Trial Profile
A Phase 3, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study Evaluating the Safety and Efficacy of Roxadustat for the Treatment of Anemia in Chronic Kidney Disease Patients not on Dialysis
Status:
Completed
Phase of Trial:
Phase III
Latest Information Update: 17 Jun 2022
Price :
$35
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At a glance
- Drugs Roxadustat (Primary)
- Indications Anaemia
- Focus Registrational; Therapeutic Use
- Acronyms OLYMPUS
- Sponsors AstraZeneca
- 18 May 2022 Results from four pivotal trials (ASCEND-NHQ , ALPS, ANDES, OLYMPUS) assessing indirect treatment comparison (ITC) of changes in SF-36 Vitality score observed in placebo-controlled RCTs of daprodustat and roxadustat presented at the 27th Annual International Meeting of the International Society for Pharmacoeconomics and Outcomes Research
- 14 Dec 2021 Results of pooled post-hoc analysis assessing the effects of roxadustat in patients (pts) with NDD-CKD across all available BL Hb values from three Phase 3 NDD-CKD trials (OLYMPUS, ALPS, ANDES) presented at the 63rd American Society of Hematology Annual Meeting and Exposition
- 09 Nov 2021 According to a FibroGen media release, the company announced that the U.S. Food and Drug Administration (FDA) issued a complete response letter regarding the New Drug Application (NDA) for roxadustat for the treatment of anemia of CKD.