Anemia, Chronic Kidney Disease
Conditions
Keywords
CKD, Anemia, correction, darbepoetin alfa
Brief summary
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.
Interventions
DRUGdarbepoetin alfa
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.
Sponsors
Amgen
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* ≥ 18 years of age * Diagnosis of chronic kidney disease with eGFR of 15-59 mL/min/1.73 m2 (MDRD equation) * Two consecutive screening Hb values taken at least 7 days apart must each be \<10.0 g/dL * TSAT ≥ 15%
Exclusion criteria
* Upper or lower GI bleeding within 6 months before enrolment * ESA use within 12 weeks before enrolment * Uncontrolled hypertension * Systemic haematologic disorders * Prior history within 12 weeks before enrollment of events including: Acute myocardial ischemia, unstable angina, myocardial infarction, hospitalization for congestive heart failure, stroke or transient ischaemic attack, limb ischaemia, deep vein thrombosis, thromboembolism. * Grand mal seizure within 6 months prior to enrolment * Evidence of, or received chemotherapy or radiation therapy for, a malignancy within 5 years prior to enrolment. * Red blood cell transfusion within 12 weeks prior to enrolment * Androgen therapy within 8 weeks prior to enrolment * Pregnancy or breast feeding, or inadequate contraception * Currently receiving immunosuppressive therapy
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Hb Change Between Baseline and the Evaluation Period (Average of Weeks 29-33) | Baseline Week 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 | 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 |
| Darbepoetin Alfa Dose at Week 3 | 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 |
| Darbepoetin Alfa Dose at Week 5 | 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 |
| Darbepoetin Alfa Dose at Week 7 | 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 |
| Darbepoetin Alfa Dose at Week 9 | 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 |
| Darbepoetin Alfa Dose at Week 11 | 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 |
| Darbepoetin Alfa Dose at Week 13 | 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 |
| Darbepoetin Alfa Dose at Week 15 | 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 |
| Darbepoetin Alfa Dose at Week 17 | 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 |
| Darbepoetin Alfa Dose at Week 19 | 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 |
| Darbepoetin Alfa Dose at Week 21 | 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 |
| Darbepoetin Alfa Dose at Week 23 | 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 |
| Darbepoetin Alfa Dose at Week 25 | 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 |
| Darbepoetin Alfa Dose at Week 27 | 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 |
| Darbepoetin Alfa Dose at Week 29 | 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 |
| Darbepoetin Alfa Dose at Week 31 | 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 |
| Darbepoetin Alfa Dose During the Evaluation Period (Average of Weeks 29-33) | 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 |
| Ratio of Darbepoetin Alfa Dose to Baseline at Week 3 | 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 |
| Ratio of Darbepoetin Alfa Dose to Baseline at Week 5 | 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 |
| Ratio of Darbepoetin Alfa Dose to Baseline at Week 7 | 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 |
| Ratio of Darbepoetin Alfa Dose to Baseline at Week 9 | 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 |
| Ratio of Darbepoetin Alfa Dose to Baseline at Week 11 | 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 |
| Ratio of Darbepoetin Alfa Dose to Baseline at Week 13 | 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 |
| Ratio of Darbepoetin Alfa Dose to Baseline at Week 15 | 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 |
| Ratio of Darbepoetin Alfa Dose to Baseline at Week 17 | 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 |
| Ratio of Darbepoetin Alfa Dose to Baseline at Week 19 | 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 |
| Ratio of Darbepoetin Alfa Dose to Baseline at Week 21 | 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 |
| Ratio of Darbepoetin Alfa Dose to Baseline at Week 23 | 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 |
| Ratio of Darbepoetin Alfa Dose to Baseline at Week 25 | 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 |
| 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 | — |
| Ratio of Darbepoetin Alfa Dose to Baseline at Week 29 | 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 |
| Ratio of Darbepoetin Alfa Dose to Baseline at Week 31 | 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 |
| 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) | 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 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) | Evaluation Period | Although the endpoint is related to dose, the sample is from the Primary Analysis Set which requires a Hb value in the evaluation period |
| Ratio of Darbepoetin Alfa Dose to Baseline at Week 27 | 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 |
Countries
Australia, Belgium, Bulgaria, Czechia, Denmark, Estonia, France, Germany, Greece, Hungary, Israel, Italy, Latvia, Mexico, Poland, Portugal, Romania, Russia, Serbia, Slovakia, Slovenia, Spain, United Kingdom
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Darbepoetin Alfa Q2W Darbepoetin alfa Intravenous Once Every 2 Weeks | 175 |
| Darbepoetin Alfa QM Darbepoetin alfa Intravenous Once Monthly | 180 |
| Total | 355 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Adverse Event | 6 | 2 |
| Overall Study | Death | 5 | 5 |
| Overall Study | Lost to Follow-up | 0 | 1 |
| Overall Study | Physician Decision | 4 | 1 |
| Overall Study | Protocol Specified Criteria | 6 | 6 |
| Overall Study | Protocol Violation | 6 | 4 |
| Overall Study | Withdrawal by Subject | 9 | 6 |
Baseline characteristics
| Characteristic | Darbepoetin Alfa Q2W | Darbepoetin Alfa QM | Total |
|---|---|---|---|
| Age, Continuous | 68.4 years STANDARD_DEVIATION 14.1 | 66.3 years STANDARD_DEVIATION 15.2 | 67.3 years STANDARD_DEVIATION 14.7 |
| Age, Customized >=65-<75 years | 42 Participants | 54 Participants | 96 Participants |
| Age, Customized <65 years | 60 Participants | 67 Participants | 127 Participants |
| Age, Customized >=75 years | 73 Participants | 59 Participants | 132 Participants |
| Baseline Hemoglobin | 9.13 g/dL STANDARD_DEVIATION 0.61 | 9.11 g/dL STANDARD_DEVIATION 0.7 | 9.12 g/dL STANDARD_DEVIATION 0.65 |
| Race/Ethnicity, Customized Black or African American | 0 Participants | 1 Participants | 1 Participants |
| Race/Ethnicity, Customized Other | 9 Participants | 16 Participants | 25 Participants |
| Race/Ethnicity, Customized White or Caucasian | 166 Participants | 163 Participants | 329 Participants |
| Sex: Female, Male Female | 107 Participants | 104 Participants | 211 Participants |
| Sex: Female, Male Male | 68 Participants | 76 Participants | 144 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 68 / 175 | 63 / 180 |
| serious Total, serious adverse events | 52 / 175 | 54 / 180 |
Outcome results
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.
Time frame: Baseline Week 33
Population: Primary Analysis Set: All subjects receiving at least one dose of darbepoetin alfa in the treatment group to which they were randomized and with at least one evaluable (not within 90 days after an RBC transfusion) Hb measurement during the evaluation period (Weeks 29-33)
| Arm | Measure | Value (LEAST_SQUARES_MEAN) |
|---|---|---|
| Darbepoetin Alfa Q2W | Hb Change Between Baseline and the Evaluation Period (Average of Weeks 29-33) | 2.157 g/dL |
| Darbepoetin Alfa QM | Hb Change Between Baseline and the Evaluation Period (Average of Weeks 29-33) | 1.969 g/dL |
Comparison: Power = 90% at sample size calculation95% CI: [-0.427, 0.052]
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.
Time frame: Baseline to Week 33
Population: Primary Analysis Set: All subjects receiving at least one dose of darbepoetin alfa in the treatment group to which they were randomized and with at least one evaluable (not within 90 days after an RBC transfusion) Hb measurement during the evaluation period (Weeks 29-33)
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Darbepoetin Alfa Q2W | 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. | 97.9 Percentage of Participants |
| Darbepoetin Alfa QM | 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. | 98.1 Percentage of Participants |
Secondary
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
Population: Primary Analysis Set: All subjects receiving at least one dose of darbepoetin alfa in the treatment group to which they were randomized and with at least one evaluable (not within 90 days after an RBC transfusion) Hb measurement during the evaluation period (Weeks 29-33)
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| Darbepoetin Alfa Q2W | Darbepoetin Alfa Dose at Week 1 | 27.65 µg/wk | 95% Confidence Interval 0.1 |
| Darbepoetin Alfa QM | Darbepoetin Alfa Dose at Week 1 | 27.06 µg/wk | 95% Confidence Interval 0.1 |
Secondary
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
Population: Primary Analysis Set: All subjects receiving at least one dose of darbepoetin alfa in the treatment group to which they were randomized and with at least one evaluable (not within 90 days after an RBC transfusion) Hb measurement during the evaluation period (Weeks 29-33)
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| Darbepoetin Alfa Q2W | Darbepoetin Alfa Dose at Week 11 | 18.99 µg/wk | 95% Confidence Interval 0.1 |
| Darbepoetin Alfa QM | Darbepoetin Alfa Dose at Week 11 | 20.50 µg/wk | 95% Confidence Interval 0.1 |
Secondary
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
Population: Primary Analysis Set: All subjects receiving at least one dose of darbepoetin alfa in the treatment group to which they were randomized and with at least one evaluable (not within 90 days after an RBC transfusion) Hb measurement during the evaluation period (Weeks 29-33)
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| Darbepoetin Alfa Q2W | Darbepoetin Alfa Dose at Week 13 | 14.67 µg/wk | 95% Confidence Interval 0.1 |
| Darbepoetin Alfa QM | Darbepoetin Alfa Dose at Week 13 | 19.52 µg/wk | 95% Confidence Interval 0.1 |
Secondary
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
Population: Primary Analysis Set: All subjects receiving at least one dose of darbepoetin alfa in the treatment group to which they were randomized and with at least one evaluable (not within 90 days after an RBC transfusion) Hb measurement during the evaluation period (Weeks 29-33)
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| Darbepoetin Alfa Q2W | Darbepoetin Alfa Dose at Week 15 | 14.19 µg/wk | 95% Confidence Interval 0.1 |
| Darbepoetin Alfa QM | Darbepoetin Alfa Dose at Week 15 | 19.15 µg/wk | 95% Confidence Interval 0.1 |
Secondary
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
Population: Primary Analysis Set: All subjects receiving at least one dose of darbepoetin alfa in the treatment group to which they were randomized and with at least one evaluable (not within 90 days after an RBC transfusion) Hb measurement during the evaluation period (Weeks 29-33)
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| Darbepoetin Alfa Q2W | Darbepoetin Alfa Dose at Week 17 | 12.71 µg/wk | 95% Confidence Interval 0.1 |
| Darbepoetin Alfa QM | Darbepoetin Alfa Dose at Week 17 | 19.94 µg/wk | 95% Confidence Interval 0.1 |
Secondary
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
Population: Primary Analysis Set: All subjects receiving at least one dose of darbepoetin alfa in the treatment group to which they were randomized and with at least one evaluable (not within 90 days after an RBC transfusion) Hb measurement during the evaluation period (Weeks 29-33)
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| Darbepoetin Alfa Q2W | Darbepoetin Alfa Dose at Week 19 | 14.52 µg/wk | 95% Confidence Interval 0.1 |
| Darbepoetin Alfa QM | Darbepoetin Alfa Dose at Week 19 | 19.94 µg/wk | 95% Confidence Interval 0.1 |
Secondary
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
Population: Primary Analysis Set: All subjects receiving at least one dose of darbepoetin alfa in the treatment group to which they were randomized and with at least one evaluable (not within 90 days after an RBC transfusion) Hb measurement during the evaluation period (Weeks 29-33)
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| Darbepoetin Alfa Q2W | Darbepoetin Alfa Dose at Week 21 | 15.42 µg/wk | 95% Confidence Interval 0.1 |
| Darbepoetin Alfa QM | Darbepoetin Alfa Dose at Week 21 | 21.59 µg/wk | 95% Confidence Interval 0.1 |
Secondary
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
Population: Primary Analysis Set: All subjects receiving at least one dose of darbepoetin alfa in the treatment group to which they were randomized and with at least one evaluable (not within 90 days after an RBC transfusion) Hb measurement during the evaluation period (Weeks 29-33)
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| Darbepoetin Alfa Q2W | Darbepoetin Alfa Dose at Week 23 | 14.73 µg/wk | 95% Confidence Interval 0.1 |
| Darbepoetin Alfa QM | Darbepoetin Alfa Dose at Week 23 | 19.98 µg/wk | 95% Confidence Interval 0.1 |
Secondary
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
Population: Primary Analysis Set: All subjects receiving at least one dose of darbepoetin alfa in the treatment group to which they were randomized and with at least one evaluable (not within 90 days after an RBC transfusion) Hb measurement during the evaluation period (Weeks 29-33)
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| Darbepoetin Alfa Q2W | Darbepoetin Alfa Dose at Week 25 | 14.55 µg/wk | 95% Confidence Interval 0.1 |
| Darbepoetin Alfa QM | Darbepoetin Alfa Dose at Week 25 | 20.70 µg/wk | 95% Confidence Interval 0.1 |
Secondary
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
Population: Primary Analysis Set: All subjects receiving at least one dose of darbepoetin alfa in the treatment group to which they were randomized and with at least one evaluable (not within 90 days after an RBC transfusion) Hb measurement during the evaluation period (Weeks 29-33)
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| Darbepoetin Alfa Q2W | Darbepoetin Alfa Dose at Week 27 | 16.07 µg/wk | 95% Confidence Interval 0.1 |
| Darbepoetin Alfa QM | Darbepoetin Alfa Dose at Week 27 | 20.79 µg/wk | 95% Confidence Interval 0.1 |
Secondary
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
Population: Primary Analysis Set: All subjects receiving at least one dose of darbepoetin alfa in the treatment group to which they were randomized and with at least one evaluable (not within 90 days after an RBC transfusion) Hb measurement during the evaluation period (Weeks 29-33)
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| Darbepoetin Alfa Q2W | Darbepoetin Alfa Dose at Week 29 | 15.06 µg/wk | 95% Confidence Interval 0.1 |
| Darbepoetin Alfa QM | Darbepoetin Alfa Dose at Week 29 | 20.57 µg/wk | 95% Confidence Interval 0.1 |
Secondary
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
Population: Primary Analysis Set: All subjects receiving at least one dose of darbepoetin alfa in the treatment group to which they were randomized and with at least one evaluable (not within 90 days after an RBC transfusion) Hb measurement during the evaluation period (Weeks 29-33)
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| Darbepoetin Alfa Q2W | Darbepoetin Alfa Dose at Week 3 | 25.80 µg/wk | 95% Confidence Interval 0.1 |
| Darbepoetin Alfa QM | Darbepoetin Alfa Dose at Week 3 | 27.06 µg/wk | 95% Confidence Interval 0.1 |
Secondary
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
Population: Primary Analysis Set: All subjects receiving at least one dose of darbepoetin alfa in the treatment group to which they were randomized and with at least one evaluable (not within 90 days after an RBC transfusion) Hb measurement during the evaluation period (Weeks 29-33)
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| Darbepoetin Alfa Q2W | Darbepoetin Alfa Dose at Week 31 | 14.48 µg/wk | 95% Confidence Interval 0.1 |
| Darbepoetin Alfa QM | Darbepoetin Alfa Dose at Week 31 | 19.39 µg/wk | 95% Confidence Interval 0.1 |
Secondary
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
Population: Primary Analysis Set: All subjects receiving at least one dose of darbepoetin alfa in the treatment group to which they were randomized and with at least one evaluable (not within 90 days after an RBC transfusion) Hb measurement during the evaluation period (Weeks 29-33)
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| Darbepoetin Alfa Q2W | Darbepoetin Alfa Dose at Week 5 | 24.40 µg/wk | 95% Confidence Interval 0.1 |
| Darbepoetin Alfa QM | Darbepoetin Alfa Dose at Week 5 | 24.52 µg/wk | 95% Confidence Interval 0.1 |
Secondary
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
Population: Primary Analysis Set: All subjects receiving at least one dose of darbepoetin alfa in the treatment group to which they were randomized and with at least one evaluable (not within 90 days after an RBC transfusion) Hb measurement during the evaluation period (Weeks 29-33)
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| Darbepoetin Alfa Q2W | Darbepoetin Alfa Dose at Week 7 | 23.42 µg/wk | 95% Confidence Interval 0.1 |
| Darbepoetin Alfa QM | Darbepoetin Alfa Dose at Week 7 | 24.52 µg/wk | 95% Confidence Interval 0.1 |
Secondary
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
Population: Primary Analysis Set: All subjects receiving at least one dose of darbepoetin alfa in the treatment group to which they were randomized and with at least one evaluable (not within 90 days after an RBC transfusion) Hb measurement during the evaluation period (Weeks 29-33)
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| Darbepoetin Alfa Q2W | Darbepoetin Alfa Dose at Week 9 | 20.01 µg/wk | 95% Confidence Interval 0.1 |
| Darbepoetin Alfa QM | Darbepoetin Alfa Dose at Week 9 | 20.59 µg/wk | 95% Confidence Interval 0.1 |
Secondary
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
Population: Primary Analysis Set: All subjects receiving at least one dose of darbepoetin alfa in the treatment group to which they were randomized and with at least one evaluable (not within 90 days after an RBC transfusion) Hb measurement during the evaluation period (Weeks 29-33)
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| Darbepoetin Alfa Q2W | Darbepoetin Alfa Dose During the Evaluation Period (Average of Weeks 29-33) | 15.21 µg/wk | 95% Confidence Interval 0.1 |
| Darbepoetin Alfa QM | Darbepoetin Alfa Dose During the Evaluation Period (Average of Weeks 29-33) | 19.68 µg/wk | 95% Confidence Interval 0.1 |
Secondary
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
Population: Primary Analysis Set: All subjects receiving at least one dose of darbepoetin alfa in the treatment group to which they were randomized and with at least one evaluable (not within 90 days after an RBC transfusion) Hb measurement during the evaluation period (Weeks 29-33)
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| Darbepoetin Alfa Q2W | 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) | 25.95 µg/wk | 95% Confidence Interval 0.1 |
| Darbepoetin Alfa QM | 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) | 29.65 µg/wk | 95% Confidence Interval 0.1 |
Secondary
Hb at Baseline
Time frame: Baseline
Population: Primary Analysis Set: All subjects receiving at least one dose of darbepoetin alfa in the treatment group to which they were randomized and with at least one evaluable (not within 90 days after an RBC transfusion) Hb measurement during the evaluation period (Weeks 29-33)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Darbepoetin Alfa Q2W | Hb at Baseline | 9.17 g/dL | Standard Error 0.05 |
| Darbepoetin Alfa QM | Hb at Baseline | 9.12 g/dL | Standard Error 0.06 |
Secondary
Hb at Week 11
Time frame: Week 11
Population: Primary Analysis Set: All subjects receiving at least one dose of darbepoetin alfa in the treatment group to which they were randomized and with at least one evaluable (not within 90 days after an RBC transfusion) Hb measurement during the evaluation period (Weeks 29-33)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Darbepoetin Alfa Q2W | Hb at Week 11 | 11.35 g/dL | Standard Error 0.1 |
| Darbepoetin Alfa QM | Hb at Week 11 | 11.17 g/dL | Standard Error 0.1 |
Secondary
Hb at Week 13
Time frame: Week 13
Population: Primary Analysis Set: All subjects receiving at least one dose of darbepoetin alfa in the treatment group to which they were randomized and with at least one evaluable (not within 90 days after an RBC transfusion) Hb measurement during the evaluation period (Weeks 29-33)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Darbepoetin Alfa Q2W | Hb at Week 13 | 11.56 g/dL | Standard Error 0.1 |
| Darbepoetin Alfa QM | Hb at Week 13 | 11.05 g/dL | Standard Error 0.1 |
Secondary
Hb at Week 15
Time frame: Week 15
Population: Primary Analysis Set: All subjects receiving at least one dose of darbepoetin alfa in the treatment group to which they were randomized and with at least one evaluable (not within 90 days after an RBC transfusion) Hb measurement during the evaluation period (Weeks 29-33)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Darbepoetin Alfa Q2W | Hb at Week 15 | 11.42 g/dL | Standard Error 0.11 |
| Darbepoetin Alfa QM | Hb at Week 15 | 11.25 g/dL | Standard Error 0.09 |
Secondary
Hb at Week 17
Time frame: Week 17
Population: Primary Analysis Set: All subjects receiving at least one dose of darbepoetin alfa in the treatment group to which they were randomized and with at least one evaluable (not within 90 days after an RBC transfusion) Hb measurement during the evaluation period (Weeks 29-33)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Darbepoetin Alfa Q2W | Hb at Week 17 | 11.66 g/dL | Standard Error 0.1 |
| Darbepoetin Alfa QM | Hb at Week 17 | 11.12 g/dL | Standard Error 0.09 |
Secondary
Hb at Week 19
Time frame: Week 19
Population: Primary Analysis Set: All subjects receiving at least one dose of darbepoetin alfa in the treatment group to which they were randomized and with at least one evaluable (not within 90 days after an RBC transfusion) Hb measurement during the evaluation period (Weeks 29-33)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Darbepoetin Alfa Q2W | Hb at Week 19 | 11.50 g/dL | Standard Error 0.12 |
| Darbepoetin Alfa QM | Hb at Week 19 | 11.20 g/dL | Standard Error 0.09 |
Secondary
Hb at Week 21
Time frame: Week 21
Population: Primary Analysis Set: All subjects receiving at least one dose of darbepoetin alfa in the treatment group to which they were randomized and with at least one evaluable (not within 90 days after an RBC transfusion) Hb measurement during the evaluation period (Weeks 29-33)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Darbepoetin Alfa Q2W | Hb at Week 21 | 11.53 g/dL | Standard Error 0.1 |
| Darbepoetin Alfa QM | Hb at Week 21 | 11.09 g/dL | Standard Error 0.08 |
Secondary
Hb at Week 23
Time frame: Week 23
Population: Primary Analysis Set: All subjects receiving at least one dose of darbepoetin alfa in the treatment group to which they were randomized and with at least one evaluable (not within 90 days after an RBC transfusion) Hb measurement during the evaluation period (Weeks 29-33)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Darbepoetin Alfa Q2W | Hb at Week 23 | 11.36 g/dL | Standard Error 0.09 |
| Darbepoetin Alfa QM | Hb at Week 23 | 11.08 g/dL | Standard Error 0.09 |
Secondary
Hb at Week 25
Time frame: Week 25
Population: Primary Analysis Set: All subjects receiving at least one dose of darbepoetin alfa in the treatment group to which they were randomized and with at least one evaluable (not within 90 days after an RBC transfusion) Hb measurement during the evaluation period (Weeks 29-33)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Darbepoetin Alfa Q2W | Hb at Week 25 | 11.34 g/dL | Standard Error 0.1 |
| Darbepoetin Alfa QM | Hb at Week 25 | 10.85 g/dL | Standard Error 0.09 |
Secondary
Hb at Week 27
Time frame: Week 27
Population: Primary Analysis Set: All subjects receiving at least one dose of darbepoetin alfa in the treatment group to which they were randomized and with at least one evaluable (not within 90 days after an RBC transfusion) Hb measurement during the evaluation period (Weeks 29-33)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Darbepoetin Alfa Q2W | Hb at Week 27 | 11.22 g/dL | Standard Error 0.09 |
| Darbepoetin Alfa QM | Hb at Week 27 | 11.07 g/dL | Standard Error 0.09 |
Secondary
Hb at Week 29
Time frame: Week 29
Population: Primary Analysis Set: All subjects receiving at least one dose of darbepoetin alfa in the treatment group to which they were randomized and with at least one evaluable (not within 90 days after an RBC transfusion) Hb measurement during the evaluation period (Weeks 29-33)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Darbepoetin Alfa Q2W | Hb at Week 29 | 11.35 g/dL | Standard Error 0.1 |
| Darbepoetin Alfa QM | Hb at Week 29 | 10.90 g/dL | Standard Error 0.09 |
Secondary
Hb at Week 3
Time frame: Week 3
Population: Primary Analysis Set: All subjects receiving at least one dose of darbepoetin alfa in the treatment group to which they were randomized and with at least one evaluable (not within 90 days after an RBC transfusion) Hb measurement during the evaluation period (Weeks 29-33)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Darbepoetin Alfa Q2W | Hb at Week 3 | 9.89 g/dL | Standard Error 0.08 |
| Darbepoetin Alfa QM | Hb at Week 3 | 10.13 g/dL | Standard Error 0.1 |
Secondary
Hb at Week 31
Time frame: Week 31
Population: Primary Analysis Set: All subjects receiving at least one dose of darbepoetin alfa in the treatment group to which they were randomized and with at least one evaluable (not within 90 days after an RBC transfusion) Hb measurement during the evaluation period (Weeks 29-33)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Darbepoetin Alfa Q2W | Hb at Week 31 | 11.31 g/dL | Standard Error 0.09 |
| Darbepoetin Alfa QM | Hb at Week 31 | 11.28 g/dL | Standard Error 0.09 |
Secondary
Hb at Week 33
Time frame: Week 33
Population: Primary Analysis Set: All subjects receiving at least one dose of darbepoetin alfa in the treatment group to which they were randomized and with at least one evaluable (not within 90 days after an RBC transfusion) Hb measurement during the evaluation period (Weeks 29-33)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Darbepoetin Alfa Q2W | Hb at Week 33 | 11.38 g/dL | Standard Error 0.1 |
| Darbepoetin Alfa QM | Hb at Week 33 | 11.15 g/dL | Standard Error 0.1 |
Secondary
Hb at Week 5
Time frame: Week 5
Population: Primary Analysis Set: All subjects receiving at least one dose of darbepoetin alfa in the treatment group to which they were randomized and with at least one evaluable (not within 90 days after an RBC transfusion) Hb measurement during the evaluation period (Weeks 29-33)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Darbepoetin Alfa Q2W | Hb at Week 5 | 10.58 g/dL | Standard Error 0.08 |
| Darbepoetin Alfa QM | Hb at Week 5 | 10.28 g/dL | Standard Error 0.09 |
Secondary
Hb at Week 7
Time frame: Week 7
Population: Primary Analysis Set: All subjects receiving at least one dose of darbepoetin alfa in the treatment group to which they were randomized and with at least one evaluable (not within 90 days after an RBC transfusion) Hb measurement during the evaluation period (Weeks 29-33)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Darbepoetin Alfa Q2W | Hb at Week 7 | 10.90 g/dL | Standard Error 0.09 |
| Darbepoetin Alfa QM | Hb at Week 7 | 10.75 g/dL | Standard Error 0.1 |
Secondary
Hb at Week 9
Time frame: Week 9
Population: Primary Analysis Set: All subjects receiving at least one dose of darbepoetin alfa in the treatment group to which they were randomized and with at least one evaluable (not within 90 days after an RBC transfusion) Hb measurement during the evaluation period (Weeks 29-33)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Darbepoetin Alfa Q2W | Hb at Week 9 | 11.24 g/dL | Standard Error 0.1 |
| Darbepoetin Alfa QM | Hb at Week 9 | 10.79 g/dL | Standard Error 0.1 |
Secondary
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
Population: Primary Analysis Set: All subjects receiving at least one dose of darbepoetin alfa in the treatment group to which they were randomized and with at least one evaluable (not within 90 days after an RBC transfusion) Hb measurement during the evaluation period (Weeks 29-33)
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| Darbepoetin Alfa Q2W | Ratio of Darbepoetin Alfa Dose to Baseline at the Evalaution Period (Average of Weeks 29-33) | 0.550 ratio | 95% Confidence Interval 0.1 |
| Darbepoetin Alfa QM | Ratio of Darbepoetin Alfa Dose to Baseline at the Evalaution Period (Average of Weeks 29-33) | 0.728 ratio | 95% Confidence Interval 0.1 |
Secondary
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
Population: Primary Analysis Set: All subjects receiving at least one dose of darbepoetin alfa in the treatment group to which they were randomized and with at least one evaluable (not within 90 days after an RBC transfusion) Hb measurement during the evaluation period (Weeks 29-33)
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| Darbepoetin Alfa Q2W | Ratio of Darbepoetin Alfa Dose to Baseline at Week 11 | 0.684 ratio | 95% Confidence Interval 0.1 |
| Darbepoetin Alfa QM | Ratio of Darbepoetin Alfa Dose to Baseline at Week 11 | 0.758 ratio | 95% Confidence Interval 0.1 |
Secondary
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
Population: Primary Analysis Set: All subjects receiving at least one dose of darbepoetin alfa in the treatment group to which they were randomized and with at least one evaluable (not within 90 days after an RBC transfusion) Hb measurement during the evaluation period (Weeks 29-33)
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| Darbepoetin Alfa Q2W | Ratio of Darbepoetin Alfa Dose to Baseline at Week 13 | 0.531 ratio | 95% Confidence Interval 0.1 |
| Darbepoetin Alfa QM | Ratio of Darbepoetin Alfa Dose to Baseline at Week 13 | 0.719 ratio | 95% Confidence Interval 0.1 |
Secondary
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
Population: Primary Analysis Set: All subjects receiving at least one dose of darbepoetin alfa in the treatment group to which they were randomized and with at least one evaluable (not within 90 days after an RBC transfusion) Hb measurement during the evaluation period (Weeks 29-33)
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| Darbepoetin Alfa Q2W | Ratio of Darbepoetin Alfa Dose to Baseline at Week 15 | 0.512 ratio | 95% Confidence Interval 0.1 |
| Darbepoetin Alfa QM | Ratio of Darbepoetin Alfa Dose to Baseline at Week 15 | 0.707 ratio | 95% Confidence Interval 0.1 |
Secondary
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
Population: Primary Analysis Set: All subjects receiving at least one dose of darbepoetin alfa in the treatment group to which they were randomized and with at least one evaluable (not within 90 days after an RBC transfusion) Hb measurement during the evaluation period (Weeks 29-33)
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| Darbepoetin Alfa Q2W | Ratio of Darbepoetin Alfa Dose to Baseline at Week 17 | 0.459 ratio | 95% Confidence Interval 0.1 |
| Darbepoetin Alfa QM | Ratio of Darbepoetin Alfa Dose to Baseline at Week 17 | 0.737 ratio | 95% Confidence Interval 0.1 |
Secondary
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
Population: Primary Analysis Set: All subjects receiving at least one dose of darbepoetin alfa in the treatment group to which they were randomized and with at least one evaluable (not within 90 days after an RBC transfusion) Hb measurement during the evaluation period (Weeks 29-33)
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| Darbepoetin Alfa Q2W | Ratio of Darbepoetin Alfa Dose to Baseline at Week 19 | 0.525 ratio | 95% Confidence Interval 0.1 |
| Darbepoetin Alfa QM | Ratio of Darbepoetin Alfa Dose to Baseline at Week 19 | 0.737 ratio | 95% Confidence Interval 0.1 |
Secondary
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
Population: Primary Analysis Set: All subjects receiving at least one dose of darbepoetin alfa in the treatment group to which they were randomized and with at least one evaluable (not within 90 days after an RBC transfusion) Hb measurement during the evaluation period (Weeks 29-33)
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| Darbepoetin Alfa Q2W | Ratio of Darbepoetin Alfa Dose to Baseline at Week 21 | 0.556 ratio | 95% Confidence Interval 0.1 |
| Darbepoetin Alfa QM | Ratio of Darbepoetin Alfa Dose to Baseline at Week 21 | 0.797 ratio | 95% Confidence Interval 0.1 |
Secondary
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
Population: Primary Analysis Set: All subjects receiving at least one dose of darbepoetin alfa in the treatment group to which they were randomized and with at least one evaluable (not within 90 days after an RBC transfusion) Hb measurement during the evaluation period (Weeks 29-33)
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| Darbepoetin Alfa Q2W | Ratio of Darbepoetin Alfa Dose to Baseline at Week 23 | 0.533 ratio | 95% Confidence Interval 0.1 |
| Darbepoetin Alfa QM | Ratio of Darbepoetin Alfa Dose to Baseline at Week 23 | 0.738 ratio | 95% Confidence Interval 0.1 |
Secondary
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
Population: Primary Analysis Set: All subjects receiving at least one dose of darbepoetin alfa in the treatment group to which they were randomized and with at least one evaluable (not within 90 days after an RBC transfusion) Hb measurement during the evaluation period (Weeks 29-33)
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| Darbepoetin Alfa Q2W | Ratio of Darbepoetin Alfa Dose to Baseline at Week 25 | 0.526 ratio | 95% Confidence Interval 0.1 |
| Darbepoetin Alfa QM | Ratio of Darbepoetin Alfa Dose to Baseline at Week 25 | 0.764 ratio | 95% Confidence Interval 0.1 |
Secondary
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
Population: Primary Analysis Set: All subjects receiving at least one dose of darbepoetin alfa in the treatment group to which they were randomized and with at least one evaluable (not within 90 days after an RBC transfusion) Hb measurement during the evaluation period (Weeks 29-33)
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| Darbepoetin Alfa Q2W | Ratio of Darbepoetin Alfa Dose to Baseline at Week 27 | 0.581 ratio | 95% Confidence Interval 0.1 |
| Darbepoetin Alfa QM | Ratio of Darbepoetin Alfa Dose to Baseline at Week 27 | 0.768 ratio | 95% Confidence Interval 0.1 |
Secondary
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
Population: Primary Analysis Set: All subjects receiving at least one dose of darbepoetin alfa in the treatment group to which they were randomized and with at least one evaluable (not within 90 days after an RBC transfusion) Hb measurement during the evaluation period (Weeks 29-33)
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| Darbepoetin Alfa Q2W | Ratio of Darbepoetin Alfa Dose to Baseline at Week 29 | 0.544 ratio | 95% Confidence Interval 0.1 |
| Darbepoetin Alfa QM | Ratio of Darbepoetin Alfa Dose to Baseline at Week 29 | 0.762 ratio | 95% Confidence Interval 0.1 |
Secondary
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
Population: Primary Analysis Set: All subjects receiving at least one dose of darbepoetin alfa in the treatment group to which they were randomized and with at least one evaluable (not within 90 days after an RBC transfusion) Hb measurement during the evaluation period (Weeks 29-33)
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| Darbepoetin Alfa Q2W | Ratio of Darbepoetin Alfa Dose to Baseline at Week 3 | 0.931 ratio | 95% Confidence Interval 0.1 |
| Darbepoetin Alfa QM | Ratio of Darbepoetin Alfa Dose to Baseline at Week 3 | 1.000 ratio | 95% Confidence Interval 0.1 |
Secondary
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
Population: Primary Analysis Set: All subjects receiving at least one dose of darbepoetin alfa in the treatment group to which they were randomized and with at least one evaluable (not within 90 days after an RBC transfusion) Hb measurement during the evaluation period (Weeks 29-33)
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| Darbepoetin Alfa Q2W | Ratio of Darbepoetin Alfa Dose to Baseline at Week 31 | 0.525 ratio | 95% Confidence Interval 0.1 |
| Darbepoetin Alfa QM | Ratio of Darbepoetin Alfa Dose to Baseline at Week 31 | 0.717 ratio | 95% Confidence Interval 0.1 |
Secondary
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
Population: Primary Analysis Set: All subjects receiving at least one dose of darbepoetin alfa in the treatment group to which they were randomized and with at least one evaluable (not within 90 days after an RBC transfusion) Hb measurement during the evaluation period (Weeks 29-33)
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| Darbepoetin Alfa Q2W | Ratio of Darbepoetin Alfa Dose to Baseline at Week 5 | 0.882 ratio | 95% Confidence Interval 0.1 |
| Darbepoetin Alfa QM | Ratio of Darbepoetin Alfa Dose to Baseline at Week 5 | 0.907 ratio | 95% Confidence Interval 0.1 |
Secondary
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
Population: Primary Analysis Set: All subjects receiving at least one dose of darbepoetin alfa in the treatment group to which they were randomized and with at least one evaluable (not within 90 days after an RBC transfusion) Hb measurement during the evaluation period (Weeks 29-33)
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| Darbepoetin Alfa Q2W | Ratio of Darbepoetin Alfa Dose to Baseline at Week 7 | 0.845 ratio | 95% Confidence Interval 0.1 |
| Darbepoetin Alfa QM | Ratio of Darbepoetin Alfa Dose to Baseline at Week 7 | 0.907 ratio | 95% Confidence Interval 0.1 |
Secondary
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
Population: Primary Analysis Set: All subjects receiving at least one dose of darbepoetin alfa in the treatment group to which they were randomized and with at least one evaluable (not within 90 days after an RBC transfusion) Hb measurement during the evaluation period (Weeks 29-33)
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| Darbepoetin Alfa Q2W | Ratio of Darbepoetin Alfa Dose to Baseline at Week 9 | 0.724 ratio | 95% Confidence Interval 0.1 |
| Darbepoetin Alfa QM | Ratio of Darbepoetin Alfa Dose to Baseline at Week 9 | 0.761 ratio | 95% Confidence Interval 0.1 |
Secondary
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
Population: Primary Analysis Set: All subjects receiving at least one dose of darbepoetin alfa in the treatment group to which they were randomized and with at least one evaluable (not within 90 days after an RBC transfusion) Hb measurement during the evaluation period (Weeks 29-33)
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Darbepoetin Alfa Q2W | Time to First Achievement of a Hb ≥10.0 g/dL and a ≥1.0 g/dL Increase From Baseline (Weeks 1-33) | 5.0 Weeks |
| Darbepoetin Alfa QM | Time to First Achievement of a Hb ≥10.0 g/dL and a ≥1.0 g/dL Increase From Baseline (Weeks 1-33) | 5.0 Weeks |