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Clinical Trial Details

Trial ID: L0603
Source ID: NCT00598442
Associated Drug: Peginesatide
Title: Safety and Efficacy of Peginesatide for the Treatment of Anemia in Participants With Chronic Renal Failure Not on Dialysis
Acronym: PEARL 2
Status: COMPLETED
Study Results: YES
Results: https://ClinicalTrials.gov/show/NCT00598442/results
Conditions: Chronic Renal Failure|Chronic Kidney Disease|Anemia
Interventions: DRUG: peginesatide|DRUG: peginesatide|DRUG: Darbepoetin alfa
Outcome Measures: Primary: Mean Change in Hemoglobin Between Baseline and the Evaluation Period, The baseline hemoglobin value is defined as the mean of three hemoglobin values: the two 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 25 through 36., Baseline and Weeks 25-36 | Secondary: Proportion of Participants Who Received Red Blood Cell (RBC) Transfusions During the Correction and Evaluation Periods, Weeks 0 to 36|Proportion of Participants Achieving Hemoglobin Response During the Correction and Evaluation Periods, A hemoglobin response is defined as a hemoglobin increase of ≥ 1.0 gram per deciliter (g/dL) above baseline and a hemoglobin ≥ 11.0 g/dL without RBC transfusion during the previous 8 weeks., Weeks 0 to 36
Sponsor/Collaborators: Sponsor: Affymax | Collaborators: Takeda
Gender: ALL
Age: ADULT, OLDER_ADULT
Phases: PHASE3
Enrollment: 493
Study Type: INTERVENTIONAL
Study Designs: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2007-11
Completion Date: 2009-12
Results First Posted: 2012-07-30
Last Update Posted: 2013-02-12
Locations: Research Facility, Phoenix, Arizona, 85012, United States|Research Facility, Fayetteville, Arkansas, 72703, United States|Research Facility, Fountain Valley, California, 92708, United States|Research Facility, Fullerton, California, 92835, United States|Research Facility, Granada Hills, California, 91344, United States|Research Facility, Los Angeles, California, 90022, United States|Research Facility, San Diego, California, 92123, United States|Research Facility, Whittier, California, 90603, United States|Research Facility, Lauderdale Lakes, Florida, 33313, United States|Research Facility, Pembroke Pines, Florida, 33028, United States|Research Facility, Pinecrest, Florida, 33156, United States|Research Facility, Canton, Georgia, 30114, United States|Research Facility, Columbus, Georgia, 31904, United States|Research Facility, Marietta, Georgia, 30060, United States|Research Facility, Caldwell, Idaho, 83605, United States|Research Facility, Meridian, Idaho, 83642, United States|Research Facility, Chicago, Illinois, 60611, United States|Research Facility, Mishawaka, Indiana, 46545, United States|Research Facility, Ames, Iowa, 50010, United States|Research Facility, Baton Rouge, Louisiana, 70809, United States|Research Facility, Lafayette, Louisiana, 70506, United States|Research Facility, Rockville, Maryland, 20852, 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, Flint, Michigan, 48504, United States|Research Facility, Petoskey, Michigan, 49770, United States|Research Facility, Troy, Michigan, 48098, United States|Research Facility, Washington, Missouri, 63090, United States|Research Facility, Flushing, New York, 11355, United States|Research Facility, Williamsville, New York, 14221, United States|Research Facility, Asheville, North Carolina, 28801, United States|Research Facility, Columbus, Ohio, 43210, United States|Research Facility, Bend, Oregon, 97701, United States|Research Facility, Arlington, Texas, 76015, United States|Research Facility, Houston, Texas, 77004, United States|Research Facility, San Antonio, Texas, 78229, United States|Research Facility, Burlington, Vermont, 05401, United States|Research Facility, Fairfax, Virginia, 22030, United States|Research Facility, Tacoma, Washington, 98405, United States|Research Facility, Morgantown, West Virginia, 26506, United States|Research Facility, Neenah, Wisconsin, 54956, United States|Research Facility, Sofia, 1431, Bulgaria|Research Facility, Sofia, 1606, Bulgaria|Research Facility, Varna, 9000, Bulgaria|Research Facility, Veliko Tarnovo, 5000, Bulgaria|Research Facility, Prague, 14021, Czech Republic|Research Facility, Tabor, 39003, Czech Republic|Research Facility, Zdar nad Sazavou, 591 01, Czech Republic|Research Facility, Demmin, 17109, Germany|Research Facility, Balatonfured, 8230, Hungary|Research Facility, Kistarcsa, 2143, Hungary|Research Facility, Szigetvar, 7900, Hungary|Research Facility, Lecco, 23900, Italy|Research Facility, Pavia, 27100, Italy|Research Facility, Bialystok, 15 540, Poland|Research Facility, Gdansk, 80 952, Poland|Research Facility, Katowice, 40 027, Poland|Research Facility, Zamosc, 22 400, Poland|Research Facility, Ponce, 00717-0634, Puerto Rico|Research Facility, Iasi, 700 503, Romania|Research Facility, Oradea, 410469, Romania|Research Facility, Timisoara, 300 736, Romania|Research Facility, London, SE5 9RS, United Kingdom
URL: https://clinicaltrials.gov/show/NCT00598442

Drug ID Drug Name Type DrugBank ID Targets Category Latest Progress