Tests nalfurafine tablets for itching in people on peritoneal dialysis
Tests nalfurafine tablets for moderate to severe itching in adults on dialysis.
Plain-language title generated from the registry record
Registry title: Efficacy and Safety of Nalfurafine Hydrochloride ODT for Moderate-to-Severe Pruritus in Patients on Peritoneal Dialysis
Key facts
- Where
- Guangzhou, ChinaSee the site
Could this be for you?
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 18 and 85 years old?
Source: NCT07098351, who can take part
Where in China
- Guangdong Provincial People's HospitalGuangzhou, ChinaTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Guangdong Provincial People's Hospital
- Trial code
- NCT07098351
- Record updated
- 14 September 2026
- Original description
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.Read full original descriptionShow less
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
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.
Inclusion: At the time of signing informed consent:; Aged 18-85 years (inclusive), regardless of gender; Chronic renal failure patients on regular peritoneal dialysis for ≥3 months, with no anticipated major treatment changes or rapid disease progression during the trial; Able to understand and comply with study procedures, voluntarily participate, and provide written informed consent; At formal enrollment:; During the baseline period, ≥5 days with both morning and evening VAS scores recorded, and the average of the higher VAS values (morning/evening) ≥50 mm; During the baseline period, ≥5 days with Xie-Kawashima itching severity assessed both morning and evening, including ≥2 days where the maximum itching score (morning/evening) was ≥3 (moderate).
Exclusion: Peritoneal dialysis regimen adjusted within 2 weeks prior to screening; Currently on or planning hemodialysis within 2 months; Planned kidney transplant or elective surgery during the study; Peritonitis within 4 weeks prior to screening, unable to continue peritoneal dialysis; Active malignancy within 12 months prior to screening, or recent radiotherapy/chemotherapy/targeted/immunotherapy; Current systemic corticosteroids/immunosuppressants (topical excluded); Initiated/adjusted restricted medications (antihistamines, systemic/local corticosteroids [excluding ear/eye], calcineurin inhibitors, gabapentin, pregabalin) within 7 days prior to screening, or anticipated changes during the study; Initiated/adjusted medications affecting pruritus assessment (antipsychotics, hypnotics, SSRIs, anxiolytics, TCAs) within 2 weeks prior to screening, or anticipated changes during the study; Opioid agonists/antagonists used within 2 weeks prior to screening; Phototherapy for pruritus within 1 month prior to screening; History of drug abuse, dependence, or alcoholism within 12 months prior to screening; Participation in another clinical trial with investigational drugs/devices within 28 days prior to screening, or residual investigational drug within 5 half-lives; Pruritus not caused by chronic kidney disease (e.g., allergic, physical, infectious skin diseases, cholestatic liver disease); Severe cardiovascular disease (NYHA Class III/IV, acute MI, unstable angina, large pericardial effusion, severe arrhythmia, or ECG abnormalities deemed unsafe for participation); Uncontrolled or drug-treated fungal/bacterial/viral infections (e.g., active TB, HIV); Uncontrolled hypertension (SBP ≥180 mmHg or DBP ≥110 mmHg); Psychiatric or cognitive disorders; Allergy to opioids or trial drug excipients; Other conditions deemed unsuitable by the investigator; ALT, AST, GGT, or total bilirubin >2× upper limit of normal (ULN) during screening; Poor dialysis compliance, deemed by the investigator to affect efficacy/safety assessments; Poor dialysis compliance, deemed by the investigator to affect efficacy/safety assessments; Pregnant, breastfeeding, positive pregnancy test, or unwilling to use contraception during the study.