Abstract
Acute kidney injury is associated with significant morbidity and mortality in hospitalized patients. Clinical trials for acute kidney injury have been hampered not only by a paucity of appropriate potential therapeutic agents, but also by several clinical trial design challenges. First, for novel therapies to have the best chance at efficacy, early patient identification is critical. Second, for certain novel therapies with a mechanism of action directed at the underlying disease state (e.g., sepsis) or a specific pathogenic process, careful disease phenotyping may be required. Third, even among patients with AKI, risk stratification may be required to select a higher-risk subset for clinical trials. Finally, clinical endpoints for clinical trials must be considered carefully, as patients may die for reasons unrelated to AKI, including withdrawal of support. However, these challenges are not unique to AKI; some possible solutions including alternative endpoints used in other clinical trial settings are reviewed here.
Keywords: Acute kidney injury, acute tubular necrosis, clinical trial design, surrogate endpoint, biomarker
Current Drug Targets
Title: Clinical Trials for Acute Kidney Injury: Design Challenges and Possible Solutions
Volume: 10 Issue: 12
Author(s): Kathleen D. Liu and David V. Glidden
Affiliation:
Keywords: Acute kidney injury, acute tubular necrosis, clinical trial design, surrogate endpoint, biomarker
Abstract: Acute kidney injury is associated with significant morbidity and mortality in hospitalized patients. Clinical trials for acute kidney injury have been hampered not only by a paucity of appropriate potential therapeutic agents, but also by several clinical trial design challenges. First, for novel therapies to have the best chance at efficacy, early patient identification is critical. Second, for certain novel therapies with a mechanism of action directed at the underlying disease state (e.g., sepsis) or a specific pathogenic process, careful disease phenotyping may be required. Third, even among patients with AKI, risk stratification may be required to select a higher-risk subset for clinical trials. Finally, clinical endpoints for clinical trials must be considered carefully, as patients may die for reasons unrelated to AKI, including withdrawal of support. However, these challenges are not unique to AKI; some possible solutions including alternative endpoints used in other clinical trial settings are reviewed here.
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Cite this article as:
Liu D. Kathleen and Glidden V. David, Clinical Trials for Acute Kidney Injury: Design Challenges and Possible Solutions, Current Drug Targets 2009; 10 (12) . https://dx.doi.org/10.2174/138945009789753282
DOI https://dx.doi.org/10.2174/138945009789753282 |
Print ISSN 1389-4501 |
Publisher Name Bentham Science Publisher |
Online ISSN 1873-5592 |
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