A Phase 1 Study of Roxadustat in Subjects With Different Degrees of Renal Function

Summary

For subjects with normal renal function or severely impaired renal function, this study will evaluate the pharmacokinetics of roxadustat and its main metabolites in plasma and urine. For subjects with end stage renal disease (ESRD) on continuous ambulatory peritoneal dialysis (CAPD) or automated peritoneal dialysis (APD), this study will evaluate the pharmacokinetics of roxadustat and its main metabolites in plasma, urine and dialysate. For subjects with ESRD on hemodialysis (HD) or hemodiafiltration (HDF), this study will evaluate the pharmacokinetics of roxadustat and its main metabolites in plasma, urine and dialysate and also the effect of dialysis on the pharmacokinetics of roxadustat and its main metabolites.

Timeline

Start

2016-12-12

Primary completion

2017-12-04

Completion

2017-12-11

Publications

• Groenendaal-van de Meent D, Kerbusch V, Kaspera R, Barroso-Fernandez B, Galletti P, Klein GK, den Adel M. Effect of Kidney Function and Dialysis on the Pharmacokinetics and Pharmacodynamics of Roxadustat, an Oral Hypoxia-Inducible Factor Prolyl Hydroxylase Inhibitor. Eur J Drug Metab Pharmacokinet. 2021 Jan;46(1):141-153. doi: 10.1007/s13318-020-00658-w.

Drugs

Indications