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A Phase II Randomized, Open-Label, Multiple-Rising Dose Clinical Trial to Study the Efficacy and Safety of MK-2578 for the Maintenance of Anemia Treatment in Patients With Chronic Kidney Disease Who a...

Mise à jour : Il y a 4 ans
Référence : EUCTR2009-010904-27

A Phase II Randomized, Open-Label, Multiple-Rising Dose Clinical Trial to Study the Efficacy and Safety of MK-2578 for the Maintenance of Anemia Treatment in Patients With Chronic Kidney Disease Who are on Hemodialysis

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Extrait

E.2.1 Main objective: To define optimal factor (e.g. μg MK-2578 per U epoetin) for conversion of epoetin alfa or epoetin beta administered three times weekly (TIW), two times weekly (BIW), or weekly (QW) IV, to MK-2578, administered intravenously monthly or weekly that will maintain Hb at the baseline value (i.e., Hb change from baseline approximately 0 where baseline is defined as the average Hb value during the epoetin alfa/epoetin beta run-in period). To assess the safety and tolerability of MK-2578 (IV) in hemodialysis patients previously treated with epoetin alfa or epoetin beta.

Critère d'inclusion

  • Anemia in patients with Kidney Disease (CKD)

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