BIOMARGIN European, Ambispective Cohort of Adult and Paediatric Renal Transplant Patients
BECS
2 other identifiers
observational
500
3 countries
6
Brief Summary
Biomargin is a European research program aimed at evaluating the diagnostic performance of biomarkers with respect to renal graft injuries, as well as their prognostic performance with respect to 3-year and 5-year graft outcomes. Nucleic acids, proteins and metabolites previously identified as candidate biomarkers of individual kidney graft lesions will be determined systematically in urine and blood samples collected in patients from the time of transplantation onwards, as well as in the graft tissue when biopsies are required for medical causes or performed systematically in the investigation centres. Their diagnostic and prognostic performance will be checked against histological reading of the biopsies and evolution of the graft function over time.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Mar 2015
Longer than P75 for all trials
6 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
March 1, 2015
CompletedFirst Submitted
Initial submission to the registry
November 16, 2015
CompletedFirst Posted
Study publicly available on registry
July 14, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
March 1, 2020
CompletedJuly 14, 2016
July 1, 2016
5 years
November 16, 2015
July 13, 2016
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
predictive value of biomarkers
at 3 years post-transplantation
Secondary Outcomes (4)
predictive value of biomarkers
at 5 years post-transplantation
Number of biopsy-proven acute rejection episodes
at 1, 3 and 5 years post-transplantation
graft survival at 3 and 5 years post-transplantation
at 3 and 5 years post-transplantation
glomerular filtration rate (GFR in ml/min) estimated using the MDRD formula
over up to 5 years post-transplantation
Eligibility Criteria
The eligible patients, 450 adults and 50 pediatrics, will be recruited among the whole list of patients followed for their kidney transplantation in the five investigating centres.
You may qualify if:
- Male or female
- Age between 1 and 17 years inclusive
- Recipient of a kidney allograft in the 24 months prior to enrolment, provided blood and urine samples had been collected between transplantation and enrolment in conditions compatible with those described in this protocol
- Written informed consents of both parents or subject's legally authorized representative prior to any study procedure being performed
- Assent form for the children more than 6 years old
- Male or female
- Age ≥18 years old (no upper age limit)
- Recipient of a kidney allograft in the 24 months prior to enrolment, provided blood and urine samples had been collected between transplantation and enrolment in conditions compatible with those described in this protocol
- Written informed consent prior to any study procedure being performed
You may not qualify if:
- Patients unable to understand the information given by the investigator
- Children less than one year old
- Transplantation of any organ other than the kidney prior or concomitant to the kidney allograft
- Patients returned to dialysis at the time of enrolment
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- University Hospital, Limogeslead
- Hannover Medical Schoolcollaborator
- KU Leuvencollaborator
- Hôpital Necker-Enfants Maladescollaborator
- Hospital Purpancollaborator
Study Sites (6)
University of Leuven - KU Leuven
Leuven, Belgium
University Hospital - INSERM
Limoges, 87 042, France
University Hospital - INSERM
Limoges, 87042, France
Necker Children University Hospital
Paris, France
Purpan Children University Hospital
Toulouse, France
Medizinische Hochschule Hannover (MHH)
Hanover, Germany
Related Publications (3)
Vaulet T, Callemeyn J, Lamarthee B, Antoranz A, Debyser T, Koshy P, Anglicheau D, Colpaert J, Gwinner W, Halloran PF, Kuypers D, Tinel C, Van Craenenbroeck A, Van Loon E, Marquet P, Bosisio F, Naesens M. The Clinical Relevance of the Infiltrating Immune Cell Composition in Kidney Transplant Rejection. J Am Soc Nephrol. 2024 Jul 1;35(7):886-900. doi: 10.1681/ASN.0000000000000350. Epub 2024 Apr 19.
PMID: 38640017DERIVEDTinel C, Lamarthee B, Gazut S, Van Loon E, Von Tokarski F, Benon A, Sauvaget V, Garcia-Paredes V, Menager M, Morin L, Aouni L, Cagnard N, Rabant M, Legendre C, Terzi F, Essig M, Gwinner W, Naesens M, Marquet P, Anglicheau D. Modulation of Monocyte Response by MicroRNA-15b/106a/374a During Antibody-mediated Rejection in Kidney Transplantation. Transplantation. 2023 May 1;107(5):1089-1101. doi: 10.1097/TP.0000000000004393. Epub 2023 Apr 22.
PMID: 36398319DERIVEDVan Loon E, Gazut S, Yazdani S, Lerut E, de Loor H, Coemans M, Noel LH, Thorrez L, Van Lommel L, Schuit F, Sprangers B, Kuypers D, Essig M, Gwinner W, Anglicheau D, Marquet P, Naesens M. Development and validation of a peripheral blood mRNA assay for the assessment of antibody-mediated kidney allograft rejection: A multicentre, prospective study. EBioMedicine. 2019 Aug;46:463-472. doi: 10.1016/j.ebiom.2019.07.028. Epub 2019 Aug 1.
PMID: 31378695DERIVED
Related Links
Biospecimen
Urine, plasma, whole blood, biopsy core (only in adults)
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
November 16, 2015
First Posted
July 14, 2016
Study Start
March 1, 2015
Primary Completion
March 1, 2020
Study Completion
March 1, 2020
Last Updated
July 14, 2016
Record last verified: 2016-07