Phase 3, Randomized, Open-label, Active-controlled Study Evaluating the Efficacy and Safety of Oral Vadadustat for the Maintenance Treatment of Anemia in Subjects With Non-dialysis-dependent Chronic Kidney Disease (NDD-CKD) (PRO2TECT-CONVERSION)
Phase of Trial: Phase III
Latest Information Update: 09 May 2018
At a glance
- Drugs Vadadustat (Primary) ; Darbepoetin alfa
- Indications Anaemia
- Focus Adverse reactions; Registrational; Therapeutic Use
- Acronyms PRO2TECT-CONVERSION
- Sponsors Akebia Therapeutics
- 09 May 2018 According to an Akebia Therapeutics media release, the Independent Data Monitoring Committee of PRO2TECT program held another meeting and recommended continuing the study without modification.
- 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.