Quantify the Benefits of Biomarkers in Routine Patient Care in Kidney Transplant Recipients (EUTRAIN IMPACT)
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ClinicalTrials.gov Identifier: NCT04774575 |
Recruitment Status :
Active, not recruiting
First Posted : March 1, 2021
Last Update Posted : May 14, 2024
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Condition or disease | Intervention/treatment | Phase |
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Renal Transplantation | Biological: biomarker-guided strategy | Not Applicable |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 300 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Intervention Model Description: | This is a 12-month follow-up multicenter, randomized, biomarker strategy design trial, whereby kidney transplant patients will be randomized 1:1 at the time of transplantation in 2 study groups:
In both groups, a biopsy can be performed up on clinical decision if needed. |
Masking: | None (Open Label) |
Primary Purpose: | Diagnostic |
Official Title: | Randomized Controlled Multicentre Trial to Quantify the Benefits of Biomarkers in Routine Patient Care in Kidney Transplant Recipients" EU-TRAIN IMPACT Trial |
Actual Study Start Date : | December 15, 2021 |
Estimated Primary Completion Date : | May 15, 2024 |
Estimated Study Completion Date : | May 15, 2024 |
Arm | Intervention/treatment |
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No Intervention: routine group
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 biopsies 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
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Experimental: biomarker guided follow-up
Patients will follow a biomarker-guided strategy based on specific non-invasive biomarkers as defined in EUTRAIN-1 study on the basis of its detection and prediction capacities for rejection at M3 to decide whether a biopsy is performed. At M12 a routine biopsy is performed. Visits with biopsies for clinical indication are left to the appreciation of the investigator |
Biological: biomarker-guided strategy
Patients will follow a biomarker-guided strategy based on specific non-invasive biomarkers as defined in EUTRAIN-1 study on the basis of its detection and prediction capacities for rejection at M3 to decide whether a biopsy is performed. At M12 a routine biopsy is performed |
- 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
- Rate of immunosuppressant treatment modifications [ Time Frame: 12month ]Rate of immunosuppressant treatment modifications in both groups.
- Rate of complications due to performed biopsies [ Time Frame: 12month ]Rate of complications due to performed biopsies between both groups
- Type of biopsy-proven rejections between both groups [ Time Frame: 12month ]Type of biopsy-proven rejections between both groups at 12 months after transplantation
- Severity of biopsy-proven rejections between both groups [ Time Frame: 12month ]Severity of biopsy-proven rejections between both groups at 12 months after transplantation
- Outcome of biopsy-proven rejections between both groups [ Time Frame: 12month ]Outcome of biopsy-proven rejections between both groups at 12 months after transplantation
- Incidence of death [ Time Frame: 12 months ]Incidence of death at 12 months after transplantation
- Incidence of allograft loss [ Time Frame: 12 months ]Incidence of allograft loss at 12 months after transplantation
- Economic impact of implementing biomarkers in European Healthcare systems (cost/benefit) [ Time Frame: up to 12 months ]Economic impact of implementing biomarkers in European Healthcare systems (cost/benefit) at 12 months after transplantation
- 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 ]Health-related Quality of life (QoL) of transplant patients after receiving a user-friendly reporting format from the EU-TRAIN report.
- Safety endpoint [ Time Frame: up to 12 months ]Comparison of The mean eGFR in both Groups estimated by glomerular filtration rate (CKD-EPI eGFR) at 12 months' post-transplantation and of the number of allograft rejection.
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- 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
Exclusion Criteria:
- Subject with Hepatitis B chronic infection and/or active infection by Hepatitis C virus (positive blood PCR result at the moment of transplant).
- Subjects with known human immunodeficiency virus (HIV) infection.
- 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.
- Primary non-function or early graft loss due to mechanical/surgical complications.
- Death within the first 6 months after transplantation.
- 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).
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04774575
France | |
Saint-Louis Hospital, Paris | |
Paris, Ile De France, France, 75010 | |
Necker Hospital, Paris | |
Paris, Ile De France, France, 75015 | |
Nantes Hospital | |
Nantes, France, 44000 | |
Germany | |
Charité-Universitätsmedizin, Berlin | |
Berlin, Germany, 10117 | |
Charité-Universitätsmedizin, | |
Berlin, Germany, 10117 | |
Spain | |
Vall d'Hebron Hospital | |
Barcelona, Spain, 08035 | |
Bellvitge University Hospital | |
Barcelona, Spain, 08907 | |
Switzerland | |
Geneva University Hospitals | |
Geneva, Geneve, Switzerland, 1205 |
Study Director: | Alexandre Loupy, Pr | APHP |
Responsible Party: | Assistance Publique - Hôpitaux de Paris |
ClinicalTrials.gov Identifier: | NCT04774575 |
Other Study ID Numbers: |
APHP200984 |
First Posted: | March 1, 2021 Key Record Dates |
Last Update Posted: | May 14, 2024 |
Last Verified: | May 2024 |
Studies a U.S. FDA-regulated Drug Product: | No |
Studies a U.S. FDA-regulated Device Product: | No |
renal transplantation non-invasive biomarkers risk evaluation randomized trial |