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

Launched by UNIVERSITY HOSPITAL, ROUEN · Jan 23, 2023

Keywords

ClinConnect Summary

This clinical trial is studying how a medication called belatacept affects the immune system of kidney transplant patients, particularly in relation to a virus called CMV (cytomegalovirus). Belatacept is used to help prevent rejection of the transplanted kidney by managing the immune response. In this trial, researchers want to understand how belatacept influences the body’s T cells, which are important for fighting infections like CMV, especially in patients who have trouble with standard treatments.

To be eligible for this trial, participants must be kidney transplant patients at Rouen University Hospital who have experienced issues with their current medication, resulting in specific kidney function problems. They must also have a recent biopsy showing certain kidney issues and must test positive for CMV. Participants will receive belatacept along with a three-month course of an antiviral medication called Valganciclovir to help prevent CMV infections. The trial is not yet recruiting, but it aims to better understand how the immune response to CMV changes over the six months following treatment. This research could help improve care for kidney transplant patients facing these challenges.

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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