Conditions: Anemia Chronic Kidney Disease
Keywords: Anemia associated with chronic kidney disease (CKD) Hemodialysis
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 39
Healthy volunteers: no

Brief summary:
This study will evaluate the efficacy and safety of intravenous MK2578, given as maintenance treatment for renal anemia in chronic kidney disease patients on dialysis who were previously receiving erythropoietin stimulating agents.

Detailed description:
This study consists of a 12-week base study (MK2578-003-AM03) and an optional 40-week extension study (MK2578-003-EXT12). Participants who complete 12 weeks of treatment in the base study will enter the extension on the most recent dose administered in the base study or a newly adjusted dose, if adjustment is required to bring Hg levels within range. Participants' doses of MK2578 will be adjusted upward or downward during the extension study to maintain Hb in the range of 10-12 g/dL.

Arms:
arm 1: Participants were randomized to receive treatment every week (QW). arm 2: Participants were randomized to receive treatment QM. arm 3: Participants were randomized to receive treatment QW. arm 4: Participants were randomized to receive treatment QM. arm 5: Participants were randomized to receive treatment QW. arm 6: Participants were randomized to receive treatment QM.

Interventions: intervention 1: MK2578 1mcg for every 600 Units (U) of Epogen® (epoetin alfa) received per week at Baseline intervention 2: MK2578 1 mcg for every 350 U of Epogen (epoetin alfa) received per week at Baseline intervention 3: MK2578 1 mcg for every 200 U of Epogen (epoetin alfa) received per week at Baseline
Intervention descriptions: intervention 1: MK2578 was to be administered intravenously (IV). Participants in Cohort 1 were to receive 1 mcg of MK2578 for every 600 U of Epogen (epoetin alfa) received per week at Baseline. Participants were to be randomized to every week (QW) or once every 4 weeks (QM) dosing schedules within each cohort. intervention 2: MK2578 was to be administered IV. Participants in Cohort 2 were to receive 1 mcg of MK2578 for every 350 U of Epogen (epoetin alfa) received per week at Baseline. Participants were to be randomized to QW or QM dosing schedules within each cohort. intervention 3: MK2578 was to be administered IV. Participants in Cohort 3 were to receive 1 mcg of MK2578 for every 200 U of Epogen (epoetin alfa) received per week at Baseline. Participants were to be randomized to QW or QM dosing schedules within each cohort.

Protocol document: