A Phase 3, Randomized, Double-Blind, Placebo-Controlled Study of Efficacy and Safety of FG-4592 for Treatment of Anemia in Subjects With Chronic Kidney Disease Not on Dialysis.
Phase of Trial: Phase III
Latest Information Update: 18 Oct 2017
At a glance
- Drugs Roxadustat (Primary)
- Indications Anaemia
- Focus Registrational; Therapeutic Use
- Sponsors FibroGen
- 18 Oct 2017 According to a FibroGen media release, 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.
- 09 May 2017 According to a FibroGen media release, NDA submission in China is targeted in the third quarter of 2017.
Most Recent Events
Table of Contents
- At a glance
- Trial Overview
- Trial Details
- Trial Centres
- Trial History