A Study of the Efficacy and Safety of MK2578 for the Treatment of Anemia in Patients With Kidney Disease (MK2578-003-AM03-EXT12)

Study Overview
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Brief Summary
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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
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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.

Official Title
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A Phase II Randomized, Open-Label, Multiple-Rising Dose Clinical Trial to Study the Efficacy and Safety of MK2578 for the Maintenance of Anemia Treatment in Patients With Chronic Kidney Disease Who Are on Hemodialysis.

Conditions
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Anemia, Chronic Kidney Disease

Intervention / Treatment
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* Drug: MK2578 1mcg for every 600 Units (U) of Epogen® (epoetin alfa) received per week at Baseline
* Drug: MK2578 1 mcg for every 350 U of Epogen (epoetin alfa) received per week at Baseline
* Drug: MK2578 1 mcg for every 200 U of Epogen (epoetin alfa) received per week at Baseline


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: MK2578 1 mcg for every 600 U of Epogen at Baseline<br>Participants were randomized to receive treatment every week (QW). | Drug: MK2578 1mcg for every 600 Units (U) of Epogen® (epoetin alfa) received per week at Baseline<br>* 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.<br>|
| Experimental: 1 mcg of MK2578 for every 600 U of Epogen at Baseline<br>Participants were randomized to receive treatment QM. | Drug: MK2578 1mcg for every 600 Units (U) of Epogen® (epoetin alfa) received per week at Baseline<br>* 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.<br>|
| Experimental: MK2578 1 mcg for every 350 U of Epogen at Baseline<br>Participants were randomized to receive treatment QW. | Drug: MK2578 1 mcg for every 350 U of Epogen (epoetin alfa) received per week at Baseline<br>* 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.<br>|
| Experimental: 1 mcg of MK2578 for every 350 U of Epogen at Baseline<br>Participants were randomized to receive treatment QM. | Drug: MK2578 1 mcg for every 350 U of Epogen (epoetin alfa) received per week at Baseline<br>* 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.<br>|
| Experimental: MK2578 1 mcg for every 200 U of Epogen at Baseline<br>Participants were randomized to receive treatment QW. | Drug: MK2578 1 mcg for every 200 U of Epogen (epoetin alfa) received per week at Baseline<br>* 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.<br>|
| Experimental: 1 mcg of MK2578 for every 200 U of Epogen at Baseline<br>Participants were randomized to receive treatment QM. | Drug: MK2578 1 mcg for every 200 U of Epogen (epoetin alfa) received per week at Baseline<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change From Baseline in Hemoglobin (Hg) Level at Week 4 |  | 4 weeks | 
| Number of Participants With Composite Events of Death, Myocardial Infarction (MI), and Cerebrovascular Accident (CVA) |  | 12 weeks | 
| Number of Participants With Composite Events of Transfusion-Related Adverse Experiences |  | 12 weeks | 
| Number of Participants With Composite Events of Infusion Reactions |  | 12 weeks | 
| Number of Participants With Events of Death, MI, CVA, Peripheral Vascular Thromboses, Vascular Access Thrombosis, Congestive Heart Failure (CHF), Hypertension, Seizure, or Pure Red Cell Aplasia |  | 12 weeks | 
| Number of Participants With Confirmed, Treatment Emergent Antibodies to MK2578 |  | 12 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change From Baseline in Hg Level at Week 12 |  | 12 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Anemia associated with chronic kidney disease (CKD), Hemodialysis