Trial Profile
A Phase III, Open-label, Confirmatory Study of MT-6548 Compared to Darbepoetin Alfa in Non-dialysis Subjects With Anemia Associated With Chronic Kidney Disease in Japan
Status:
Completed
Phase of Trial:
Phase III
Latest Information Update: 10 Apr 2023
Price :
$35
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At a glance
- Drugs Vadadustat (Primary) ; Darbepoetin alfa
- Indications Anaemia
- Focus Registrational; Therapeutic Use
- Sponsors Mitsubishi Tanabe Pharma America
- 29 Jun 2020 According to Akebia Therapeutics Media Release, company has obtained manufacturing and marketing approval of vadadustat as a treatment for anemia due to CKD in both dialysis-dependent and non-dialysis dependent adult patients by the Ministry of Health, Labour and Welfare in Japan on June 29, 2020.
- 05 May 2020 According to an Akebia Therapeutics media release, in collaboration with Mitsubishi Tanabe, the company is advancing key pre-commercial activities in support of the first regulatory approval of vadadustat expected in Japan this year.
- 11 Nov 2019 According to a Mitsubishi Tanabe Pharma Corporation media release, results presented at American Society of Nephrology (ASN) Kidney Week 2019.