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

NCT07098351 | Recruiting

• 1 other identifier: SYSS-Remitch-PD-IIT-05
• Study Type: interventional
• Target: 93
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Outcome Measures

Primary Outcomes (1)

• Change in Visual Analog Scale (VAS) score for Itch from baseline to Week4 of treatment period

  Calculation: Change = (Average of daily maximum VAS scores during baseline period) - (Average of daily maximum VAS scores during the 4th week of treatment period). Only dates with both daytime and nighttime VAS recordings were included in the assessment. Daily maximum VAS score: Defined as the higher value between the VAS measured at waking and bedtime each day. VAS scores range from 0 to 10 points.0 = "No itch" ,10 = "Worst itch". Higher scores indicate worse itch severity.

  This study includes a screening period (1-2 weeks, baseline assessment), a 4-week treatment phase (starting with nalfurafine 2.5μg/day, potentially increased to 5μg), and a 1-week follow-up period (to evaluate changes in itching severity).

Secondary Outcomes (6)

• Change in Visual Analog Scale(VAS) for Itch scores at Weeks 1, 2, 4 of treatment and follow-up period

  Baseline, Week 1, Week 2, Week 4, and Follow-up

• Change in Xie-Kawashima Itch Scale scores

  Baseline, Week 1, Week 2, Week 4, and Follow-up

• The degree of change in Visual Analog Scale (VAS) scores from Baseline to Week 2,4 of treatment period

  Baseline to Week 2,4 of treatment period

• Change in Health-Related Quality of Life Scores

  Baseline to Week 4 of treatment period

• Change in Pittsburgh Sleep Quality Index (PSQI) total score

  Baseline to Week 4 of treatment period

Study Arms (1)

Singe-arm study: active treatment group

OTHER

Nalfurafine Hydrochloride Orally Disintegrating Tablets should be initially administered at a dose of 2.5 μg once daily after dinner or before bedtime for two consecutive weeks. After this initial treatment period, the dose should be adjusted based on the therapeutic response assessed by the change in Visual Analog Scale (VAS) scores for pruritus. If the treatment is effective, defined as a reduction of ≥20 mm in the average VAS score at Week 2 compared to baseline, the patient should continue taking 2.5 μg once daily for another two weeks. If the treatment response is inadequate (failure to meet the ≥20 mm VAS reduction criterion), the dose should be increased to 5 μg once daily and maintained for an additional two weeks. The medication should be taken consistently either after dinner or prior to bedtime throughout the treatment course.

Drug: Remitch

Interventions

Remitch DRUG

Nalfurafine 2.5μg daily for 2 weeks. Afterwards, the dose can be increased to 5μg daily if necessary (maximum dose not exceeding 5μg daily), continued for another 2 weeks.

Singe-arm study: active treatment group

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).

You may not qualify if:

• 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.

Sponsors & Collaborators

• Guangdong Provincial People's Hospital: lead

Study Sites (1)

Guangdong Provincial People's Hospital

Guangzhou, Guangdong, 510080, China

RECRUITING

Study Officials

• Xueqing Yu

  Guangdong Provincial People's Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Xueqing Yu, Ph.D

CONTACT

8620-83827897; yuxueqing@gdph.org.cn

Zhiming Ye

CONTACT

+8613826161678

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 23, 2025
• First Posted: August 1, 2025
• Study Start: August 7, 2025
• Primary Completion (Estimated): June 30, 2026
• Study Completion (Estimated): June 30, 2026
• Last Updated: September 3, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)