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

NCT05708534 | Recruiting

• 1 other identifier: 2020/0432/OB
• Study Type: observational
• Target: 28
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Kidney Transplant Infection

Outcome Measures

Primary Outcomes (1)

• 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

  Number of interferon gamma-producing T lymphocytes in response to the IE-1 antigen determined by ELISPOT at M0, M3 and M6.

  6 months

Interventions

Belatacept DRUG

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

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Cohort of kidney transplant recipients seropositive for CMV

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University Hospital, Rouen: lead

Study Sites (1)

University Rouen Hospital

Rouen, 76031, France

RECRUITING

MeSH Terms

Interventions

Abatacept

Intervention Hierarchy (Ancestors)

Immunoconjugates; Antibodies; Immunoglobulins; Serum Globulins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Globulins

Central Study Contacts

LAURENT Charlotte

CONTACT

02 32 88 90 02; charlotte.laurent@chu-rouen.fr

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 23, 2023
• First Posted: February 1, 2023
• Study Start: November 14, 2023
• Primary Completion (Estimated): September 1, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: June 26, 2025

Record last verified: 2025-01

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)