CMV-associated Immunomodulation in Renal Transplant Patients
IMMCMV
2 other identifiers
interventional
60
1 country
4
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Oct 2025
Longer than P75 for not_applicable
4 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
May 9, 2025
CompletedFirst Posted
Study publicly available on registry
May 16, 2025
CompletedStudy Start
First participant enrolled
October 1, 2025
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 1, 2029
ExpectedStudy Completion
Last participant's last visit for all outcomes
October 1, 2029
September 12, 2025
September 1, 2025
4 years
May 9, 2025
September 5, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Impact of CMV infection on the heterologous innate immune response in kidney transplant patients
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.
12 months
Secondary Outcomes (1)
Impact of CMV infection on the heterologous adaptive immune response in kidney transplant patients
12 months
Study Arms (2)
Kidney transplant recipients followed since the day of the transplantation
EXPERIMENTALKidney transplant recipients followed since the day of the transplantation
kidney transplant recipients with CMV viremia
EXPERIMENTALkidney transplant recipients with CMV viremia
Interventions
Blood samples will be taken at different timepoints following CMV viremia to evaluate the impact of CMV viremia over time.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- \- Patients under guardianship, curatorship, legal protection.
- For patients with end-stage renal failure scheduled to receive a kidney transplant from a living donor :
- patients receiving a desensitization protocol (ABO or anti-HLA)
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (4)
Hôpital Bicêtre
Le Kremlin-Bicêtre, 94270, France
Hôpital européen Georges Pompidou
Paris, 75015, France
Hôpital Necker-Enfants Malades
Paris, 75015, France
Insitut Pasteur
Paris, 75015, France
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Alexandra Serris
Assistance Publique - Hôpitaux de Paris
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- BASIC SCIENCE
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 9, 2025
First Posted
May 16, 2025
Study Start
October 1, 2025
Primary Completion (Estimated)
October 1, 2029
Study Completion (Estimated)
October 1, 2029
Last Updated
September 12, 2025
Record last verified: 2025-09
Data Sharing
- IPD Sharing
- Will not share