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 @ 10:47 PM
Ignite Modification Date:
2025-12-24 @ 10:47 PM
NCT ID:
NCT05562869
Eligibility Criteria:
Inclusion Criteria:
* adult older than 18 years old.
* transplantation of a deceased or living donor kidney (non-human leukocyte antigen(HLA)-identical) with blood type (ABO) compatibility
* no contraindication to the protocol graft biopsy (10 weeks post transplant)
* treatment by CNI / MPA +/- prednisone
* renal function estimated by creatinine clearance according to CKD-EPI \<30 ml / min / 1.73m2.
* having no difficulty in understanding and communicating with the investigator and his representatives.
* Agreeing to give informed written consent
* benefiting from a Social Security policy.
* results of the 10-week post-transplant renal biopsy finding no rejection or BK virus (member of the polyomavirus family) nephropathy, no recurrence, no thrombotic microangiopathy, no cortical necrosis.
* Seropositivity for Epstein-Barr virus (EBV)
* negative pregnancy test and agreement on the use of effective contraception throughout the study
Exclusion Criteria:
* Presence of Donor Specific Antibody during kidney transplant or appeared at 3 months post-transplantation.
* seropositivity for HIV
* another history of other solid organ transplants (outside the kidney)
* primary non-function (persistence of a need for dialysis at 3 months post-transplantation)
* participation in progress to another interventional clinical study
* any clinical condition that the investigator considers incompatible with the course of the study.
* contraindication to belatacept and Tacrolimus
* Pregnant or breastfeeding woman
* Inability of the patient to comply with study procedures
* Person placed under guardianship or curatorship, under safeguard of justice
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
99 Years
Study:
NCT05562869
Study Brief:
Protocol Section:
NCT05562869