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Anti-CMV Cellular Immunity Quantification Using an IGRA Test in Kidney Transplant récipients and Hemodialysis Patients, Comparison to Control Patients (Quantiferon)

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ClinicalTrials.gov Identifier: NCT03916497
Recruitment Status : Completed
First Posted : April 16, 2019
Last Update Posted : September 4, 2020
Sponsor:
Information provided by (Responsible Party):
University Hospital, Grenoble

Brief Summary:
Evaluation of anti-CMV T cellular immunity using an IGRA test (Quantiferon-CMV test) in kidney transplant recipients and hemodialysis patients, comparison to control patients.

Condition or disease Intervention/treatment
Quantiferon-CMV Cytomegalovirus Infections Kidney Transplant Infection Hemodialysis Diagnostic Test: Quantiferon CMV

Detailed Description:

Cytomegalovirus (CMV) infection is a common opportunistic complication after kidney transplantation (KT). It has been associated with high morbidity and mortality in kidney transplant recipients (KTR). Its actual management is only based on the humoral immunity : the main risk factor for CMV infection after KT is the association of a seropositive donor and a seronegative recipient (so-called "D+/R- mismatch").

However several studies have highlighted the essential role of cellular immunity to control CMV infection. The Quantiferon-CMV (QF-CMV) is an IGRA test (Interferon Gamma Releasing Assay) which evaluates T CD8 lymphocytes production of Interferon Gamma (IFNy) exposed to CMV antigens. Some studies have shown the possible interest of the QF-CMV in predicting CMV infection after antiviral prophylaxis discontinuation or when CMV viremia is detected.

However some limits have been underlined. First its positivity threshold hasn't been approved in KTR. Hemodialysis patients (HP) called to receive a renal allograft also suffered from altered immunity. No study has directly compared the QF-CMV value in KTR, HP and control patients.

That's why we propose evaluating the expression of basal cellular immunity against CMV (far from any active infection) in KTR and HP using the QF-CMV and comparing it to control patients population (not suffering from kidney dysfunction or immunosuppression).

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Study Type : Observational
Actual Enrollment : 60 participants
Observational Model: Cohort
Time Perspective: Cross-Sectional
Official Title: Quantification de l'immunité T Anti-CMV à l'Aide d'un Test IGRA Chez Des Patients greffés rénaux et Des Patients dialysés, Comparaison Avec Une Population de témoins
Actual Study Start Date : April 30, 2019
Actual Primary Completion Date : July 30, 2019
Actual Study Completion Date : July 30, 2019

Resource links provided by the National Library of Medicine


Group/Cohort Intervention/treatment
Group 1 : kidney transplant recipients (KTR) Diagnostic Test: Quantiferon CMV
Evaluate and compare interferon gamma (IFNy) production by T CD8 cells exposed to CMV antigens in CMV seropositive kidney transplant recipients, hemodialysis and control patients

Group 2 : hemodialysis patients Diagnostic Test: Quantiferon CMV
Evaluate and compare interferon gamma (IFNy) production by T CD8 cells exposed to CMV antigens in CMV seropositive kidney transplant recipients, hemodialysis and control patients

Group 3 : Control patients Diagnostic Test: Quantiferon CMV
Evaluate and compare interferon gamma (IFNy) production by T CD8 cells exposed to CMV antigens in CMV seropositive kidney transplant recipients, hemodialysis and control patients




Primary Outcome Measures :
  1. Quantification of anti-CMV T cellular immunity in kidney transplant recipients, hemodialysis patients and control patients. [ Time Frame: Single measurement at Day 0 of patient inclusion ]
    Quantification of IFNy level producted by T cells exposed to CMV antigens using a Quantiferon-CMV test in kidney transplant recipients, hemodialysis patients and control patients.


Secondary Outcome Measures :
  1. Quantification of patient cellular immunity. [ Time Frame: Single measurement at Day 0 of patient inclusion ]
    Quantification of lymphocytes subpopulations.

  2. Evaluation of kidney transplant recipient exposure to immunosuppressive therapy. [ Time Frame: Single collection at Day 0 of patient inclusion ]
    Assessment of last tacrolimus trough concentration.

  3. Estimation of renal function. [ Time Frame: Single measurement at Day 0 of patient inclusion ]
    Evaluation of estimated glomerular filtration rate by plasmatic creatinin dosage using CKD-EPI estimate.

  4. Assessment of CMV donor humoral immunity in kidney transplant recipients. [ Time Frame: Single collection at Day 0 of patient inclusion ]
    Assessment of donor CMV serology.



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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Kidney transplant recipients will be recruited among KTR followed in the Kidney transplant department of Grenoble University Hospital.

Hemodialysis patients will be recruited among hemodialysis patients on the waiting list for a kidney transplant in the Kidney transplant department of Grenoble University Hospital.

Control patients will be recruited among non-hemodialysis and non-kidney transplanted patients followed in the Grenoble University Hospital.

Criteria

Inclusion Criteria :

  • For all patients :

    • to be seropositive for CMV
    • to not be opposed to the study
  • For kidney transplant recipients :

    • to have received a kidney graft for over 1 year
    • to have received an induction therapy at transplantation time by anti-lymphocytes antibodies and steroids
    • to be currently receiving immunosuppressive therapy by calcineurins inhibitors (tacrolimus or cyclosporine), mycophenolic acid with or without steroids
    • to not suffer from another cause of immunosuppression
  • For hemodialysis patients :

    • to be treated by hemodialysis for end stage renal disease
    • without prior solid organ transplant history
    • to not suffer from another cause of immunosuppression
  • For control patients :

    • with normal kidney function (estimated GFR > 90 ml/min)
    • to not suffer from another cause of immunosuppression

Exclusion Criteria :

  • patient under guardianship or deprived of his liberty

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03916497


Locations
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France
Chu Grenoble Alpes
Grenoble, France, 38043
Sponsors and Collaborators
University Hospital, Grenoble
Investigators
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Principal Investigator: Lionel Rostaing Centre Hospitalier Universitaire Grenoble-Alpes
Publications:

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Responsible Party: University Hospital, Grenoble
ClinicalTrials.gov Identifier: NCT03916497    
Other Study ID Numbers: 38RC19.002
2019-A00101-56 ( Other Identifier: ID RCB )
First Posted: April 16, 2019    Key Record Dates
Last Update Posted: September 4, 2020
Last Verified: September 2020

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Infection
Communicable Diseases
Cytomegalovirus Infections
Herpesviridae Infections
DNA Virus Infections
Virus Diseases