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

Completed

• Conditions: Hemodialysis; Cytomegalovirus Infections; Kidney Transplant Infection; Quantiferon-CMV
• Interventions: Diagnostic Test: Quantiferon CMV

• Registration Number: NCT03916497
• Lead Sponsor: 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.

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 Timeline

• Study First Submitted: 2019-03-18
• Study First Submitted QC: 2019-04-15
• Study First Posted: 2019-04-16
• Study Start: 2019-04-30
• Primary Completion: 2019-07-30
• Study Completion: 2019-07-30
• Status Verified: 2020-09
• Last Update Submitted: 2020-09-03
• Last Update Posted: 2020-09-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 60

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Group 3 : Control patients	Quantiferon CMV	-
Group 2 : hemodialysis patients	Quantiferon CMV	-
Group 1 : kidney transplant recipients (KTR)	Quantiferon CMV	-

Primary Outcome Measures

Name	Time	Method
Quantification of anti-CMV T cellular immunity in kidney transplant recipients, hemodialysis patients and control patients.	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

Name	Time	Method
Quantification of patient cellular immunity.	Single measurement at Day 0 of patient inclusion	Quantification of lymphocytes subpopulations.
Assessment of CMV donor humoral immunity in kidney transplant recipients.	Single collection at Day 0 of patient inclusion	Assessment of donor CMV serology.
Evaluation of kidney transplant recipient exposure to immunosuppressive therapy.	Single collection at Day 0 of patient inclusion	Assessment of last tacrolimus trough concentration.
Estimation of renal function.	Single measurement at Day 0 of patient inclusion	Evaluation of estimated glomerular filtration rate by plasmatic creatinin dosage using CKD-EPI estimate.

Trial Locations

Locations (1)

Chu Grenoble Alpes; 🇫🇷 Grenoble, France