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

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.

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Journal
ESMO Open
Published
2025-03-01
DOI
https://doi.org/10.1016/j.esmoop.2025.104249
Primary Topic
Statistical Methods in Clinical Trials
Type
article
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article

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

Matthieu Roulleaux Dugage, Paul Matte, C. Massard, Y. Loriot et al.
ESMO Open
Statistical Methods in Clinical Trials
article

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

Matthieu Roulleaux Dugage, Paul Matte, C. Massard, Y. Loriot, Matthieu Delaye
article en

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.

ESMO OpenVol. 10
Institut Gustave Roussy (FR)
Reduced inequalities
Openalex Percentile: Top 95%
Statistical Methods in Clinical Trials
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