A Study of the Efficacy and Safety of MK2578 for the Treatment of Anemia in Patients With Kidney Disease - Full Text View

Sponsor:	Merck
Information provided by:	Merck
ClinicalTrials.gov Identifier:	NCT00924781

Purpose

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.

Condition	Intervention	Phase
Anemia Chronic Kidney Disease	Drug: MK2578 Drug: Comparator: MK2578	Phase II

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment
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

Resource links provided by NLM:

MedlinePlus related topics: Anemia Dialysis High Blood Pressure Kidney Failure

U.S. FDA Resources

Further study details as provided by Merck:

Primary Outcome Measures:

Change from baseline in hemoglobin level [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]
Percentage of patients with composite events of death, myocardial infarction (MI), and cerebrovascular accident (CVA) [ Time Frame: 12 weeks ] [ Designated as safety issue: Yes ]
Percentage of patients with composite events of transfusion-related adverse experiences [ Time Frame: 12 weeks ] [ Designated as safety issue: Yes ]
Percentage of patients with composite events of infusion reactions [ Time Frame: 12 weeks ] [ Designated as safety issue: Yes ]
Percentage of patients with events of death, MI, CVA, peripheral vascular thromboses (including vascular access thrombosis), congestive heart failure, hypertension, seizure, pure red cell aplasia [ Time Frame: 12 weeks ] [ Designated as safety issue: Yes ]
Percentage of patients with confirmed, treatment emergent antibodies to MK2578 [ Time Frame: 12 weeks ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:

Change from baseline in hemoglobin level [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]

Enrollment:	158
Study Start Date:	June 2009
Study Completion Date:	May 2010
Primary Completion Date:	May 2010 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: 1 MK2578	Drug: MK2578 Low Dose MK2578
Experimental: 2 MK2578	Drug: Comparator: MK2578 Mid Dose MK2578
Experimental: 3 MK2578	Drug: Comparator: MK2578 High Dose MK2578

Detailed Description:

This study consists of a 12-week base study (MK2578-003-00) and an optional 40-week extension study (MK2578-003-10). Patients 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 hemoglobin (Hb) levels within range. Patients' doses of MK2578 will be adjusted upward or downward during the extension study to maintain Hb in the range of 10-12 g/dL.

Eligibility

Ages Eligible for Study:	18 Years to 65 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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 HIV
Patient has history of blood dyscrasia, hematologic disorders or any other disease known to cause anemia
Patient has severe congestive heart failure
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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00924781

Sponsors and Collaborators

Merck

Investigators

Study Director:

Medical Monitor

Merck

More Information

No publications provided

Responsible Party:	Executive Vice President, Clinical and Quantitative Sciences, Merck Sharp & Dohme Corp
ClinicalTrials.gov Identifier:	NCT00924781 History of Changes
Other Study ID Numbers:	2009_603, MK2578-003
Study First Received:	June 18, 2009
Last Updated:	May 27, 2010
Health Authority:	United States: Food and Drug Administration

Keywords provided by Merck:

Anemia associated with chronic kidney disease (CKD)

Additional relevant MeSH terms:

Anemia
Kidney Diseases
Kidney Failure, Chronic
Renal Insufficiency, Chronic

Hematologic Diseases
Urologic Diseases
Renal Insufficiency

ClinicalTrials.gov processed this record on February 09, 2012