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Efficacy of Nalfurafine for Chronic Kidney Disease-Associated Pruritus in Twice-Weekly Hemodialysis Patients: A Randomized Controlled Trial

NCT07769073 · Status: NOT_YET_RECRUITING · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 36

Last updated 2026-08-17

No results posted yet for this study

Summary

This study evaluates the efficacy and safety of nalfurafine as a treatment for chronic kidney disease-associated pruritus (CKD-aP) in patients undergoing maintenance hemodialysis twice weekly.

Pruritus (severe itching) is a common and distressing symptom in patients with end-stage renal disease receiving hemodialysis, significantly impairing their quality of life. Nalfurafine is a selective kappa-opioid receptor agonist designed to reduce itching.

The main objective of this clinical trial is to evaluate whether nalfurafine effectively reduces itch intensity and improves symptom control compared to control, while monitoring for any adverse effects.

Conditions

  • Chronic Kidney Disease Associated Pruritus
  • End Stage Renal Disease on Dialysis

Interventions

DRUG

Nalfurafine Hydrochloride

administered orally

DRUG

plasebo

administered orally

Sponsors & Collaborators

  • Indonesia University

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-08-17
Primary Completion
2026-09-30
Completion
2026-10-13

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07769073 on ClinicalTrials.gov