| Outcome Measures: |
Primary: Change From Baseline Hemoglobin at End-of-Treatment: Least-Squares Mean, Mean change from baseline Hgb (the average of the three most recent Hgb values preceding randomization) assessments during the last one-sixth of the treatment period for patients who prematurely withdraw from study treatment, but will include a minimum of at least the last two Hgb values. Value is expressed as least-squares mean, along with standard error., Hgb measured weekly; up to 48 weeks from date of randomization|Change From Baseline Hemoglobin at End-of-Treatment: Mean Baseline and End-of-Treatment Hemoglobin, Mean change from baseline Hgb (the average of the three most recent Hgb values preceding randomization) assessments during the last one-sixth of the treatment period for patients who prematurely withdraw from study treatment, but will include a minimum of at least the last two Hgb values. Values expressed are mean baseline and end-of-treatment Hgb, along with the mean difference (standard deviation)., Hgb measured weekly; up to 48 weeks from date of randomization | Secondary: Mean Change in Serum Iron From Pre-Dialysis to Post-Dialysis, The mean difference between the pre-dialysis and post-dialysis serum iron was calculated, using all post-baseline values obtained during Stage 2. Subjects could participate in Stage 2 for up to 48 weeks, provided that they did not complete Stage 2 early due to a protocol-mandated change in anemia management or withdraw from the study entirely for other reasons., Up to 48 weeks from date of randomization|Mean Change in Transferrin Saturation From Pre-Dialysis to Post-Dialysis, The mean difference between the pre-dialysis and post-dialysis TSAT (transferrin) was calculated, using all post-baseline values obtained during Stage 2. Subjects could participate in Stage 2 for up to 48 weeks, provided that they did not complete Stage 2 early due to a protocol-mandated change in anemia management or withdraw from the study entirely for other reasons., Up to 48 weeks from date of randomization|Mean Change in Unsaturated Iron-Binding Capacity (UIBC) From Pre-Dialysis to Post-Dialysis, The mean difference between the pre-dialysis and post-dialysis unsaturated iron binding capacity (UIBC) was calculated, using all post-baseline values obtained during Stage 2. Subjects could participate in Stage 2 for up to 48 weeks, provided that they did not complete Stage 2 early due to a protocol-mandated change in anemia management or withdraw from the study entirely for other reasons., Up to 48 weeks from date of randomization|Red Blood Cell or Whole Blood Transfusion: Number of Patients Who Received a Transfusion, The number of patients requiring red blood cell or whole blood transfusion while in the randomized treatment stage (Stage 2). Patients remained in Stage 2 until they met protocol-defined criteria for Stage 2 completion or until they had participated in Stage 2 for 48 weeks (whichever came sooner). If a patient was transfused, they were withdrawn from Stage 2., Up to 48 weeks from date of randomization|Red Blood Cell or Whole Blood Transfusion: Number of Units Transfused, The total number of units of red blood cells or whole blood that were received by patients while in the randomized treatment stage (Stage 2). This number is the total number of units received across all randomized patients in each treatment group (it is not the average number of units received per patient). Patients remained in Stage 2 until they met protocol-defined criteria for Stage 2 completion or until they had participated in Stage 2 for 48 weeks (whichever came sooner). If a patient was transfused, they were withdrawn from Stage 2., Up to 48 weeks from date of randomization|Percentage of Change From Baseline to End-of-Treatment for: Reticulocyte Hemoglobin Content (CHr), Ferritin, and the Pre-Dialysis Serum Iron Panel, A comparison of the lab values at the end-of-treatment (EoT) to baseline was performed, and the percentage of change from baseline was calculated for the following lab parameters: reticulocyte hemoglobin content (CHr), Ferritin, pre-dialysis unbound iron-binding capacity (UIBC), pre-dialysis serum iron, pre-dialysis transferrin, pre-dialysis total iron-binding capacity TIBC), and transferrin saturation (TSAT)., up to 48 weeks from date of randomization|Change From Baseline to End-of-Treatment (EoT) in Pre-Dialysis Unsaturated Iron-Binding Capacity (UIBC), Pre-Dialysis Serum Iron, and Pre-Dialysis Total Iron-Binding Capacity (TIBC), The Mean Change from Stage 2 Baseline to End-of-Treatment (EoT) in Pre-Dialysis Unsaturated Iron-Binding Capacity (UIBC), Pre-Dialysis Serum Iron, and Pre-Dialysis Total Iron-Binding Capacity (TIBC) will be quantified., Up to 48 weeks from date of randomization|Change From Baseline to End-of-Treatment (EoT) in Reticulocyte Hemoglobin (CHr), The Mean Change from Stage 2 Baseline to End-of-Treatment (EoT) in Reticulocyte Hemoglobin (CHr), Up to 48 weeks from date of randomization|Change From Baseline to End-of-Treatment (EoT) in Ferritin, The Mean Change from Stage 2 Baseline to End-of-Treatment (EoT) in Ferritin, Up to 48 weeks from date of randomization|Change From Baseline to End-of-Treatment (EoT) in Pre-Dialysis Transferrin, The Mean Change from Stage 2 Baseline to End-of-Treatment (EoT) in Pre-Dialysis Transferrin, Up to 48 weeks from date of randomization|Change From Baseline to End-of-Treatment (EoT) in Pre-Dialysis Transferrin Saturation (TSAT), The Mean Change from Stage 2 Baseline to End-of-Treatment (EoT) in Pre-Dialysis Transferrin Saturation (TSAT), Up to 48 weeks from date of randomization|Variability of Hemoglobin Concentration: Temporal Trend, The mean temporal trend of hemoglobin concentration value changes, as measured weekly from baseline until the end of participation in Stage 2., up to 48 weeks from date of randomization|Variability of Hemoglobin Concentration: Residual Standard Deviation, The mean residual standard deviation of the hemoglobin concentration changes, as measured weekly from baseline until the end of participation in Stage 2., up to 48 weeks from date of randomization
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| Locations: |
Investigator, Paragould, Arkansas, 72450, United States|Investigator, Pine Bluff, Arkansas, 71603, United States|Investigator, Alhambra, California, 91801, United States|Investigator, Beverly Hills, California, 90211, United States|Investigator, Glendale, California, 91204, United States|Investigator, La Mesa, California, 91942, United States|Investigator, Long Beach, California, 90807, United States|Investigator, Lynwood, California, 90262, United States|Investigator, Paramount, California, 90723, United States|Investigator, Whittier, California, 90603, United States|Investigator, Pembroke Pines, Florida, 33025, United States|Investigator, Augusta, Georgia, 30901, United States|Investigator, Macon, Georgia, 31217, United States|Investigator, Meridian, Idaho, 83642, United States|Investigator, Hines, Illinois, 60141, United States|Investigator, Rockville, Maryland, 20850, United States|Investigator, Detroit, Michigan, 48236, United States|Investigator, Pontiac, Michigan, 48341, United States|Investigator, Southfield, Michigan, 48034, United States|Investigator, Eatontown, New Jersey, 07724, United States|Investigator, Brooklyn, New York, 11212, United States|Investigator, Fresh Meadows, New York, 11365, United States|Investigator, Great Neck, New York, 11021, United States|Investigator, Orchard Park, New York, 14127, United States|Investigator, The Bronx, New York, 10461, United States|Investigator, Bethany, Oklahoma, 73008, United States|Investigator, Bethlehem, Pennsylvania, 18017, United States|Investigator, Philadelphia, Pennsylvania, 19106, United States|Investigator, Philadelphia, Pennsylvania, 19144, United States|Investigator, Nashville, Tennessee, 37205, United States|Investigator, Nashville, Tennessee, 37232, United States|Investigator, Arlington, Texas, 76015, United States|Investigator, Fort Worth, Texas, 76104, United States|Investigator, Fort Worth, Texas, 76105, United States|Investigator, Houston, Texas, 77004, United States|Investigator, Houston, Texas, 77099, United States|Investigator, San Antonio, Texas, 78229, United States|Investigator, Fairfax, Virginia, 22033, United States|Investogator, Edmonton, Alberta, T6G 2B7, Canada|Investigator, Greenfield Park, Quebec, J4V 2H1, Canada
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