Design of clinical trials in acute kidney injury

A report from an NIDDK workshop-prevention trials

Mark D. Okusa, Bruce Molitoris, Paul M. Palevsky, Vernon M. Chinchilli, Kathleen D. Liu, Alfred K. Cheung, Steven D. Weisbord, Sarah Faubel, John A. Kellum, Ron Wald, Glenn M. Chertow, Adeera Levin, Sushrut S. Waikar, Patrick T. Murray, Chirag R. Parikh, Andrew D. Shaw, Alan S. Go, Lakhmir S. Chawla, James S. Kaufman, Prasad Devarajan & 15 others Robert M. Toto, Chi Yuan Hsu, Tom H. Greene, Ravindra L. Mehta, John B. Stokes, Aliza M. Thompson, B. Taylor Thompson, Christof S. Westenfelder, James A. Tumlin, David G. Warnock, Sudhir V. Shah, Yining Xie, Emily G. Duggan, Paul L. Kimmel, Robert A. Star

Research output: Contribution to journalArticle

31 Citations (Scopus)

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.

Original languageEnglish (US)
Pages (from-to)851-855
Number of pages5
JournalClinical Journal of the American Society of Nephrology
Volume7
Issue number5
DOIs
StatePublished - May 1 2012
Externally publishedYes

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National Institute of Diabetes and Digestive and Kidney Diseases (U.S.)
Acute Kidney Injury
Clinical Trials
Education
Mortality
National Institutes of Health (U.S.)
United States Food and Drug Administration
Primary Prevention
Therapeutics
Population
Chronic Kidney Failure
Industry
Kidney
Wounds and Injuries

ASJC Scopus subject areas

  • Nephrology
  • Transplantation
  • Epidemiology
  • Critical Care and Intensive Care Medicine

Cite this

Design of clinical trials in acute kidney injury : A report from an NIDDK workshop-prevention trials. / Okusa, Mark D.; Molitoris, Bruce; Palevsky, Paul M.; Chinchilli, Vernon M.; Liu, Kathleen D.; Cheung, Alfred K.; Weisbord, Steven D.; Faubel, Sarah; Kellum, John A.; Wald, Ron; Chertow, Glenn M.; Levin, Adeera; Waikar, Sushrut S.; Murray, Patrick T.; Parikh, Chirag R.; Shaw, Andrew D.; Go, Alan S.; Chawla, Lakhmir S.; Kaufman, James S.; Devarajan, Prasad; Toto, Robert M.; Hsu, Chi Yuan; Greene, Tom H.; Mehta, Ravindra L.; Stokes, John B.; Thompson, Aliza M.; Taylor Thompson, B.; Westenfelder, Christof S.; Tumlin, James A.; Warnock, David G.; Shah, Sudhir V.; Xie, Yining; Duggan, Emily G.; Kimmel, Paul L.; Star, Robert A.

In: Clinical Journal of the American Society of Nephrology, Vol. 7, No. 5, 01.05.2012, p. 851-855.

Research output: Contribution to journalArticle

Okusa, MD, Molitoris, B, Palevsky, PM, Chinchilli, VM, Liu, KD, Cheung, AK, Weisbord, SD, Faubel, S, Kellum, JA, Wald, R, Chertow, GM, Levin, A, Waikar, SS, Murray, PT, Parikh, CR, Shaw, AD, Go, AS, Chawla, LS, Kaufman, JS, Devarajan, P, Toto, RM, Hsu, CY, Greene, TH, Mehta, RL, Stokes, JB, Thompson, AM, Taylor Thompson, B, Westenfelder, CS, Tumlin, JA, Warnock, DG, Shah, SV, Xie, Y, Duggan, EG, Kimmel, PL & Star, RA 2012, 'Design of clinical trials in acute kidney injury: A report from an NIDDK workshop-prevention trials', Clinical Journal of the American Society of Nephrology, vol. 7, no. 5, pp. 851-855. https://doi.org/10.2215/cjn.12811211
Okusa, Mark D. ; Molitoris, Bruce ; Palevsky, Paul M. ; Chinchilli, Vernon M. ; Liu, Kathleen D. ; Cheung, Alfred K. ; Weisbord, Steven D. ; Faubel, Sarah ; Kellum, John A. ; Wald, Ron ; Chertow, Glenn M. ; Levin, Adeera ; Waikar, Sushrut S. ; Murray, Patrick T. ; Parikh, Chirag R. ; Shaw, Andrew D. ; Go, Alan S. ; Chawla, Lakhmir S. ; Kaufman, James S. ; Devarajan, Prasad ; Toto, Robert M. ; Hsu, Chi Yuan ; Greene, Tom H. ; Mehta, Ravindra L. ; Stokes, John B. ; Thompson, Aliza M. ; Taylor Thompson, B. ; Westenfelder, Christof S. ; Tumlin, James A. ; Warnock, David G. ; Shah, Sudhir V. ; Xie, Yining ; Duggan, Emily G. ; Kimmel, Paul L. ; Star, Robert A. / Design of clinical trials in acute kidney injury : A report from an NIDDK workshop-prevention trials. In: Clinical Journal of the American Society of Nephrology. 2012 ; Vol. 7, No. 5. pp. 851-855.
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