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Active, not recruiting Observational

Evolution of CMV Antiviral T-cell Immunity Over the Next Six Months Initiation of Treatment With Belatacept.

NCT05708534 · tracked via the Priya Life Science France tracker
Phase
Observational
Started
2023-11-14
Last updated
2026-05-22

Condition(s) studied

Kidney Transplant Infection

Investigational drug(s) / intervention(s)

Belatacept →

Belatacept: Switching from anticalcineurins to belatacept in a cohort of kidney transplant recipients seropositive for CMV

Study 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

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
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

Primary outcome measure(s)

  • To study the quantitative changes in anti-CMV T-lymphocyte immunity to the IE-1 antigen within 6 months of a switch from anticalcineurin treatment to belatacept in a cohort of kidney transplant recipients seropositive for CMV — 6 months
    Number of interferon gamma-producing T lymphocytes in response to the IE-1 antigen determined by ELISPOT at M0, M3 and M6.

Trial sites (1)

FacilityCityRegionStatus
University Rouen Hospital Rouen France
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT05708534 on ClinicalTrials.gov ↗ ← All trials in France