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Clinical Trial Details

Trial ID: L0620
Source ID: NCT00597753
Associated Drug: Peginesatide
Title: Safety & Efficacy of Peginesatide for Maintenance Treatment of Anemia in Participants With Chronic Kidney Disease on Hemodialysis
Acronym: EMERALD 1
Status: COMPLETED
Study Results: YES
Results: https://ClinicalTrials.gov/show/NCT00597753/results
Conditions: Chronic Renal Failure|Chronic Kidney Disease|Anemia
Interventions: DRUG: peginesatide|DRUG: Epoetin Alfa
Outcome Measures: Primary: Mean Change in Hemoglobin Between Baseline and the Evaluation Period, The baseline hemoglobin value is defined as the mean of five hemoglobin values: the four most recent hemoglobin values taken prior to the day of randomization and the value obtained on the day of randomization. The mean hemoglobin during the Evaluation Period for each participant is calculated as the mean of the available hemoglobin values during study Weeks 29 through 36., Baseline and Weeks 29-36 | Secondary: Proportion of Participants Who Receive Red Blood Cell (RBC) Transfusions During the Titration and Evaluation Periods, Weeks 0 to 36|Proportion of Participants Whose Mean Hemoglobin Level During the Evaluation Period is Within the Target Range of 10.0 - 12.0 Grams Per Deciliter (g/dL), Weeks 29 to 36
Sponsor/Collaborators: Sponsor: Affymax | Collaborators: Takeda
Gender: ALL
Age: ADULT, OLDER_ADULT
Phases: PHASE3
Enrollment: 803
Study Type: INTERVENTIONAL
Study Designs: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2007-09
Completion Date: 2010-01
Results First Posted: 2012-07-30
Last Update Posted: 2013-02-12
Locations: Research Facility, Paragould, Arkansas, 72450, United States|Research Facility, Fairfield, California, 94533, United States|Research Facility, Granada Hills, California, 91344, United States|Research Facility, Los Alamitos, California, 90720, United States|Research Facility, Los Angeles, California, 90022, United States|Research Facility, Los Angeles, California, 90033, United States|Research Facility, Los Angeles, California, 90095, United States|Research Facility, Lynwood, California, 90262, United States|Research Facility, Monterey Park, California, 91754, United States|Research Facility, Mountain View, California, 94041, United States|Research Facility, Paramount, California, 90723, United States|Research Facilities (2), San Diego, California, 92123, United States|Research Facility, San Dimas, California, 91773, United States|Research Facility, Whittier, California, 90603, United States|Research Facility, Denver, Colorado, 80230, United States|Research Facility, Middlebury, Connecticut, 06762, United States|Research Facility, Hudson, Florida, 34667, United States|Research Facility, Ocala, Florida, 34471, United States|Research Facility, Orlando, Florida, 32804, United States|Research Facility, Orlando, Florida, 32806, United States|Research Facility, Pembroke Pines, Florida, 33028, United States|Research Facility, Augusta, Georgia, 30901, United States|Research Facility, Augusta, Georgia, 30912, United States|Research Facility, Decatur, Georgia, 30030, United States|Research Facility, Marietta, Georgia, 30060, United States|Research Facility, Honolulu, Hawaii, 96817, United States|Research Facility, Boise, Idaho, 83706, United States|Research Facility, Chicago, Illinois, 60661, United States|Research Facility, Evergreen Park, Illinois, 60805, United States|Research Facility, Gurnee, Illinois, 60031, United States|Research Facility, Peoria, Illinois, 61603, United States|Research Facility, Evansville, Indiana, 47714, United States|Research Facility, Wichita, Kansas, 67214, United States|Research Facility, Lexington, Kentucky, 40513, United States|Research Facility, Baton Rouge, Louisiana, 70809, United States|Research Facility, Lafayette, Louisiana, 70506, United States|Research Facility, New Orleans, Louisiana, 70112, United States|Research Facility, Shreveport, Louisiana, 71101, United States|Research Facility, Bethesda, Maryland, 20817, United States|Research Facility, Rockville, Maryland, 20852, United States|Research Facility, Fall River, Massachusetts, 02720, United States|Research Facility, Worcester, Massachusetts, 01605, United States|Research Facility, Dearborn, Michigan, 48195, United States|Research Facility, Kalamazoo, Michigan, 49007, United States|Research Facility, Columbus, Mississippi, 39705, United States|Research Facility, Tupelo, Mississippi, 38801, United States|Research Facility, St. Louis, Missouri, 63110, United States|Research Facility, Las Vegas, Nevada, 89106, United States|Research Facility, Eatontown, New Jersey, 07724, United States|Research Facility, Bronx, New York, 10461, United States|Research Facility, Bronx, New York, 10467, United States|Research Facility, Brooklyn, New York, 11212, United States|Research Facility, New York, New York, 10128, United States|Research Facility, Williamsville, New York, 14221, United States|Research Facility, Yonkers, New York, 10710, United States|Research Facility, Durham, North Carolina, 27704, United States|Research Facility, Raleigh, North Carolina, 27609, United States|Research Facility, Canton, Ohio, 44718, United States|Research Facility, Cincinnati, Ohio, 45267, United States|Research Facility, Columbus, Ohio, 43210, United States|Research Facility, Roseburg, Oregon, 97471, United States|Research Facility, Allentown, Pennsylvania, 18103, United States|Research Facility, Philadelphia, Pennsylvania, 19106, United States|Research Facility, Philadelphia, Pennsylvania, 19144, United States|Research Facility, Pittsburgh, Pennsylvania, 15224, United States|Research Facilities (2), Greenville, South Carolina, 29605, United States|Research Facility, Sumter, South Carolina, 29150, United States|Research Facility, Dyersburg, Tennessee, 38024, United States|Research Facility, Knoxville, Tennessee, 37923, United States|Research Facility, Nashville, Tennessee, 37205, United States|Research Facility, Arlington, Texas, 76011, United States|Research Facility, Fort Worth, Texas, 76105, United States|Research Facility, Fort Worth, Texas, 76106, United States|Research Facility, Fort Worth, Texas, 76133, United States|Research Facility, Grand Prairie, Texas, 75050, United States|Research Facilities (2), Houston, Texas, 77054, United States|Research Facility, Houston, Texas, 77091, United States|Research Facility, McAllen, Texas, 78503, United States|Research Facility, San Antonio, Texas, 78205, United States|Research Facility, San Antonio, Texas, 78229, United States|Research Facility, Tyler, Texas, 75701, United States|Research Facility, Alexandria, Virginia, 22304, United States|Research Facility, Chesapeake, Virginia, 23320, United States|Research Facility, Fairfax, Virginia, 22030, United States|Research Facility, Mechanicsville, Virginia, 23116, United States|Research Facilities (2), Norfolk, Virginia, 23507, United States|Research Facility, Morgantown, West Virginia, 26506, United States|Research Facility, Appleton, Wisconsin, 54956, United States|Research Facility, Oshkosh, Wisconsin, 54904, United States
URL: https://clinicaltrials.gov/show/NCT00597753

Drug ID Drug Name Type DrugBank ID Targets Category Latest Progress