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CMV-associated Immunomodulation in Renal Transplant Patients

ConditionKidney Transplantation
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorAssistance Publique - Hôpitaux de Paris

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Age > 18 years

patients with end-stage renal failure programmed for kidney transplantation with a live donor

Age > 18 years

kidney transplant recipient with CMV viremia

Disqualifiers

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)

Trial design

Design model

Parallel

Treatments tested in this trial

  • blood sampling

    Other intervention

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

Treatment groups

60 Participants
are divided into 2 treatment groups
Group A: Kidney transplant recipients followed since the day of the transplantationExperimental treatment 1 intervention
Group B: kidney transplant recipients with CMV viremiaExperimental treatment 1 intervention

Trial outcomes

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.

Time frame
12 months

Secondary outcomes

1

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

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.

Time frame
12 months

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Assistance Publique - Hôpitaux de Paris

Lead sponsor

URC-CIC Paris Descartes Necker Cochin

Collaborator

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: