Anemia of Chronic Kidney Disease Clinical Trial
Official title:
A Phase III, Randomized, Investigator-Blinded, Active-Controlled Study of Efficacy and Safety of Efepoetin Alfa for Treatment of Anemia in Patients With Chronic Kidney Disease on Dialysis
An investigator-blinded, randomized, multicenter, active-controlled Phase III study for the treatment of anemia in patients with CKD on hemodialysis
This is an investigator-blinded, randomized, multicenter, active-controlled Phase III study for the treatment of anemia in patients with CKD on hemodialysis. Eligible patients will be randomized to efepoetin alfa or darbepoetin alfa at a ratio of 2:1. An unblinded team will prepare and administer the study drug at the dosages decided by the blinded Investigator. The study consists of 3 study periods: - Screening (up to 28 days before Day 1): subjects in screening will continue treatment with epoetin, methoxy polyethylene glycol-epoetin beta (Mircera®), or darbepoetin alfa as per local standard of care. - Treatment: subjects will discontinue any prior erythropoietin analogue and will be randomized to switch to efepoetin alfa or darbepoetin alfa in a 2:1 ratio. The aim of the treatment period is to maintain Hb levels between 10.0 g/dL and 12.0 g/dL. It is recommended that study treatment be administered any time after completion of dialysis if dosing is scheduled on a dialysis day to avoid potential bias on study assessments. • Follow-up (4 weeks) Phone contacts can be done for follow-up for up to Week 56 or at the time of the last patient's Week 56 visit, whichever is shorter. ;
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