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

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

The trial will try nalfurafine orally disintegrating tablets to reduce moderate-to-severe itching in adults on peritoneal dialysis.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 93 (estimated)
• Ages: 18 Years to 85 Years
• Sex: All
• Sponsor: Guangdong Provincial People's Hospital (Academic / other)
• Drugs / interventions: chemotherapy, immunotherapy
• Locations: 1 site (Guangzhou, Guangdong)
• Trial ID: NCT07098351 on ClinicalTrials.gov

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.

Who should consider this trial

Good fit: Adults 18–85 years old on stable peritoneal dialysis for at least 3 months with documented moderate-to-severe pruritus (average VAS ≥50 mm and Xie-Kawashima scores meeting entry criteria) are ideal candidates.

Not a fit: Patients with poor dialysis compliance, rapidly changing clinical status, or who do not meet the baseline VAS or itching-severity requirements are unlikely to benefit from this protocol.

Why it matters

Potential benefit: If successful, the treatment could reduce severe itching and improve sleep and overall quality of life for people on peritoneal dialysis.

How similar studies have performed: Kappa-opioid receptor agonists, including nalfurafine, have shown benefit for uremic pruritus in prior studies, although direct evidence specifically in peritoneal dialysis populations is more limited.

Eligibility criteria

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 this trial is running

Guangzhou, Guangdong

• 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

Conditions Adverse Event; Peritoneal Dialysis; Moderate-to-severe Pruritus; Chronic Kidney Disease-associated Itch