A Phase 3, Randomized, Open-Label, Active-Controlled Study to Evaluate the Efficacy and Safety of Roxadustat in the Treatment of Anemia in Chronic Kidney Disease Patients Not on Dialysis
Phase of Trial: Phase III
Latest Information Update: 24 Aug 2017
At a glance
- Drugs Roxadustat (Primary) ; Darbepoetin alfa
- Indications Anaemia
- Focus Registrational; Therapeutic Use
- Acronyms Dolomites
- Sponsors Astellas Pharma Europe Ltd
- 26 Jul 2017 Planned End Date changed from 1 Jul 2017 to 1 Apr 2020.
- 26 Jul 2017 Planned primary completion date changed from 1 Jul 2017 to 1 Dec 2018.
- 29 Jun 2015 Approximately 8000 chronic kidney disease patients will be enrolled in this and nine other phase III trials, according to a FibroGen media release.