CMV-associated Immunomodulation in Renal Transplant Patients

NCT ID: NCT06976008

Last Updated: 2025-09-12

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

NA

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-10-01

Study Completion Date

2029-10-01

Brief Summary

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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

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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

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Kidney Transplantation

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

NONE

Study Groups

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Kidney transplant recipients followed since the day of the transplantation

Kidney transplant recipients followed since the day of the transplantation

Group Type EXPERIMENTAL

blood sampling

Intervention Type OTHER

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

kidney transplant recipients with CMV viremia

kidney transplant recipients with CMV viremia

Group Type EXPERIMENTAL

blood sampling

Intervention Type OTHER

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

Interventions

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blood sampling

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

Intervention Type OTHER

Eligibility Criteria

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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)
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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URC-CIC Paris Descartes Necker Cochin

OTHER

Sponsor Role collaborator

Assistance Publique - Hôpitaux de Paris

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Alexandra Serris

Role: PRINCIPAL_INVESTIGATOR

Assistance Publique - Hôpitaux de Paris

Locations

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Hôpital Bicêtre

Le Kremlin-Bicêtre, , France

Site Status

Hôpital européen Georges Pompidou

Paris, , France

Site Status

Hôpital Necker-Enfants Malades

Paris, , France

Site Status

Insitut Pasteur

Paris, , France

Site Status

Countries

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France

Central Contacts

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Alexandra Serris, MD, PhD

Role: CONTACT

0144 381799 ext. +33

Hélène Morel

Role: CONTACT

0171196346 ext. +33

Facility Contacts

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Renaud Snanoudj, MD, PhD

Role: primary

0145212721 ext. +33

Eric Thervet, M.D., PhD

Role: primary

0156095700 ext. +33

Alexandra Serris, MD, PhD

Role: primary

+33144381799

Serris

Role: backup

Alexandra Serris, MD, PhD

Role: primary

+33144381799

Serris

Role: backup

Other Identifiers

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ID-RCB Number : 2024-A01039-38

Identifier Type: OTHER

Identifier Source: secondary_id

APHP240837

Identifier Type: -

Identifier Source: org_study_id

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