Trial Profile
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
Status:
Completed
Phase of Trial:
Phase III
Latest Information Update: 23 Aug 2019
Price :
$35
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At a glance
- Drugs Roxadustat (Primary)
- Indications Anaemia
- Focus Registrational; Therapeutic Use
- Sponsors FibroGen
- 22 Aug 2019 According to an Astrazeneca media release, FibroGen has received a marketing authorisation for roxadustat in China for the treatment of anaemia caused by chronic kidney disease (CKD) in non-dialysis-dependent (NDD) patients on the basis of this trial. This aprroval was granted by National Medical Products Administration.
- 08 Aug 2019 According to a FibroGen media release, the regulatory decision for Roxadustat in China is expected in the third quarter of 2019.
- 24 Jul 2019 Results published in the New England Journal of Medicine