AzTrials
AzTrials

Kidney TransplantationBECSNCT02832661

BIOMARGIN European, Ambispective Cohort of Adult and Paediatric Renal Transplant Patients

An observational study of Kidney Transplantation, run by University Hospital, Limoges at 6 sites in 3 countries.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
Search all trials

Trial 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. Read more about this study

Who is it for?
Ages 1 year and older
Conditions the study is for
Kidney Transplantation
How many people
500 participants
Where
6 sitesin 3 countries
Study dates
Mar 2015to Mar 2020
Phase
Observational
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 1 year and older
  • All sexes
  • No healthy volunteers
  • Child, Adult, Older adult

Study population: 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.

Who may be able to join

  • 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
Show all 9Show fewer
  • 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

Who cannot join

  • 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

Trial locations and contacts

6 sites in 3 countries.

Pierre MARQUET, MD, PhD contact

+33 555 05 61 07

pierre.marquet@unilim.fr

6 sites in 3 countries

France4 sites, 4 recruiting

  • University Hospital - INSERM

    Limoges, 87 042

    Pierre MARQUET, MD, PhD, 05 55 05 60 17, pierre.marquet@unilim.fr

    Recruiting

  • University Hospital - INSERM

    Limoges, 87042

    Marie ESSIG

    Recruiting

  • Necker Children University Hospital

    Paris

    Dany ANGLICHEAU

    Recruiting

  • Purpan Children University Hospital

    Toulouse

    Stéphane DECRAMER

    Recruiting

Other trials in France

Belgium1 site, 1 recruiting

  • University of Leuven - KU Leuven

    Leuven

    Maarten NAESSENS

    Recruiting

Other trials in Belgium

Germany1 site, 1 recruiting

  • Medizinische Hochschule Hannover (MHH)

    Hanover

    Wilfried GWINNER

    Recruiting

Other trials in Germany

About this study

Official title: BIOMARGIN European, Ambispective Cohort of Adult and Paediatric Renal Transplant Patients for the Evaluation of the Diagnostic and Prognostic Performance of Biomarkers of Renal Graft Injuries

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.

Read the detailed description

Background: In renal allograft recipients, 10-year graft survival has not much improved over the past decades. There is thus a need for robust, non-invasive methods to predict and diagnose acute and chronic graft lesions, to improve patient treatment, quality of life and long-term graft survival. Also, there is an unmet need for better understanding of the immune and non-immune mechanisms of interstitial fibrosis /tubular atrophy and graft loss. Several teams have searched for biomarkers of renal graft lesions, but there has been no cross-fecundation of the different "omics" approaches, nor any consolidation of the different clusters of biomarkers discovered using different technologies. An analysis of these different omics levels based on the principles of systems biology is therefore necessary to gain insight into the disease mechanisms and will help to develop predictors at the individual level. Purpose: The European project BIOMARGIN aims to discover, select and validate blood and/or urine biomarkers of renal allograft lesions in adult and paediatric kidney transplant recipients by integrating several omics approaches (mRNA, miRNA, peptides, proteins, lipids and metabolites) in blood, graft tissue and urine. The European cohort study BECS aims to evaluate the diagnostic and prognostic performance of the selected biomarkers over the first 3 and 5 years post-transplantation. Study design: This is a multicenter, international, ambispective, open and non-interventional cohort study, with collection of biological samples. Number of subjects: 450 adult and 50 paediatric renal transplant recipients. Outcomes: The primary endpoint is the graft outcome, assessed at three years as any lesion appeared on graft biopsies after patient enrolment, decline in graft function ≥ 30%, graft loss or patient death. Secondary endpoints include: histological findings in indication biopsies as well as in systematic biopsies (as per centre procedures) at 5 years; cumulated acute rejection episodes; 3-year and 5-year graft survival; and change of renal function assessed by the glomerular filtration rate (GFR) estimated using the MDRD formula. Statistical analysis: The sensitivity, specificity, positive and negative predictive values of the different biomarkers or sets of biomarkers will be evaluated for each of the primary and secondary endpoints. In order to compare the performance of the biomarkers with those of the other known risk factors for the deterioration of renal graft function, longitudinal statistical modelling will be used.

Keywords
renal allograft, graft injuries, biopsy, biomarkers, omics approach

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. predictive value of biomarkers

    Measured: at 3 years post-transplantation

Secondary outcomes (4)

  1. predictive value of biomarkers

    Measured: at 5 years post-transplantation

  2. Number of biopsy-proven acute rejection episodes

    Measured: at 1, 3 and 5 years post-transplantation

  3. graft survival at 3 and 5 years post-transplantation

    Measured: at 3 and 5 years post-transplantation

  4. glomerular filtration rate (GFR in ml/min) estimated using the MDRD formula

    Measured: over up to 5 years post-transplantation

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted14 Jul 2016 (estimated)
  2. Study startMar 2015
  3. Primary completionMar 2020 (estimated)
  4. Study completionMar 2020 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Enrolment
500 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02832661
Sponsor's protocol ID
I15038
Other IDs
grant agreement no: 305499
Acronym
BECS
Status last verified
Jul 2016
First submitted
16 Nov 2015
Last updated
14 Jul 2016
Results posted
No
Data monitoring committee
No

Publications

  • 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.

    PubMed 38640017

  • Tinel 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.

    PubMed 36398319

  • Van 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.

    PubMed 31378695

Questions about this trial

What is this clinical trial studying?

An observational study of Kidney Transplantation, run by University Hospital, Limoges at 6 sites in 3 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 9 inclusion and 4 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: status not confirmed, as of the sponsor's last update on 14 Jul 2016. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 6 sites in France, Belgium, Germany. 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?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Pierre MARQUET, MD, PhD (+33 555 05 61 07, pierre.marquet@unilim.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

predictive value of biomarkers (time frame: at 3 years post-transplantation). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02832661, which also lists 3 linked publications.

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 14 Jul 2016.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in