RecruitingNCT05708534
Evolution of CMV Antiviral T-cell Immunity Over the Next Six Months Initiation of Treatment With Belatacept.
Sponsor
University Hospital, Rouen
Enrollment
28 participants
Start Date
Nov 14, 2023
Study Type
OBSERVATIONAL
Conditions
Summary
Belatacept inhibits T cell activation by blocking the costimulatory signal. In kidney transplantation, it limits the use of anticalcineurins while ensuring a satisfactory level of immunosuppression.
Eligibility
Min Age: 18 Years
Inclusion Criteria7
- 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 Criteria4
- 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
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Interventions
DRUGBelatacept
Switching from anticalcineurins to belatacept in a cohort of kidney transplant recipients seropositive for CMV
Locations(1)
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NCT05708534
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