Pediatric Nephrology

, Volume 28, Issue 2, pp 207–217

Acute kidney injury clinical trial design: old problems, new strategies


DOI: 10.1007/s00467-012-2171-3

Cite this article as:
Endre, Z.H. & Pickering, J.W. Pediatr Nephrol (2013) 28: 207. doi:10.1007/s00467-012-2171-3


Apart from supportive dialysis there are no universally accepted interventions in acute kidney injury (AKI). We have summarized the outcomes of all published randomized, placebo-controlled studies of non-dialysis treatment of AKI. Forty-nine trials were identified, only one of which was in a paediatric population. Sixteen trials had positive outcomes; these trials are not comparable in terms of methodology used or outcomes assessed, and they share many of the problems of the negative trials. We discuss the flaws in clinical trial design that have contributed to poor or uncertain outcomes and propose minimum requirements for future trials. In particular, future trials should incorporate biomarkers specific to the etiology of the AKI, and treatment should match the phase of injury.


BiomarkersAcute kidney injuryPhase-specific renal injuryEarly interventionLate intervention

Copyright information

© IPNA 2012

Authors and Affiliations

  1. 1.Christchurch Kidney Research Group, Department of MedicineUniversity of OtagoChristchurchNew Zealand
  2. 2.Department of Nephrology, Prince of Wales Clinical SchoolUniversity of New South WalesSydneyAustralia
  3. 3.Department of NephrologyPrince of Wales HospitalRandwick, SydneyAustralia