Back to results

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

Primary Purpose

Anemia, Chronic Kidney Disease

Status

Terminated

Phase

Phase 2

Locations

Study Type

Interventional

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

About this trial

This is an interventional treatment trial for Anemia focused on measuring Anemia associated with chronic kidney disease (CKD), Hemodialysis

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm 6

Arm Type

Experimental

Arm Label

MK2578 1 mcg for every 600 U of Epogen at Baseline

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

MK2578 1 mcg for every 350 U of Epogen at Baseline

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

MK2578 1 mcg for every 200 U of Epogen at Baseline

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

Arm Description

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

Participants were randomized to receive treatment QM.

Participants were randomized to receive treatment QW.

Participants were randomized to receive treatment QM.

Participants were randomized to receive treatment QW.

Participants were randomized to receive treatment QM.

Outcomes

Primary Outcome Measures

Change From Baseline in Hemoglobin (Hg) Level at Week 4

Number of Participants With Composite Events of Death, Myocardial Infarction (MI), and Cerebrovascular Accident (CVA)

Number of Participants With Composite Events of Transfusion-Related Adverse Experiences

Number of Participants With Composite Events of Infusion Reactions

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

Number of Participants With Confirmed, Treatment Emergent Antibodies to MK2578

Secondary Outcome Measures

Change From Baseline in Hg Level at Week 12

Full Information

NCT ID

NCT00924781

First Posted

June 18, 2009

Last Updated

October 30, 2015

Sponsor

Merck Sharp & Dohme LLC

1. Study Identification

Unique Protocol Identification Number

NCT00924781

Brief Title

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

Official Title

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.

Study Type

Interventional

2. Study Status

Record Verification Date

October 2015

Overall Recruitment Status

Terminated

Study Start Date

June 2009 (undefined)

Primary Completion Date

April 2010 (Actual)

Study Completion Date

May 2010 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Merck Sharp & Dohme LLC

4. Oversight

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Anemia, Chronic Kidney Disease

Keywords

Anemia associated with chronic kidney disease (CKD), Hemodialysis

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

39 (Actual)

8. Arms, Groups, and Interventions

Arm Title

MK2578 1 mcg for every 600 U of Epogen at Baseline

Arm Type

Experimental

Arm Description

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

Arm Title

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

Arm Type

Experimental

Arm Description

Participants were randomized to receive treatment QM.

Arm Title

MK2578 1 mcg for every 350 U of Epogen at Baseline

Arm Type

Experimental

Arm Description

Participants were randomized to receive treatment QW.

Arm Title

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

Arm Type

Experimental

Arm Description

Participants were randomized to receive treatment QM.

Arm Title

MK2578 1 mcg for every 200 U of Epogen at Baseline

Arm Type

Experimental

Arm Description

Participants were randomized to receive treatment QW.

Arm Title

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

Arm Type

Experimental

Arm Description

Participants were randomized to receive treatment QM.

Intervention Type

Drug

Intervention Name(s)

MK2578 1mcg for every 600 Units (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.

Intervention Type

Drug

Intervention Name(s)

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

Intervention Description

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

Intervention Name(s)

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

Intervention Description

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.

Primary Outcome Measure Information:

Title

Change From Baseline in Hemoglobin (Hg) Level at Week 4

Time Frame

4 weeks

Title

Number of Participants With Composite Events of Death, Myocardial Infarction (MI), and Cerebrovascular Accident (CVA)

Time Frame

12 weeks

Title

Number of Participants With Composite Events of Transfusion-Related Adverse Experiences

Time Frame

12 weeks

Title

Number of Participants With Composite Events of Infusion Reactions

Time Frame

12 weeks

Title

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

Time Frame

12 weeks

Title

Number of Participants With Confirmed, Treatment Emergent Antibodies to MK2578

Time Frame

12 weeks

Secondary Outcome Measure Information:

Title

Change From Baseline in Hg Level at Week 12

Time Frame

12 weeks

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

70 Years

Accepts Healthy Volunteers

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Medical Monitor

Organizational Affiliation

Merck Sharp & Dohme LLC

Official's Role

Study Director

12. IPD Sharing Statement

Learn more about this trial

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

We'll reach out to this number within 24 hrs