| Outcome Measures: |
Primary: The Percent Change From Baseline in ESA Dose Required to Maintain Hemoglobin in the Target Range, Adjusted for Hgb., The statistical endpoint is the change from baseline between groups at End of Treatment, where the baseline prescribed ESA dose (expressed as U/week epoetin) per subject is defined as the average weekly dose of ESA prescribed for administration over the two-week period of time immediately prior to randomization. The end-of-treatment prescribed ESA dose (expressed as U/week epoetin) per subject is defined as the average weekly dose of ESA prescribed for administration over the last two weeks of the treatment period., Hemoglobin measured weekly and serum ferritin and Transferrin Saturation (TSAT) determined every other week; ESA dose recorded at each visit for 36 weeks. | Secondary: The Distribution of Changes From Baseline in the Prescribed ESA Dose Between the Two Treatment Arms, The change from baseline in prescribed ESA dose at end-of-treatment was categorized as being greater than or equal to 25%, 10 to less than 25%, -10 to 10%, greater than -25 to -10% and less than or equal to -25%. The number of subjects in each treatment group that fit each category was compared., ESA dose is monitored and recorded at each dialysis session for 36 weeks.|Stability of Hemoglobin Over Time (Maintenance of Hemoglobin Between 9.5-11.5 g/dL., The number of patients in each treatment group who had maintained their hemoglobin between 95 and 115 grams/liter at the end of treatment was quantified., 36 weeks|The Amount of Supplemental Intravenous (IV) Iron Needed During Study Participation., The absolute amount of IV iron administered to subjects in each treatment group was divided by the number of weeks on study and the number of subjects per treatment group such that the mean dose of IV iron (mg) per week per subject (for the entire treatment group) was calculated., 36 weeks|Comparison of Iron Delivery to the Erythron From Baseline to End of Treatment Between the Treatment Groups., Iron delivery to the erythron was estimated by Hgb generation in response to erythropoietin (ERI, calculated as ESA dose/Hgb). In addition, ERI was also divided by body weight in kilograms to obtain a modified ERI (ERI/kg)., 36 weeks
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| Locations: |
Investigator, Birmingham, Alabama, 35211, United States|Investigator, Tempe, Arizona, 85284, United States|Investigator, Granada Hills, California, 91344, United States|Investigator, Colorado Springs, Colorado, 80909, United States|Investigator, Miami, Florida, 33128, United States|Investigator, Miami, Florida, 33173, United States|Investigator, Albany, Georgia, 31702, United States|Investigator, Hayden, Idaho, 83835, United States|Investigator, Louisville, Kentucky, 40202, United States|Investigator, New Orleans, Louisiana, 70122, United States|Investigator, Columbus, Mississippi, 39705, United States|Investigator, Kansas City, Missouri, 64114, United States|Investigator, Las Vegas, Nevada, 89120, United States|Investigator, Paterson, New Jersey, 07503, United States|Investigator, Lexington, North Carolina, 27292, United States|Investigator, Columbia, Tennessee, 38401, United States|Investigator, Duncanville, Texas, 75137, United States|Investigator, Greenville, Texas, 75402, United States|Investigator, San Antonio, Texas, 78215, United States|Investigator, San Antonio, Texas, 78221, United States|Investigator, Saint George, Utah, 84770, United States|Investigator, Taylorsville, Utah, 84118, United States|Investigator, Fajardo, 00738, Puerto Rico
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