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

July 13, 2016 updated by: University Hospital, Limoges

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.

Study Overview

Status

Unknown

Conditions

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.

Study Type

Observational

Enrollment (Anticipated)

500

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Belgium
      • Leuven, Belgium
        • Recruiting
        • University of Leuven - KU Leuven
        • Contact:
          • Maarten NAESSENS
  • France
      • Limoges, France, 87 042
        • Recruiting
        • University Hospital - INSERM
        • Contact:
      • Limoges, France, 87042
        • Recruiting
        • University Hospital - INSERM
        • Contact:
          • Marie ESSIG
      • Paris, France
        • Recruiting
        • Necker Children University Hospital
        • Contact:
          • Dany ANGLICHEAU
      • Toulouse, France
        • Recruiting
        • Purpan Children University Hospital
        • Contact:
          • Stéphane DECRAMER
  • Germany
      • Hannover, Germany
        • Recruiting
        • Medizinische Hochschule Hannover (MHH)
        • Contact:
          • Wilfried GWINNER

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

1 year and older (ADULT, OLDER_ADULT, CHILD)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

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.

Description

Inclusion Criteria for paediatric patients :

  • 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

Inclusion Criteria for adult patients:

  • 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

Exclusion Criteria:

  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
predictive value of biomarkers
Time Frame: at 3 years post-transplantation
at 3 years post-transplantation

Secondary Outcome Measures

Outcome Measure
Time Frame
predictive value of biomarkers
Time Frame: at 5 years post-transplantation
at 5 years post-transplantation
Number of biopsy-proven acute rejection episodes
Time Frame: at 1, 3 and 5 years post-transplantation
at 1, 3 and 5 years post-transplantation
graft survival at 3 and 5 years post-transplantation
Time Frame: 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
Time Frame: over up to 5 years post-transplantation
over up to 5 years post-transplantation

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital, Limoges

Collaborators

Hannover Medical School
KU Leuven
Hospital Purpan
Hôpital Necker-Enfants Malades

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2015

Primary Completion (ANTICIPATED)

March 1, 2020

Study Completion (ANTICIPATED)

March 1, 2020

Study Registration Dates

First Submitted

November 16, 2015

First Submitted That Met QC Criteria

July 13, 2016

First Posted (ESTIMATE)

July 14, 2016

Study Record Updates

Last Update Posted (ESTIMATE)

July 14, 2016

Last Update Submitted That Met QC Criteria

July 13, 2016

Last Verified

July 1, 2016

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • I15038
  • grant agreement no: 305499 (OTHER_GRANT: European Community's Seventh Framework Programme (FP7))

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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