A Phase 3, Multi-center, Randomized, 2-arm, Open-label Study of Intermittent Oral Dosing of ASP1517 in Erythropoiesis Stimulating Agent-naive Hemodialysis Chronic Kidney Disease Patients With Anemia
Latest Information Update: 17 Sep 2021
At a glance
- Drugs Roxadustat (Primary)
- Indications Anaemia
- Focus Registrational; Therapeutic Use
- Sponsors Astellas Pharma
- 05 Aug 2021 Result (n=367) of pooled analysis from four studies (NCT01888445, NCT02952092, NCT02780726 and NCT02780141) evaluating the population PK model of roxadustat in Japanese DD-CKD patients with renal anemia and to identify the covariate factors that affect roxadustat pharmacokinetic, published in the British Journal of Clinical Pharmacology.
- 20 Sep 2019 According to a FibroGen media release, Japan's Ministry of Health, Labour and Welfare (MHLW) approved roxadustat for the treatment of anemia associated with chronic kidney disease (CKD) in dialysis patients.
- 08 Aug 2019 According to a FibroGen media release, the regulatory decision for roxadustat approval in Japan is expected in the second half of 2019.