Clinical Trial Details
| Trial ID: | L0468 |
| Source ID: | NCT00924781 |
| Associated Drug: | Mk2578 1mcg For Every 600 Units (U) Of Epogen® (Epoetin Alfa) Received Per Week At Baseline |
| Title: | A Study of the Efficacy and Safety of MK2578 for the Treatment of Anemia in Patients With Kidney Disease (MK2578-003-AM03-EXT12) |
| Acronym: | |
| Status: | TERMINATED |
| Study Results: | YES |
| Results: | https://ClinicalTrials.gov/show/NCT00924781/results |
| Conditions: | Anemia|Chronic Kidney Disease |
| Interventions: | DRUG: MK2578 1mcg for every 600 Units (U) of Epogen® (epoetin alfa) received per week at Baseline|DRUG: MK2578 1 mcg for every 350 U of Epogen (epoetin alfa) received per week at Baseline|DRUG: MK2578 1 mcg for every 200 U of Epogen (epoetin alfa) received per week at Baseline |
| Outcome Measures: | Primary: Change From Baseline in Hemoglobin (Hg) Level at Week 4, 4 weeks|Number of Participants With Composite Events of Death, Myocardial Infarction (MI), and Cerebrovascular Accident (CVA), 12 weeks|Number of Participants With Composite Events of Transfusion-Related Adverse Experiences, 12 weeks|Number of Participants With Composite Events of Infusion Reactions, 12 weeks|Number of Participants With Events of Death, MI, CVA, Peripheral Vascular Thromboses, Vascular Access Thrombosis, Congestive Heart Failure (CHF), Hypertension, Seizure, or Pure Red Cell Aplasia, 12 weeks|Number of Participants With Confirmed, Treatment Emergent Antibodies to MK2578, 12 weeks | Secondary: Change From Baseline in Hg Level at Week 12, 12 weeks |
| Sponsor/Collaborators: | Sponsor: Merck Sharp & Dohme LLC |
| Gender: | ALL |
| Age: | ADULT, OLDER_ADULT |
| Phases: | PHASE2 |
| Enrollment: | 39 |
| Study Type: | INTERVENTIONAL |
| Study Designs: | Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: TREATMENT |
| Start Date: | 2009-06 |
| Completion Date: | 2010-05 |
| Results First Posted: | 2012-03-29 |
| Last Update Posted: | 2015-11-01 |
| Locations: | |
| URL: | https://clinicaltrials.gov/show/NCT00924781 |
| Drug ID | Drug Name | Type | DrugBank ID | Targets | Category | Latest Progress |
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