The need for changes in clinical trials for improving cancer care for patients with CKD

The majority of chemotherapy drugs used to treat cancer have limited therapeutic indices and potentially dangerous side effects. Since many cancer medications are at least partially excreted through the kidney, reliable information on the safe and efficient dosage of these medications in patients with Chronic Kidney Disease (CKD) is crucial for assisting in treatment decisions. Initial clinical studies for new drugs frequently only include patients with normal or barely compromised renal function. A small number of individuals with more severe kidney disease are included in further preregistration studies. Data from patients with End Stage Kidney Disease (ESKD) requiring kidney replacement therapy or severe renal impairment (here defined as an estimated Glomerular Filtration Rate (eGFR) 30 ml/min or stage 4G CKD) are particularly important. Data from this group are only seldom included in new drug applications submitted to the US Food and Drug Administration (FDA), which is particularly limited prior to drug registration. Unfortunately, a manufacturer's statement that a drug is contraindicated in patients with advanced kidney disease may be the consequence of a lack of data or other safety concerns, which prevents these patients from getting access to potentially helpful medications. This persistent issue of the systemic exclusion of cancer treatment trial participants with CKD hampers the provision of the best possible clinical care for these patients and highlights issues of inclusion, diversity, and equity. Additionally, as the population ages, more and more people with CKD and cancer are dealing with these problems. In this study, we assess the scientific justification for excluding CKD patients from cancer trials and provide an all-encompassing solution.