Estimation of GFR in Renal Impairment Studies

抄録

Chronic kidney disease is a progressive condition that affects >10% of the general population worldwide. Glomerular filtration rate (GFR) is accepted as the best surrogate for kidney function and is estimated using mathematical models that rely on measurement of endogenous markers such as creatinine and cystatin C. From a clinical pharmacology perspective, renal impairment can lead to changes in drug exposure and, therefore, accurate determination of GFR is important for robust characterization of the relationship between kidney function and drug pharmacokinetics. In this presentation, the International Consortium for Innovation and Quality (IQ) Clinical Pharmacology (CP) Organ Impairment Working Group will highlight important advancements in models used to estimate GFR and their utilization in clinical pharmacology. Common factors encountered in clinical trials or real-world settings that impact serum creatinine measurement and thus the ability to accurately estimate GFR will be presented. Additionally, the recommendations of the IQ CP Organ Impairment Working Group for GFR assessment during drug development and for deriving dosing recommendations in subjects with kidney disease will be shared.