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

Sponsored by Guangdong Provincial People's Hospital

About this trial

Last updated 9 months ago

Study ID

SYSS-Remitch-PD-IIT-05

Status

Recruiting

Type

Interventional

Phase

N/A

Placebo

Accepting

18 to 85 Years

All Sexes

Trial Timing

Started 10 months ago

What is this trial 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.

What are the participation requirements?

Inclusion Criteria

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 Criteria

* Poor dialysis compliance, deemed by the investigator to affect efficacy/safety assessments. * Poor dialysis compliance, deemed by the investigator to affect efficacy/safety assessments. * 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. * ALT, AST, GGT, or total bilirubin >2× upper limit of normal (ULN) during screening. * 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). * Active malignancy within 12 months prior to screening, or recent radiotherapy/chemotherapy/targeted/immunotherapy. * Uncontrolled or drug-treated fungal/bacterial/viral infections (e.g., active TB, HIV). * Uncontrolled hypertension (SBP ≥180 mmHg or DBP ≥110 mmHg). * Current systemic corticosteroids/immunosuppressants (topical excluded). * Psychiatric or cognitive disorders. * 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. * Allergy to opioids or trial drug excipients. * Participation in another clinical trial with investigational drugs/devices within 28 days prior to screening, or residual investigational drug within 5 half-lives. * Pregnant, breastfeeding, positive pregnancy test, or unwilling to use contraception during the study. * Other conditions deemed unsuitable by the investigator.