CMV-associated Immunomodulation in Renal Transplant Patients
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: blood sampling.
- Who it may be relevant to
- Registry conditions: Kidney Transplantation. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- France
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
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
- Other blood sampling
Blood samples will be taken at different timepoints following CMV viremia to evaluate the impact of CMV viremia over time.
Primary outcome measures
- Impact of CMV infection on the heterologous innate immune response in kidney transplant patients [Time frame: 12 months]
Secondary outcome measures (1)
- Impact of CMV infection on the heterologous adaptive immune response in kidney transplant patients [Time frame: 12 months]
Eligibility criteria
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)
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Non-randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Basic science
Study locations
France · 4 centers
- Hôpital Bicêtre — Le Kremlin-Bicêtre
- Hôpital européen Georges Pompidou — Paris
- Hôpital Necker-Enfants Malades — Paris
- Insitut Pasteur — Paris
Identifiers
NCT: NCT06976008 · APHP240837 · ID-RCB Number : 2024-A01039-38