How CMV T-cell Immunity Changes After Starting Belatacept in Kidney Transplant Patients

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

This project will test how CMV-specific T-cell immunity changes over six months after starting belatacept in kidney transplant patients who cannot tolerate calcineurin inhibitors.

Quick facts

• Study type: Observational
• Enrollment: 28 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: University Hospital, Rouen (Academic / other)
• Locations: 1 site (Rouen)
• Trial ID: NCT05708534 on ClinicalTrials.gov

What this trial studies

This is an observational follow-up of kidney transplant recipients at Rouen who are switched to belatacept because of clinical or laboratory intolerance to calcineurin inhibitors and histological toxicity. Patients start belatacept alongside a systematic three-month course of oral valganciclovir prophylaxis, and clinicians will monitor CMV viral load and the quantity and function of CMV-specific effector/memory T cells over six months. The study aims to document quantitative and functional changes in the antiviral T-cell pool and relate them to CMV replication and clinical outcomes. Results will help clarify whether costimulation blockade with belatacept alters long-term CMV immune control.

Who should consider this trial

Good fit: Ideal candidates are Rouen University Hospital kidney transplant recipients who have never received belatacept, have positive CMV serostatus, show clinico-biological intolerance to calcineurin inhibitors (e.g., GFR <25 mL/min or related complications), and have a recent graft biopsy showing specified vascular lesions.

Not a fit: Patients with symptomatic infection, pregnant or breastfeeding women, those without proven effective contraception, people deprived of liberty, CMV-seronegative patients, or those who do not meet the Rouen inclusion criteria are unlikely to benefit from participation.

Why it matters

Potential benefit: If successful, the findings could help predict which patients are at higher risk for CMV complications and guide antiviral prophylaxis and monitoring when switching to belatacept.

How similar studies have performed: Previous reports have documented higher CMV risk after switching to belatacept and that prophylactic valganciclovir reduces infections, but the specific effects of belatacept on the CMV-specific effector/memory T-cell pool over time remain largely untested.

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

Where this trial is running

Rouen

• University Rouen Hospital — Rouen, France (Recruiting)

Study contacts

• Study coordinator: LAURENT Charlotte

Conditions Kidney Transplant Infection