Functional Non Specific Immunity Monitoring After Kidney Transplantation Using an Interferon Gamma Test (QuantiFERON)

Functional Non Specific Immunity Monitoring After Kidney Transplantation Using an Interferon Gamma Test, QuantiFERON Monitor®

The best renal replacement therapy is kidney transplantation. It improves end-stage renal kidney disease (ESRD) patients quality of life and increases their survival, but still remains risky. Morbidity in kidney transplantation is dominated by two main complications : acute graft rejection and infections. To maintain an accurate balance between rejection and infection, immunosuppressive therapy must to be used with caution and kept into a tight spectrum.

The investigators dispose of a new test measuring interferon gamma production after T cells and Natural Killers (NK) in vitro stimulation : QuantiFERON Monitor® (QFM). They hypothesized QFM monitoring could improve management after kidney transplantation providing functional immune data to optimize balance between rejection and infection.

The investigators aim to assess whether QFM could be an objective biomarker to predict infection and rejection risks after kidney transplantation.

Study Overview

• Status: Completed
• Conditions: Kidney Transplantation
• Intervention / Treatment: Other: quantiferon monitor test

Detailed Description

The best renal replacement therapy is kidney transplantation. It improves end-stage renal kidney disease (ESRD) patients quality of life and increases their survival, but still remains risky. Morbidity in kidney transplantation is dominated by two main complications : acute graft rejection and infections. According to literature, acute rejection appears in more than 10% of kidney graft recipients. The first month after transplantation is frequently affected by bacterial infections such as pneumopathies (4.5 to 16%), urinary tract infections (22.7 to 56.7 %), surgical site infections (7.3 to 18.5%) and bacteremia (3.5 to 4.6%). Then, during the first year, infections, most of them opportunist ones, are essentially due to cytomegalovirus (8%), BK virus (most than 10%) and herpes simplex reactivation (most than 50%). Those immunosuppressed patients can also develop community acquired infections : respiratory tract infections (flu or bacterial pneumonias) or urinary tract infections. Therefore, long-term anticalcineurin use can lead to chronic graft dysfunction. To maintain an accurate balance between rejection and infection, immunosuppressive therapy must to be used with caution and kept into a tight spectrum. To guide physicians maintaining this balance, therapeutic drug monitoring is performed in routine.

An objective marker for cellular immune response, based on cellular immunodeficiency status specific for each patient could, guide a personalized immunosuppressive treatment. The investigators now dispose of a new test measuring interferon gamma production after T cells and Natural Killers (NK) in vitro stimulation : QuantiFERON Monitor® (QFM). They hypothesized QFM monitoring could improve management after kidney transplantation providing functional immune data to optimize balance between rejection and infection.

The best renal replacement therapy is kidney transplantation. It improves end-stage renal kidney disease (ESRD) patients quality of life and increases their survival, but still remains risky. Morbidity in kidney transplantation is dominated by two main complications : acute graft rejection and infections. According to literature, acute rejection appears in more than 10% of kidney graft recipients. The first month after transplantation is frequently affected by bacterial infections such as pneumopathies (4.5 to 16%), urinary tract infections (22.7 to 56.7 %), surgical site infections (7.3 to 18.5%) and bacteremia (3.5 to 4.6%). Then, during the first year, infections, most of them opportunist ones, are essentially due to cytomegalovirus (8%), BK virus (most than 10%) and herpes simplex reactivation (most than 50%). Those immunosuppressed patients can also develop community acquired infections : respiratory tract infections (flu or bacterial pneumonias) or urinary tract infections. Therefore, long-term anticalcineurin use can lead to chronic graft dysfunction. To maintain an accurate balance between rejection and infection, immunosuppressive therapy must to be used with caution and kept into a tight spectrum. To guide physicians maintaining this balance, therapeutic drug monitoring is performed in routine.

An objective marker for cellular immune response, based on cellular immunodeficiency status specific for each patient could, guide a personalized immunosuppressive treatment. The investigators now dispose of a new test measuring interferon gamma production after T cells and Natural Killers (NK) in vitro stimulation : QuantiFERON Monitor® (QFM). They hypothesized QFM monitoring could improve management after kidney transplantation providing functional immune data to optimize balance between rejection and infection.

They aim to assess whether QFM could be an objective biomarker to predict infection and rejection risks after kidney transplantation.

The investigators plan to perform a monocentric interventional prospective study. They will dose QFM at D0, before patients discharge (between D7 and D21), M3 and M6 after kidney transplantation. Patients will be followed up to 24 months.

Their primary endpoint will be non specific cellular immunity evaluation after kidney transplantation using serial measurements of QFM. Their secondary endpoints will be : (i) correlate QFM levels with infectious risk, (ii) and with graft rejection, (iii) correlate QFM levels with lymphocytes sub-populations monitoring.

The investigators aim to assess whether QFM could be an objective biomarker to predict infection and rejection risks after kidney transplantation.

They plan to perform a monocentric interventional prospective study. They will dose QFM at D0, before patients discharge (between D7 and D21), M3 and M6 after kidney transplantation. Patients will be followed up to 24 months. Their primary endpoint will be non specific cellular immunity evaluation after kidney transplantation using serial measurements of QFM. The investigator's secondary endpoints will be : (i) correlate QFM levels with infectious risk, (ii) and with graft rejection, (iii) correlate QFM levels with lymphocytes sub-populations monitoring.

• Study Type: Interventional
• Enrollment (Actual): 134
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Nice, France, 06000
    • Nephrology Department, Nice University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Kidney transplantation in Nice University Hospital during the inclusion period
• Free and informed consent
• Age > 18 years-old

Exclusion Criteria:

• Current infection
• Vulnerable people (minors, guardianship or curatorship, pregnant women, deprivation of liberty, person who does not speak French)
• Non-affiliated person with Social Security
• Kidney transplantation contraindication Exclusion criterion
• Transplantectomy before sixth month

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: quantiferon monitor; Test measuring interferon gamma production after T cells and Natural Killers (NK) in vitro stimulation : QuantiFERON Monitor® (QFM)	Other: quantiferon monitor test; different blood test with quantiferon monitor

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change of QuantiFERON Monitor® levels (interferon gamma, UI/mL)	QuantiFERON Monitor® levels (interferon gamma, UI/mL)	At day 0 (inclusion), Between Day 7 and Day 21 (before discharge), 3 month post-transplantation, 6 month post-transplantation

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Acute cellular and/or antibodies mediated graft rejection	Acute cellular and/or antibodies mediated graft rejection	At day 0 (inclusion), Between Day 7 and Day 21 (before discharge), 3 month post-transplantation, 6 month post-transplantation
Infections	occurence of infections	At day 0 (inclusion), Between Day 7 and Day 21 (before discharge), 3 month post-transplantation, 6 month post-transplantation
Lymphocytes sub-populations	Lymphocytes sub-populations	At day 0 (inclusion), Between Day 7 and Day 21 (before discharge), 3 month post-transplantation, 6 month post-transplantation

Collaborators and Investigators

• Sponsor: Centre Hospitalier Universitaire de Nice
• Investigators: Study Chair: Barbara SEITZ-POLSKI, Dr, Nephrology Department, Nice University Hospital; Principal Investigator: Marion CREMONI GAUCI, Nephrology Department, Nice University Hospital

Study record dates

Study Major Dates

• Study Start (Actual): January 24, 2019
• Primary Completion (Actual): January 24, 2021
• Study Completion (Actual): October 11, 2023

Study Registration Dates

• First Submitted: May 29, 2018
• First Submitted That Met QC Criteria: June 19, 2018
• First Posted (Actual): June 28, 2018

Study Record Updates

• Last Update Posted (Actual): August 1, 2024
• Last Update Submitted That Met QC Criteria: July 31, 2024
• Last Verified: July 1, 2024

More Information

Terms related to this study

• Other Study ID Numbers: 18-AOI-04

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No