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)

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)

Recruiting
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
  • Most Recent Events

    • 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.
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