• Cell Mediated Immunity With Risk of Cytomegalovirus (CMV) in Solid Organ Transplant Recipients

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  CompletedObservationalUpdated Apr 5, 2013
• Cell Mediated Immunity and the Prediction of CMV Infection In Solid Organ Transplant Recipients

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• Natural History of Cytomegalovirus (CMV) Infection and Disease Among Renal Transplant Recipients

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• Effectiveness of an Immune-guided Cytomegalovirus Infection Preventive Strategy Compared to a Universal Prophylactic Strategy in Renal Transplant Patients

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  RecruitingInterventionalPhase 3Updated Feb 17, 2026
• Proportion of CMV Seropositive Kidney Transplant Recipients Who Will Develop a CMV Infection When Treated With an Immunosuppressive Regimen Including Everolimus and Reduced Dose of Cyclosporine Versus an Immunosuppressive Regimen With Mycophenolic Acid and Standard Dose of Cyclosporine A

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• Assessing the Risk of CMV Infection of the Renal Transplant About R + by Cellular Immunity Analyzed by the QuantiFERON ®-CMV Test.

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ClinicalTrials.gov ID

NCT06976008

Lead Sponsor

Assistance Publique - Hôpitaux de ParisOTHER

Overall Status

Not yet recruiting

Study Type

Interventional

Phase

Not Applicable

Enrollment

60Estimated

Last Update Posted

Sep 12, 2025Actual

Start Date

Oct 1, 2025Estimated

Primary Completion Date

Oct 1, 2029Estimated

Completion Date

Oct 1, 2029Estimated

Official Title

CMV-associated Immunomodulation in Renal Transplant Patients

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.

• Kidney Transplantation

• blood sampling

Ages Eligible for Study

Adult (18-64)Older Adult (65+)

Sexes Eligible for Study

All

Accepts Healthy Volunteers

No

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 Purpose

Basic Science

Allocation

Non-Randomized

Interventional Model

Parallel Assignment

Masking

None (Open Label)

Lead Sponsor

Assistance Publique - Hôpitaux de ParisOTHER

Collaborators

URC-CIC Paris Descartes Necker CochinOTHER

eric.thervet@aphp.fr0156095700 ext. +33

alexandra.serris@aphp.fr+33144381799

alexandra.serris@aphp.fr+33144381799