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NCT04774575

Quantify the Benefits of Biomarkers in Routine Patient Care in Kidney Transplant Recipients

Sponsor: Assistance Publique - Hôpitaux de Paris

View on ClinicalTrials.gov

Summary

The investigator hypothesize that the combined use of (1) non-invasive biomarkers in peripheral blood predicting anti-donor immunological activation or quiescence (2) interactive and actionable data analytics delivered at the bedside will promote safe clinical follow-up of kidney transplant patients with less need for invasive and induced risk surveillance by allograft protocol biopsies to assess allograft rejection in clinically stable kidney transplant patients. It is therefore proposed an European, multicenter, prospective randomized comparing two strategies of follow-up: in the first, biopsies are guided by biomarkers, 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.

Official title: Randomized Controlled Multicentre Trial to Quantify the Benefits of Biomarkers in Routine Patient Care in Kidney Transplant Recipients" EU-TRAIN IMPACT Trial

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

342

Start Date

2021-12-15

Completion Date

2024-05-28

Last Updated

2026-06-24

Healthy Volunteers

Conditions

Renal Transplantation

Interventions

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

Inclusion Criteria: 1. All men and women, age ≥18 years old. 2. Subject must be a recipient of a single renal transplant from a deceased or living donor. 3. Subject is willing and able to provide signed written informed consent and willing to comply with study procedures 4. 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: 1. Subject with Hepatitis B chronic infection and/or active infection by Hepatitis C virus (positive blood PCR result at the moment of transplant). 2. Subjects with known human immunodeficiency virus (HIV) infection. 3. Patients with active systemic infection that requires the continued use of antibiotics. 4. Patients with neoplasia except localized skin cancer receiving appropriate treatment. 5. 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. 6. Subjects who are legally detained in an official institution. 7. Primary non-function or early graft loss due to mechanical/surgical complications. 8. Death within the first 6 months after transplantation. 9. 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 10. History of multi-organ transplant (interference with rejection natural history).

Locations (8)

Nantes Hospital

Nantes, France

Saint-Louis Hospital, Paris

Paris, Île-de-France Region, France

Necker Hospital, Paris

Paris, Île-de-France Region, France

Charité-Universitätsmedizin, Berlin

Berlin, Germany

Charité-Universitätsmedizin,

Berlin, Germany

Vall d'Hebron Hospital

Barcelona, Spain

Bellvitge University Hospital