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Tests treatment safety and results for Adverse Event
Official title Efficacy and Safety of Nalfurafine Hydrochloride ODT for Moderate-to-Severe Pruritus in Patients on Peritoneal Dialysis
ClinicalTrials.gov ID: NCT07098351
What this study is testing
What is Remitch?
Remitch is an investigational medicine, given as an once-daily pill taken by mouth, being studied as a potential treatment for adverse event.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 85
You may be able to join 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...
- 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...
You likely can't join if
- Poor dialysis compliance, deemed by the investigator to affect how well it works/safety assessments.
- Poor dialysis compliance, deemed by the investigator to affect how well it works/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.
See the full eligibility 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).
- Poor dialysis compliance, deemed by the investigator to affect how well it works/safety assessments.
- Poor dialysis compliance, deemed by the investigator to affect how well it works/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...
- 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.
The study team makes the final eligibility decision.
Where it's taking place
- Guangzhou, Guangdong, China
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 85 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Guangzhou, Guangdong, China. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.