Renal TransplantationEUTRAIN IMPACTNCT04774575
Non-Invasive Biomarker Strategy Integrating Dd-cfDNA Versus Biopsy-Based Monitoring in Kidney Transplant Recipients
A study testing biomarker-guided strategy in people with Renal Transplantation, run by Assistance Publique - Hôpitaux de Paris at 8 sites in 4 countries.
Trial summary
The investigator hypothesizes that the combined use of 1. non-invasive biomarkers including dd-cfDNA in peripheral blood predicting anti-donor immunological activation or quiescence with 2. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Renal Transplantation
- What is being tested?
- biomarker-guided strategy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 342 participants
- Where
- 8 sitesin 4 countries
- Study dates
- 15 Dec 2021to 28 May 2024
- 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
- All men and women, age ≥18 years old.
- Subject must be a recipient of a single renal transplant from a deceased or living donor.
- Subject is willing and able to provide signed written informed consent and willing to comply with study procedures
- Women of Childbearing Potential (WOCBP) must be using an adequate method of contraception to avoid pregnancy throughout the study in such a manner that the risk of pregnancy is minimized. WOCBP include any female who has experienced menarche and who has not undergone successful surgical sterilization (hysterectomy, bilateral tubal ligation, or bilateral oophorectomy) or is not postmenopausal [defined as amenorrhea ≥ 12 consecutive months; or women on hormone replacement therapy (HRT) with documented serum follicle stimulating hormone (FSH) level > 35 mIU/mL]. WOCBP must have a negative serum or urine pregnancy test (minimum sensitivity 25 IU/L or equivalent units of HCG) within 72 hours prior to the start of clinical trial
Who cannot join
- Patients with active systemic infection that requires the continued use of antibiotics.
- Patients with neoplasia except localized skin cancer receiving appropriate treatment.
- WOCBP who are unwilling or unable to use an acceptable method to avoid pregnancy for the entire study period, women who are pregnant or breastfeeding or women with a positive pregnancy test on enrolment.
- Subjects who are legally detained in an official institution.
- Any condition that, in the opinion of the investigator, might interfere with the patient's participation in the study, poses an added risk for the patient, or confounds the assessment of the patient
- History of multi-organ transplant (interference with rejection natural history).
Trial locations and contacts
8 sites in 4 countries.
8 sites in 4 countries
France3 sites
Nantes Hospital
Nantes, 44000
Saint-Louis Hospital, Paris
Paris, Île-de-France Region, 75010
Necker Hospital, Paris
Paris, Île-de-France Region, 75015
Germany2 sites
Charité-Universitätsmedizin, Berlin
Berlin, 10117
Charité-Universitätsmedizin,
Berlin, 10117
Spain2 sites
Vall d'Hebron Hospital
Barcelona, 08035
Bellvitge University Hospital
Barcelona, 08907
Switzerland1 site
Geneva University Hospitals
Geneva, Canton of Geneva, 1205
About this study
Official title: Randomized Controlled Multicentre Trial to Quantify the Benefits of Biomarkers in Routine Patient Care in Kidney Transplant Recipients" EU-TRAIN IMPACT Trial
The investigator hypothesizes that the combined use of
- non-invasive biomarkers including dd-cfDNA in peripheral blood predicting anti-donor immunological activation or quiescence with
- interactive and actionable data analytics delivered at the bedside will promote safe clinical follow-up of kidney transplant patients with less need for invasive biopsies to assess allograft rejection.
Read more
It is therefore proposed a European, multicenter, prospective randomized trial comparing two strategies of follow-up: in the first, M3 biopsy decision is guided by a non-invasive, integrative dd-cfDNA-based decision support system, in the second one, a routine biopsy is performed at M3.
In both groups, a biopsy is performed at M12 and whenever considered necessary by the clinician
Read the detailed description
The main objective of this study is to demonstrate the ability of combined non-invasive biomarkers including dd-cfDNA to reduce the number of allograft biopsies during the first year after transplantation.
A total of 300 newly transplanted patients will be included in the prospective multicenter EU-TRAIN Impact study across seven clinical transplant sites.
The number of biopsies performed between month-3 and month-12 along with the number of biopsies performed over the entire year post-transplant will be compared between both group of randomization.
A biocollection with centralized storage of samples at CHUN (blood mRNA), ICS (blood cellular assays), Saint-Louis Hospital (blood anti-HLA DSA and non-HLA antibodies), and INSERM (biopsy mRNA and dd-cfDNA) will be assembled.
Patient recruitment will begin on the day of transplantation (day -8 for recipients of living-donor transplants), and data and samples will be collected over the first year following transplantation.
All procedures performed as part of the research are part of usual medical practice (standard of care, SOC), except for six additional blood samples that will be collected and analyzed specifically for research purposes and additional analyses performed specifically for research purposes on half of one of the two biopsy cores obtained from each recipient. Three additional blood samples will also be collected from living donors and analysed specifically for research purposes (sampling time points: any time between 8 days before transplantation and the day of transplantation).
- Conditions
- Renal Transplantation
- Being tested
- biomarker-guided strategy
- Keywords
- renal transplantation, non-invasive biomarkers, dd-cfDNA, risk evaluation, randomized trial
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
biomarker-guided strategyBiological
Patients will follow a biomarker-guided strategy including dd-cfDNA integrating with other biological and clinical parameters (serum creatinine, estimated glomerular filtration rate (eGFR), proteinuria) to inform the decision on performing the M3 biopsy
| Study group | Role | What they receive |
|---|---|---|
| routine group | No intervention | Patients will follow a standard clinical follow-up based on kidney allograft function (serum creatinine, estimated glomerular filtration rate (eGFR), proteinuria) and a surveillance allograft biopsy performed at 3 and 12 months after transplantation (M3 and M12). Visits with biopsies for clinical indication are left to the appreciation of the investigator At M12 a surveillance biopsy is performed. |
| biomarker guided follow-up | Experimental | Patients will follow a biomarker-guided including dd-cfDNA strategy with other biological and clinical parameters to inform the decision on performing the M3 biopsy
Visits with biopsies for clinical indication are left to the appreciation of the investigator
At M12 a surveillance biopsy is performed. Receives: Biological: biomarker-guided strategy |
What is being measured
The primary outcome is the main question the study is designed to answer.
The rate of biopsies
comparison of the rate of biopsies performed during the first year in the Group of biomarkers guided biopsies vs. routine Group ( from M3 to M12 and from transplant to M12)
Measured: up to 12 months
Secondary outcomes (9)
Rate of immunosuppressant treatment modifications
Rate of immunosuppressant treatment modifications in both groups as defined by :
- Conversion from tacrolimus to belatacept while maintaining other immunosuppressive drugs
- Conversion from mycophenolate mofetil to mTOR inhibitor while maintaining other immunosuppressive drugs
- Conversion from mycophenolate mofetil to azathioprine while maintaining other immunosuppressive drugs
- Steroid withdrawal while maintaining other immunosuppressive drugs
Measured: 12month
Rate of complications due to performed biopsies
Rate of complications due to performed biopsies between both groups including : pyelonephritis, hematoma, gross hematuria, blood transfusion, arterial embolization, hospitalization due to biopsy, inadequate biopsy specimen
Measured: 12month
Type of biopsy-proven rejections between both groups
Type of biopsy-proven rejections between both groups at 12 months after transplantation
Measured: 12month
Severity of biopsy-proven rejections between both groups
Severity of biopsy-proven rejections between both groups at 12 months after transplantation
Measured: 12month
Outcome of biopsy-proven rejections between both groups
Outcome of biopsy-proven rejections between both groups at 12 months after transplantation
Measured: 12month
Incidence of death
Incidence of death at 12 months after transplantation
Measured: 12 months
Incidence of allograft loss
Incidence of allograft loss at 12 months after transplantation
Measured: 12 months
Economic impact of implementing biomarkers in European Healthcare systems
Economic impact of implementing biomarkers in European Healthcare systems (cost/benefit) at 12 months after transplantation by quantifiying the reduction in hospitalizations and the break-even price of dd-cfDNA
Measured: up to 12 months
Health-related Quality of life (QoL) of transplant patients after receiving a user-friendly reporting format from the EU-TRAIN report.
Patient-reported health-related quality of life: EQ-5D-5L utility scores (country-specific value sets) and Visual Analogue Scale (VAS)
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Mar 2021
- Study start15 Dec 2021
- Primary completion28 May 2024
- Study completion28 May 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Renal TransplantationStudies of the same condition, open and under way.
- More trials run by Assistance Publique - Hôpitaux de ParisThe 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
- Randomised
- Intervention model
- Parallel groups
- Model description
- This is a 12-month follow-up international, multicenter, prospective, randomized trial, whereby kidney transplant patients will be randomized 1:1 at the time of transplantation in 2 study groups: Group I ("routine group"): Patients will follow a standard clinical follow-up based on kidney allograft function (serum creatinine, estimated glomerular filtration rate (eGFR), proteinuria) with a surveillance allograft biopsies performed at 3 months (M3). Group II ("biomarker guided follow-up"): Patients will follow a biomarker-guided strategy including dd-cfDNA integrating with other biological and clinical parameters (serum creatinine, estimated glomerular filtration rate (eGFR), proteinuria) to inform the decision on performing the M3 biopsy At M12 a routine biopsy is performed. In both groups, a biopsy can be performed up on clinical decision if needed. .
- Masking
- None (open label)
- Enrolment
- 342 participants (actual)
Sponsor and investigators
- Lead sponsor
- Assistance Publique - Hôpitaux de Paris
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Alexandre Loupy, Pr, Study director, APHP
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04774575
- Sponsor's protocol ID
- APHP200984
- Acronym
- EUTRAIN IMPACT
- Status last verified
- Oct 2026
- First submitted
- 24 Feb 2021
- Last updated
- 27 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Controlled Multicentre Trial to Quantify the Benefits of Biomarkers in Routine Patient Care in Kidney Transplant Recipients" EU-TRAIN IMPACT Trial
- ClinicalTrials.gov ID
- NCT04774575
- Acronym / sponsor ID
- EUTRAIN IMPACT / APHP200984
- Conditions
- Renal Transplantation
- Keywords
- renal transplantation, non-invasive biomarkers, dd-cfDNA, risk evaluation, randomized trial
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 342 participants (actual)
- Lead sponsor
- Assistance Publique - Hôpitaux de ParisUniversity, hospital or other
- Study start
- 15 Dec 2021 (actual)
- Primary completion
- 28 May 2024 (actual)
- Study completion
- 28 May 2024 (actual)
- First posted
- 1 Mar 2021 (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 investigator hypothesizes that the combined use of
- non-invasive biomarkers including dd-cfDNA in peripheral blood predicting anti-donor immunological activation or quiescence with
- interactive and actionable data analytics delivered at the bedside will promote safe clinical follow-up of kidney transplant patients with less need for invasive biopsies to assess allograft rejection.
It is therefore proposed a European, multicenter, prospective randomized trial comparing two strategies of follow-up: in the first, M3 biopsy decision is guided by a non-invasive, integrative dd-cfDNA-based decision support system, in the second one, a routine biopsy is performed at M3.
In both groups, a biopsy is performed at M12 and whenever considered necessary by the clinician
Detailed description
The main objective of this study is to demonstrate the ability of combined non-invasive biomarkers including dd-cfDNA to reduce the number of allograft biopsies during the first year after transplantation.
A total of 300 newly transplanted patients will be included in the prospective multicenter EU-TRAIN Impact study across seven clinical transplant sites.
The number of biopsies performed between month-3 and month-12 along with the number of biopsies performed over the entire year post-transplant will be compared between both group of randomization.
A biocollection with centralized storage of samples at CHUN (blood mRNA), ICS (blood cellular assays), Saint-Louis Hospital (blood anti-HLA DSA and non-HLA antibodies), and INSERM (biopsy mRNA and dd-cfDNA) will be assembled.
Patient recruitment will begin on the day of transplantation (day -8 for recipients of living-donor transplants), and data and samples will be collected over the first year following transplantation.
All procedures performed as part of the research are part of usual medical practice (standard of care, SOC), except for six additional blood samples that will be collected and analyzed specifically for research purposes and additional analyses performed specifically for research purposes on half of one of the two biopsy cores obtained from each recipient. Three additional blood samples will also be collected from living donors and analysed specifically for research purposes (sampling time points: any time between 8 days before transplantation and the day of transplantation).
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- This is a 12-month follow-up international, multicenter, prospective, randomized trial, whereby kidney transplant patients will be randomized 1:1 at the time of transplantation in 2 study groups: Group I ("routine group"): Patients will follow a standard clinical follow-up based on kidney allograft function (serum creatinine, estimated glomerular filtration rate (eGFR), proteinuria) with a surveillance allograft biopsies performed at 3 months (M3). Group II ("biomarker guided follow-up"): Patients will follow a biomarker-guided strategy including dd-cfDNA integrating with other biological and clinical parameters (serum creatinine, estimated glomerular filtration rate (eGFR), proteinuria) to inform the decision on performing the M3 biopsy At M12 a routine biopsy is performed. In both groups, a biopsy can be performed up on clinical decision if needed. .
| Arm | Type | Receives |
|---|---|---|
| routine group | No intervention | –Patients will follow a standard clinical follow-up based on kidney allograft function (serum creatinine, estimated glomerular filtration rate (eGFR), proteinuria) and a surveillance allograft biopsy performed at 3 and 12 months after transplantation (M3 and M12). Visits with biopsies for clinical indication are left to the appreciation of the investigator At M12 a surveillance biopsy is performed. |
| biomarker guided follow-up | Experimental | Biological: biomarker-guided strategyPatients will follow a biomarker-guided including dd-cfDNA strategy with other biological and clinical parameters to inform the decision on performing the M3 biopsy Visits with biopsies for clinical indication are left to the appreciation of the investigator At M12 a surveillance biopsy is performed. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- All men and women, age ≥18 years old.
- Subject must be a recipient of a single renal transplant from a deceased or living donor.
- Subject is willing and able to provide signed written informed consent and willing to comply with study procedures
- Women of Childbearing Potential (WOCBP) must be using an adequate method of contraception to avoid pregnancy throughout the study in such a manner that the risk of pregnancy is minimized. WOCBP include any female who has experienced menarche and who has not undergone successful surgical sterilization (hysterectomy, bilateral tubal ligation, or bilateral oophorectomy) or is not postmenopausal [defined as amenorrhea ≥ 12 consecutive months; or women on hormone replacement therapy (HRT) with documented serum follicle stimulating hormone (FSH) level > 35 mIU/mL]. WOCBP must have a negative serum or urine pregnancy test (minimum sensitivity 25 IU/L or equivalent units of HCG) within 72 hours prior to the start of clinical trial
Key exclusion criteria (6 listed)
- Patients with active systemic infection that requires the continued use of antibiotics.
- Patients with neoplasia except localized skin cancer receiving appropriate treatment.
- WOCBP who are unwilling or unable to use an acceptable method to avoid pregnancy for the entire study period, women who are pregnant or breastfeeding or women with a positive pregnancy test on enrolment.
- Subjects who are legally detained in an official institution.
- Any condition that, in the opinion of the investigator, might interfere with the patient's participation in the study, poses an added risk for the patient, or confounds the assessment of the patient
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 |
|---|---|---|
| biomarker-guided strategyPatients will follow a biomarker-guided strategy including dd-cfDNA integrating with other biological and clinical parameters (serum creatinine, estimated glomerular filtration rate (eGFR), proteinuria) to inform the decision on performing the M3 biopsy | Biological | biomarker guided follow-up |
Primary outcome
The rate of biopsies
Time frame: up to 12 months
comparison of the rate of biopsies performed during the first year in the Group of biomarkers guided biopsies vs. routine Group ( from M3 to M12 and from transplant to M12)
9 secondary outcomes
Rate of immunosuppressant treatment modifications
Time frame: 12month
Rate of complications due to performed biopsies
Time frame: 12month
Type of biopsy-proven rejections between both groups
Time frame: 12month
Severity of biopsy-proven rejections between both groups
Time frame: 12month
Outcome of biopsy-proven rejections between both groups
Time frame: 12month
Incidence of death
Time frame: 12 months
Incidence of allograft loss
Time frame: 12 months
Economic impact of implementing biomarkers in European Healthcare systems
Time frame: up to 12 months
Health-related Quality of life (QoL) of transplant patients after receiving a user-friendly reporting format from the EU-TRAIN report.
Time frame: 12 months
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 27 Oct 2026.
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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.
Alexandre Loupy, Pr study director
APHP
8 sites in 4 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing biomarker-guided strategy in people with Renal Transplantation, run by Assistance Publique - Hôpitaux de Paris at 8 sites in 4 countries.
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 4 inclusion and 6 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 27 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 8 sites in France, Germany, Spain, Switzerland. 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?
The rate of biopsies (time frame: up to 12 months). 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 27 Oct 2026.