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

September 3, 2020 updated by: University Hospital, Grenoble

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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).

Study Type

Observational

Enrollment (Actual)

60

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Grenoble, France, 38043
        • CHU Grenoble Alpes

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years to 78 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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.

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Cross-Sectional

Cohorts and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Single measurement at Day 0 of patient inclusion

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Quantification of patient cellular immunity.
Time Frame: Single measurement at Day 0 of patient inclusion
Quantification of lymphocytes subpopulations.
Single measurement at Day 0 of patient inclusion
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.
Single collection at Day 0 of patient inclusion
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.
Single measurement at Day 0 of patient inclusion
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.
Single collection at Day 0 of patient inclusion

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital, Grenoble

Investigators

  • Principal Investigator: Lionel Rostaing, Centre Hospitalier Universitaire Grenoble-Alpes

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 30, 2019

Primary Completion (Actual)

July 30, 2019

Study Completion (Actual)

July 30, 2019

Study Registration Dates

First Submitted

March 18, 2019

First Submitted That Met QC Criteria

April 15, 2019

First Posted (Actual)

April 16, 2019

Study Record Updates

Last Update Posted (Actual)

September 4, 2020

Last Update Submitted That Met QC Criteria

September 3, 2020

Last Verified

September 1, 2020

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 38RC19.002
  • 2019-A00101-56 (Other Identifier: ID RCB)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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