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A Large Animal Model for Acute Kidney Injury by Temporary Bilateral Renal Artery Occlusion
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Designing acute kidney injury clinical trials

Alexander Zarbock1,2, Lui G Forni3,4, Marlies Ostermann5

  • 1Department of Anaesthesiology, Intensive Care and Pain Medicine, University Hospital of Münster, Münster, Germany. zarbock@uni-muenster.de.

Nature Reviews. Nephrology
|August 31, 2023
PubMed

Insights

Acute kidney injury (AKI) is a serious condition with no specific treatments. This study proposes new clinical trial designs and patient selection strategies to develop effective AKI therapies.

Area of Science:

  • Nephrology
  • Clinical Trials
  • Translational Medicine

Background:

  • Acute kidney injury (AKI) is a prevalent clinical syndrome linked to high mortality and progression to chronic kidney disease.
  • Current management of AKI relies on supportive care, with no specific therapies available to prevent or treat the condition.
  • There is a critical need for novel therapeutic interventions targeting AKI's underlying mechanisms.

Purpose of the Study:

  • To discuss strategies for patient selection in clinical trials for AKI.
  • To outline appropriate endpoints for evaluating novel AKI interventions.
  • To guide the design of future prevention and treatment trials for AKI.

Main Methods:

  • Review of predictive and prognostic enrichment strategies for AKI patient selection.
  • Discussion of primary and secondary endpoints for AKI clinical trials.
  • Consideration of trial designs for both AKI prevention and treatment.

Main Results:

  • Enrichment strategies can identify high-risk patients for AKI trials.
  • Carefully chosen endpoints are crucial for demonstrating intervention efficacy.
  • Tailored trial designs are necessary for different AKI contexts.

Conclusions:

  • Developing novel AKI therapies requires innovative clinical trial designs.
  • Effective patient selection and endpoint definition are key to successful AKI research.
  • Improved trial methodologies will advance AKI patient outcomes.

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