14/12/2016

The European Medicines Agency (EDMA) reviewed it's 2014 advice about novel biomarkers to assess Drug-induced Kidney Injury and issued a Letter of Support to the SAFE-T Consortium and Critical Path Institute’s (C-Path) Predictive Safety Testing Consortium (PSTC) to encourage the further development and exploratory use of urinary alpha-glutathione S-transferase (α-GST), urinary clusterin (CLU), urinary cystatin C (CysC), urinary Kidney Injury Molecule-1 (KIM-1), urinary neutrophil gelatinase-associated lipocalin (NGAL), urinary osteopontin (OPN), urinary albumin (ALB) and urinary total protein (TPRO), as well as serum cystatin C, as biomarkers of drug-induced renal tubular injury in early clinical trials.

The Letter states taht current clinical monitoring for nephrotoxicity with serum creatinine (sCr) lacks adequate sensitivity for early detection of clinically relevant kidney injury. Unlike sCr, which is a marker of function, urinary α-GST, CLU, CysC, KIM-1, NGAL, and OPN are thought to be markers of cellular injury and/or stress in the kidney. Because these biomarkers are localised in different regions of the nephron, the panel is expected to respond to a diversity of nephrotoxicants. It is anticipated that the candidate biomarkers will have the most utility when combined with traditional biomarkers.

A copy of the full Statement is attached, (© European Medicines Agency, 2017)