Overcoming barriers in the design and implementation of clinical trials for Acute Kidney Injury: a report from the 2020 Kidney Disease Clinical Trialists meeting.

Fiche publication

Date publication

janvier 2022

Journal

Nephrology, dialysis, transplantation : official publication of the European Dialysis and Transplant Association - European Renal Association

Auteurs

Membres identifiés du Cancéropôle Est :
Pr ROSSIGNOL Patrick

Tous les auteurs :
Lazzareschi D, Mehta RL, Dember LM, Bernholz J, Turan A, Sharma A, Kheterpal S, Parikh CR, Ali O, Schulman IH, Ryan A, Feng J, Simon N, Pirracchio R, Rossignol P, Legrand M

Lien Pubmed

https://www.ncbi.nlm.nih.gov/pubmed/35022767

Résumé

Acute Kidney Injury (AKI) is a growing epidemic and is independently associated with increased risk of death, chronic kidney disease, and cardiovascular events. Randomized-controlled trials (RCTs) in this domain are notoriously challenging, and many clinical studies in AKI have yielded inconclusive findings. Underlying this conundrum is the inherent heterogeneity of AKI in its etiology, presentation, and course. AKI is best understood as a syndrome, and identification of AKI subphenotypes is needed to elucidate the disease's myriad etiologies and tailor effective prevention and treatment strategies. Conventional RCTs are logistically cumbersome and often feature highly selected patient populations that limit external generalizability, and thus alternative trial designs should be considered when appropriate. In this narrative review of recent developments in AKI trials based on the Kidney Disease Clinical Trialists (KDCT) 2020 meeting, we discuss barriers to and strategies for improved design and implementation of clinical trials for AKI patients, including predictive and prognostic enrichment techniques, the use of pragmatic trials, and adaptive trials.