Outcome Measures: |
Primary: Mean Erythropoietin Dose Per Visit, The requirement of erythropoietin (EPO) treatment to maintain serum hemoglobin levels between 10 to 11.5 g/dL during the study was assessed by analysis of the dose of darbepoetin alfa used at baseline and during each month of the study. The mean EPO dosage per injection for each study month is reported., Baseline and Months 1, 2, 3, 4, 5 and 6 | Secondary: Mean Scores of Short Form Health Survey 36 (SF-36) Questionnaire, The Medical Outcome Study Short Form 36-Item Health Survey (SF-36) is a self-administered questionnaire that measures the impact of disease on overall quality of life and consists of 36 questions in eight domains. The domains include physical (physical functioning, role limitations due to physical health (role-physical), general health perceptions and pain) and mental domains (energy/fatigue (vitality), social functioning, emotional well-being (mental health), and role limitations due to emotional problems (role emotional)). The individual domain scores are calculated and transformed to range from 0 to 100, with higher scores indicating a better level of functioning., Baseline and Month 6|Mean Intact Parathyroid Hormone (iPTH) Level at Baseline and Month 6, Baseline and Month 6|Mean Calcium Level at Baseline and Month 6, Baseline and Month 6|Mean Phosphorus Level at Baseline and Month 6, Baseline and Month 6|Mean Alkaline Phosphatase Level at Baseline and Month 6, Baseline and Month 6|Vitamin B12 Levels, Vitamin B12 levels were categorized according to the following laboratory reference ranges: Low: \< 200 pg/mL Normal: 200 - 950 pg/mL High: \> 950 pg/mL, Baseline and month 6|Folic Acid Levels, Folic acid levels were categorized according to the following laboratory reference ranges: Low: \< 4.6 ng/mL Normal: 4.6 - 18.7 ng/mL High: \> 18.7 ng/mL, Baseline and month 6|Mean High Sensitivity C-reactive Protein (hsCRP) Level at Baseline and Month 6, Baseline and Month 6|Mean Fibroblast Growth Factor-23 (FGF-23) Level at Baseline and Month 6, Baseline and Month 6|Number of Participants With Adverse Events, Serious adverse events were any adverse events meeting any of the following criteria: * An event that resulted in the death of a participant; * An event that, in the opinion of the investigator, would have resulted in immediate fatality if medical intervention had not been taken (life-threatening); * Resulted in an admission to the hospital for any length of time or prolonged hospital stay; * An anomaly detected at or after birth, or any anomaly that results in fetal loss; * An event that resulted in a condition that substantially interfered with the activities of daily living; * An important medical event that may not be immediately life-threatening or result in death or hospitalization, but based on medical judgment may have jeopardized the participant and may have required medical or surgical intervention to prevent any of the outcomes listed above. Adverse events were assessed by the investigator for possible relationship to study drug., From the time of study drug administration until 4 weeks after the discontinuation of the study drug; up to 7 months.
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