title: Drug-induced renal injury in neonates: challenges in clinical practice and perspectives in drug development.
abstract: Acute kidney injury (AKI) is frequently diagnosed in the neonatal population, especially in those admitted to intensive care units, and poses several challenges for clinicians mainly because of difficulties in timely identification of renal impairment and the need to administer drugs with potential nephrotoxicity. In this context, research on biomarkers is growing for their implication in the early detection of renal damage and their higher sensitivity in monitoring renal activity, but also as an important tool for drug development. Areas covered: We described the tools currently used to detect renal damage in neonatal settings, their limits and applicability, as well as the role of drugs on renal toxicity occurrence. Subsequently, we discuss current knowledge on new biomarkers for the detection of kidney injury and drug-induced kidney injury in neonates, and the qualification programs developed by regulatory agencies for biomarkers intended as tools in drug development. Expert opinion: Some molecules are emerging as potential biomarkers for early detection of AKI: promising data has demonstrated higher sensitivity and accuracy compared with tools currently used in the clinical setting. In addition, novel techniques (e.g. high power magnetic resonance imaging) to assess long-term consequences of AKI in neonates are in early steps of development.
authors.affiliation: a Department of Medical and Surgical Sciences , University of Bologna , Bologna , Italy.
authors.forename: Anna
authors.initials: A
authors.lastname: Girardi
authors.affiliation: a Department of Medical and Surgical Sciences , University of Bologna , Bologna , Italy.
authors.forename: Emanuel
authors.initials: E
authors.lastname: Raschi
authors.affiliation: a Department of Medical and Surgical Sciences , University of Bologna , Bologna , Italy.
authors.forename: Silvia
authors.initials: S
authors.lastname: Galletti
authors.affiliation: b Intensive Care and Department of Surgery , Erasmus MC Sophia Children's Hospital , Rotterdam , The Netherlands.|c Department of Development and Regeneration , KU Leuven , Leuven , Belgium.
authors.forename: Karel
authors.initials: K
authors.lastname: Allegaert
authors.affiliation: a Department of Medical and Surgical Sciences , University of Bologna , Bologna , Italy.
authors.forename: Elisabetta
authors.initials: E
authors.lastname: Poluzzi
authors.affiliation: a Department of Medical and Surgical Sciences , University of Bologna , Bologna , Italy.
authors.forename: Fabrizio
authors.initials: F
authors.lastname: De Ponti
mesh_terms: D058186:Acute Kidney Injury / Q000139:chemically induced* / Q000175:diagnosis; D000818:Animals; D015415:Biomarkers / Q000378:metabolism; D015195:Drug Design; D006801:Humans; D007231:Infant, Newborn; D007363:Intensive Care Units, Neonatal; D008279:Magnetic Resonance Imaging / Q000379:methods; D012680:Sensitivity and Specificity
chemical_list: D015415:Biomarkers
keywords: Acute kidney injury; biomarkers; drug-induced renal injury; neonates