Actively Recruiting
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
Led by Guangdong Provincial People's Hospital · Updated on 2025-09-03
93
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the efficacy and safety of nalfurafine hydrochloride orally disintegrating tablets for treating moderate-to-severe itching in patients undergoing peritoneal dialysis. Itching severely impacts quality of life in these patients, and current treatments are limited. This multicenter, prospective, single-arm clinical trial aims to test whether nalfurafine tablets can reduce itch severity compared to baseline with acceptable safety in 93 participants. The study includes a screening period of 1 to 2 weeks to establish baseline itch levels using standardized scales. During the 4-week treatment phase, participants start with 2.5 mcg of nalfurafine daily, taken after dinner or before bedtime. After 2 weeks, the dose may be increased to 5 mcg daily if the initial response is insufficient. A 1-week follow-up period then assesses itch improvement and safety. Treatment response is monitored with Visual Analog Scale scores and other itch severity measures. Participants will report itch severity twice daily during baseline and treatment phases. Researchers will evaluate changes in itch scores, quality of life, and sleep quality, while monitoring vital signs, lab tests, and any adverse events. The primary outcome is the change in itch severity from baseline to week 4. The study carefully controls data quality and dropout rates to ensure reliable results over a total participation period of about 6 to 7 weeks.
CONDITIONS
Brief 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 (inclusive), any gender
- Diagnosed with chronic renal failure and receiving regular peritoneal dialysis for at least 3 months
- Able to understand and comply with study procedures and provide informed consent
- During baseline, recorded Visual Analog Scale (VAS) itch scores at least 5 days with average higher value of 50 mm or more
- During baseline, recorded Xie-Kawashima itching severity scores at least 5 days including 2 days with severity score 3 or higher (moderate)
You will not qualify if you...
- Poor dialysis compliance affecting safety or efficacy assessments
- Peritoneal dialysis regimen changed within 2 weeks before screening
- Currently on or planning hemodialysis within 2 months
- Planned kidney transplant or elective surgery during study
- Peritonitis within 4 weeks before screening preventing continuation of dialysis
- Elevated liver enzymes or bilirubin above 2 times upper normal limit during screening
- Itching not caused by chronic kidney disease
- Severe cardiovascular disease or unsafe ECG abnormalities
- Active malignancy within 12 months or recent cancer treatments
- Uncontrolled infections such as tuberculosis or HIV
- Uncontrolled high blood pressure (SBP ≥180 mmHg or DBP ≥110 mmHg)
- Current systemic corticosteroids or immunosuppressants (topical excluded)
- Psychiatric or cognitive disorders
- Recent use or planned changes in medications affecting itching assessment within 7 to 14 days before screening
- Use of opioid agonists/antagonists within 2 weeks before screening
- Phototherapy for itching within 1 month before screening
- History of substance abuse or alcoholism within 12 months
- Allergy to opioids or study drug components
- Participation in other clinical trials with investigational drugs within 28 days before screening
- Pregnant, breastfeeding, positive pregnancy test, or unwilling to use contraception during study
- Other conditions deemed unsuitable by investigator
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 1 to 2 weeks
Participants are screened for eligibility to participate in the trial.
1 screening and enrollment visit
Duration - 4 weeks
Participants receive nalfurafine hydrochloride orally disintegrating tablets starting at 2.5 μg daily for 2 weeks. Based on symptom response, the dose may be increased to 5 μg daily for an additional 2 weeks. Pruritus severity and quality of life are regularly assessed.
Visits at Weeks 1, 2, and 4 during treatment
Duration - 1 week
Participants are monitored for changes in itching severity and safety for 1 week after completing treatment.
1 follow-up visit
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
Z
Zhiming Ye
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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