CMV-associated Immunomodulation in Renal Transplant Patients

Not Applicable

Not yet recruiting

• Conditions: Kidney Transplantation

• Registration Number: NCT06976008
• Lead Sponsor: Assistance Publique - Hôpitaux de Paris

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. We hypothesize 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.

Study Timeline

• Status Verified: 2025-05
• Study First Submitted: 2025-05-09
• Study First Submitted QC: 2025-05-09
• Last Update Submitted: 2025-05-09
• Study First Posted: 2025-05-16
• Last Update Posted: 2025-05-16
• Study Start: 2025-07-01
• Primary Completion: 2029-07-01
• Study Completion: 2029-07-01

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 60

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)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Impact of CMV infection on the heterologous innate immune response in kidney transplant patients	12 months	Comparison of the amount of cytokine production after stimulation of innate immune cells with whole microorganisms (E. Coli, Candida, Aspergillus, influenza virus) in solid organ transplant recipients with and without CMV over time.

Secondary Outcome Measures

Name	Time	Method
Impact of CMV infection on the heterologous adaptive immune response in kidney transplant patients	12 months	Comparison of the amount of cytokine production after stimulation of adaptative immune cells with a T-cell superantigen and CMV proteins in solid organ transplant recipients with and without CMV over time.

Trial Locations

Locations (4)

Hôpital Bicêtre; 🇫🇷 Le Kremlin-Bicêtre, France

Hôpital européen Georges Pompidou; 🇫🇷 Paris, France

Hôpital Necker-Enfants Malades; 🇫🇷 Paris, France

Insitut Pasteur; 🇫🇷 Paris, France