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

Phase 2

Terminated

• Conditions: Anemia; Chronic Kidney Disease
• Interventions: 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

• Registration Number: NCT00924781
• Lead Sponsor: Merck Sharp & Dohme LLC

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.

Study Timeline

• Study Start: 2009-06
• Study First Submitted: 2009-06-18
• Study First Submitted QC: 2009-06-18
• Study First Posted: 2009-06-19
• Primary Completion: 2010-04
• Study Completion: 2010-05
• Results First Submitted: 2011-10-25
• Results First Submitted QC: 2012-02-28
• Results First Posted: 2012-03-29
• Status Verified: 2015-10
• Last Update Submitted: 2015-10-30
• Last Update Posted: 2015-11-01

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 39

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
MK2578 1 mcg for every 600 U of Epogen at Baseline	MK2578 1mcg for every 600 Units (U) of Epogen® (epoetin alfa) received per week at Baseline	Participants were randomized to receive treatment every week (QW).
1 mcg of MK2578 for every 600 U of Epogen at Baseline	MK2578 1mcg for every 600 Units (U) of Epogen® (epoetin alfa) received per week at Baseline	Participants were randomized to receive treatment QM.
MK2578 1 mcg for every 350 U of Epogen at Baseline	MK2578 1 mcg for every 350 U of Epogen (epoetin alfa) received per week at Baseline	Participants were randomized to receive treatment QW.
1 mcg of MK2578 for every 350 U of Epogen at Baseline	MK2578 1 mcg for every 350 U of Epogen (epoetin alfa) received per week at Baseline	Participants were randomized to receive treatment QM.
MK2578 1 mcg for every 200 U of Epogen at Baseline	MK2578 1 mcg for every 200 U of Epogen (epoetin alfa) received per week at Baseline	Participants were randomized to receive treatment QW.
1 mcg of MK2578 for every 200 U of Epogen at Baseline	MK2578 1 mcg for every 200 U of Epogen (epoetin alfa) received per week at Baseline	Participants were randomized to receive treatment QM.

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
Change From Baseline in Hg Level at Week 12	12 weeks