RecruitingNot ApplicableNCT07098351

Efficacy and Safety of Nalfurafine Hydrochloride ODT for Moderate-to-Severe Pruritus in Patients on Peritoneal Dialysis

A Clinical Study on the Efficacy and Safety of Nalfurafine Hydrochloride Orally Disintegrating Tablets in the Treatment of Moderate to Severe Pruritus in Peritoneal Dialysis Patients


Sponsor

Guangdong Provincial People's Hospital

Enrollment

93 participants

Start Date

Aug 7, 2025

Study Type

INTERVENTIONAL

Conditions

Summary

Moderate to severe pruritus significantly impairs the quality of life in peritoneal dialysis patients, and effective treatment options remain limited. κ-opioid receptor agonists may alleviate itching by modulating neural signaling pathways. This study is a multicenter, prospective, single-arm clinical trial, planning to enroll 93 patients. It aims to test the hypothesis that nalfurafine hydrochloride orally disintegrating tablets compared to baseline, with acceptable safety.


Eligibility

Min Age: 18 YearsMax Age: 85 Years

Plain Language Summary

Simplified for easier understanding

This study is testing a medication called nalfurafine hydrochloride (a dissolvable tablet) for people on peritoneal dialysis — a type of home kidney dialysis — who suffer from moderate to severe, persistent itching. Itching is an extremely common and distressing problem for people with kidney failure, and this drug works on a different pathway than standard antihistamines. **You may be eligible if...** - You are aged 18–85 - You have been on peritoneal dialysis for at least 3 months - You have moderate to severe itching that has not responded well to other treatments - Your itching severity scores are consistently high during the study baseline period **You may NOT be eligible if...** - You plan to switch to hemodialysis or get a kidney transplant during the study - You have severe liver problems - Your itching is caused by something other than kidney disease (such as an allergy or skin infection) - You have severe heart failure or a recent heart attack - You are pregnant or breastfeeding - You have a psychiatric condition or substance use disorder - You have taken opioid medications within the past 2 weeks - You have been in another clinical trial within the past 28 days Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGRemitch

Nalfurafine 2.5μg daily for 2 weeks. Afterwards, the dose can be increased to 5μg daily if necessary (maximum dose not exceeding 5μg daily), continued for another 2 weeks.


Locations(1)

Guangdong Provincial People's Hospital

Guangzhou, Guangdong, China

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NCT07098351


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