Pyrenees
Research type
Research Study
Full title
A Phase 3, Randomized, Open-Label, Active-Controlled Study to Evaluate the Efficacy and Safety of Roxadustat in the Maintenance Treatment of Anemia in End Stage Renal Disease Subjects on Stable Dialysis
IRAS ID
149317
Contact name
Ashraf Mikhail
Contact email
Sponsor organisation
Astellas Pharma Europe B.V.
Eudract number
2013-001497-16
Duration of Study in the UK
years, months, days
Research summary
Roxadustat is an investigational drug, a tablet to be taken by mouth, that is developed for the treatment of anemia in patients with chronic kidney disease. Roxadustat stimulates the production of red blood cells in a way consistent to the body’s normal response to anemia.
The purpose of this study is to investigate if roxadustat is both effective and safe as a treatment for anemia in patients with end stage renal disease. Roxadustat is not an approved product.
Approximately 750 patients will take part in this study across several European countries.
The study population consists of adult subjects with ESRD who are on stable hemodialysis (HD) or peritoneal dialysis (PD) and on stable treatment with epoetin (i.e. epoetin alfa, beta, theta, zeta, delta or omega) or darbepoetin alfa for anemia. Subjects on hemodiafiltration (HDF) are also allowed to participate in the study and will follow the same study procedures and requirements as HD subjects.The primary objective of this study is to evaluate the efficacy of roxadustat compared to epoetin alfa and darbepoetin alfa in the maintenance treatment of anemia in End Stage Renal Disease (ESRD)subjects on stable dialysis.
This is a phase 3, multicenter, randomized, open-label, active-controlled study. The study will consist of three study periods:
Screening Period: up to 6 weeks
Treatment Period: 104 weeks
Follow-Up Period: 4 weeksREC name
London - City & East Research Ethics Committee
REC reference
14/LO/1443
Date of REC Opinion
5 Nov 2014
REC opinion
Further Information Favourable Opinion