Work

89P Evaluation of exclusion criteria based on renal function in early-phase oncology clinical trials: The EXKID study

Year: 2025

Type: article

Abstract: Chronic kidney disease (CKD), defined by the KDIGO Consensus as a glomerular filtration rate (GFR) <60 mL/min/1.73 m2 or markers of kidney damage persisting for more than three months, is prevalent in cancer patients due to factors like tumor location, drug-induced toxicities or comorbidities. Despite its high prevalence, CKD remains a frequent exclusion criterion in clinical trials due to concerns over drug pharmacokinetics and potential safety risks, limiting data on cancer treatment efficacy and safety in this population.

Source: ESMO Open

DOI: 10.1016/j.esmoop.2025.104249

Authors: P. Matte, M. Delaye, Y. Loriot, C.P. Massard, M. Roulleaux Dugage

Institution: Institut Gustave Roussy

Language: English

Topic: Statistical Methods in Clinical Trials

Subfield: Statistics and Probability

Field: Mathematics

Domain: Physical Sciences

SDG: Good health and well-being

Open Access status: gold

Estimated APC paid: $3,910