Clinical trial NCT06976008: CMV-associated Immunomodulation in Renal Transplant Patients
Official title: CMV-associated Immunomodulation in Renal Transplant Patients
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Kidney Transplantation
Keywords: Kidney transplant
Solid organ transplantation
Cytomegalovirus infection
Immunomodulatory effect of cytomegalovirus infection
Heterologous infection
Lead sponsor: Assistance Publique - Hôpitaux de Paris
Sponsor class: OTHER
First posted: 2025-05-16
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

Brief summary: 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.

Detailed 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.

Eligibility criteria: 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)

Primary outcomes:
measure: Impact of CMV infection on the heterologous innate immune response in kidney transplant patients
timeFrame: 12 months
Secondary outcomes:
measure: Impact of CMV infection on the heterologous adaptive immune response in kidney transplant patients
timeFrame: 12 months
Other outcomes:
Locations:
city: Le Kremlin-Bicêtre
country: France
facility: Hôpital Bicêtre
city: Paris
country: France
facility: Hôpital européen Georges Pompidou
city: Paris
country: France
facility: Hôpital Necker-Enfants Malades
city: Paris
country: France
facility: Insitut Pasteur
Study officials:
affiliation: Assistance Publique - Hôpitaux de Paris
name: Alexandra Serris
role: PRINCIPAL_INVESTIGATOR
References: