Overview

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

Status:
Completed
Trial end date:
2017-12-11
Target enrollment:
Participant gender:
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.
Phase:
Phase 1
Details
Lead Sponsor:
Astellas Pharma Europe B.V.
Collaborator:
FibroGen