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  • 1
    Online Resource
    Online Resource
    Design of Clinical Trials in Acute Kidney Injury : Report from an NIDDK Workshop on Trial Methodology
    Ovid Technologies (Wolters Kluwer Health) ; 2012
    In:  Clinical Journal of the American Society of Nephrology Vol. 7, No. 5 ( 2012-05), p. 844-850
    Details
    In: Clinical Journal of the American Society of Nephrology, Ovid Technologies (Wolters Kluwer Health), Vol. 7, No. 5 ( 2012-05), p. 844-850
    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 from academia, 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.
    Type of Medium: Online Resource
    ISSN: 1555-9041
    URL: Article
    DOI: 10.2215/CJN.12791211
    Language: English
    Publisher: Ovid Technologies (Wolters Kluwer Health)
    Publication Date: 2012
    detail.hit.zdb_id: 2216582-4
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    Online Resource
  • 2
    Online Resource
    Online Resource
    Design of Clinical Trials in AKI : A Report from an NIDDK Workshop. Trials of Patients with Sepsis and in Selected Hospital Settings
    Ovid Technologies (Wolters Kluwer Health) ; 2012
    In:  Clinical Journal of the American Society of Nephrology Vol. 7, No. 5 ( 2012-05), p. 856-860
    Details
    In: Clinical Journal of the American Society of Nephrology, Ovid Technologies (Wolters Kluwer Health), Vol. 7, No. 5 ( 2012-05), p. 856-860
    Abstract: AKI remains an important clinical problem, with a high mortality 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 of Health and the Food and Drug 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 short- and long-term primary endpoints in these patients.
    Type of Medium: Online Resource
    ISSN: 1555-9041
    URL: Article
    DOI: 10.2215/CJN.12821211
    Language: English
    Publisher: Ovid Technologies (Wolters Kluwer Health)
    Publication Date: 2012
    detail.hit.zdb_id: 2216582-4
    Location Call Number Limitation Availability
    BibTip Others were also interested in ...
    Online Resource
  • 3
    Online Resource
    Online Resource
    Design of Clinical Trials in Acute Kidney Injury : A Report from an NIDDK Workshop—Prevention Trials
    Ovid Technologies (Wolters Kluwer Health) ; 2012
    In:  Clinical Journal of the American Society of Nephrology Vol. 7, No. 5 ( 2012-05), p. 851-855
    Details
    In: Clinical Journal of the American Society of Nephrology, Ovid Technologies (Wolters Kluwer Health), Vol. 7, No. 5 ( 2012-05), p. 851-855
    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.
    Type of Medium: Online Resource
    ISSN: 1555-9041
    URL: Article
    DOI: 10.2215/CJN.12811211
    Language: English
    Publisher: Ovid Technologies (Wolters Kluwer Health)
    Publication Date: 2012
    detail.hit.zdb_id: 2216582-4
    Location Call Number Limitation Availability
    BibTip Others were also interested in ...
    Online Resource
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