An interventional study of Remitch in Adverse Event, Peritoneal Dialysis and Moderate-to-severe Pruritus, sponsored by Guangdong Provincial People's Hospital. Recruiting at 1 site in China. Open to participants aged 18 Years to 85 Years. Per ClinicalTrials.gov, last updated 2026-09-14.
Sponsored by Guangdong Provincial People's Hospital · Not applicable, Interventional, and Treatment
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.
This is a multicenter, prospective, single-arm clinical study designed to evaluate the efficacy and safety of nalfurafine hydrochloride orally disintegrating tablets in treating moderate-to-severe pruritus in peritoneal dialysis patients. The study consists of three phases: a screening period (1-2 weeks), a treatment period (4 weeks), and a follow-up period (1 week). During the screening phase, baseline pruritus levels are established using the Visual Analog Scale (VAS) and the Shichuan-Kawashima Pruritus Severity Score. The treatment period begins with an initial dose of 2.5 μg/day, which may be adjusted to 5 μg/day after 2 weeks based on symptom response; the follow-up phase assesses pruritus improvement and safety. The study plans to enroll 93 patients (including a 20% dropout rate), with the primary endpoint being the change in VAS score from baseline to week 4 of treatment. Secondary endpoints include VAS score changes at different stages, quality-of-life improvements, and adverse event incidence.
Eligible patients are aged 18-85 years, undergoing regular peritoneal dialysis for ≥3 months, and meeting baseline VAS criteria for moderate-to-severe pruritus. The primary efficacy measure is the mean change in daily maximum VAS scores (baseline vs. week 4), while secondary measures include pruritus severity scores, sleep quality, dose adjustment rates, and laboratory safety data. Statistical analyses will follow intention-to-treat (ITT) and per-protocol (PP) principles. Based on preliminary data (mean 28.4 mm, standard deviation 21.82 mm), the sample size calculation ensures 95% power to validate efficacy hypotheses.
The intervention involves monotherapy with nalfurafine hydrochloride orally disintegrating tablets, starting at 2.5 μg/day, with a potential increase to 5 μg/day after 2 weeks. Standardized scales assess pruritus, quality of life, and sleep improvements, alongside monitoring of vital signs, electrocardiograms, and laboratory parameters for safety evaluation. Enrollment criteria require ≥5 days of recorded morning/evening VAS scores during the baseline period (average ≥50 mm) and ≥2 days with Shichuan-Kawashima pruritus scores ≥3 (moderate severity).
The study anticipates a significant reduction in VAS scores as the primary endpoint, with secondary endpoints including dose adjustments, safety events, and patient-reported outcomes. This single-arm self-controlled study validates drug efficacy while strictly controlling dropout rates and data integrity to ensure result reliability.
490 studies on the registry are indexed under Pruritus; 93 are open to participants now.
This study's planned enrollment of 93 is above the median of 60 across 422 interventional studies indexed under Pruritus.
Browse Pruritus studies →Guangdong Provincial People's Hospital is the lead sponsor of 237 studies on the registry; 102 are open to participants now.
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Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.
A yellow substance made when red blood cells are broken down, which the liver clears. A high level can mean a problem with the liver or the bile ducts.
Criteria often allow more for people with Gilbert’s syndrome, a harmless inherited condition that raises bilirubin.
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“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.
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Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
The other ingredients in a medicine besides the active drug, such as fillers, colours or preservatives.
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ALT and AST (liver enzymes)
Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.
Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Bilirubin
A yellow substance made when red blood cells are broken down, which the liver clears. A high level can mean a problem with the liver or the bile ducts.
Criteria often allow more for people with Gilbert’s syndrome, a harmless inherited condition that raises bilirubin.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ULN (upper limit of normal)
The top of the normal range for a blood test, as set by the laboratory that runs it. Each lab prints its own range next to your result.
“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
NYHA class (heart failure)
The New York Heart Association’s four classes of how much heart failure limits physical activity.
Studies set their own limit — many outside heart failure leave out class III–IV, while heart failure studies may ask for a particular class. Check the class this study names.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ECG (electrocardiogram)
A recording of the heart’s electrical activity, taken with stickers on the chest, arms and legs. It takes a few minutes and does not hurt.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Cancer (malignancy)
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
HIV
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Corticosteroids (steroids)
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Immunosuppression
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Excipients
The other ingredients in a medicine besides the active drug, such as fillers, colours or preservatives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Investigational drug or device
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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
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.
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.
Time frame: 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).
Change in Visual Analog Scale(VAS) for Itch scores at Weeks 1, 2, 4 of treatment and follow-up period
Change from baseline in daily maximum Visual Analog Scale for Itch (VAS) scores at each assessment time point (Weeks 1, 2, 4 of treatment and follow-up period).VAS scores range from 0 to 10 points.0 = "No itch" ,10 = "Worst itch". Higher scores indicate worse itch severity.
Time frame: Baseline, Week 1, Week 2, Week 4, and Follow-up
Change in Xie-Kawashima Itch Scale scores
Change from baseline in daily maximum Xie-Kawashima Itch Scale scores at each assessment time point (Weeks 1, 2, 4 of treatment and follow-up period). Xie-Kawashima Itch Scale scores range from 0 to 4 points.0 = "No itch" ,4 = "Worst itch". Higher scores indicate worse itch severity.
Time frame: 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
Change of itch intensity,assessed by the Visual Analog Scale for Itch from baseline to Week 2,4 of treatment period. Calculated as: average of baseline VAS score minus average of VAS score during Week 2,4 of treatment period. Response Criteria: Clinically Significant Improvement:Mean VAS score \< 20 mm during treatment period OR reduction ≥40 mm from baseline Improvement:Reduction ≥20 mm but \<40 mm from baseline (excluding Clinically Significant Improvement) No Clinically Meaningful Improvement:Neither Category 1 nor Category 2 criteria met.
Time frame: Baseline to Week 2,4 of treatment period
Change in Health-Related Quality of Life Scores
Kidney Disease Quality of Life-36 (KDQOL-36) Scale score Range: 36-185 points.Higher scores indicate better quality of life. Skindex-16 Dermatology Life Quality Index Scale score Range: 0-96 points.Higher scores indicate worse quality of life.
Time frame: Baseline to Week 4 of treatment period
Change in Pittsburgh Sleep Quality Index (PSQI) total score
Change from baseline to Week 4 of treatment in sleep quality measured by Pittsburgh Sleep Quality Index (PSQI). Total Score Range: 0 to 21 points.Higher scores indicate worse sleep quality.
Time frame: Baseline to Week 4 of treatment period
Proportion of participants escalating dosage of nalfurafine hydrochloride
Proportion of participants escalating dosage from 2.5μg QD to 5μg QD during 4-week treatment period. Drug Formulation: Nalfurafine hydrochloride orally disintegrating tablets. Calculation: Numerator: Patients with dose escalation Denominator: Total treated patients
Time frame: Day 1 to Week 4 of treatment period
Plan to share: No
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Studies of the drug tested here: TRK 820
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