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NCT Number: NCT03916497

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

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.

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Key information

Conditions

Quantiferon-CMV Cytomegalovirus Infections DNA Virus Infections Hemodialysis Herpesviridae Infections Infections Kidney Transplant Infection Virus Diseases

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Chu Grenoble Alpes

Grenoble, 38043, France

About this study

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).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Quantiferon CMV

Diagnostic Test

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 outcomes

  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 outcomes

  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.

Sponsors and collaborators

Lead sponsor

University Hospital, Grenoble

Other

Registry information

Official study 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

Acronym: Quantiferon

Important dates

Study start
2019
Primary completion
2019
Study completion
2019
First posted
Apr 16, 2019
Registry last updated
Sep 4, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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