Design of clinical trials in AKI: A report from an NIDDK workshop. Trials of patients with sepsis and in selected hospital settings

Academic Article


  • AKI remains an important clinical problem,with a highmortality rate, increasing incidence, and no Food and Drug Administration-approved therapeutics. Advances in addressing this clinical need require approaches for rapid diagnosis and stratification of injury, development of therapeutic agents based on precise understanding of key pathophysiological events, and implementation of well designed clinical trials. In the near future, AKI biomarkers may facilitate trial design. To address these issues, the National Institute of Diabetes and Digestive and Kidney Diseases sponsored a meeting, "Clinical Trials in Acute Kidney Injury: Current Opportunities and Barriers," in December of 2010 that brought together academic investigators, industry partners, and representatives from the National Institutes ofHealth and the Food andDrug Administration. Important issues in the design of clinical trials for interventions in AKI in patients with sepsis or AKI in the setting of critical illness after surgery or trauma were discussed. The sepsis working group discussed use of severity of illness scores and focus on patients with specific etiologies to enhance homogeneity of trial participants. The group also discussed endpoints congruent with those endpoints used in critical care studies. The second workgroup emphasized difficulties in obtaining consent before admission and collaboration among interdisciplinary healthcare groups. Despite the difficult trial design issues, these clinical situations represent a clinical opportunity because of the high event rates, severity of AKI, and poor outcomes. The groups considered trial design issues and discussed advantages and disadvantages of several shortand long-term primary endpoints in these patients. © 2012 by the American Society of Nephrology.
  • Authors

    Digital Object Identifier (doi)

    Author List

  • Molitoris BA; Okusa MD; Palevsky PM; Chawla LS; Kaufman JS; Devarajan P; Toto RM; Hsu CY; Greene TH; Faubel SG
  • Start Page

  • 856
  • End Page

  • 860
  • Volume

  • 7
  • Issue

  • 5