Skip to content

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

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03572842
Acronym
QuantiFERON
Enrollment
134
Registered
2018-06-28
Start date
2019-01-24
Completion date
2023-10-11
Last updated
2024-08-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Kidney Transplantation

Brief summary

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.

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.

Interventions

OTHERquantiferon monitor test

different blood test with quantiferon monitor

Sponsors

Centre Hospitalier Universitaire de Nice
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Change of 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-transplantationQuantiFERON Monitor® levels (interferon gamma, UI/mL)

Secondary

MeasureTime frameDescription
Acute cellular and/or antibodies mediated graft rejectionAt day 0 (inclusion), Between Day 7 and Day 21 (before discharge), 3 month post-transplantation, 6 month post-transplantationAcute cellular and/or antibodies mediated graft rejection
InfectionsAt day 0 (inclusion), Between Day 7 and Day 21 (before discharge), 3 month post-transplantation, 6 month post-transplantationoccurence of infections
Lymphocytes sub-populationsAt day 0 (inclusion), Between Day 7 and Day 21 (before discharge), 3 month post-transplantation, 6 month post-transplantationLymphocytes sub-populations

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026