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Monitoring kidney safety in drug development: emerging technologies and their implications

Frank Dieterle1, Estelle Marrer, Eiko Suzuki

  • 1Novartis Pharma AG, Klybeckstrasse 141, CH-4057 Basel, Switzerland. frank.dieterle@novartis.com

Current Opinion in Drug Discovery & Development
|January 5, 2008
PubMed

Insights

New biomarkers and technologies offer improved early detection of drug-induced kidney injury, aiding timely intervention. Regulatory acceptance is crucial for their clinical use in drug development.

Area of Science:

  • Nephrology
  • Pharmacology
  • Biomarker Discovery

Background:

  • Drug-induced kidney injury (DIKI) is a significant adverse event in drug development.
  • Current kidney function tests (e.g., BUN, serum creatinine) are late indicators, hindering early intervention.
  • Novel biomarkers and sensitive measurement technologies are needed for improved DIKI monitoring.

Purpose of the Study:

  • To review advancements in technologies for monitoring drug-induced nephrotoxicity.
  • To discuss the application and implications of peripheral urinary and serum biomarkers.
  • To explore regulatory pathways for biomarker acceptance in clinical decision-making.

Main Methods:

  • Review of recent technological achievements in DIKI monitoring (gene expression, imaging, in vitro screening, protein assays).
  • Analysis of promising peripheral biomarkers: urinary GST-α, NAG, total protein, cystatin C, β2-microglobulin, KIM-1, lipocalin-2, and serum cystatin C.
  • Examination of regulatory processes for biomarker validation and use.

Main Results:

  • Emerging technologies show promise for sensitive and specific DIKI detection.
  • Several urinary and serum biomarkers (e.g., KIM-1, lipocalin-2) are highlighted for their potential.
  • Regulatory acceptance is a key step for translating biomarker research into clinical practice.

Conclusions:

  • Advanced technologies and novel biomarkers are essential for early DIKI detection and intervention.
  • Biomarker validation and regulatory approval are critical for their adoption in drug development and clinical trials.
  • Integrated approaches combining technology and biomarkers will enhance patient safety.

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