Anemia, Non-Myeloid Malignancies
Conditions
Keywords
anemia, chemotherapy induced anemia, darbepoetin alfa, cancer
Brief summary
To deterime the efficacy of 500 μg and 300 μg darbepoetin alfa administered subcutaneously (SC) on an every 3 weeks (Q3W) schedule, and the effect of intravenous (IV) iron supplementation in the treatment of anemia in patients with non-myeloid malignancies who were receiving multicycle chemotherapy.
Interventions
DRUGdarbepoetin alfa
Darbepoetin alfa administered by subcutaneous injection.
DRUGIV iron dextran
Administered by intravenous (IV) injection.
Sponsors
Amgen
Study design
Allocation
RANDOMIZED
Intervention model
FACTORIAL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Active non myeloid malignancy(cies) including lymphocytic leukemias * Received chemotherapy and expected to receive at least 8 additional weeks of cyclic cytotoxic chemotherapy * Anemia due to chemotherapy (screening Hgb \<or = 10.0 g/dL) * at least 18 years of age at screening
Exclusion criteria
* Acute myelogenous leukemia (AML), chronic myelogenous leukemia (CML), or myelodysplastic syndromes (MDS) * Other underlying hematologic disorder, which could cause anemia, other than a non myeloid malignancy * Active bleeding * Severe, unstable, active chronic inflammatory disease (eg ulcerative disease, peptic ulcer disease, rheumatoid arthritis) * Active, unstable systemic or chronic infection * Planned elective surgery during the study where significant blood loss is expected * Unstable angina, or uncontrolled cardiac arrhythmia * Uncontrolled hypertension (diastolic blood pressure \> 100 mmHg) * History of pure red cell aplasia (PRCA) * History of deep venous thrombosis * Known positive human immunodeficiency virus (HIV) test or acquired immune deficiency syndrome (AIDS) status * Any red-blood-cell (RBC) transfusion within 28 days before randomization and/or during screening * Currently receiving thalidomide or lenalidomide without prophylactic anticoagulant therapy * Currently receiving or planned to receive myeloablative radiation therapy * Received bone marrow or stem cell transplant in the 6 months prior to screening or planned during the study * Received any erythropoietic therapy within 28 days before randomization and/or during screening (eg rHuEPO or darbepoetin alfa) * Known sensitivity to any erythropoietic agents, the investigational product or its excipients to be administered during this study * Known sensitivity to iron administration * Pregnant or breast feeding
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants Who Achieved the Target Hemoglobin Level, by Darbepoetin Alfa Dose | From Week 1 to Week 16 | Target hemoglobin was defined as ≥ 11 g/dL during the treatment period in the absence of a red blood cell (RBC) transfusion on the day of measurement or during the preceding 28 days. |
| Number of Participants Who Achieved the Target Hemoglobin Levels, by IV Iron Usage | From Week 1 to Week 16 | Target hemoglobin was defined as ≥ 11 g/dL during the treatment period in the absence of a red blood cell (RBC) transfusion on the day of measurement or during the preceding 28 days. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change From Baseline in Hemoglobin Concentration, by Darbepoetin Alfa Dose | Baseline and Week 16 | Change in hemoglobin concentration from Baseline to the end of the treatment period (Week 16). |
| Change From Baseline in Hemoglobin Concentration, by IV Iron Usage | Baseline and Week 16 | Change in hemoglobin concentration from Baseline to the end of the treatment period (Week 16). |
| Number of Participants With ≥ 1 Red Blood Cell Transfusion From Week 1 to End of Study, by Darbepoetin Alfa Dose | From Week 1 to Week 16 | The number of participants with ≥ 1 red blood cell (RBC) transfusion from week 1 to end of study (EOS). Participants with a hemoglobin value ≤ 8 g/dL but no RBC transfusion were counted as having had a transfusion. |
| Number of Participants With ≥ 1 Red Blood Cell Transfusion From Week 1 to End of Study, by IV Iron Usage | From Week 1 to Week 16 | The number of participants with ≥ 1 red blood cell (RBC) transfusion from week 1 to end of study (EOS). Participants with a hemoglobin value ≤ 8 g/dL but no RBC transfusion were counted as having had a transfusion. |
| Number of Participants With ≥ 1 Red Blood Cell Transfusion From Week 5 to End of Study | From Week 5 to Week 16 | Number of participants with ≥ 1 RBC transfusion from Week 5 to end of study (Week 16)). Participants with a hemoglobin value ≤ 8 g/dL but no RBC transfusion were counted as having had a transfusion. |
| Time to Achieve Target Hemoglobin Level, by Darbepoetin Alfa Dose | From Week 1 to Week 16 | The time to target hemoglobin is the interval in weeks between study day 1 and the first day that a hemoglobin value ≥ 11.0 g/dL is observed during the treatment period. If a participant did not achieve the target hemoglobin by the time of withdrawal or the end of the treatment period (EOTP), the time to target hemoglobin was censored on the day of the last hemoglobin measurement or the EOTP, whichever was earlier. Median was calculated using Kaplan-Meier estimates. |
| Number of Participants With a Hematopoietic Response, by IV Iron Usage | From Week 1 to Week 16 | Number of participants with a hematopoietic response, defined as \> 2 g/dL increase from baseline or hemoglobin ≥ 12 g/dL during the treatment period in the absence of a red blood cell transfusion within the prior 28 days. Assessing the effect of iron in a factorial experiment. |
| Time to Hematopoietic Response, by Darbepoetin Alfa Dose | From Week 1 to Week 16 | The time to hematopoietic response is the interval in weeks between study day 1 and the first day that a hematopoietic response is observed during the treatment period. Hematopoietic response is defined as an increase in hemoglobin concentration of ≥ 2.0 g/dL from baseline or a hemoglobin concentration ≥ 12.0 g/dL in the absence of RBC transfusions on the day of measurement and during the preceding 28 days of the treatment period. If a participant did not achieve a hematopoietic response by the time of withdrawal or the end of the treatment period (EOTP), the time to hematopoietic response was censored on the day of the last hemoglobin measurement or the EOTP, whichever was earlier. Median was calculated using using Kaplan-Meier estimates. |
| Time to Hematopoietic Response, by IV Iron Usage | From Week 1 to Week 16 | The time to hematopoietic response is the interval in weeks between study day 1 and the first day that a hematopoietic response is observed during the treatment period. Hematopoietic response is defined as an increase in hemoglobin concentration of ≥ 2.0 g/dL from baseline or a hemoglobin concentration ≥ 12.0 g/dL in the absence of RBC transfusions on the day of measurement and during the preceding 28 days of the treatment period. If a participant did not achieve a hematopoietic response by the time of withdrawal or the end of the treatment period (EOTP), the time to hematopoietic response was censored on the day of the last hemoglobin measurement or the EOTP, whichever was earlier. Median was calculated using using Kaplan-Meier estimates. |
| Change From Baseline in Functional Assessment of Cancer Therapy (FACT) - Fatigue Score, by Darbepoetin Alfa Dose | Baseline and Week 16 | Health related quality of life was measured using the Functional Assessment of Cancer Therapy (FACT) - Fatigue subscale. The FACT-F includes 13 fatigue items, with each item assessed on a 5-point scale (ie, response values of 0 to 4). The FACT-F subscale score ranges from 0 to 52, where a higher score represents less fatigue. |
| Change From Baseline in Functional Assessment of Cancer Therapy (FACT) - Fatigue Score, by IV Iron Usage | Baseline and Week 16 | Health related quality of life was measured using the Functional Assessment of Cancer Therapy (FACT) - Fatigue subscale. The FACT-F includes 13 fatigue items, with each item assessed on a 5-point scale (ie, response values of 0 to 4). The FACT-F subscale score ranges from 0 to 52, where a higher score represents less fatigue. |
| Number of Participants With a Hematopoietic Response, by Darbepoetin Alfa Dose | From Week 1 to Week 16 | Number of participants with a hematopoietic response, defined as \> 2 g/dL increase from baseline or hemoglobin ≥ 12 g/dL during the treatment period in the absence of a red blood cell transfusion within the prior 28 days. |
| Time to Achieve the Target Hemoglobin Level, by IV Iron Usage | From Week 1 to Week 16 | The time to target hemoglobin is the interval in weeks between study day 1 and the first day that a hemoglobin value ≥ 11.0 g/dL is observed during the treatment period. If a participant did not achieve the target hemoglobin by the time of withdrawal or the end of the treatment period (EOTP), the time to target hemoglobin was censored on the day of the last hemoglobin measurement or the EOTP, whichever was earlier. Median was calculated using Kaplan-Meier estimates. |
Participant flow
Recruitment details
Participants were enrolled from 18 December 2006 through 27 August 2007.
Pre-assignment details
A total of 243 patients were randomizd and 238 received study drug (4 participants in the Darbepoetin alfa 300 μg plus Iron group and 1 in the Darbepoetin alfa 500 μg plus Iron group were not treated)
Participants by arm
| Arm | Count |
|---|---|
| Darbepoetin Alfa 300 μg Plus Iron Darbepoetin alfa 300 μg subcutaneous injection plus intravenous (IV) iron 400 mg, every three weeks (Q3W), for up to 15 weeks (a total of 5 doses). | 56 |
| Darbepoetin Alfa 300 μg Darbepoetin alfa 300 μg subcutaneous injection every three weeks (Q3W), for up to 15 weeks (a total of 5 doses). | 62 |
| Darbepoetin Alfa 500 μg Darbepoetin alfa 500 μg subcutaneous injection every three weeks (Q3W), for up to 15 weeks (a total of 5 doses). | 60 |
| Darbepoetin Alfa 500 μg Plus Iron Darbepoetin alfa 500 μg subcutaneous injection plus intravenous (IV) iron 400 mg, every three weeks (Q3W), for up to 15 weeks (a total of 5 doses). | 60 |
| Total | 238 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 | FG003 |
|---|---|---|---|---|---|
| Overall Study | Adverse Event | 5 | 1 | 1 | 1 |
| Overall Study | Death | 3 | 6 | 2 | 5 |
| Overall Study | Disease progression | 0 | 1 | 0 | 0 |
| Overall Study | Ineligibility determined | 0 | 1 | 0 | 2 |
| Overall Study | Lost to Follow-up | 2 | 0 | 1 | 1 |
| Overall Study | Other | 0 | 0 | 2 | 2 |
| Overall Study | Physician Decision | 1 | 3 | 0 | 0 |
| Overall Study | Withdrawal by Subject | 7 | 6 | 6 | 5 |
Baseline characteristics
| Characteristic | Darbepoetin Alfa 300 μg | Darbepoetin Alfa 300 μg Plus Iron | Total | Darbepoetin Alfa 500 μg Plus Iron | Darbepoetin Alfa 500 μg |
|---|---|---|---|---|---|
| Age, Continuous | 62.1 Years STANDARD_DEVIATION 14.1 | 61.2 Years STANDARD_DEVIATION 12.5 | 63.1 Years STANDARD_DEVIATION 13.1 | 62.3 Years STANDARD_DEVIATION 13.3 | 66.7 Years STANDARD_DEVIATION 12 |
| FACT-Fatigue Score | 30.24 Units on a scale STANDARD_DEVIATION 12.46 | 28.54 Units on a scale STANDARD_DEVIATION 12.32 | 29.44 Units on a scale STANDARD_DEVIATION 12.08 | 30.25 Units on a scale STANDARD_DEVIATION 11.79 | 28.60 Units on a scale STANDARD_DEVIATION 11.95 |
| Hemoglobin | 9.4 g/dL STANDARD_DEVIATION 0.9 | 9.4 g/dL STANDARD_DEVIATION 1.1 | 9.4 g/dL STANDARD_DEVIATION 1 | 9.2 g/dL STANDARD_DEVIATION 0.9 | 9.4 g/dL STANDARD_DEVIATION 1.2 |
| Race/Ethnicity, Customized Asian | 1 Participants | 2 Participants | 3 Participants | 0 Participants | 0 Participants |
| Race/Ethnicity, Customized Black or African American | 5 Participants | 7 Participants | 32 Participants | 11 Participants | 9 Participants |
| Race/Ethnicity, Customized Hispanic or Latino | 7 Participants | 2 Participants | 13 Participants | 3 Participants | 1 Participants |
| Race/Ethnicity, Customized Other | 1 Participants | 0 Participants | 1 Participants | 0 Participants | 0 Participants |
| Race/Ethnicity, Customized White or Caucasian | 48 Participants | 45 Participants | 189 Participants | 46 Participants | 50 Participants |
| Sex: Female, Male Female | 44 Participants | 34 Participants | 158 Participants | 47 Participants | 33 Participants |
| Sex: Female, Male Male | 18 Participants | 22 Participants | 80 Participants | 13 Participants | 27 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk |
|---|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — | — / — |
| other Total, other adverse events | 48 / 61 | 46 / 57 | 51 / 60 | 48 / 60 |
| serious Total, serious adverse events | 26 / 61 | 18 / 57 | 19 / 60 | 23 / 60 |
Outcome results
Primary
Number of Participants Who Achieved the Target Hemoglobin Level, by Darbepoetin Alfa Dose
Target hemoglobin was defined as ≥ 11 g/dL during the treatment period in the absence of a red blood cell (RBC) transfusion on the day of measurement or during the preceding 28 days.
Time frame: From Week 1 to Week 16
Population: Subset of Primary Analysis Set, composed of all randomized participants who received at least one dose of blinded study medication, who had baseline hemoglobin values \< 11.0 g/dL.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Combined Darbepoetin Alfa 300 μg | Number of Participants Who Achieved the Target Hemoglobin Level, by Darbepoetin Alfa Dose | 71 Participants |
| Combined Darbepoetin Alfa 500 μg | Number of Participants Who Achieved the Target Hemoglobin Level, by Darbepoetin Alfa Dose | 82 Participants |
95% CI: [63, 80]
95% CI: [54, 72]
Primary
Number of Participants Who Achieved the Target Hemoglobin Levels, by IV Iron Usage
Target hemoglobin was defined as ≥ 11 g/dL during the treatment period in the absence of a red blood cell (RBC) transfusion on the day of measurement or during the preceding 28 days.
Time frame: From Week 1 to Week 16
Population: Subset of Primary Analysis Set, composed of all randomized participants who received at least one dose of blinded study medication, who had baseline hemoglobin values \< 11.0 g/dL.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Combined Darbepoetin Alfa 300 μg | Number of Participants Who Achieved the Target Hemoglobin Levels, by IV Iron Usage | 73 Participants |
| Combined Darbepoetin Alfa 500 μg | Number of Participants Who Achieved the Target Hemoglobin Levels, by IV Iron Usage | 80 Participants |
95% CI: [64, 81]
95% CI: [54, 71]
Secondary
Change From Baseline in Functional Assessment of Cancer Therapy (FACT) - Fatigue Score, by Darbepoetin Alfa Dose
Health related quality of life was measured using the Functional Assessment of Cancer Therapy (FACT) - Fatigue subscale. The FACT-F includes 13 fatigue items, with each item assessed on a 5-point scale (ie, response values of 0 to 4). The FACT-F subscale score ranges from 0 to 52, where a higher score represents less fatigue.
Time frame: Baseline and Week 16
Population: Patient-Reported Outcomes (PRO) Analysis Set, composed of all participants who were randomized, properly consented, and received at least one dose of blinded study drug, and who completed at least one baseline and one post-baseline PRO assessment.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Combined Darbepoetin Alfa 300 μg | Change From Baseline in Functional Assessment of Cancer Therapy (FACT) - Fatigue Score, by Darbepoetin Alfa Dose | 3.1 Units on a scale | Standard Deviation 11.8 |
| Combined Darbepoetin Alfa 500 μg | Change From Baseline in Functional Assessment of Cancer Therapy (FACT) - Fatigue Score, by Darbepoetin Alfa Dose | 0.6 Units on a scale | Standard Deviation 12.5 |
Secondary
Change From Baseline in Functional Assessment of Cancer Therapy (FACT) - Fatigue Score, by IV Iron Usage
Health related quality of life was measured using the Functional Assessment of Cancer Therapy (FACT) - Fatigue subscale. The FACT-F includes 13 fatigue items, with each item assessed on a 5-point scale (ie, response values of 0 to 4). The FACT-F subscale score ranges from 0 to 52, where a higher score represents less fatigue.
Time frame: Baseline and Week 16
Population: Patient-Reported Outcomes (PRO) Analysis Set, composed of all participants who were randomized, properly consented, and received at least one dose of blinded study drug, and who completed at least one baseline and one post-baseline PRO assessment.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Combined Darbepoetin Alfa 300 μg | Change From Baseline in Functional Assessment of Cancer Therapy (FACT) - Fatigue Score, by IV Iron Usage | 1.0 Units on a scale | Standard Deviation 13.1 |
| Combined Darbepoetin Alfa 500 μg | Change From Baseline in Functional Assessment of Cancer Therapy (FACT) - Fatigue Score, by IV Iron Usage | 2.7 Units on a scale | Standard Deviation 11.2 |
Secondary
Change From Baseline in Hemoglobin Concentration, by Darbepoetin Alfa Dose
Change in hemoglobin concentration from Baseline to the end of the treatment period (Week 16).
Time frame: Baseline and Week 16
Population: Primary Analysis Set, composed of all participants who were randomized, properly consented, and received at least one dose of blinded study drug. Imputation by last value carried forward (LVCF) was applied.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Combined Darbepoetin Alfa 300 μg | Change From Baseline in Hemoglobin Concentration, by Darbepoetin Alfa Dose | 1.5 g/dL | Standard Deviation 1.8 |
| Combined Darbepoetin Alfa 500 μg | Change From Baseline in Hemoglobin Concentration, by Darbepoetin Alfa Dose | 1.6 g/dL | Standard Deviation 1.8 |
Secondary
Change From Baseline in Hemoglobin Concentration, by IV Iron Usage
Change in hemoglobin concentration from Baseline to the end of the treatment period (Week 16).
Time frame: Baseline and Week 16
Population: Primary Analysis Set, composed of all participants who were randomized, properly consented, and received at least one dose of blinded study drug. Imputation by last value carried forward (LVCF) was applied.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Combined Darbepoetin Alfa 300 μg | Change From Baseline in Hemoglobin Concentration, by IV Iron Usage | 1.3 g/dL | Standard Deviation 1.7 |
| Combined Darbepoetin Alfa 500 μg | Change From Baseline in Hemoglobin Concentration, by IV Iron Usage | 1.9 g/dL | Standard Deviation 1.8 |
Secondary
Number of Participants With ≥ 1 Red Blood Cell Transfusion From Week 1 to End of Study, by Darbepoetin Alfa Dose
The number of participants with ≥ 1 red blood cell (RBC) transfusion from week 1 to end of study (EOS). Participants with a hemoglobin value ≤ 8 g/dL but no RBC transfusion were counted as having had a transfusion.
Time frame: From Week 1 to Week 16
Population: Primary Analysis Set, composed of all participants who were randomized, properly consented, and received at least one dose of blinded study drug.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Combined Darbepoetin Alfa 300 μg | Number of Participants With ≥ 1 Red Blood Cell Transfusion From Week 1 to End of Study, by Darbepoetin Alfa Dose | 45 Participants |
| Combined Darbepoetin Alfa 500 μg | Number of Participants With ≥ 1 Red Blood Cell Transfusion From Week 1 to End of Study, by Darbepoetin Alfa Dose | 43 Participants |
95% CI: [27, 44]
95% CI: [29, 47]
Secondary
Number of Participants With ≥ 1 Red Blood Cell Transfusion From Week 1 to End of Study, by IV Iron Usage
The number of participants with ≥ 1 red blood cell (RBC) transfusion from week 1 to end of study (EOS). Participants with a hemoglobin value ≤ 8 g/dL but no RBC transfusion were counted as having had a transfusion.
Time frame: From Week 1 to Week 16
Population: Primary Analysis Set, composed of all participants who were randomized, properly consented, and received at least one dose of blinded study drug.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Combined Darbepoetin Alfa 300 μg | Number of Participants With ≥ 1 Red Blood Cell Transfusion From Week 1 to End of Study, by IV Iron Usage | 47 Participants |
| Combined Darbepoetin Alfa 500 μg | Number of Participants With ≥ 1 Red Blood Cell Transfusion From Week 1 to End of Study, by IV Iron Usage | 41 Participants |
95% CI: [27, 44]
95% CI: [30, 47]
Secondary
Number of Participants With ≥ 1 Red Blood Cell Transfusion From Week 5 to End of Study
Number of participants with ≥ 1 RBC transfusion from Week 5 to end of study (Week 16)). Participants with a hemoglobin value ≤ 8 g/dL but no RBC transfusion were counted as having had a transfusion.
Time frame: From Week 5 to Week 16
Population: Subset of Primary Analysis Set, composed of all randomized participants who received at least one dose of blinded study medication, and who were eligible for an RBC transfusion at week 5.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Combined Darbepoetin Alfa 300 μg | Number of Participants With ≥ 1 Red Blood Cell Transfusion From Week 5 to End of Study | 14 Participants |
| Combined Darbepoetin Alfa 500 μg | Number of Participants With ≥ 1 Red Blood Cell Transfusion From Week 5 to End of Study | 17 Participants |
| Darbepoetin Alfa 500 μg Plus Iron | Number of Participants With ≥ 1 Red Blood Cell Transfusion From Week 5 to End of Study | 18 Participants |
| Darbepoetin Alfa 500 μg | Number of Participants With ≥ 1 Red Blood Cell Transfusion From Week 5 to End of Study | 15 Participants |
95% CI: [15, 38]
95% CI: [19, 42]
95% CI: [17, 40]
95% CI: [14, 36]
Secondary
Number of Participants With a Hematopoietic Response, by Darbepoetin Alfa Dose
Number of participants with a hematopoietic response, defined as \> 2 g/dL increase from baseline or hemoglobin ≥ 12 g/dL during the treatment period in the absence of a red blood cell transfusion within the prior 28 days.
Time frame: From Week 1 to Week 16
Population: Subset of Primary Analysis Set, composed of all participants who were randomized, properly consented, and received at least one dose of blinded study drug, who had a baseline hemoglobin value.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Combined Darbepoetin Alfa 300 μg | Number of Participants With a Hematopoietic Response, by Darbepoetin Alfa Dose | 70 Participants |
| Combined Darbepoetin Alfa 500 μg | Number of Participants With a Hematopoietic Response, by Darbepoetin Alfa Dose | 81 Participants |
95% CI: [59, 76]
95% CI: [50, 68]
Secondary
Number of Participants With a Hematopoietic Response, by IV Iron Usage
Number of participants with a hematopoietic response, defined as \> 2 g/dL increase from baseline or hemoglobin ≥ 12 g/dL during the treatment period in the absence of a red blood cell transfusion within the prior 28 days. Assessing the effect of iron in a factorial experiment.
Time frame: From Week 1 to Week 16
Population: Subset of Primary Analysis Set, composed of all participants who were randomized, properly consented, and received at least one dose of blinded study drug, who had a baseline hemoglobin value.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Combined Darbepoetin Alfa 300 μg | Number of Participants With a Hematopoietic Response, by IV Iron Usage | 65 Participants |
| Combined Darbepoetin Alfa 500 μg | Number of Participants With a Hematopoietic Response, by IV Iron Usage | 86 Participants |
95% CI: [44, 62]
95% CI: [66, 82]
Secondary
Time to Achieve Target Hemoglobin Level, by Darbepoetin Alfa Dose
The time to target hemoglobin is the interval in weeks between study day 1 and the first day that a hemoglobin value ≥ 11.0 g/dL is observed during the treatment period. If a participant did not achieve the target hemoglobin by the time of withdrawal or the end of the treatment period (EOTP), the time to target hemoglobin was censored on the day of the last hemoglobin measurement or the EOTP, whichever was earlier. Median was calculated using Kaplan-Meier estimates.
Time frame: From Week 1 to Week 16
Population: Subset of Primary Analysis Set, composed of all randomized participants who received at least one dose of blinded study medication, who had baseline hemoglobin values \< 11.0 g/dL.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Combined Darbepoetin Alfa 300 μg | Time to Achieve Target Hemoglobin Level, by Darbepoetin Alfa Dose | 10.0 Weeks |
| Combined Darbepoetin Alfa 500 μg | Time to Achieve Target Hemoglobin Level, by Darbepoetin Alfa Dose | 8.0 Weeks |
Secondary
Time to Achieve the Target Hemoglobin Level, by IV Iron Usage
The time to target hemoglobin is the interval in weeks between study day 1 and the first day that a hemoglobin value ≥ 11.0 g/dL is observed during the treatment period. If a participant did not achieve the target hemoglobin by the time of withdrawal or the end of the treatment period (EOTP), the time to target hemoglobin was censored on the day of the last hemoglobin measurement or the EOTP, whichever was earlier. Median was calculated using Kaplan-Meier estimates.
Time frame: From Week 1 to Week 16
Population: Subset of Primary Analysis Set, composed of all randomized participants who received at least one dose of blinded study medication, who had baseline hemoglobin values \< 11.0 g/dL.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Combined Darbepoetin Alfa 300 μg | Time to Achieve the Target Hemoglobin Level, by IV Iron Usage | 9.0 Weeks |
| Combined Darbepoetin Alfa 500 μg | Time to Achieve the Target Hemoglobin Level, by IV Iron Usage | 8.0 Weeks |
Secondary
Time to Hematopoietic Response, by Darbepoetin Alfa Dose
The time to hematopoietic response is the interval in weeks between study day 1 and the first day that a hematopoietic response is observed during the treatment period. Hematopoietic response is defined as an increase in hemoglobin concentration of ≥ 2.0 g/dL from baseline or a hemoglobin concentration ≥ 12.0 g/dL in the absence of RBC transfusions on the day of measurement and during the preceding 28 days of the treatment period. If a participant did not achieve a hematopoietic response by the time of withdrawal or the end of the treatment period (EOTP), the time to hematopoietic response was censored on the day of the last hemoglobin measurement or the EOTP, whichever was earlier. Median was calculated using using Kaplan-Meier estimates.
Time frame: From Week 1 to Week 16
Population: Subset of Primary Analysis Set, composed of all participants who were randomized, properly consented, and received at least one dose of blinded study drug, who had a baseline hemoglobin value.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Combined Darbepoetin Alfa 300 μg | Time to Hematopoietic Response, by Darbepoetin Alfa Dose | 11.0 Weeks |
| Combined Darbepoetin Alfa 500 μg | Time to Hematopoietic Response, by Darbepoetin Alfa Dose | 9.0 Weeks |
Secondary
Time to Hematopoietic Response, by IV Iron Usage
The time to hematopoietic response is the interval in weeks between study day 1 and the first day that a hematopoietic response is observed during the treatment period. Hematopoietic response is defined as an increase in hemoglobin concentration of ≥ 2.0 g/dL from baseline or a hemoglobin concentration ≥ 12.0 g/dL in the absence of RBC transfusions on the day of measurement and during the preceding 28 days of the treatment period. If a participant did not achieve a hematopoietic response by the time of withdrawal or the end of the treatment period (EOTP), the time to hematopoietic response was censored on the day of the last hemoglobin measurement or the EOTP, whichever was earlier. Median was calculated using using Kaplan-Meier estimates.
Time frame: From Week 1 to Week 16
Population: Subset of Primary Analysis Set, composed of all participants who were randomized, properly consented, and received at least one dose of blinded study drug, who had a baseline hemoglobin value.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Combined Darbepoetin Alfa 300 μg | Time to Hematopoietic Response, by IV Iron Usage | 12.0 Weeks |
| Combined Darbepoetin Alfa 500 μg | Time to Hematopoietic Response, by IV Iron Usage | 8.0 Weeks |