CMV-associated Immunomodulation in Renal Transplant Patients (IMMCMV)

Assistance Publique - Hôpitaux de Paris

Status: Not yet enrolling

Conditions: Kidney Transplantation

Treatments: Other: blood sampling

Study type: Interventional

Funder types: Other

Identifiers

NCT06976008

ID-RCB Number : 2024-A01039-38 (Other Identifier)

APHP240837

Details and patient eligibility

About

Cytomegalovirus (CMV) infection has been associated with an increased risk of bacterial, fungal and viral infections in solid organ transplant recipients. The purpose of this study to evaluate if the occurrence of CMV viremia modify the ability to develop optimal immune responses against other pathogens in kidney transplant recipients (heterologous immunity). The objective of this project is to identify the immune pathways affected by CMV in the context of immunosuppression associated with kidney transplantation.

Full description

Cytomegalovirus (CMV) infection remains one of the most frequent and problematic complications of solid organ transplantation. Several epidemiological studies have shown an association between CMV infection and the occurrence of severe bacterial or fungal infections. However, the mechanisms by which CMV increases the risk of heterologous infection are still poorly understood. Several data support a direct or indirect immunomodulatory effect of CMV. Indeed, in healthy subjects, CMV seropositivity has a strong phenotypic and functional impact on adaptive immunity while in solid organ transplant patients, a decrease in the innate response to various antigenic stimuli has been observed during CMV viremia. The hypothesis of the study is that the occurrence of CMV viremia reduces the ability to develop optimal immune responses against other targeted pathogens in kidney transplant recipients (heterologous immunity). The objective of this project is to identify the immune pathways affected by CMV in the context of immunosuppression associated with kidney transplantation.

Enrollment: 60 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. st cohort :

   • Age > 18 years
   • patients with end-stage renal failure programmed for kidney transplantation with a live donor

2. nd cohort :

   • Age > 18 years
   • kidney transplant recipient with CMV viremia

Exclusion criteria

- Patients under guardianship, curatorship, legal protection.

For patients with end-stage renal failure scheduled to receive a kidney transplant from a living donor :

• Patients with an active viral (other than CMV), bacterial or fungal infection at the time of inclusion
• patients receiving a desensitization protocol (ABO or anti-HLA)

Trial design

Primary purpose: Basic Science

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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60 participants in 2 patient groups

Kidney transplant recipients followed since the day of the transplantation

Experimental group

Description:

Kidney transplant recipients followed since the day of the transplantation

Treatment:

Other: blood sampling

kidney transplant recipients with CMV viremia

Experimental group

Description:

kidney transplant recipients with CMV viremia

Treatment:

Other: blood sampling