Trial · NCT07098351
Efficacy and Safety of Nalfurafine Hydrochloride ODT for Moderate-to-Severe Pruritus in Patients on Peritoneal Dialysis
NCT07098351, Not applicable, Recruiting, Guangdong Provincial People's Hospital
3 sourcestrials-2026-11-12-0.4.0
Cite this record
ConductScience Library. Efficacy and Safety of Nalfurafine Hydrochloride ODT for Moderate-to-Severe Pruritus in Patients on Peritoneal Dialysis. Trials, record NCT07098351. Release trials-2026-11-12-0.4.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT07098351
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Efficacy and Safety of Nalfurafine Hydrochloride ODT for Moderate-to-Severe Pruritus in Patients on Peritoneal Dialysis
- NCT number
- NCT07098351
- Status
- Recruiting
- Phases
- Not applicable
- Enrollment
- 93 participants, estimated
- Lead sponsor
- Guangdong Provincial People's Hospital
- Conditions
- Adverse Event, Peritoneal Dialysis, Moderate-to-severe Pruritus, Chronic Kidney Disease-associated Itch
- Interventions
- Remitch
- First posted
- 2025-08-01
- Last updated
- 2026-09-14
Source ClinicalTrials.gov
Registered outcomes7
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Change in Visual Analog Scale (VAS) score for Itch from baseline to Week4 of treatment period | 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. |
| Secondary | 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 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. |
| Secondary | Change in Xie-Kawashima Itch Scale scores | Baseline, Week 1, Week 2, Week 4, and Follow-up | 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. |
| Secondary | 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 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. |
| Secondary | Change in Health-Related Quality of Life Scores | Baseline to Week 4 of treatment period | 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. |
| Secondary | Change in Pittsburgh Sleep Quality Index (PSQI) total score | Baseline to Week 4 of treatment period | 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. |
| Secondary | Proportion of participants escalating dosage of nalfurafine hydrochloride | Day 1 to Week 4 of treatment period | 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 |
Source ClinicalTrials.gov
Outcomes0
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
None in this release.
Results by group0
Each measurement the trial posted, group by group, in the words and numbers it posted.
None in this release.
Participant flow0
How many started, completed or left each group, period by period.
None in this release.
Adverse events0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
None in this release.
Adverse event totals0
The totals the trial posted for each group.
None in this release.
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Source
- Release
- trials-2026-11-12-0.4.0
- Release manifest SHA-256
- 0f4a8d8c48aee2a7573ae0fa94ecbeab70c1adbe449bbc95c424bc7d3e97b9d4
- Registry capture
- 2026-11-12
- Results copy, AACT
- 2026-03-23
- NIH clinical studies file
- 2026-11-13
Source ClinicalTrials.gov
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNone stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT07098351
GET https://conductscience.org/api/trials/v1/NCT07098351/registered