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 @ 9:42 PM
Ignite Modification Date:
2025-12-24 @ 9:42 PM
NCT ID:
NCT05385432
Eligibility Criteria:
Inclusion Criteria:
* Patients aged between 18-79
* Registered on the transplant waiting list
* At least one anti-HLA antibody identified by the Luminex Single Antigen test with MFI ≥ 2000 (MFI threshold in agreement with French kidney allocation system.)
* Graft incompatibility rate (TGI) \< 85%
* Ability for participant to comply with the requirements of the study
* Written informed consent obtained from the participant
* Participants covered by or entitled to social security.
Exclusion Criteria:
* DSA (negative virtual crossmatch with MFI threshold at 1000)
* Combined transplantation
* Usual contraindications to a kidney transplantation such as morbid obesity (BMI \> 40 kg/m2), active drug abuse, uncontrolled psychiatric disease, or decompensated heart failure
* Beneficiaries of kidney transplants from donations after uncontrolled circulatory death (Maastricht II)
* Incompatible ABO transplantation
* Leukopenia lower than 3000/mm3
* Thrombocytopenia (platelets \< 50G/L)
* Donor EBV Positive / Recipient EBV Negative
* Active HIV infection (positive viral charge)
* History of solid cancer (\< 5 years), except to skin carcinoma (squamous-cell and basal-cell carcinoma).History of some solid cancer (prostate, breast) can be reduced (\<2 years), depending on the prognosis for cancer recurrence as assessed by the oncologist.
* History of lymphoma
* Patients with severe uncontrolled systemic infection or severe allergy requiring acute or chronic treatment; Aspartate aminotransferase (ASAT), Alanine Amino Transferase (ALAT) or bilirubin greater than 3 times normal
* Known hypersensitivity or contra-indication to rabbit proteins, basiliximab including the product excipients
* Contra-indication to tacrolimus,mycophenolic acid ans steroids
* Pregnant or breastfeeding woman, or woman of childbearing potential not using a highly effective method of contraception, or having a desire to conceive, during the whole trial duration. A β-HCG test will be performed for inclusion.
* Patient under judicial protection, deprivation of liberty
* Participation in other interventional research with an investigational drug or medical device.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
79 Years
Study:
NCT05385432
Study Brief:
Protocol Section:
NCT05385432