Nalfurafine orally disintegrating tablets for moderate-to-severe itching in people on peritoneal dialysis

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is a multicenter, prospective, single-arm study enrolling about 93 peritoneal dialysis patients with moderate-to-severe pruritus to test nalfurafine orally disintegrating tablets over a 4-week treatment period. After a 1–2 week screening/baseline phase to document itch severity using the Visual Analog Scale (VAS) and Xie-Kawashima scores, patients start 2.5 μg/day with an optional increase to 5 μg/day at week 2 based on response. The primary endpoint is the change in daily maximum VAS from baseline to week 4, and secondary endpoints include pruritus severity scores, sleep quality, dose-adjustment rates, quality-of-life measures, and safety labs. A 1-week follow-up period after treatment monitors durability of effect and adverse events.

Why it matters

Who can join: the full rules

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.

Where it's running

• Guangdong Provincial People's Hospital
  Guangzhou, Guangdong, China Recruiting

Study contacts

• Principal investigator: Xueqing Yu — Guangdong Provincial People's Hospital
• Study coordinator: Xueqing Yu, Ph.D
• Email: yuxueqing@gdph.org.cn
• Phone: 8620-83827897

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Other studies for the same condition or treatment. Recruiting studies are listed first.

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.