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A Large Animal Model for Acute Kidney Injury by Temporary Bilateral Renal Artery Occlusion
Published on: February 2, 2021
Clinical trials for acute kidney injury: design challenges and possible solutions
Kathleen D Liu1, David V Glidden
1Department of Medicine, University of California, San Francisco, 94143-0532, USA. Kathleen.Liu@ucsf.edu
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.
Insights
Clinical trials for acute kidney injury (AKI) face challenges in patient identification, phenotyping, risk stratification, and endpoint selection. Solutions from other trials may help advance AKI therapeutics.
Area of Science:
- Nephrology
- Clinical Trials
- Translational Medicine
Background:
- Acute kidney injury (AKI) is a critical condition linked to high morbidity and mortality in hospitalized individuals.
- Developing effective treatments for AKI is hindered by a lack of therapeutic agents and significant clinical trial design hurdles.
Purpose of the Study:
- To identify and review the key challenges in designing clinical trials for acute kidney injury.
- To explore potential solutions and alternative strategies for overcoming these design challenges, drawing from other research settings.
Main Methods:
- The study reviews common challenges encountered in acute kidney injury clinical trial design.
- It examines the necessity for early patient identification, precise disease phenotyping, and risk stratification.
- Alternative clinical endpoint considerations are discussed, referencing successful strategies from other trial contexts.
Main Results:
- Early patient identification is crucial for the efficacy of novel AKI therapies.
- Disease phenotyping and risk stratification are essential for selecting appropriate patient cohorts.
- Careful selection of clinical endpoints is necessary to accurately assess treatment effects, considering potential non-AKI related mortality.
Conclusions:
- Clinical trials for acute kidney injury are complex due to patient selection and endpoint challenges.
- Strategies employed in other clinical trial settings may offer viable solutions for advancing AKI research.
- Addressing these design challenges is vital for the successful development of new AKI treatments.
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