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 @ 2:27 AM
Ignite Modification Date:
2025-12-25 @ 2:27 AM
NCT ID:
NCT05708534
Eligibility Criteria:
Inclusion Criteria:
* Renal transplant follow-up at Rouen University Hospital
* Clinico-biological intolerance to anticalcineurins defined by GFR \< 25 mL/min and/or water and sodium overload justifying the prescription of loop diuretics and/or post-transplant diabetes and/or resistant hypertension (requiring at least 3 treatments antihypertensives including a thiazide diuretic to reach an objective ≤ 140/90 mmHg).
* Having performed a graft biopsy \< 3 months old finding lesions of fibrous endarteritis ≥ 2 or arteriolar hyalinosis ≥ 2
* Having undergone collegial validation for the initiation of treatment with belatacept combined with 3-month anti-CMV prophylaxis with oral Valganciclovir.
* Absence of contraindication to belatacept
* Patient who has never received belatacept
* Having a positive CMV serological status
Exclusion Criteria:
* Patient with symptomatic infection
* Pregnant or parturient or breast-feeding woman or lack of proven effective contraception
* Person deprived of liberty by an administrative or judicial decision or person placed under legal safeguard / sub-tutorship or curatorship
* Patient participating in another therapeutic trial or having participated in another trial within 1 month
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT05708534
Study Brief:
Protocol Section:
NCT05708534