The purpose of this study is to determine whether once monthly (QM) dosing of darbepoetin alfa is non-inferior to that of once every 2 week (Q2W) dosing of darbepoetin alfa for the correction of anemia in patients with Chronic Kidney Disease who are not receiving dialysis.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
358
Drug administered either Q2W or QM using a prefilled syringe. Allowable doses of: 10, 20, 30, 40, 50, 60, 80, 100, 130, 150, 200, 300, 400 or 600 mcg.
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.
Time frame: Baseline Week 33
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.
Time frame: Baseline to Week 33
Hb at Baseline
Time frame: Baseline
Hb at Week 3
Time frame: Week 3
Hb at Week 5
Time frame: Week 5
Hb at Week 7
Time frame: Week 7
Hb at Week 9
Time frame: Week 9
Hb at Week 11
Time frame: Week 11
Hb at Week 13
Time frame: Week 13
Hb at Week 15
Time frame: Week 15
Hb at Week 17
Time frame: Week 17
Hb at Week 19
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Research Site
Gosford, New South Wales, Australia
Research Site
Liverpool, New South Wales, Australia
Research Site
New Lambton, New South Wales, Australia
Research Site
Randwick, New South Wales, Australia
Research Site
Cairns, Queensland, Australia
Research Site
Box Hill, Victoria, Australia
Research Site
Footscray, Victoria, Australia
Research Site
Parkville, Victoria, Australia
Research Site
Reservoir, Victoria, Australia
Research Site
Brussels, Belgium
...and 147 more locations
Time frame: Week 19
Hb at Week 21
Time frame: Week 21
Hb at Week 23
Time frame: Week 23
Hb at Week 25
Time frame: Week 25
Hb at Week 27
Time frame: Week 27
Hb at Week 29
Time frame: Week 29
Hb at Week 31
Time frame: Week 31
Hb at Week 33
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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)
Time frame: 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
Time frame: Evaluation Period