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

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.

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.

Study Overview

• Status: Terminated
• Conditions: Anemia; Chronic Kidney Disease
• Intervention / Treatment: 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

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 Type: Interventional
• Enrollment (Actual): 39
• Phase: Phase 2

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

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

Number of Arms

6

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Merck Sharp & Dohme LLC

Study record dates

Study Major Dates

• Study Start: June 1, 2009
• Primary Completion (Actual): April 1, 2010
• Study Completion (Actual): May 1, 2010

Study Registration Dates

• First Submitted: June 18, 2009
• First Submitted That Met QC Criteria: June 18, 2009
• First Posted (Estimate): June 19, 2009

Study Record Updates

• Last Update Posted (Estimate): November 1, 2015
• Last Update Submitted That Met QC Criteria: October 30, 2015
• Last Verified: October 1, 2015

More Information

Terms related to this study

• Keywords: Hemodialysis; Anemia associated with chronic kidney disease (CKD)
• Additional Relevant MeSH Terms: Urologic Diseases; Hematologic Diseases; Renal Insufficiency; Kidney Diseases; Renal Insufficiency, Chronic; Anemia; Hematinics; Epoetin Alfa
• Other Study ID Numbers: 2578-003; 2009_603