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A Study of MK2578 in Patients With Chronic Kidney Disease Who Are Not on Dialysis (2578-002)

Primary Purpose

Anemia, Chronic Kidney Disease

Status

Terminated

Phase

Phase 2

Locations

Study Type

Interventional

Intervention

MK2578

Comparator: darbepoetin alfa

About this trial

This is an interventional treatment trial for Anemia focused on measuring Anemia

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Patient is male or is a female who either cannot have children or who agrees to use appropriate contraceptive measures
Patient has chronic kidney disease

Exclusion Criteria:

Patient is morbidly obese
Patient has used another erythropoiesis (red blood cell formation) stimulating agent within 12 weeks of screening
Patient will require dialysis during the study or is planning to have 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 the past 12 weeks or plans to have surgery
Patient has Human Immunodeficiency Virus (HIV)
Patient has a history of diseases other than CKD known to cause anemia
Patient has severe congestive heart failure
Patient has history of malignant cancer, except certain skin or cervical cancers
Patient has a history of grand mal seizures within the last 6 months
Patient is pregnant or breastfeeding

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Active Comparator

Arm Label

MK2578 1.0 mcg/kg

MK2578 2.0 mcg/kg

MK2578 3.6 mcg/kg

Darbepoetin alfa

Arm Description

MK2578

darbepoetin alfa

Outcomes

Primary Outcome Measures

Change From Baseline in Hemoglobin Level at Week 4

Number of Participants With Composite Events of Death, Myocardial Infarction and Cerebrovascular Accident, Serious Events of Unstable Angina, Transient Ischemic Attack, Arrythmia and Congestive Heart Failure, Peripheral Thrombo-embolic Events

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

Number of of Participants With Composite Events of Injection Site Reactions

Number of Participants With Hypertension, Seizure, and Pure Red Cell Aplasia

Number of Participants With Confirmed, Treatment Emergent Antibodies to MK2578

Secondary Outcome Measures

Hemoglobin Concentration After Treatment With MK2578

Change From Baseline in Hemoglobin Level

Number of Participants Who Were Responders

Responder was defined as a participant achieving (pre-transfusion) an increase from baseline hemoglobin of greater than or equal to 1 g/dL and a hemoglobin concentration of greater than or equal to 11 g/dL.

Full Information

NCT ID

NCT00968617

First Posted

August 27, 2009

Last Updated

October 30, 2015

Sponsor

Merck Sharp & Dohme LLC

1. Study Identification

Unique Protocol Identification Number

NCT00968617

Brief Title

A Study of MK2578 in Patients With Chronic Kidney Disease Who Are Not on Dialysis (2578-002)

Official Title

A Phase IIb Randomized, Active Comparator-Controlled, Open-Label Clinical Trial to Study the Efficacy and Safety of MK2578 for the Treatment of Anemia in ESA (Erythropoiesis-Stimulating Agent)-Naive Patients With Chronic Kidney Disease Who Are Not on Dialysis.

Study Type

Interventional

2. Study Status

Record Verification Date

October 2015

Overall Recruitment Status

Terminated

Study Start Date

November 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 define an effective starting dose for subcutaneous administration of MK2578 to correct anemia in erythropoiesis-stimulating agent (ESA)-naive patients with chronic kidney disease (CKD) who are not on dialysis while evaluating its safety.

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

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

7 (Actual)

8. Arms, Groups, and Interventions

Arm Title

MK2578 1.0 mcg/kg

Arm Type

Experimental

Arm Description

MK2578

Arm Title

MK2578 2.0 mcg/kg

Arm Type

Experimental

Arm Description

MK2578

Arm Title

MK2578 3.6 mcg/kg

Arm Type

Experimental

Arm Description

MK2578

Arm Title

Darbepoetin alfa

Arm Type

Active Comparator

Arm Description

darbepoetin alfa

Intervention Type

Drug

Intervention Name(s)

MK2578

Intervention Description

MK2578 1.0 mcg/kg/month

Intervention Type

Drug

Intervention Name(s)

MK2578

Intervention Description

MK2578 2.0 mcg/kg/month

Intervention Type

Drug

Intervention Name(s)

MK2578

Intervention Description

MK2578 3.6 mcg/kg/month

Intervention Type

Drug

Intervention Name(s)

Comparator: darbepoetin alfa

Intervention Description

darbepoetin alfa

Primary Outcome Measure Information:

Title

Change From Baseline in Hemoglobin Level at Week 4

Time Frame

4 weeks

Title

Time Frame

16 Weeks

Title

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

Time Frame

16 Weeks

Title

Number of of Participants With Composite Events of Injection Site Reactions

Time Frame

16 Weeks

Title

Number of Participants With Hypertension, Seizure, and Pure Red Cell Aplasia

Time Frame

16 Weeks

Title

Number of Participants With Confirmed, Treatment Emergent Antibodies to MK2578

Time Frame

16 Weeks

Secondary Outcome Measure Information:

Title

Hemoglobin Concentration After Treatment With MK2578

Time Frame

Weeks 1-10 and Week 12

Title

Change From Baseline in Hemoglobin Level

Time Frame

Weeks 1-3, 5-10, and Week 12

Title

Number of Participants Who Were Responders

Description

Time Frame

Each week up to 12 weeks

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

75 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Patient is male or is a female who either cannot have children or who agrees to use appropriate contraceptive measures Patient has chronic kidney disease Exclusion Criteria: Patient is morbidly obese Patient has used another erythropoiesis (red blood cell formation) stimulating agent within 12 weeks of screening Patient will require dialysis during the study or is planning to have 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 the past 12 weeks or plans to have surgery Patient has Human Immunodeficiency Virus (HIV) Patient has a history of diseases other than CKD known to cause anemia Patient has severe congestive heart failure Patient has history of malignant cancer, except certain skin or cervical cancers Patient has a history of grand mal seizures within the last 6 months Patient is pregnant or breastfeeding

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 MK2578 in Patients With Chronic Kidney Disease Who Are Not on Dialysis (2578-002)

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