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

Phase 4Not Yet RecruitingNCT07769073

Universitas Indonesia36 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Enrollment

Conditions

Chronic Kidney Disease Associated Pruritus End Stage Renal Disease on Dialysis

Interventions

Eligibility

Sex: ALLMin age: 18 YearsMax age: 65 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Patients with chronic kidney disease-associated pruritus (CKD-aP) undergoing maintenance hemodialysis twice weekly for more than 6 months and in a hemodynamically stable condition. * Aged 18 to 65 years old and willing to participate in the study. * Received standard therapy for at least 2 weeks and met the moderate to severe pruritus criteria based on Visual Analog Scale (VAS) score and 5-D Pruritus Scale. * Able to understand and comply with the study instructions/protocol. Exclusion Criteria: * Patients with active malignancy or active infection. * Patients with primary skin diseases, such as allergic dermatitis, irritant contact dermatitis, neurodermatitis, or psoriasis. * Patients with chronic liver disease or cholestatic disease. * Received phototherapy or acupuncture therapy within the last 1 week prior to study enrollment.

Outcomes

Primary Outcomes

Change from baseline in Visual Analog Scale (VAS) score for pruritus

Pruritus intensity measured using a Visual Analog Scale (VAS) ranging from 0 to 10 (or 0 to 100 mm), where 0 represents no itch and 10 (or 100) represents the worst imaginable itch. Lower scores indicate reduction in itch severity.

Time frame: Baseline, Week 1, Week 2, Week 3, and Week 4