What endpoints should not be used for clinical studies of acute kidney injury?

Excerpt

In the accompanying commentary, Kellum and colleagues [1] opine that “…the easiest way to ruin a clinical trial is to choose the wrong endpoint.” We strongly agree with this view; here, we review pitfalls in endpoint selection for acute kidney injury (AKI) trials. The development of novel AKI therapies is fraught with challenges, including the timing of renal injury relative to therapy (with the exceptions of post-operative, medication and contrast-associated AKI, it is impossible to provide therapy before AKI) and the heterogeneous nature of AKI, including the clinical entities that lead to AKI and the multiple tissue compartments (endothelium, epithelium, vasculature) that may be involved. Another consideration complicating endpoint selection is the (often implicit) paradigm that treats AKI as a discrete disease rather than a condition with multiple phenotypes. Designing studies using an endpoint that is not specific for the specific phenotype of interest may result in inconclusive or potentially misleading study results. …