NCT07650851

Brief 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.

Trial Health

63
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
150

participants targeted

Target at P75+ for not_applicable

Timeline
29mo left

Started Jul 2026

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress3%
Jul 2026Dec 2028

First Submitted

Initial submission to the registry

June 4, 2026

Completed
12 days until next milestone

First Posted

Study publicly available on registry

June 16, 2026

Completed
15 days until next milestone

Study Start

First participant enrolled

July 1, 2026

Completed
2.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2028

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2028

Last Updated

June 16, 2026

Status Verified

March 1, 2026

Enrollment Period

2.5 years

First QC Date

June 4, 2026

Last Update Submit

June 14, 2026

Conditions

Chronic Kidney Disease-Associated Pruritus in Hemodialysis

Outcome Measures

Primary Outcomes (1)

  • Change in Visual Analogue Scale (VAS) from baseline

    Visual Analog Scale (VAS) is a scale that allows patients to indicate their level of itching on a 10cm scale. The larger the value, the higher the level of itching

    Change from baseline at 12 weeks

Secondary Outcomes (9)

  • Change in average VAS value from baseline across each evaluation period

    Changes from baseline at weeks 1, 2, 4, 8, 12 of drug administration and during the follow-up period (1 week after the end of drug administration)

  • Change in itch score based on the Xie-Kawashima Itch Severity Assessment compared to baseline

    Change from baseline at 12 weeks

  • The change in itch score from baseline for the Xie-Kawashima Itch Severity Assessment during each evaluation period

    Changes from baseline at weeks 1, 2, 4, 8, 12 of drug administration and during the follow-up period (1 week after the end of drug administration)

  • Improvement degree of VAS

    Change from baseline at 12 weeks

  • Skin Disease Quality of Life Scale (Skindrex-16)

    Change from baseline at 12 weeks

  • +4 more secondary outcomes

Other Outcomes (1)

  • Adverse events and serious adverse events

    Within 12 weeks of taking nalfurafine hydrochloride

Study Arms (2)

Nalfurafine

EXPERIMENTAL

The experimental group took nalfurafine hydrochloride orally disintegrating tablets at a dose of 2.5μg (1 tablet) once daily for 12 consecutive weeks.

Drug: Nalfurafine Hydrochloride

Basic treatment

OTHER
Other: Basic treatment

Interventions

Basic treatmentOTHER

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.

Basic treatment
Nalfurafine HydrochlorideDRUG

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

Nalfurafine

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Age range of 18-80 years old (including both ends), male or female not limited.
  • Chronic renal failure patients who undergo stable dialysis for 3 months or more, receive regular hemodialysis 3 times a week, and are expected to have no significant changes in treatment or rapid changes in their condition during the clinical trial period.
  • Within one year prior to signing the informed consent form, the effectiveness of itch treatment (including topical medications such as moisturizers/moisturizers, systemic medications such as antihistamines or antiepileptic drugs, and non pharmacological treatments) was not satisfactory.
  • Those who are able to understand and comply with the research procedures and methods, voluntarily participate in this study, and sign a written informed consent form.
  • The number of days during which VAS values are measured at both wake-up and bedtime in the baseline period must be no less than 5 days, and the average value of the larger VAS values in morning and evening measurements must not be less than 50 mm.
  • The number of days evaluated for the severity of itching in Xie Chuandao during the baseline period must be no less than 5 days at both wake-up and bedtime.

You may not qualify if:

  • Given poor compliance with dialysis treatment, researchers believe that it may affect the effectiveness and safety of clinical studies.
  • Patients who plan to undergo kidney transplantation or other elective surgeries during the study period.
  • Patients with alanine aminotransferase (ALT), aspartate aminotransferase (AST), or glutamine transferase (GGT) levels exceeding the upper limit of normal (ULN) by 2 times, or total bilirubin levels exceeding the upper limit of normal (ULN) by 2 times during the screening period.
  • Skin itching is not caused by chronic kidney disease, including allergic skin diseases (atopic dermatitis, urticaria, eczema, drug rash, etc.), physical skin diseases (prickly heat, solar rash, etc.), infectious skin diseases (insect bite dermatitis, chickenpox, measles, pyoderma, tinea corporis, etc.), cholestatic liver disease, etc.
  • Screening for individuals who have been in the active stage of malignant tumors within the previous 12 months, or have received radiotherapy, chemotherapy, targeted therapy, and immunotherapy during this period.
  • There are uncontrollable or drug-induced fungal, bacterial, viral, or other infections, including tuberculosis patients undergoing anti tuberculosis treatment, patients known to be infected with human immunodeficiency virus (HIV), etc.
  • Hypertensive patients who cannot achieve good control with drug therapy: systolic blood pressure ≥ 180mmHg, or diastolic blood pressure ≥ 110mmHg.
  • Patients who are currently using glucocorticoids and immunosuppressants.
  • Patients with mental illness or cognitive impairment who are unable to correctly understand VAS scores and describe their own feelings.
  • Received or adjusted antihistamines, systemic or local corticosteroids (excluding ear or eye preparations), calcineurin inhibitors, gabapentin, pregabalin, and other restricted combination drugs within 7 days prior to screening, or expected to change their treatment regimen during the study period.
  • Started receiving or adjusting drugs that may affect the assessment of itch relief efficacy within 2 weeks prior to screening, including but not limited to antipsychotics, sedatives, selective serotonin reuptake inhibitors (SSRIs), anxiolytics, or tricyclic antidepressants, or expected to change their treatment regimen during the study period.
  • Individuals with a history of drug abuse, drug dependence, or alcohol abuse within the past 12 months prior to screening.
  • Select patients who have received phototherapy for pruritus within the previous month.
  • Individuals who have used opioid receptor agonists or antagonists within the past 2 weeks prior to screening.
  • Individuals with a known history of allergy to opioid drugs, or those who are allergic to test drug excipients.
  • +3 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Chinese PLA General Hospital

Beijing, Beijing Municipality, 100853, China

Location

MeSH Terms

Interventions

TRK 820

Central Study Contacts

xiangmei Chen

CONTACT

01066935462liping.8@163.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

June 4, 2026

First Posted

June 16, 2026

Study Start

July 1, 2026

Primary Completion (Estimated)

December 31, 2028

Study Completion (Estimated)

December 31, 2028

Last Updated

June 16, 2026

Record last verified: 2026-03

Locations

CN(1)