| 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 with standard error., Hgb measured weekly; up to 48 weeks from the date of randomization|Change From Baseline Hemoglobin at End-of-Treatment: Mean Baseline and End-of-Treatment Hgb, 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 the 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 the date of randomization|Mean Change in TSAT (Transferrin) 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 the date of randomization|Mean Change in Unsaturated Iron Binding Capacity (UIBC) From Pre- 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 the date of randomization|Red Blood Cell or Whole Blood Transfusion: Number of Patients Receiving 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 the 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 the date of randomization|Percentage of Change From Baseline to End-of-Treatment (EoT) for: Reticulocyte Hemoglobin Content (CHr), Ferritin, and 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 the date of randomization|Change From Baseline to End-of-Treatment (EoT) in Pre-Dialysis Unsaturated Iron-Binding Capacity (UIBC), Serum Iron, and 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 the date of randomization|Change From Baseline to End-of-Treatment (EoT) in Reticulocyte Hemoglobin Content (CHr), The Mean Change from Stage 2 Baseline to End-of-Treatment (EoT) in Reticulocyte Hemoglobin Content (CHr) will be quantified., Up to 48 weeks from the 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 will be quantified., Up to 48 weeks from the 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 will be quantified., Up to 48 weeks from the 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) will be quantified., Up to 48 weeks from the 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., Hgb measured weekly; up to 48 weeks from the date of randomization|Variability of Hemoglobin Concentration: Residual Standard Deviation, The mean residual standard deviation of hemoglobin concentration value changes, as measured weekly from baseline until the end of participation in Stage 2., Hgb measured weekly; up to 48 weeks from the date of randomization
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| Locations: |
Bakersfield, California, 93308, United States|Investigative Site, Chula Vista, California, 91910, United States|Cudahy, California, 90201, United States|Downey, California, 90240, United States|Encino, California, 91316, United States|Los Angeles, California, 90022, United States|Los Angeles, California, 90033, United States|Los Angeles, California, 90057, United States|Los Angeles, California, 90404, United States|National City, California, 91950, United States|Northridge, California, 91324, United States|Ontario, California, 91764, United States|Panorama City, California, 91402, United States|Riverside, California, 92505, United States|San Dimas, California, 91773, United States|Simi Valley, California, 93065, United States|West Covina, California, 91792, United States|Yuba City, California, 95991, United States|Investigative Site, Waterbury, Connecticut, 06708, United States|Waterbury, Connecticut, 06708, United States|Coral Springs, Florida, 33071, United States|Miami, Florida, 33150, United States|Investigative Site, Augusta, Georgia, 30901, United States|Chicago, Illinois, 60617, United States|Michigan City, Indiana, 46360, United States|Detroit, Michigan, 48202, United States|Las Vegas, Nevada, 89102, United States|Investigative Site, Mineola, New York, 11501, United States|Investigative Site, Ridgewood, New York, 11385, United States|Rosedale, New York, 11422, United States|Yonkers, New York, 10704, United States|Asheville, North Carolina, 28801, United States|Durham, North Carolina, 27704, United States|Winston-Salem, North Carolina, 27105, United States|Cincinnati, Ohio, 45206, United States|Toledo, Ohio, 43613, United States|Sumter, South Carolina, 29150, United States|Chattanooga, Tennessee, 37404, United States|Arlington, Texas, 76011, United States|Fort Worth, Texas, 76164, United States|Investigative Site, Houston, Texas, 77004, United States|Houston, Texas, 77081, United States|San Antonio, Texas, 78207, United States|Fairfax, Virginia, 22030, United States|Shorewood, Wisconsin, 53211, United States|Caguas, 00725, Puerto Rico|Carolina, 00987, Puerto Rico
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