| Outcome Measures: |
Primary: Hb Change Between Baseline and the Evaluation Period (Average of Weeks 29-33), The Adjusted Analysis is the primary analysis and includes treatment group and baseline Hb value as covariates. Non-inferiority is concluded if the lower limit of the 95% confidence interval for the mean difference is above -0.5g/dL., Baseline Week 33 | Secondary: Achievement of Both a Hb >= 10.0 g/dL and a >= 1.0 g/dL Increase From Baseline at Any Time Point Following de Novo Darbepoetin Alfa Administration., Baseline to Week 33|Hb at Baseline, Baseline|Hb at Week 3, Week 3|Hb at Week 5, Week 5|Hb at Week 7, Week 7|Hb at Week 9, Week 9|Hb at Week 11, Week 11|Hb at Week 13, Week 13|Hb at Week 15, Week 15|Hb at Week 17, Week 17|Hb at Week 19, Week 19|Hb at Week 21, Week 21|Hb at Week 23, Week 23|Hb at Week 25, Week 25|Hb at Week 27, Week 27|Hb at Week 29, Week 29|Hb at Week 31, Week 31|Hb at Week 33, Week 33|Darbepoetin Alfa Dose at Week 1, Although the endpoint is related to dose, the sample is from the Primary Analysis Set which requires a Hb value in the evaluation period, Week 1|Darbepoetin Alfa Dose at Week 3, Although the endpoint is related to dose, the sample is from the Primary Analysis Set which requires a Hb value in the evaluation period, Week 3|Darbepoetin Alfa Dose at Week 5, Although the endpoint is related to dose, the sample is from the Primary Analysis Set which requires a Hb value in the evaluation period, Week 5|Darbepoetin Alfa Dose at Week 7, Although the endpoint is related to dose, the sample is from the Primary Analysis Set which requires a Hb value in the evaluation period, Week 7|Darbepoetin Alfa Dose at Week 9, Although the endpoint is related to dose, the sample is from the Primary Analysis Set which requires a Hb value in the evaluation period, Week 9|Darbepoetin Alfa Dose at Week 11, Although the endpoint is related to dose, the sample is from the Primary Analysis Set which requires a Hb value in the evaluation period, Week 11|Darbepoetin Alfa Dose at Week 13, Although the endpoint is related to dose, the sample is from the Primary Analysis Set which requires a Hb value in the evaluation period, Week 13|Darbepoetin Alfa Dose at Week 15, Although the endpoint is related to dose, the sample is from the Primary Analysis Set which requires a Hb value in the evaluation period, Week 15|Darbepoetin Alfa Dose at Week 17, Although the endpoint is related to dose, the sample is from the Primary Analysis Set which requires a Hb value in the evaluation period, Week 17|Darbepoetin Alfa Dose at Week 19, Although the endpoint is related to dose, the sample is from the Primary Analysis Set which requires a Hb value in the evaluation period, Week 19|Darbepoetin Alfa Dose at Week 21, Although the endpoint is related to dose, the sample is from the Primary Analysis Set which requires a Hb value in the evaluation period, Week 21|Darbepoetin Alfa Dose at Week 23, Although the endpoint is related to dose, the sample is from the Primary Analysis Set which requires a Hb value in the evaluation period, Week 23|Darbepoetin Alfa Dose at Week 25, Although the endpoint is related to dose, the sample is from the Primary Analysis Set which requires a Hb value in the evaluation period, Week 25|Darbepoetin Alfa Dose at Week 27, Although the endpoint is related to dose, the sample is from the Primary Analysis Set which requires a Hb value in the evaluation period, Week 27|Darbepoetin Alfa Dose at Week 29, Although the endpoint is related to dose, the sample is from the Primary Analysis Set which requires a Hb value in the evaluation period, Week 29|Darbepoetin Alfa Dose at Week 31, Although the endpoint is related to dose, the sample is from the Primary Analysis Set which requires a Hb value in the evaluation period, Week 31|Darbepoetin Alfa Dose During the Evaluation Period (Average of Weeks 29-33), Although the endpoint is related to dose, the sample is from the Primary Analysis Set which requires a Hb value in the evaluation period, Weeks 29-33|Ratio of Darbepoetin Alfa Dose to Baseline at Week 3, Although the endpoint is related to dose, the sample is from the Primary Analysis Set which requires a Hb value in the evaluation period, Week 3|Ratio of Darbepoetin Alfa Dose to Baseline at Week 5, Although the endpoint is related to dose, the sample is from the Primary Analysis Set which requires a Hb value in the evaluation period, Week 5|Ratio of Darbepoetin Alfa Dose to Baseline at Week 7, Although the endpoint is related to dose, the sample is from the Primary Analysis Set which requires a Hb value in the evaluation period, Week 7|Ratio of Darbepoetin Alfa Dose to Baseline at Week 9, Although the endpoint is related to dose, the sample is from the Primary Analysis Set which requires a Hb value in the evaluation period, Week 9|Ratio of Darbepoetin Alfa Dose to Baseline at Week 11, Although the endpoint is related to dose, the sample is from the Primary Analysis Set which requires a Hb value in the evaluation period, Week 11|Ratio of Darbepoetin Alfa Dose to Baseline at Week 13, Although the endpoint is related to dose, the sample is from the Primary Analysis Set which requires a Hb value in the evaluation period, Week 13|Ratio of Darbepoetin Alfa Dose to Baseline at Week 15, Although the endpoint is related to dose, the sample is from the Primary Analysis Set which requires a Hb value in the evaluation period, Week 15|Ratio of Darbepoetin Alfa Dose to Baseline at Week 17, Although the endpoint is related to dose, the sample is from the Primary Analysis Set which requires a Hb value in the evaluation period, Week 17|Ratio of Darbepoetin Alfa Dose to Baseline at Week 19, Although the endpoint is related to dose, the sample is from the Primary Analysis Set which requires a Hb value in the evaluation period, Week 19|Ratio of Darbepoetin Alfa Dose to Baseline at Week 21, Although the endpoint is related to dose, the sample is from the Primary Analysis Set which requires a Hb value in the evaluation period, Week 21|Ratio of Darbepoetin Alfa Dose to Baseline at Week 23, Although the endpoint is related to dose, the sample is from the Primary Analysis Set which requires a Hb value in the evaluation period, Week 23|Ratio of Darbepoetin Alfa Dose to Baseline at Week 25, Although the endpoint is related to dose, the sample is from the Primary Analysis Set which requires a Hb value in the evaluation period, Week 25|Ratio of Darbepoetin Alfa Dose to Baseline at Week 27, Although the endpoint is related to dose, the sample is from the Primary Analysis Set which requires a Hb value in the evaluation period, Week 27|Ratio of Darbepoetin Alfa Dose to Baseline at Week 29, Although the endpoint is related to dose, the sample is from the Primary Analysis Set which requires a Hb value in the evaluation period, Week 29|Ratio of Darbepoetin Alfa Dose to Baseline at Week 31, Although the endpoint is related to dose, the sample is from the Primary Analysis Set which requires a Hb value in the evaluation period, Week 31|Dose of Darbepoetin Alfa at the First Achievement of a Hb ≥10.0 g/dL and a ≥1.0 g/dL Increase From Baseline (Weeks 1-33), Although the endpoint is related to dose, the sample is from the Primary Analysis Set which requires a Hb value in the evaluation period, Weeks 1-33|Time to First Achievement of a Hb ≥10.0 g/dL and a ≥1.0 g/dL Increase From Baseline (Weeks 1-33), Weeks 1-33|Ratio of Darbepoetin Alfa Dose to Baseline at the Evalaution Period (Average of Weeks 29-33), Although the endpoint is related to dose, the sample is from the Primary Analysis Set which requires a Hb value in the evaluation period, Evaluation Period
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| Locations: |
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