Kidney TransplantationQuantiFERONNCT03572842
Functional Non Specific Immunity Monitoring After Kidney Transplantation Using an Interferon Gamma Test
A study testing quantiferon monitor test in people with Kidney Transplantation, run by Centre Hospitalier Universitaire de Nice at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Kidney Transplantation
- What is being tested?
- quantiferon monitor test
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 134 participants
- Where
- 1 siteFrance
- Study dates
- 24 Jan 2019to 11 Oct 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Kidney transplantation in Nice University Hospital during the inclusion period
- Free and informed consent
- Age > 18 years-old
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Conditions
- Kidney Transplantation
- Being tested
- quantiferon monitor test
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
quantiferon monitor testOther
different blood test with quantiferon monitor
| Study group | Role | What they receive |
|---|---|---|
| quantiferon monitor | Other | Test measuring interferon gamma production after T cells and Natural Killers (NK) in vitro stimulation : QuantiFERON Monitor® (QFM) Receives: Other: quantiferon monitor test |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change of QuantiFERON Monitor® levels (interferon gamma, UI/mL)
QuantiFERON Monitor® levels (interferon gamma, UI/mL)
Measured: At day 0 (inclusion), Between Day 7 and Day 21 (before discharge), 3 month post-transplantation, 6 month post-transplantation
Secondary outcomes (3)
Acute cellular and/or antibodies mediated graft rejection
Acute cellular and/or antibodies mediated graft rejection
Measured: At day 0 (inclusion), Between Day 7 and Day 21 (before discharge), 3 month post-transplantation, 6 month post-transplantation
Infections
occurence of infections
Measured: 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
Measured: At day 0 (inclusion), Between Day 7 and Day 21 (before discharge), 3 month post-transplantation, 6 month post-transplantation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jun 2018
- Study start24 Jan 2019
- Primary completion24 Jan 2021
- Study completion11 Oct 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Kidney TransplantationStudies of the same condition, open and under way.
- More trials run by Centre Hospitalier Universitaire de NiceThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 134 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire de Nice
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Barbara SEITZ-POLSKI, Dr, Study chair, Nephrology Department, Nice University HospitalMarion CREMONI GAUCI, Principal investigator, Nephrology Department, Nice University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03572842
- Sponsor's protocol ID
- 18-AOI-04
- Acronym
- QuantiFERON
- Status last verified
- Jul 2024
- First submitted
- 29 May 2018
- Last updated
- 1 Aug 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Functional Non Specific Immunity Monitoring After Kidney Transplantation Using an Interferon Gamma Test, QuantiFERON Monitor®
- ClinicalTrials.gov ID
- NCT03572842
- Acronym / sponsor ID
- QuantiFERON / 18-AOI-04
- Conditions
- Kidney Transplantation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 134 participants (actual)
- Lead sponsor
- Centre Hospitalier Universitaire de NiceUniversity, hospital or other
- Study start
- 24 Jan 2019 (actual)
- Primary completion
- 24 Jan 2021 (actual)
- Study completion
- 11 Oct 2023 (actual)
- First posted
- 28 Jun 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| quantiferon monitor | Other | Other: quantiferon monitor testTest measuring interferon gamma production after T cells and Natural Killers (NK) in vitro stimulation : QuantiFERON Monitor® (QFM) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Kidney transplantation in Nice University Hospital during the inclusion period
- Free and informed consent
- Age > 18 years-old
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| quantiferon monitor testdifferent blood test with quantiferon monitor | Other | quantiferon monitor |
Primary outcome
Change of QuantiFERON Monitor® levels (interferon gamma, UI/mL)
Time frame: At day 0 (inclusion), Between Day 7 and Day 21 (before discharge), 3 month post-transplantation, 6 month post-transplantation
QuantiFERON Monitor® levels (interferon gamma, UI/mL)
3 secondary outcomes
Acute cellular and/or antibodies mediated graft rejection
Time frame: At day 0 (inclusion), Between Day 7 and Day 21 (before discharge), 3 month post-transplantation, 6 month post-transplantation
Infections
Time frame: At day 0 (inclusion), Between Day 7 and Day 21 (before discharge), 3 month post-transplantation, 6 month post-transplantation
Lymphocytes sub-populations
Time frame: At day 0 (inclusion), Between Day 7 and Day 21 (before discharge), 3 month post-transplantation, 6 month post-transplantation
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Aug 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Barbara SEITZ-POLSKI, Dr study chair
Nephrology Department, Nice University Hospital
Marion CREMONI GAUCI principal investigator
Nephrology Department, Nice University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing quantiferon monitor test in people with Kidney Transplantation, run by Centre Hospitalier Universitaire de Nice at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 1 Aug 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change of QuantiFERON Monitor® levels (interferon gamma, UI/mL) (time frame: At day 0 (inclusion), Between Day 7 and Day 21 (before discharge), 3 month post-transplantation, 6 month post-transplantation). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Aug 2024.