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

NCT ID: NCT00924781

Last Updated: 2015-11-02

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE2
• Total Enrollment: 39 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2009-06-30
• Study Completion Date: 2010-05-31

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.

Conditions

Anemia; Chronic Kidney Disease

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

MK2578 1 mcg for every 600 U of Epogen at Baseline

Participants were randomized to receive treatment every week (QW).

Group Type: EXPERIMENTAL

MK2578 1mcg for every 600 Units (U) of Epogen® (epoetin alfa) received per week at Baseline

Intervention Type: DRUG

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.

1 mcg of MK2578 for every 600 U of Epogen at Baseline

Participants were randomized to receive treatment QM.

Group Type: EXPERIMENTAL

MK2578 1mcg for every 600 Units (U) of Epogen® (epoetin alfa) received per week at Baseline

Intervention Type: DRUG

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 1 mcg for every 350 U of Epogen at Baseline

Participants were randomized to receive treatment QW.

Group Type: EXPERIMENTAL

MK2578 1 mcg for every 350 U of Epogen (epoetin alfa) received per week at Baseline

Intervention Type: DRUG

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.

1 mcg of MK2578 for every 350 U of Epogen at Baseline

Participants were randomized to receive treatment QM.

Group Type: EXPERIMENTAL

MK2578 1 mcg for every 350 U of Epogen (epoetin alfa) received per week at Baseline

Intervention Type: DRUG

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 1 mcg for every 200 U of Epogen at Baseline

Participants were randomized to receive treatment QW.

Group Type: EXPERIMENTAL

MK2578 1 mcg for every 200 U of Epogen (epoetin alfa) received per week at Baseline

Intervention Type: DRUG

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.

1 mcg of MK2578 for every 200 U of Epogen at Baseline

Participants were randomized to receive treatment QM.

Group Type: EXPERIMENTAL

MK2578 1 mcg for every 200 U of Epogen (epoetin alfa) received per week at Baseline

Intervention Type: DRUG

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.

Interventions

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.

Intervention Type: 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.

Intervention Type: 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.

Intervention Type: DRUG

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Merck Sharp & Dohme LLC

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Medical Monitor

Role: STUDY_DIRECTOR

Merck Sharp & Dohme LLC

Other Identifiers

2009_603

Identifier Type: -

Identifier Source: secondary_id

2578-003

Identifier Type: -

Identifier Source: org_study_id