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 @ 3:16 PM
Ignite Modification Date:
2025-12-24 @ 3:16 PM
NCT ID:
NCT06235892
Eligibility Criteria:
Inclusion Criteria:
* First kidney transplantation
* Living or brain death or
* Donation after circulatory death (Maastricht 3) donor,Compatible for ABO group with the donor,
* cPRA (Panel Reactive Antibody Calculated ) (or TGI: Incompatible Graft Rate )\<20% on the day of the transplantation and no DSA (MFI \<500) at pre transplant and at the time of the inclusion at one-year post transplantation (between 350 and 515 days after the transplantation.
* Eplet Mismatchs \<= 14
* Normal or IFTA 1-2 histology on one-year surveillance biopsy.
* Patient insured under a health insurance scheme, according to national regulation.
* Patient (of childbearing age) with effective contraception.
* Patients treated with Tacrolimus (Prograf® or Advagraf®) and MMF / MPS (Mycophenolate Sodium) +/- Corticosteroid (CS)
Exclusion Criteria:
* Donation after circulatory death maastricht 2 (uncontrolled) and maastricht 1
* Pregnant women (serum or urine test), breastfeeding women
* Patient under legal protection (incl. under guardianship or trusteeship)
* Participation to a drug interventional study within 1 month prior to the inclusion
* Any retransplantation and combined transplantations and also other organ previous transplantations
* History of lymphoproliferative disorders
* Diagnosis of a malignant disease (according to the type of malignancy)
* Hepatitis C antibody or hepatitis B surface antigen (HbsAg) positive patient or HIV infection
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT06235892
Study Brief:
Protocol Section:
NCT06235892