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)
Phase of Trial: Phase III
Latest Information Update: 21 Mar 2018
At a glance
- Drugs Vadadustat (Primary) ; Darbepoetin alfa
- Indications Anaemia
- Focus Adverse reactions; Registrational; Therapeutic Use
- Acronyms PRO2TECT-CORRECTION
- Sponsors Akebia Therapeutics
- 07 Mar 2018 Planned number of patients changed from 1000 to 1600.
- 12 Feb 2018 According to an Akebia Therapeutics media release, enrolment completion expected by the end of 2018 and top-line results expected in 2019, subject to the accrual of MACE events.
- 22 Jan 2018 Planned End Date changed from 1 Nov 2018 to 1 Sep 2019.