Design of clinical trials in acute kidney injury: Report from an NIDDK workshop on trial methodology

Paul M. Palevsky, Bruce A. Molitoris, Mark D. Okusa, Adeera Levin, Sushrut S. Waikar, Ron Wald, Glenn M. Chertow, Patrick T. Murray, Chirag R. Parikh, Andrew D. Shaw, Alan S. Go, Sarah G. Faubel, John A. Kellum, Vernon M. Chinchilli, Kathleen D. Liu, Alfred K. Cheung, Steven D. Weisbord, Lakhmir S. Chawla, James S. Kaufman, Prasad DevarajanRobert M. Toto, Chi Yuan Hsu, Tom 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

64 Citations (Scopus)

Abstract

Acute kidney injury (AKI) remains a complex clinical problem associated with significant short-term morbidity and mortality and lacking effective pharmacologic interventions. Patients with AKI experience longer-term risks for progressive chronic ESRD, which diminish patients' health-related quality of life and create a larger burden on the healthcare system. Although experimental models have yielded numerous promising agents, translation into clinical practice has been unsuccessful, possibly because of issues in clinical trial design, such as delayed drug administration,masking of therapeutic benefit by adverse events, and inadequate sample size. To address issues of clinical trial design, the National Institute of Diabetes and Digestive and Kidney Diseases sponsored a workshop titled "Clinical Trials in Acute Kidney Injury: Current Opportunities and Barriers" in December 2010. Workshop participants included representatives fromacademia, industry, and government agencies whose areas of expertise spanned basic science, clinical nephrology, critical care medicine, biostatistics, pharmacology, and drug development. This document summarizes the discussions of collaborative workgroups that addressed issues related to patient selection, study endpoints, the role of novel biomarkers, sample size and power calculations, and adverse events and pilot/feasibility studies in prevention and treatment of AKI. Companion articles outline the discussions of workgroups for model trials related to prevention or treatment of established AKI in different clinical settings, such as in patients with sepsis.

Original languageEnglish (US)
Pages (from-to)844-850
Number of pages7
JournalClinical Journal of the American Society of Nephrology
Volume7
Issue number5
DOIs
StatePublished - May 1 2012

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National Institute of Diabetes and Digestive and Kidney Diseases (U.S.)
Acute Kidney Injury
Clinical Trials
Education
Sample Size
Biostatistics
Government Agencies
Nephrology
Feasibility Studies
Critical Care
Pharmaceutical Preparations
Patient Selection
Chronic Kidney Failure
Sepsis
Industry
Theoretical Models
Therapeutics
Biomarkers
Quality of Life
Medicine

ASJC Scopus subject areas

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

Cite this

Palevsky, P. M., Molitoris, B. A., Okusa, M. D., Levin, A., Waikar, S. S., Wald, R., ... Star, R. A. (2012). Design of clinical trials in acute kidney injury: Report from an NIDDK workshop on trial methodology. Clinical Journal of the American Society of Nephrology, 7(5), 844-850. https://doi.org/10.2215/CJN.12791211

Design of clinical trials in acute kidney injury : Report from an NIDDK workshop on trial methodology. / Palevsky, Paul M.; Molitoris, Bruce A.; Okusa, Mark D.; Levin, Adeera; Waikar, Sushrut S.; Wald, Ron; Chertow, Glenn M.; Murray, Patrick T.; Parikh, Chirag R.; Shaw, Andrew D.; Go, Alan S.; Faubel, Sarah G.; Kellum, John A.; Chinchilli, Vernon M.; Liu, Kathleen D.; Cheung, Alfred K.; Weisbord, Steven D.; Chawla, Lakhmir S.; Kaufman, James S.; Devarajan, Prasad; Toto, Robert M.; Hsu, Chi Yuan; Greene, Tom; 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. 844-850.

Research output: Contribution to journalArticle

Palevsky, PM, Molitoris, BA, Okusa, MD, Levin, A, Waikar, SS, Wald, R, Chertow, GM, Murray, PT, Parikh, CR, Shaw, AD, Go, AS, Faubel, SG, Kellum, JA, Chinchilli, VM, Liu, KD, Cheung, AK, Weisbord, SD, Chawla, LS, Kaufman, JS, Devarajan, P, Toto, RM, Hsu, CY, Greene, T, 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: Report from an NIDDK workshop on trial methodology', Clinical Journal of the American Society of Nephrology, vol. 7, no. 5, pp. 844-850. https://doi.org/10.2215/CJN.12791211
Palevsky, Paul M. ; Molitoris, Bruce A. ; Okusa, Mark D. ; Levin, Adeera ; Waikar, Sushrut S. ; Wald, Ron ; Chertow, Glenn M. ; Murray, Patrick T. ; Parikh, Chirag R. ; Shaw, Andrew D. ; Go, Alan S. ; Faubel, Sarah G. ; Kellum, John A. ; Chinchilli, Vernon M. ; Liu, Kathleen D. ; Cheung, Alfred K. ; Weisbord, Steven D. ; Chawla, Lakhmir S. ; Kaufman, James S. ; Devarajan, Prasad ; Toto, Robert M. ; Hsu, Chi Yuan ; Greene, Tom ; 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 : Report from an NIDDK workshop on trial methodology. In: Clinical Journal of the American Society of Nephrology. 2012 ; Vol. 7, No. 5. pp. 844-850.
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