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Clinical Trial Details

Trial ID: L0621
Source ID: NCT00597584
Associated Drug: Peginesatide
Title: Safety & Efficacy of Peginesatide for Maintenance Treatment of Anemia in Participants With Chronic Kidney Disease on Hemodialysis
Acronym: EMERALD 2
Status: COMPLETED
Study Results: YES
Results: https://ClinicalTrials.gov/show/NCT00597584/results
Conditions: Chronic Renal Failure|Chronic Kidney Disease|Anemia
Interventions: DRUG: peginesatide|DRUG: Epoetin alfa or Epoetin beta
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 to 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: 823
Study Type: INTERVENTIONAL
Study Designs: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2007-10
Completion Date: 2010-01
Results First Posted: 2012-07-30
Last Update Posted: 2013-03-08
Locations: Research Facility, Phoenix, Arizona, 85012, United States|Research Facility, Hot Springs, Arkansas, 71901, United States|Research Facility, McGehee, Arkansas, 71654, United States|Research Facility, Pine Bluff, Arkansas, 71603, United States|Research Facility, Bakersfield, California, 93309, United States|Research Facility, Glendale, California, 91205, United States|Research Facility, Los Angeles, California, 90033, United States|Research Facility, Los Angeles, California, 90048, United States|Research Facility, Los Angeles, California, 90073, United States|Research Facility, Riverside, California, 92505, United States|Research Facility, Simi Valley, California, 93065, United States|Research Facility, Whittier, California, 90602, United States|Research Facility, Yuba City, California, 95991, United States|Research Facility, Westminster, Colorado, 80031, United States|Research Facility, Lauderdale Lakes, Florida, 33313, United States|Research Facility, Miami, Florida, 33173, United States|Research Facility, Pinecrest, Florida, 33156, United States|Research Facility, Flossmoor, Illinois, 60422, United States|Research Facility, Hines, Illinois, 60141, United States|Research Facility, Louisville, Kentucky, 40202, United States|Research Facility, Rockville, Maryland, 20850, United States|Research Facility, Springfield, Massachusetts, 01107, United States|Research Facility, Detroit, Michigan, 48202, United States|Research Facility, Detroit, Michigan, 48236, United States|Research Facility, Brookhaven, Mississippi, 39601, United States|Research Facility, Bronx, New York, 10461, United States|Research Facility, Brooklyn, New York, 11238, United States|Research Facility, Flushing, New York, 11355, United States|Research Facility, Asheville, North Carolina, 28801, United States|Research Facility, Toledo, Ohio, 43606, United States|Research Facility, Oklahoma City, Oklahoma, 73116, United States|Research Facility, Erie, Pennsylvania, 16507, United States|Research Facility, Philadelphia, Pennsylvania, 19141, United States|Research Facility, Providence, Rhode Island, 02904, United States|Research Facility, Orangeburg, South Carolina, 29118, United States|Research Facility, Arlington, Texas, 76015, United States|Research Facility, Houston, Texas, 77099, United States|Research Facility, San Antonio, Texas, 78215, United States|Research Facility, Fairfax, Virginia, 22033, United States|Research Facility, Burgas, 8000, Bulgaria|Research Facility, Pazardzhik, 4400, Bulgaria|Research Facility, Pleven, 5800, Bulgaria|Research Facility, Plovdiv, 4000, Bulgaria|Research Facility, Plovdiv, 4003, Bulgaria|Research Facility, Rousse, 7002, Bulgaria|Research Facility, Sofia, 1309, Bulgaria|Research Facilities (2), Sofia, 1431, Bulgaria|Research Facility, Sofia, 1527, Bulgaria|Research Facility, Sofia, 1606, Bulgaria|Research Facility, Varna, 9010, Bulgaria|Research Facility, Veliko Tarnovo, 5000, Bulgaria|Research Facility, Amiens Cedex 1, 80054, France|Research Facility, Bordeaux, 33000, France|Research Facility, Montpellier Cedex 5, 34295, France|Research Facility, Vannes, 56017, France|Research Facilities (2), Bremen, 28359, Germany|Research Facility, Franfurt, 60528, Germany|Research Facility, Hamburg, 22297, Germany|Research Facility, Kaiserslautern, 67655, Germany|Research Facility, Como, 22100, Italy|Research Facility, Cremona, 26100, Italy|Research Facility, Lecco, 23900, Italy|Research Facility, Modena, 41100, Italy|Research Facility, Prato, 59100, Italy|Research Facility, Ciechanow, 06-400, Poland|Research Facility, Katowice, 40-027, Poland|Research Facility, Pabianice, 95-200, Poland|Research Facility, Wloclawek, 87-800, Poland|Research Facility, Bucuresti, 014461, Romania|Research Facility, Bucuresti, 050098, Romania|Research Facility, Iasi, 700503, Romania|Research Facility, Alicante, 03010, Spain|Research Facility, Barcelona, 08025, Spain|Research Facility, Barcelona, 08902, Spain|Research Facility, Barcelona, 08907, Spain|Research Facility, Ciudad Real, 13005, Spain|Research Facility, Madrid, 28041, Spain|Research Facility, Madrid, 28922, Spain|Research Facility, Santander, 39008, Spain|Research Facility, Carshalton, SM5 1AA, United Kingdom|Research Facility, London, E1 1BB, United Kingdom|Research Facility, London, SE5 9RS, United Kingdom|Research Facility, London, SW17 0QT, United Kingdom|Research Facility, Swansea, SA6 6NL, United Kingdom
URL: https://clinicaltrials.gov/show/NCT00597584

Drug ID Drug Name Type DrugBank ID Targets Category Latest Progress