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NCT Number: NCT06976008

CMV-associated Immunomodulation in Renal Transplant Patients

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Hôpital Bicêtre, Le Kremlin-Bicêtre, France

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Treatment and study plan

Blood sampling

Other

Blood samples will be taken at different timepoints following CMV viremia to evaluate the impact of CMV viremia over time.

Primary outcomes

  1. Impact of CMV infection on the heterologous innate immune response in kidney transplant patients

    Time frame: 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 outcomes

  1. Impact of CMV infection on the heterologous adaptive immune response in kidney transplant patients

    Time frame: 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Alexandra Serris, MD, PhD

CONTACT

[email protected]

0144 381799 ext. +33

Hélène Morel

CONTACT

[email protected]

0171196346 ext. +33

Sponsors and collaborators

Lead sponsor

Assistance Publique - Hôpitaux de Paris

Other

Collaborators

  • URC-CIC Paris Descartes Necker Cochin

Registry information

Acronym: IMMCMV

Important dates

Study start
2025
Primary completion
2029
Study completion
2029
First posted
May 16, 2025
Registry last updated
Sep 12, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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