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

Sponsor:	Merck
Information provided by (Responsible Party):	Merck
ClinicalTrials.gov Identifier:	NCT00968617

Purpose

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.

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

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

Resource links provided by NLM:

MedlinePlus related topics: Anemia Dialysis High Blood Pressure Kidney Failure

Drug Information available for: Darbepoetin alfa

U.S. FDA Resources

Further study details as provided by Merck:

Primary Outcome Measures:

Change From Baseline in Hemoglobin Level at Week 4 [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]
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 [ Time Frame: 16 Weeks ] [ Designated as safety issue: Yes ]
Number of Participants With Composite Events of Transfusion-related Adverse Experiences [ Time Frame: 16 Weeks ] [ Designated as safety issue: Yes ]
Number of of Participants With Composite Events of Injection Site Reactions [ Time Frame: 16 Weeks ] [ Designated as safety issue: Yes ]
Number of Participants With Hypertension, Seizure, and Pure Red Cell Aplasia [ Time Frame: 16 Weeks ] [ Designated as safety issue: Yes ]
Number of Participants With Confirmed, Treatment Emergent Antibodies to MK2578 [ Time Frame: 16 Weeks ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:

Hemoglobin Concentration After Treatment With MK2578 [ Time Frame: Weeks 1-10 and Week 12 ] [ Designated as safety issue: No ]
Change From Baseline in Hemoglobin Level [ Time Frame: Weeks 1-3, 5-10, and Week 12 ] [ Designated as safety issue: No ]
Number of Participants Who Were Responders [ Time Frame: Each week up to 12 weeks ] [ Designated as safety issue: No ]
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.

Enrollment:	7
Study Start Date:	November 2009
Study Completion Date:	May 2010
Primary Completion Date:	April 2010 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: MK2578 1.0 mcg/kg MK2578	Drug: MK2578 MK2578 1.0 mcg/kg/month
Experimental: MK2578 2.0 mcg/kg MK2578	Drug: MK2578 MK2578 2.0 mcg/kg/month
Experimental: MK2578 3.6 mcg/kg MK2578	Drug: MK2578 MK2578 3.6 mcg/kg/month
Active Comparator: Darbepoetin alfa darbepoetin alfa	Drug: Comparator: darbepoetin alfa darbepoetin alfa

Eligibility

Ages Eligible for Study:	18 Years to 75 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00968617

Sponsors and Collaborators

Merck

Investigators

Study Director:

Medical Monitor

Merck

More Information

No publications provided

Responsible Party:	Merck
ClinicalTrials.gov Identifier:	NCT00968617 History of Changes
Other Study ID Numbers:	MK-2578-002, 2009_653
Study First Received:	August 27, 2009
Results First Received:	October 7, 2011
Last Updated:	October 7, 2011
Health Authority:	United States: Food and Drug Administration

Keywords provided by Merck:

Anemia

Additional relevant MeSH terms:

Anemia
Kidney Diseases
Kidney Failure, Chronic
Renal Insufficiency, Chronic
Hematologic Diseases
Urologic Diseases

Renal Insufficiency
Darbepoetin alfa
Hematinics
Hematologic Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on February 09, 2012