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Clinical Trial Details

Trial ID: L0477
Source ID: NCT00968617
Associated Drug: Mk2578
Title: A Study of MK2578 in Patients With Chronic Kidney Disease Who Are Not on Dialysis (2578-002)
Acronym:
Status: TERMINATED
Study Results: YES
Results: https://ClinicalTrials.gov/show/NCT00968617/results
Conditions: Anemia|Chronic Kidney Disease
Interventions: DRUG: MK2578|DRUG: MK2578|DRUG: MK2578|DRUG: Comparator: darbepoetin alfa
Outcome Measures: Primary: Change From Baseline in Hemoglobin Level at Week 4, 4 weeks|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, 16 Weeks|Number of Participants With Composite Events of Transfusion-related Adverse Experiences, 16 Weeks|Number of of Participants With Composite Events of Injection Site Reactions, 16 Weeks|Number of Participants With Hypertension, Seizure, and Pure Red Cell Aplasia, 16 Weeks|Number of Participants With Confirmed, Treatment Emergent Antibodies to MK2578, 16 Weeks | Secondary: Hemoglobin Concentration After Treatment With MK2578, Weeks 1-10 and Week 12|Change From Baseline in Hemoglobin Level, Weeks 1-3, 5-10, and Week 12|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., Each week up to 12 weeks
Sponsor/Collaborators: Sponsor: Merck Sharp & Dohme LLC
Gender: ALL
Age: ADULT, OLDER_ADULT
Phases: PHASE2
Enrollment: 7
Study Type: INTERVENTIONAL
Study Designs: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2009-11
Completion Date: 2010-05
Results First Posted: 2011-11-11
Last Update Posted: 2015-11-01
Locations:
URL: https://clinicaltrials.gov/show/NCT00968617