Population pharmacokinetics of vadadustat, a hypoxia-inducible factor prolyl hydroxylase inhibitor for treatment of anemia associated with chronic kidney disease

Authors: Roberts JK, Navarro-Gonzales P, Humphrey RL, Bihorel S, Dykstra, K
Conference: PAGE
Keywords: anemia, chronic kidney disease, pop PK, population PK, Vadadustat
Division: Clinical Pharmacology and Pharmacometrics (CPP)

Vadadustat is an oral hypoxia-inducible factor prolyl hydroxylase inhibitor, a class of drugs that stabilize HIF and stimulates endogenous erythropoietin and red blood cell production. It is indicated for treatment of anemia associated with CKD and is an alternative to ESAs.
• Approved in EU and Japan; under review in US and other countries
• Vadadustat is given once daily to patients with CKD anemia
• Starting daily dose is 300 mg
– Dose adjusted up or down as needed depending on Hb response (target Hb range: 10–11 g/dL in US; 10–12 g/dL in EU and RoW)
– Minimum dose of 150 mg; maximum is 600 mg, with dose adjustments every 4 weeks in 150-mg increments

By: Jessica Roberts, Pamela Navarro-Gonzales, Rebecca Humphrey, Sebastien Bihorel, and Kevin Dykstra

Poster presented at the 31st Population Approach Group Europe (PAGE) Meeting; June 28-30, 2023; A Coruña, Spain.