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Phase 3, Randomized, Open Label, Active Controlled Study Evaluating the Efficacy and Safety of Three Times Per Week (TIW) Oral Dosing of Vadadustat for the Treatment of Anemia in Subjects With Dialysis-Dependent Chronic Kidney Disease (DD-CKD) (TRILO2GY)

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Trial Profile

Phase 3, Randomized, Open Label, Active Controlled Study Evaluating the Efficacy and Safety of Three Times Per Week (TIW) Oral Dosing of Vadadustat for the Treatment of Anemia in Subjects With Dialysis-Dependent Chronic Kidney Disease (DD-CKD) (TRILO2GY)

Status: Withdrawn prior to enrolment
Phase of Trial: Phase III

Latest Information Update: 16 Nov 2018

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At a glance

  • Drugs Vadadustat (Primary)
  • Indications Anaemia
  • Focus Registrational; Therapeutic Use
  • Acronyms TRILO2GY
  • Sponsors Akebia Therapeutics

    • Most Recent Events

    • 07 Mar 2018 Status changed from not yet recruiting to withdrawn prior to enrolment due to revised study design
    • 12 Feb 2018 According to an Akebia Therapeutics media release, new study is expected to initiate in late 2018 or early 2019, with top-line results expected in early 2020
    • 12 Feb 2018 According to an Akebia Therapeutics media release, the company is planning the former TRILO2GY study with new study design to include once-daily and three-times-weekly dosing, an ESA control and a larger sample size and to generate data to inform switching from Epogen (epoetin alfa), Aranesp (darbepoetin alfa) and Mircera (methoxy PEG-epoetin beta).
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