Last updated on April 2016

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)


Brief description of study

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)

Detailed Study Description

The study drug (vadadustat) is an investigational drug. This potential new drug is being tested to treat anemia (low red blood cell count) in patients with chronic (long-term) kidney disease. This is a Phase 3 study, which means that the study drug has already been tested in other studies involving humans. This study will gather more information about the study drug. The purpose of this study is to look at the safety and effectiveness of the study drug compared with an approved medication, called darbepoetin alfa. The study will focus on the treatment of anemia in patients with chronic kidney disease.

Clinical Study Identifier: TX143221

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Columbus Regional Research Institute

Columbus Regional Research Institute
Columbus, GA USA
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