Imprecise Kidney Function Thresholds in Cancer Clinical Trials and the Potential for Harm

Abstract

Current guidance for evaluation of kidney function and drug dosing emphasize using measured or estimated glomerular filtration rate (GFR) rather than measured or estimated creatinine clearance or serum creatinine (Scr) alone. We assessed the definitions of kidney function thresholds for eligibility in cancer clinical trials. A random sample of active Phase I–III trials with cisplatin (n = 465) and studies in cancer with decreased kidney function (n = 74) were identified from clinicaltrials.gov. Among cisplatin trials, kidney function thresholds were defined by Scr alone or a composite of Scr or creatinine clearance in 46% (212/465) of studies. Only 2% (n = 11) used GFR. Among trials in participants with decreased kidney function, the proportion utilizing GFR (14%, 10/74) was modestly higher. Imprecise and logically inconsistent kidney function thresholds are in frequent use in clinical trials in cancer and may cause harm from either toxicity or impaired efficacy. We recommend the adoption and harmonization of recommended standards.