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Abstract: FR-PO080

Renal Tubular Injury Biomarkers in the Early Detection and Diagnosis of Drug-Induced AKI: IMI/SAFE-T/TransBioLine

Session Information

Category: Pharmacology (PharmacoKinetics, -Dynamics, -Genomics)

  • 2000 Pharmacology (PharmacoKinetics, -Dynamics, -Genomics)


  • Strader, Michael, University College Dublin, Dublin, Ireland
  • Benain, Xavier, Sanofi SA, Paris, Île-de-France, France
  • Sultana, Stefan, AstraZeneca PLC, Cambridge, United Kingdom
  • Camerlingo, Nunzio, Pfizer Inc, New York, New York, United States
  • Murray, Patrick T., University College Dublin, Dublin, Ireland

Drug induced kidney injury (DIKI) is a common adverse outcome in clinical practice and clinical trials. Serum creatinine (Scr) and urine output are “gold” standard biomarkers used to diagnose and stage acute kidney injury (AKI), limited by their sensitivity and delayed detection of measurable change from time of injury. Novel AKI biomarkers with more proximal times to onset are increasingly recognized as clinically useful for earlier detection of AKI.


IMI/SAFE-T analyzed data from 2 different clinical trial cohorts — (i)105 oncology patients (normal baseline eGFR) receiving their 1st dose of IV cisplatin (≥65 mg/ m2/ cycle); (ii) 20 patients with similar cancers treated with non-nephrotoxic agents. Blood and urine samples were collected for all participants. 3 blinded expert nephrologists adjudicated presence or absence of AKI. Biomarkers (adjusted for Ucreat for urine biomarkers) maximum change from baseline accuracy — area under the ROC (AUROC), sensitivity, specificity, and 95% confidence intervals — for Cisplatin treated and AKI cases versus non-treated patients were then estimated for 3 standard biomarkers or 8 novel biomarkers.


Individual novel biomarkers exceeded performance in treated vs non-treated control patients and in AKI-adjudicated vs non-treated control patients. Well performing novel biomarker median time-to-peak value was 1-3 days vs. standard biomarkers (7 days). Combination of biomarkers has also the potential to increase sensitivity and specificity of detecting AKI (exploratory result not shown in abstract).


Multiple individual novel urine biomarkers (uαGST, uKIM1, uOPN) exceeded performance and/or signalled AKI onset prior to individual standard biomarkers (Screat, eGFR, uALB).