Adverse EventKARE-PDNCT07098351
Efficacy and Safety of Nalfurafine Hydrochloride ODT for Moderate-to-Severe Pruritus in Patients on Peritoneal Dialysis
A study testing Remitch in people with Adverse Event and Peritoneal Dialysis, run by Guangdong Provincial People's Hospital at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Adverse Event, Peritoneal Dialysis, Moderate-to-severe Pruritus
- What is being tested?
- Remitch
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 93 participants
- Where
- 1 siteChina
- Study dates
- 7 Aug 2025to 12 Dec 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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).
Who cannot join
- 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.
Show all 23Show fewer
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Zhiming Ye contact
China1 site, 1 recruiting
- Recruiting
Guangdong Provincial People's Hospital
Guangzhou, Guangdong, 510080
Zhiming Ye
About this study
Official title: 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
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.
Read the detailed description
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.
- Conditions
- Adverse Event, Peritoneal Dialysis, Moderate-to-severe Pruritus, Chronic Kidney Disease-associated Itch
- Being tested
- Remitch
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RemitchDrug
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Drug: Remitch |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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
Measured: Day 1 to Week 4 of treatment period
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Aug 2025
- Study start7 Aug 2025
- Primary completion30 Jun 2027 (estimated)
- Study completion12 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Adverse EventStudies of the same condition, open and under way.
- More trials run by Guangdong Provincial People's HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 93 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Guangdong Provincial People's Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Xueqing Yu, Principal investigator, Guangdong Provincial People's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07098351
- Sponsor's protocol ID
- SYSS-Remitch-PD-IIT-05
- Acronym
- KARE-PD
- Status last verified
- Sep 2026
- First submitted
- 23 May 2025
- Last updated
- 14 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT07098351
- Acronym / sponsor ID
- KARE-PD / SYSS-Remitch-PD-IIT-05
- Conditions
- Adverse Event, Peritoneal Dialysis, Moderate-to-severe Pruritus, Chronic Kidney Disease-associated Itch
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 93 participants (estimated)
- Lead sponsor
- Guangdong Provincial People's HospitalUniversity, hospital or other
- Study start
- 7 Aug 2025 (actual)
- Primary completion
- 30 Jun 2027 (estimated)
- Study completion
- 12 Dec 2027 (estimated)
- First posted
- 1 Aug 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Singe-arm study: active treatment group | Other | Drug: RemitchNalfurafine 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. |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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.
- 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).
Key exclusion criteria (23 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| RemitchNalfurafine 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. | Drug | Singe-arm study: active treatment group |
Primary outcome
Change in Visual Analog Scale (VAS) score for Itch from baseline to Week4 of treatment period
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).
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.
6 secondary outcomes
Change in Visual Analog Scale(VAS) for Itch scores at Weeks 1, 2, 4 of treatment and follow-up period
Time frame: Baseline, Week 1, Week 2, Week 4, and Follow-up
Change in Xie-Kawashima Itch Scale scores
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
Time frame: Baseline to Week 2,4 of treatment period
Change in Health-Related Quality of Life Scores
Time frame: Baseline to Week 4 of treatment period
Change in Pittsburgh Sleep Quality Index (PSQI) total score
Time frame: Baseline to Week 4 of treatment period
Proportion of participants escalating dosage of nalfurafine hydrochloride
Time frame: Day 1 to Week 4 of treatment period
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Sep 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Zhiming Ye contact
Xueqing Yu principal investigator
Guangdong Provincial People's Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Remitch in people with Adverse Event and Peritoneal Dialysis, run by Guangdong Provincial People's Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 23 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 14 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Xueqing Yu, Ph.D (8620-83827897, yuxueqing@gdph.org.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Visual Analog Scale (VAS) score for Itch from baseline to Week4 of treatment period (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).). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Sep 2026.