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:
2025-12-25 @ 12:34 AM
Ignite Modification Date:
2025-12-25 @ 12:34 AM
NCT ID:
NCT07045467
Eligibility Criteria:
Inclusion Criteria Signed informed consent
Age ≥18 years and \<65 years
Chronic renal failure scheduled for renal transplantation
Body mass index (BMI) 18-30 kg/m² (inclusive)
Weight ≥50 kg (males) or ≥45 kg (females)
ASA physical status classification III or IV
Exclusion Criteria Hepatic, psychiatric, or neurological disorders
Coagulopathy
Heart failure
Respiratory failure
Long-term sedative or antidepressant use
Pregnancy or lactation
Inability to communicate or cooperate
Participation in other drug/device trials within 3 months prior
Positive hepatitis B surface antigen (HBsAg)
Positive hepatitis C antibody (HCV-Ab)
Positive HIV antibody
Positive syphilis antibody
Use of hepatic enzyme inhibitors/inducers within 30 days prior (per Appendix 1)
Known hypersensitivity to ≥2 substances
Alcohol consumption \>14 units/week within 6 months prior\*
Drug abuse history within 3 months prior
Major infection/trauma within 1 month prior
Gastrointestinal surgery affecting drug absorption within 1 month prior
Vaccination within 1 month prior or planned during study
Blood loss/donation \>400 mL within 3 months prior
Blood transfusion within 1 month prior
INR \>1.5, PT \>ULN+4 seconds, or APTT \>15×ULN
Significant bleeding history within 3 months prior
Current anticoagulant therapy
Any condition deemed unsuitable by investigator
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
65 Years
Study:
NCT07045467
Study Brief:
Protocol Section:
NCT07045467