Drug Disposition Issues in CKD: Implications for Drug Discovery and Regulatory Approval.

Patients with chronic kidney disease (CKD) have several comorbidities that require pharmacologic intervention including hypertension, diabetes, anemia, and cardiovascular disease. Advanced CKD patients (eg, treated with hemodialysis) take an average of 12 medications concurrently and are known to suffer from an increased number of medication-related adverse drug events. Recent basic and clinical research has identified altered renal and nonrenal drug clearance in CKD as one mediator of the increased adverse drug events observed in this patient population. This review will briefly describe pharmacokinetic considerations in CKD, review the Food and Drug Administration guidelines for performing pharmacokinetic studies in CKD patients, and outline the roles of academia, industry, and regulatory agencies in improving drug safety in CKD patients.