Trial Profile
Phase 3, Randomized, Open-Label, Active-Controlled Study Evaluating the Efficacy and Safety of Oral Vadadustat for the Correction of Anemia in Subjects With Non-Dialysis-Dependent Chronic Kidney Disease (NDD-CKD) (PRO2TECT-CORRECTION)
Status:
Completed
Phase of Trial:
Phase III
Latest Information Update: 23 Oct 2023
Price :
$35
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At a glance
- Drugs Vadadustat (Primary) ; Darbepoetin alfa
- Indications Anaemia
- Focus Adverse reactions; Registrational; Therapeutic Use
- Acronyms PRO2TECT; PRO2TECT-CORRECTION
- Sponsors Akebia Therapeutics
- 18 Oct 2023 According to an Akebia Therapeutics media release, the company expects a Prescription Drug User Fee Act (PDUFA) date to be assigned before the end of October 2023.
- 24 Aug 2023 According to an Akebia Therapeutics media release, the company expects to resubmit New Drug Application (NDA) for vadadustat as a treatment for anemia due to chronic kidney disease in adult patients on dialysis by the end of the third quarter of 2023. Upon acceptance of the NDA, Akebia expects the U.S. Food and Drug Administration (FDA) to set a PDUFA date of six months from the date of submission.
- 09 Mar 2023 According to an Akebia Therapeutics media release, potential Marketing Authorization for Vafseo is expected in Europe in May 2023.