medication is received by the start of the screening period, no other itching treatment medication will be used as the baseline treatment during the itch evaluation period of the study.

Sponsors & Collaborators

• The First Affiliated Hospital of Dalian Medical University

  collaborator OTHER

• Beijing Friendship Hospital

  collaborator OTHER

• The General Hospital of Northern Theater Command

  collaborator OTHER

• Tianjin First Central Hospital

  collaborator OTHER

• RenJi Hospital

  collaborator OTHER

• Xinhua Hospital, Shanghai Jiao Tong University School of Medicine

  collaborator OTHER

• Xiangyang Central Hospital

  collaborator OTHER

• Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University

  collaborator OTHER

• Jiangsu Taizhou People's Hospital

  collaborator OTHER

• Qilu Hospital of Shandong University

  collaborator OTHER

• First Affiliated Hospital Xi'an Jiaotong University

  collaborator OTHER

• Zigong No.1 Peoples Hospital

  collaborator OTHER

• Chengdu First People's Hospital

  collaborator OTHER

• The People's Hospital of Leshan

  collaborator OTHER

• The Third Affiliated Hospital of Wenzhou Medical University

  collaborator OTHER

• Henan Provincial People's Hospital

  collaborator OTHER

• Shanghai Changzheng Hospital

  collaborator OTHER

• Daping Hospital of Army Medical University

  collaborator OTHER

• First Affiliated Hospital of Wannan Medical College

  collaborator OTHER

• Chinese PLA General Hospital

  lead OTHER

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

18 Years

Max Age

80 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2026-07-01

Primary Completion

2028-12-31

Completion

2028-12-31

Countries

• China

Study Locations