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

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.

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Key information

Conditions

Chronic Kidney Disease Associated Pruritus End Stage Renal Disease on Dialysis

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

nalfurafine hydrochloride

Drug

administered orally

plasebo

Drug

administered orally

Primary outcomes

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

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

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.

Study contacts

Contact information is provided by the study sponsor or research team.

Ayu Cahya Andhayani, Internist

CONTACT

[email protected]

+6281359152656

Sponsors and collaborators

Lead sponsor

Indonesia University

Other

Registry information

Important dates

Study start: 2026
Primary completion: 2026
Study completion: 2026
First posted: Aug 17, 2026
Registry last updated: Aug 17, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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