Special symposium on drug-induced kidney injury

IMI, together with the Critical Path Institute and Foundation for the National Institutes for Health held a special symposium at the ERA-EDTA (European Renal Association - European Dialysis and Transplant Association) Congress in Paris, France.

About the session

The special symposium, entitled Drug-induced renal injury: the quest for sensitive biomarkers, took place on Thursday 24 May, the opening day of the Congress, and attracted over 120 participants. The session was chaired by IMI Executive Director Michel Goldman.

Kidney toxicity (nephrotoxicity) is a serious problem for drug development and the tests currently used to detect acute kidney injury are not good enough. This has important consequences for both patient care and the development of safe and innovative drugs. To address this issue, three public-private partnerships (PPPs) have been formed:

• the Drug Induced Kidney Injury (DIKI) working group of the IMI SAFE-T consortium;
• the Predictive Safety Testing Consortium (PSTC) Nephrotoxicity Working Group;
• the Biomarkers Consortium Kidney Safety Project Team.

All three partnerships conduct research to develop new ways of detecting injury in different parts of the kidney in order to enhance decision making in drug development. Clinical studies are being conducted in patients receiving treatments known to cause injuries to the kidney via different mechanisms. The data generated will be submitted to global health authorities for regulatory qualification of new ways of monitoring early onset and reversal of drug-induced kidney injury. During this session, the achievements and ongoing activities of the three partnerships were presented and the complementary scope of their approaches was discussed.

Agenda

Keynote introduction: Why do we need new biomarkers for drug-kidney interaction?
Raymond Vanholder, Ghent, Belgium

Preclinical approaches by the PSTC consortium to support translational drug-induced kidney injury monitoring in drug development
Jonathan Phillips, Boehringer Ingelheim, Ridgefield, US

The Biomarkers Consortium: Prospective clinical trial design to qualify biomarkers for drug development
Irene Nunes, Merck, West Point, US

Acute kidney injury biomarkers in clinical practice: current status
Ralf Schindler, Berlin, Germany

IMI project - SAFE-T: a European consortium approach to renal safety biomarkers
Stefan Sultana, Novartis, UK

Panel Discussion
Moderator: Jean-Marc Vidal, European Medicines Agency, London, UK

About the ERA-EDTA Congress

The annual ERA-EDTA Congress attracts thousands of kidney experts from Europe and beyond. The Scientific Programme covers basic and clinical nephrology, and has a major focus on the potential of translating research results into novel therapies and diagnostic tools. The 2012 edition of the event was held in Paris, France. It is organised by the ERA-EDTA (European Renal Association - European Dialysis and Transplant Association), whose purpose is to encourage and report on advances in the field of clinical nephrology, dialysis, renal transplantation, and related subjects.