Study Evaluating the Efficacy and Safety of Dose Conversion From a Long-acting Erythropoiesis-stimulating Agent (Mircera ) to Three Times Weekly Oral Vadadustat for the Maintenance Treatment of Anemia in Hemodialysis Subjects
This study will be conducted to demonstrate the efficacy and safety of vadadustat
administered three times weekly (TIW) compared to a long-acting erythropoiesis-stimulating
agent (ESA) (Mircera) for the maintenance treatment of anemia in hemodialysis participants.
Following randomization, there will be 2 periods during the study:
Conversion and Maintenance Period (Weeks 0 to 52): conversion to vadadustat TIW or to
remain on Mircera (Weeks 0 to 20). There will be a primary efficacy evaluation period
(Weeks 20 to 26) and a secondary efficacy evaluation period (Weeks 46 to 52).
Safety Follow-up Period (Early Termination [ET] and Follow-Up): post-treatment safety
follow-up visit (ET/End of Treatment [EOT] +4 weeks) either in person or via telephone.
If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.
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