title: Design of clinical trials in acute kidney injury: a report from an NIDDK workshop--prevention trials.
abstract: AKI is an important clinical problem that has become increasingly more common. Mortality rates associated with AKI remain high despite advances in supportive care. Patients surviving AKI have increased long-term mortality and appear to be at increased risk of developing CKD and progressing to ESRD. No proven effective pharmacologic therapies are currently available for the prevention or treatment of AKI. Advances in addressing this unmet need will require the development of novel therapeutic agents based on precise understanding of key pathophysiological events and the implementation of well designed clinical trials. To address this need, the National Institute of Diabetes and Digestive and Kidney Diseases sponsored the "Clinical Trials in Acute Kidney Injury: Current Opportunities and Barriers" workshop in December 2010. The event brought together representatives from academia, industry, the National Institutes of Health, and the US Food and Drug Administration. We report the discussions of workgroups that developed outlines of clinical trials for the prevention of AKI in two patient populations: patients undergoing elective surgery who are at risk for or who develop AKI, and patients who are at risk for contrast-induced AKI. In both of these populations, primary prevention or secondary therapy can be delivered at an optimal time relative to kidney injury. The workgroups detailed primary and secondary endpoints for studies in these groups, and explored the use of adaptive clinical trial designs for trials of novel preventive strategies to improve outcomes of patients with AKI.
authors.affiliation: Division of Nephrology, University of Virginia Health System, Charlottesville, VA 22908-0133, USA.
authors.forename: Mark D
authors.initials: MD
authors.lastname: Okusa
authors.forename: Bruce A
authors.initials: BA
authors.lastname: Molitoris
authors.forename: Paul M
authors.initials: PM
authors.lastname: Palevsky
authors.forename: Vernon M
authors.initials: VM
authors.lastname: Chinchilli
authors.forename: Kathleen D
authors.initials: KD
authors.lastname: Liu
authors.forename: Alfred K
authors.initials: AK
authors.lastname: Cheung
authors.forename: Steven D
authors.initials: SD
authors.lastname: Weisbord
authors.forename: Sarah
authors.initials: S
authors.lastname: Faubel
authors.forename: John A
authors.initials: JA
authors.lastname: Kellum
authors.forename: Ron
authors.initials: R
authors.lastname: Wald
authors.forename: Glenn M
authors.initials: GM
authors.lastname: Chertow
authors.forename: Adeera
authors.initials: A
authors.lastname: Levin
authors.forename: Sushrut S
authors.initials: SS
authors.lastname: Waikar
authors.forename: Patrick T
authors.initials: PT
authors.lastname: Murray
authors.forename: Chirag R
authors.initials: CR
authors.lastname: Parikh
authors.forename: Andrew D
authors.initials: AD
authors.lastname: Shaw
authors.forename: Alan S
authors.initials: AS
authors.lastname: Go
authors.forename: Lakhmir S
authors.initials: LS
authors.lastname: Chawla
authors.forename: James S
authors.initials: JS
authors.lastname: Kaufman
authors.forename: Prasad
authors.initials: P
authors.lastname: Devarajan
authors.forename: Robert M
authors.initials: RM
authors.lastname: Toto
authors.forename: Chi-yuan
authors.initials: CY
authors.lastname: Hsu
authors.forename: Tom H
authors.initials: TH
authors.lastname: Greene
authors.forename: Ravindra L
authors.initials: RL
authors.lastname: Mehta
authors.forename: John B
authors.initials: JB
authors.lastname: Stokes
authors.forename: Aliza M
authors.initials: AM
authors.lastname: Thompson
authors.forename: B Taylor
authors.initials: BT
authors.lastname: Thompson
authors.forename: Christof S
authors.initials: CS
authors.lastname: Westenfelder
authors.forename: James A
authors.initials: JA
authors.lastname: Tumlin
authors.forename: David G
authors.initials: DG
authors.lastname: Warnock
authors.forename: Sudhir V
authors.initials: SV
authors.lastname: Shah
authors.forename: Yining
authors.initials: Y
authors.lastname: Xie
authors.forename: Emily G
authors.initials: EG
authors.lastname: Duggan
authors.forename: Paul L
authors.initials: PL
authors.lastname: Kimmel
authors.forename: Robert A
authors.initials: RA
authors.lastname: Star
mesh_terms: D058186:Acute Kidney Injury / Q000517:prevention & control*; D015415:Biomarkers; D002986:Clinical Trials as Topic / Q000379:methods*; D023381:Endpoint Determination; D005240:Feasibility Studies; D006801:Humans; D018579:Patient Selection; D010865:Pilot Projects; D018401:Sample Size; D013223:Statistics as Topic
chemical_list: D015415:Biomarkers