NCT06976008

CMV-associated Immunomodulation in Renal Transplant Patients

• Status: Not Yet Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 60 (estimated)
• Sponsor: Assistance Publique - Hôpitaux de Paris · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Kidney Transplantation

Interventions

Type	Name	Description
OTHER	blood sampling	Blood samples will be taken at different timepoints following CMV viremia to evaluate the impact of CMV viremia over time.

Timeline

• Start date: 2025-10-01
• Primary completion: 2029-10-01
• Completion: 2029-10-01
• First posted: 2025-05-16
• Last updated: 2025-09-12

Locations

4 sites across 1 country: France