Objectives

The BIOMARGIN consortium has the ambitious but realistic goal to provide transplant clinicians with validated and easily accessible tools for early prediction of graft lesions and renal function deterioration, offering them the possibility to personalize renal transplant patients’ treatment. Indeed, with the development of new immunosuppressive agents, transplant clinicians have multiple therapeutic options and need objective information to choose the most appropriate combination, and/or sequence, for each individual ‘case’ (defined as the current status of an individual patient).

The practical objectives of BIOMARGIN are to :

• Discover, select and validate :
  • blood and/or urine biomarkers, at different omics levels, of renal allograft lesions, with good diagnostic performance as compared to biopsy histological analysis (‘Gold standard’); 
  • mechanism-based classifiers of graft lesions, including intra-graft mRNA or miRNA as well as lipid, peptide and protein localization within the graft, to help histological interpretation of the biopsy; and 
  • early biomarkers of chronic graft dysfunction and ultimately graft loss, less invasive than graft biopsy and with improved predictive values of long-term outcome. 
  • Provide clinicians with tools (analytical techniques, interpretation algorithms, a dedicated website) to obtain such information in a timely manner, and promote these innovations towards scientific societies and patient associations.
  • Set-up a research environment for further biomarker research in transplantation, by providing a database of all biomarker candidates in renal transplantation, either issued from BIOMARGIN or previously discovered by BIOMARGIN partners and other groups, as well as a BIOMARGIN network-biobank of urine and plasma samples from kidney transplant recipients.

The BIOMARGIN consortium, which includes 3 SMEs, will employ an innovative strategy tackling several complementary –omics and mass spectrometry imaging approaches, based on: the practical and smart exploitation of the techniques and biomarker candidates issued from recent research from BIOMARGIN partners or recently published by others; and on a rigorous bench-to-bedside discovery and validation procedure, complying with the highest European ethical and regulatory standards for such clinical studies and later, for the routine use of such diagnostic tools. The biomarker candidates will be selected and integrated using molecular biology, computational biology, statistics and disease progression models.