Study of Vadadustat in Hemodialysis Participants With Anemia Switching From Epoetin Alfa

Authors
Category Primary study
Registry of Trialsclinicaltrials.gov
Year 2019
This is a Phase 2, randomized, open‐label study to evaluate efficacy and safety of oral Vadadustat for the treatment of anemia in hemodialysis participants converting from Epoetin Alfa therapy. The study will be conducted in two parts running in parallel: Part 1, Main Study in a hemodialysis population on maintenance treatment with Epoetin Alfa; Part 2 is in a hemodialysis population that are erythropoiesis‐stimulating agent (ESA) hyporesponders on maintenance treatment with Epoetin Alfa. For all participants (Main and ESA hyporesponder parallel study), the study will include a Screening Period, a Treatment Period, and a Safety Follow‐Up Period. PK and PD sampling will be done throughout the study. The aim is to achieve and maintain hemoglobin (Hb) levels within the target range of 10.0 to 11.0 grams per deciliter (g/dL), inclusive, while targeting the middle of the range and minimizing excursions outside the target range.
Epistemonikos ID: a76720349fe10f1b1ee9be9b5192d6b00ee8ccf5
First added on: May 21, 2024