A Study of the Efficacy and Safety of MK2578 for the Treatment of Anemia in Patients With Kidney Disease (MK2578-003-AM03-EXT12)
Condition: Anemia; Chronic Kidney Disease
MeSH terms: Kidney Diseases; Renal Insufficiency, Chronic; Anemia
Intervention: MK2578 1mcg for every 600 Units (U) of Epogen® (epoetin alfa) received per week at Baseline; MK2578 1 mcg for every 350 U of Epogen (epoetin alfa) received per week at Baseline; MK2578 1 mcg for every 200 U of Epogen (epoetin alfa) received per week at Baseline
Intervention description: 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.; 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.; 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.
Intervention MeSH terms: Epoetin Alfa
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 39.0
Sex: All
Minimum age: 18 Years
Maximum age: 70 Years
Healthy volunteers: No
Keywords: Anemia associated with chronic kidney disease (CKD); Hemodialysis

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.
    

Eligibility criteria:

        Inclusion Criteria:

        Base Study:

          -  Patient is male or is a female who either cannot have children or who agrees to use
             appropriate contraceptive measures

          -  Patient has been on hemodialysis for at least 6 months when informed consent is signed

          -  Patient has received intravenous epoetin alfa or epoetin beta for a least 6 months
             when the informed consent is signed

        Extension Study:

          -  Patient completed the base study through Week 12

          -  Patient tolerated MK2578 and demonstrated compliance with study procedures

        Exclusion Criteria:

          -  Patient has a life expectancy of less than 6 months

          -  Patient is scheduled for a kidney transplant within the next 6 months

          -  Patient has had a blood transfusion within 12 weeks of screening

          -  Patient has had major surgery within 12 weeks of screening or plans to have surgery

          -  Patient has Human Immunodeficiency Virus (HIV)

          -  Patient has history of blood dyscrasia, hematologic disorders or any other disease
             known to cause anemia

          -  Patient has severe congestive heart failure (CHF)

          -  Patient has a history of malignant cancer, except certain skin or cervical cancers

          -  Patient has a history of grand mal seizures within the last 6 months