Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 11:41 PM
Ignite Modification Date:
2025-12-24 @ 11:41 PM
NCT ID:
NCT07098351
Eligibility Criteria:
Inclusion 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).
Exclusion Criteria:
* 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.
* 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.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
85 Years
Study:
NCT07098351
Study Brief:
Protocol Section:
NCT07098351