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CMV-associated Immunomodulation in Renal Transplant Patients

CMV-associated Immunomodulation in Renal Transplant Patients

Status
Not yet recruiting
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06976008
Acronym
IMMCMV
Enrollment
60
Registered
2025-05-16
Start date
2025-10-01
Completion date
2029-10-01
Last updated
2025-09-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Kidney Transplantation

Keywords

Kidney transplant, Solid organ transplantation, Cytomegalovirus infection, Immunomodulatory effect of cytomegalovirus infection, Heterologous infection

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.

Interventions

OTHERblood sampling

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

Sponsors

URC-CIC Paris Descartes Necker Cochin
CollaboratorOTHER
Assistance Publique - Hôpitaux de Paris
Lead SponsorOTHER

Study design

Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
BASIC_SCIENCE
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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)

Design outcomes

Primary

MeasureTime frameDescription
Impact of CMV infection on the heterologous innate immune response in kidney transplant patients12 monthsComparison 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

MeasureTime frameDescription
Impact of CMV infection on the heterologous adaptive immune response in kidney transplant patients12 monthsComparison 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.

Countries

France

Contacts

Primary ContactAlexandra Serris, MD, PhD
alexandra.serris@aphp.fr0144 381799
Backup ContactHélène Morel
helene.morel@aphp.fr0171196346

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026