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Main
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Note: This record shows only the 20 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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17 October 2012 |
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Main ID: |
NCT00968617 |
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Date of registration:
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27/08/2009 |
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Primary sponsor: |
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Public title:
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A Study of MK2578 in Patients With Chronic Kidney Disease Who Are Not on Dialysis (2578-002)
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Scientific title:
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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 |
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Date of first enrolment:
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November 2009 |
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Target sample size:
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7 |
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Recruitment status: |
Terminated |
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URL:
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http://clinicaltrials.gov/show/NCT00968617 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
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Countries of recruitment
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United States
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Contacts
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Name:
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Medical Monitor |
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Address:
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Telephone:
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Email:
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Affiliation:
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Merck |
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Key inclusion & exclusion criteria
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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
Age minimum:
18 Years
Age maximum:
75 Years
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Anemia
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Chronic Kidney Disease
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Intervention(s)
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Drug: Comparator: darbepoetin alfa
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Drug: MK2578
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Primary Outcome(s)
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Change From Baseline in Hemoglobin Level at Week 4
[Time Frame: 4 weeks]
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Number of of Participants With Composite Events of Injection Site Reactions
[Time Frame: 16 Weeks]
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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]
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Number of Participants With Composite Events of Transfusion-related Adverse Experiences
[Time Frame: 16 Weeks]
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Number of Participants With Confirmed, Treatment Emergent Antibodies to MK2578
[Time Frame: 16 Weeks]
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Number of Participants With Hypertension, Seizure, and Pure Red Cell Aplasia
[Time Frame: 16 Weeks]
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Secondary Outcome(s)
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Change From Baseline in Hemoglobin Level
[Time Frame: Weeks 1-3, 5-10, and Week 12]
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Hemoglobin Concentration After Treatment With MK2578
[Time Frame: Weeks 1-10 and Week 12]
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Number of Participants Who Were Responders
[Time Frame: Each week up to 12 weeks]
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Secondary ID(s)
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2009_653
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MK-2578-002
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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