title: Therapeutic strategies for clinical trials targeting renal recovery.
abstract: Although at present we have developed consensus definitions for acute kidney injury (AKI) and there is a major focus on the treatment and prevention of AKI in high-risk populations, little is known about renal recovery per se and the impact of therapies on renal recovery. Here, we will focus on the specifics of clinical trial design relevant to studies of AKI recovery. While certain design considerations will be common to all trials, others elements will be more specific for studies focused on best practice or novel therapeutics. We will first discuss clinical trial considerations for all studies followed by specific proposals for best practice trials and therapy trials. Other presentations during this round table have focused on other aspects that are highly important for clinical trial design, including definitions for recovery, the potential use of biomarkers, as well as clinical trial endpoints, so we will not address these issues here.
authors.affiliation: Divisions of Nephrology and Critical Care Medicine, Departments of Medicine and Anesthesia, University of California, San Francisco, Calif., USA.
authors.forename: Kathleen D
authors.initials: KD
authors.lastname: Liu
mesh_terms: D058186:Acute Kidney Injury / Q000150:complications / Q000401:mortality / Q000628:therapy*; D000818:Animals; D000077868:Atrasentan; D015415:Biomarkers; D031204:Caloric Restriction; D002986:Clinical Trials as Topic / Q000379:methods*; D004195:Disease Models, Animal; D005355:Fibrosis; D005500:Follow-Up Studies; D006801:Humans; D007249:Inflammation; D007668:Kidney / Q000473:pathology / Q000502:physiology; D007677:Kidney Function Tests; D045164:Mesenchymal Stem Cell Transplantation; D015201:Meta-Analysis as Topic; D011759:Pyrrolidines / Q000627:therapeutic use; D020127:Recovery of Function; D012038:Regeneration; D051436:Renal Insufficiency, Chronic / Q000209:etiology / Q000517:prevention & control; D017582:Renal Replacement Therapy; D012128:Respiratory Distress Syndrome / Q000150:complications / Q000401:mortality; D012307:Risk Factors; D016896:Treatment Outcome
chemical_list: D015415:Biomarkers; D011759:Pyrrolidines; D000077868:Atrasentan