NCT07098351 Efficacy and Safety of Nalfurafine Hydrochloride ODT for Moderate-to-Severe Pruritus in Patients on Peritoneal Dialysis
| NCT ID | NCT07098351 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Guangdong Provincial People's Hospital |
| Condition | Adverse Event |
| Study Type | INTERVENTIONAL |
| Enrollment | 93 participants |
| Start Date | 2025-08-07 |
| Primary Completion | 2026-06-30 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 93 participants in total. It began in 2025-08-07 with a primary completion date of 2026-06-30.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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.
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.
Contact & Investigator
Xueqing Yu
PRINCIPAL INVESTIGATOR
Guangdong Provincial People's Hospital
Frequently Asked Questions
Who can join the NCT07098351 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 85 Years, studying Adverse Event. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07098351 currently recruiting?
Yes, NCT07098351 is actively recruiting participants. Contact the research team at yuxueqing@gdph.org.cn for enrollment information.
Where is the NCT07098351 trial being conducted?
This trial is being conducted at Guangzhou, China.
Who is sponsoring the NCT07098351 clinical trial?
NCT07098351 is sponsored by Guangdong Provincial People's Hospital. The principal investigator is Xueqing Yu at Guangdong Provincial People's Hospital. The trial plans to enroll 93 participants.