Actively Recruiting
Efficacy and Safety of Nalfurafine Hydrochloride ODT for Moderate-to-Severe Pruritus in Patients on Peritoneal Dialysis
Led by Guangdong Provincial People's Hospital · Updated on 2025-09-03
93
Participants Needed
1
Research Sites
46 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Efficacy and Safety of Nalfurafine Hydrochloride ODT for Moderate-to-Severe Pruritus in Patients on Peritoneal Dialysis
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Aged 18-85 years old, any gender
- Undergoing regular peritoneal dialysis for at least 3 months without expected major changes or rapid disease progression
- Able to understand and follow study procedures and provide written informed consent
- During baseline period, have recorded morning and evening itch scores using Visual Analog Scale (VAS) for at least 5 days, with average VAS scores of 50 mm or higher
- During baseline period, have recorded Shichuan-Kawashima pruritus severity scores morning and evening for at least 5 days, including at least 2 days with moderate or higher itching severity (score 3 or above)
You will not qualify if you...
- Poor dialysis compliance affecting study assessments
- Changes in peritoneal dialysis regimen within 2 weeks before screening
- Current or planned hemodialysis within 2 months
- Planned kidney transplant or elective surgery during the study
- Peritonitis within 4 weeks before screening
- Elevated liver enzymes or bilirubin above twice the normal upper limit
- Itching caused by conditions other than chronic kidney disease (e.g., allergic or infectious skin diseases, liver disease)
- Severe cardiovascular diseases or unsafe heart conditions
- Active cancer or recent cancer treatments within 12 months
- Uncontrolled or treated fungal, bacterial, or viral infections
- Uncontrolled high blood pressure
- Use of systemic corticosteroids or immunosuppressants (topical excluded)
- Psychiatric or cognitive disorders
- Recent adjustment or initiation of medications affecting itching within specified time frames
- Use of opioid agonists or antagonists within 2 weeks before screening
- Phototherapy for itching within 1 month before screening
- History of drug abuse or alcoholism within 12 months
- Allergy to opioids or study drug ingredients
- Participation in another clinical trial involving investigational drugs/devices within 28 days before screening
- Pregnancy, breastfeeding, positive pregnancy test, or unwillingness to use contraception during the study
- Other conditions deemed unsuitable by the investigator
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
Guangdong Provincial People's Hospital
Guangzhou, Guangdong, China, 510080
Actively Recruiting
Research Team
X
Xueqing Yu, Ph.D
CONTACT
Z
Zhiming Ye
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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