A Phase 3, Randomized, Open-Label, Active-Controlled Study of Efficacy and Safety of FG-4592 for Treatment of Anemia in Subjects With Chronic Kidney Disease on Dialysis
Phase of Trial: Phase III
Latest Information Update: 09 May 2018
At a glance
- Drugs Roxadustat (Primary) ; Epoetin alfa
- Indications Anaemia
- Focus Therapeutic Use
- Sponsors FibroGen
- 09 May 2018 According to a FibroGen media release, company anticipate regulatory approval by China Food and Drug Administration by year-end 2018.
- 18 Oct 2017 the China Food and Drug Administration (CFDA) has accepted the company's recently submitted New Drug Application for registration of roxadustat for the treatment of anemia in dialysis-dependent CKD (DD-CKD) and non-dialysis-dependent CKD (NDD-CKD) patients. Data from this and another phase III trial (profile 257941) supported the application.
- 23 Aug 2017 Status changed from active, no longer recruiting to completed.
Most Recent Events
Table of Contents
- At a glance
- Trial Overview
- Trial Details
- Trial Centres
- Trial History