Anemia, Chronic Kidney Disease, Kidney Disease
Conditions
Keywords
Chronic Kidney Disease, Dialysis, Anemia, Nephrology, Pediatric, Hemodialysis, Peritoneal Dialysis, Chronic Renal Insufficiency
Brief summary
The primary objectives of this study are the following: 1. To test if the proportion of participants achieving a hemoglobin value greater than or equal to 10.0 g/dL at any time point after the first dose during the study is greater than 0.8 when administered de novo darbepoetin alfa once a week (QW) for treatment of anemia in pediatric patients with chronic kidney disease receiving and not receiving dialysis, and 2. To test if the proportion of participants achieving a hemoglobin value greater than or equal to 10.0 g/dL at any time point after the first dose during the study is greater than 0.8 when administered de novo darbepoetin alfa every 2 weeks (Q2W) for treatment of anemia in pediatric patients with chronic kidney disease receiving and not receiving dialysis.
Interventions
DRUGDarbepoetin Alfa
Administered by subcutaneous or intravenous injection
DRUGPlacebo
Matching placebo solution for subcutaneous or intravenous injection to maintain the blind in the Q2W arm.
Sponsors
Amgen
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Investigator)
Eligibility
Sex/Gender
ALL
Age
1 Years to 18 Years
Healthy volunteers
No
Inclusion criteria
* Current diagnosis of Chronic Kidney Disease, either receiving or not receiving dialysis * Anemic, with two consecutive screening hemoglobin values drawn at least 7 days apart \< 11.0 g/dL * Transferrin saturation (Tsat) greater than or equal to 20%
Exclusion criteria
* Any erythropoiesis stimulating agent (ESA) use within 12 weeks prior to randomization * other hematologic disorders * upper or lower gastrointenstinal bleeding within 6 months prior to randomization * uncontrolled hypertension * prior history (within 12 weeks prior to randomization) of acute myocardial ischemia, hospitalization for congestive heart failure, myocardial infarction, stroke or transient ischemic attack * prior history (within 6 months prior to randomization) of thromboembolism
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Proportion of Participants Achieving Hemoglobin ≥ 10.0 g/dL | 24 weeks | The proportion of participants achieving hemoglobin ≥ 10.0 g/dL (the correction proportion) was calculated as the number of participants achieving a hemoglobin ≥ 10.0 g/dL at any time point during the study when administered de novo darbepoetin alfa without receiving any red blood cell transfusion after randomization and within 90 days before the achievement, divided by the number of participants in the efficacy analysis set. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Hemoglobin Concentration Over Time | Baseline and Weeks 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 21, 22, 23, 24 and 25. | — |
| Weight-adjusted Darbepoetin Alfa Dose at Time of Achieving First Hemoglobin ≥ 10.0 g/dL | 24 weeks | The darbepoetin alfa dose at the time a participant achieved a first hemoglobin level ≥ 10.0 g/dL, divided by the participant's weight measured at the closest study week prior to the dosing, post dialysis. |
| Darbepoetin Alfa Weight-Adjusted Dose Over Time | Day 1 (initial dose) and Weeks 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 21, 22, 23, 24 and 25. | Arithmetic means are provided; Withheld doses are counted as 0 μg. |
| Change From Baseline at Week 13 and Week 25 in Parent-reported Pediatric Quality of Life Inventory (PedsQL) Scores | Baseline, Week 13 and Week 25 (or end of study visit if earlier than Week 25) | The PedsQL is a health-related quality of life (HRQOL) questionnaire that can be used to measure quality of life in children ≥ 2 years old. The 23-item PedsQL 4.0 includes physical functioning (8 items), emotional functioning (5 items), social functioning (5 items), and school functioning (5 items). Separate questionnaires for ages 2 to 4 (toddler), 5-7, 8-12, and 13-18 years are used for parent proxy-reporting, which assesses parents' perceptions of their child's HRQOL. The instructions ask how much of a problem each item has been during the past 1 month; each item is answered on a 5-point scale: 0 = never a problem; 1 = almost never a problem; 2 = sometimes a problem; 3 = often a problem; 4 = almost always a problem. Scores from the 4 subscales, the total score, and the psychosocial composite score were generated using standard algorithms. Each item's score in the questionnaire was converted to a 0 to 100 scale (with higher scores indicating better HRQOL). |
| Change From Baseline at Week 13 and Week 25 in Child Self-reported Pediatric Quality of Life Inventory (PedsQL) Scores | Baseline, Week 13 and Week 25 (or end of study visit if earlier than Week 25) | The PedsQL child self-reported questionnaire was used in children \> 5 years old. The 23-item PedsQL 4.0 includes physical functioning (8 items), emotional functioning (5 items), social functioning (5 items), and school functioning (5 items). Separate questionnaires for ages 5-7, 8-12, and 13-18 years was used for child self-reporting. The instructions asked how much of a problem each item has been during the past 1 month; each item is answered on a 5-point scale for ages 8 to 18 (0 = never a problem; 1 = almost never a problem; 2 = sometimes a problem; 3 = often a problem; 4 = almost always a problem), or simplified to a 3-point scale for ages 5 to 7 (0 = not at all a problem; 2 = sometimes a problem; 4 = a lot of a problem). Scores from the 4 subscales, the total score, and the psychosocial composite score were generated using standard algorithms. Each item's score in the questionnaire was converted to a 0 to 100 scale (with higher scores indicating better HRQOL). |
| Number of Participants With Treatment-emergent Adverse Events | 25 weeks | A serious adverse event (SAE) is defined as an adverse event that meets at least one of the following serious criteria: • is fatal, • is life threatening, • requires in-patient hospitalization or prolongation of existing hospitalization, • results in persistent or significant disability/incapacity, • is a congenital anomaly/birth defect, and/or • other significant medical hazard. The investigator assessed whether the adverse event was related to the investigational product (IP). Events of interest included hypertension, ischemic heart disease, cardiac failure, cerebrovascular disorders, convulsions, embolic and thrombotic events, embolic and thrombotic events: venous, embolic and thrombotic events: arterial, embolic and thrombotic events: vessel type unspecified and mixed arterial and venous, dialysis vascular access thrombosis, antibody-mediated pure red cell aplasia, hypersensitivity, lack of efficacy-effect, and malignancies. |
| Time to First Hemoglobin Value ≥ 10.0 g/dL | 24 weeks | The time from study Day 1 to the day a participant first achieved hemoglobin ≥ 10.0 g/dL for participants who achieved hemoglobin ≥ 10.0 g/dL. |
| Number of Participants With Hemoglobin > 12.0, > 13.0, and > 14.0 g/dL During the Study | 25 weeks | — |
| Maximum Increase in Hemoglobin Over Any 2 Week Period | 25 weeks | The maximum increase between any 2 non-missing hemoglobin measurements over any 2-week period from Day 1. |
| Change From Baseline in Systolic Blood Pressure Over Time | Baseline and Weeks 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 21, 22, 23, 24 and 25. | — |
| Change From Baseline in Diastolic Blood Pressure Over Time | Baseline and Weeks 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 21, 22, 23, 24 and 25. | — |
| Number of Participants Who Developed Anti-erythropoiesis Antibodies | 25 weeks | Participants who were negative for anti-erythropoiesis antibodies at Baseline (pre-dose) and who developed anti-erythropoiesis antibodies during the study. Serum samples were tested using Amgen's Surface Plasmon Resonance Immunoassay (SPRIA) method. |
| Darbepoetin Alfa Serum Concentrations for Participants Less Than 6 Years of Age | Weeks 1, 2, and 3 before the investigational product dose and 2 days after the first investigational product dose | Serum concentrations of darbepoetin alfa were measured by an enzyme-linked immunosorbent assay (ELISA). |
| Hemoglobin Serial Rate of Change (ROC) Over Time | Weeks 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 21, 22, 23, 24 and 25. | Calculated using the serial method as the change in hemoglobin from the previous non-missing hemoglobin level divided by number of days in between, and then multiplied by 7. |
Countries
Belgium, Latvia, Lithuania, Mexico, Poland, Puerto Rico, Russia, Slovakia, United Kingdom, United States
Participant flow
Recruitment details
This trial enrolled pediatric patients with chronic kidney disease (CKD) who were anemic and not treated with an erythropoiesis-stimulating agent (ESA). The study was conducted at 43 centers in the US, Europe and Mexico. The first participant was enrolled on 16 September 2008 and the last participant was enrolled on 02 December 2013.
Pre-assignment details
A total of 189 participants were screened, 116 participants were enrolled, and 73 screen failed. The primary reasons for screen failure were hemoglobin concentration \> 10 g/dL or transferrin saturation \< 20%. Randomization was stratified by age and dialysis status.
Participants by arm
| Arm | Count |
|---|---|
| Darbepoetin Alfa QW Participants received darbepoetin alfa once a week (QW) for 24 weeks. The initial dose was 0.45 μg/kg; thereafter, active doses were administered to achieve and then maintain hemoglobin levels within a target range of 10.0 to 12.0 g/dL. Participants not on dialysis or who were receiving peritoneal dialysis were administered darbepoetin alfa subcutaneously; participants receiving hemodialysis were administered darbepoetin alfa intravenously. | 58 |
| Darbepoetin Alfa Q2W Participants received darbepoetin alfa every 2 weeks (Q2W) and a placebo every other 2 weeks to maintain the blind for 24 weeks. The initial dose was 0.75 μg/kg; thereafter, active doses were administered to achieve and then maintain hemoglobin levels within a target range of 10.0 to 12.0 g/dL. Participants not on dialysis or who were receiving peritoneal dialysis were administered darbepoetin alfa subcutaneously; participants receiving hemodialysis were administered darbepoetin alfa intravenously. | 56 |
| Total | 114 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Administrative Decision | 1 | 0 |
| Overall Study | Adverse Event | 0 | 2 |
| Overall Study | Consent Withdrawn | 1 | 4 |
| Overall Study | Ineligibility Determined | 1 | 1 |
| Overall Study | Lost to Follow-up | 0 | 1 |
| Overall Study | Other | 3 | 0 |
| Overall Study | Protocol-specified Criteria | 5 | 4 |
Baseline characteristics
| Characteristic | Darbepoetin Alfa QW | Darbepoetin Alfa Q2W | Total |
|---|---|---|---|
| Age, Continuous | 12.6 years STANDARD_DEVIATION 3.6 | 12.8 years STANDARD_DEVIATION 3.7 | 12.7 years STANDARD_DEVIATION 3.6 |
| Age, Customized 12 - 18 years | 37 participants | 37 participants | 74 participants |
| Age, Customized 1 - < 6 years | 2 participants | 1 participants | 3 participants |
| Age, Customized 6 - < 12 years | 19 participants | 18 participants | 37 participants |
| Dialysis Status Not receiving dialysis | 33 participants | 33 participants | 66 participants |
| Dialysis Status Receiving hemodialysis | 15 participants | 14 participants | 29 participants |
| Dialysis Status Receiving peritoneal dialysis | 10 participants | 9 participants | 19 participants |
| Hemoglobin Concentration | 8.59 g/dL STANDARD_DEVIATION 0.84 | 8.73 g/dL STANDARD_DEVIATION 0.84 | 8.66 g/dL STANDARD_DEVIATION 0.84 |
| Race/Ethnicity, Customized Black or African American | 4 participants | 5 participants | 9 participants |
| Race/Ethnicity, Customized Hispanic or Latino | 23 participants | 20 participants | 43 participants |
| Race/Ethnicity, Customized Other | 1 participants | 1 participants | 2 participants |
| Race/Ethnicity, Customized White or Caucasian | 30 participants | 30 participants | 60 participants |
| Sex: Female, Male Female | 23 Participants | 23 Participants | 46 Participants |
| Sex: Female, Male Male | 35 Participants | 33 Participants | 68 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 42 / 58 | 43 / 56 |
| serious Total, serious adverse events | 16 / 58 | 14 / 56 |
Outcome results
Primary
Proportion of Participants Achieving Hemoglobin ≥ 10.0 g/dL
The proportion of participants achieving hemoglobin ≥ 10.0 g/dL (the correction proportion) was calculated as the number of participants achieving a hemoglobin ≥ 10.0 g/dL at any time point during the study when administered de novo darbepoetin alfa without receiving any red blood cell transfusion after randomization and within 90 days before the achievement, divided by the number of participants in the efficacy analysis set.
Time frame: 24 weeks
Population: Efficacy analysis set
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Darbepoetin Alfa QW | Proportion of Participants Achieving Hemoglobin ≥ 10.0 g/dL | 0.983 proportion of participants |
| Darbepoetin Alfa Q2W | Proportion of Participants Achieving Hemoglobin ≥ 10.0 g/dL | 0.839 proportion of participants |
Comparison: The null hypothesis for the Darbepoetin Alfa QW group was that the correction proportion (p) ≤ 0.8 ; Th alternative hypothesis was that p \> 0.8. The correction proportion was compared with 0.8 using the exact method to test the null hypothesis at a 1-sided overall significance level of 0.025.p-value: <0.001Exact
Comparison: The null hypothesis for the Darbepoetin Alfa Q2W group was that the correction proportion (p) ≤ 0.8 ; Th alternative hypothesis was that p \> 0.8. The correction proportion was compared with 0.8 using the exact method to test the null hypothesis at a 1-sided overall significance level of 0.025.p-value: 0.293Exact
Secondary
Change From Baseline at Week 13 and Week 25 in Child Self-reported Pediatric Quality of Life Inventory (PedsQL) Scores
The PedsQL child self-reported questionnaire was used in children \> 5 years old. The 23-item PedsQL 4.0 includes physical functioning (8 items), emotional functioning (5 items), social functioning (5 items), and school functioning (5 items). Separate questionnaires for ages 5-7, 8-12, and 13-18 years was used for child self-reporting. The instructions asked how much of a problem each item has been during the past 1 month; each item is answered on a 5-point scale for ages 8 to 18 (0 = never a problem; 1 = almost never a problem; 2 = sometimes a problem; 3 = often a problem; 4 = almost always a problem), or simplified to a 3-point scale for ages 5 to 7 (0 = not at all a problem; 2 = sometimes a problem; 4 = a lot of a problem). Scores from the 4 subscales, the total score, and the psychosocial composite score were generated using standard algorithms. Each item's score in the questionnaire was converted to a 0 to 100 scale (with higher scores indicating better HRQOL).
Time frame: Baseline, Week 13 and Week 25 (or end of study visit if earlier than Week 25)
Population: Efficacy analysis set aged \> 5 years and with available data for each score at each time point (indicated by n).
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Darbepoetin Alfa QW | Change From Baseline at Week 13 and Week 25 in Child Self-reported Pediatric Quality of Life Inventory (PedsQL) Scores | Week 13 Total Score (n=46, 46) | 2.94 units on a scale | Standard Error 1.7 |
| Darbepoetin Alfa QW | Change From Baseline at Week 13 and Week 25 in Child Self-reported Pediatric Quality of Life Inventory (PedsQL) Scores | Week 25 Total Score (n=40, 42) | 5.00 units on a scale | Standard Error 1.75 |
| Darbepoetin Alfa QW | Change From Baseline at Week 13 and Week 25 in Child Self-reported Pediatric Quality of Life Inventory (PedsQL) Scores | Week 13 Physical function score (n=46, 46) | 3.78 units on a scale | Standard Error 2.43 |
| Darbepoetin Alfa QW | Change From Baseline at Week 13 and Week 25 in Child Self-reported Pediatric Quality of Life Inventory (PedsQL) Scores | Week 25 Psychosocial composite score (n=40, 42) | 3.81 units on a scale | Standard Error 1.97 |
| Darbepoetin Alfa QW | Change From Baseline at Week 13 and Week 25 in Child Self-reported Pediatric Quality of Life Inventory (PedsQL) Scores | Week 25 Social function score (n=40, 42) | 7.00 units on a scale | Standard Error 3.1 |
| Darbepoetin Alfa QW | Change From Baseline at Week 13 and Week 25 in Child Self-reported Pediatric Quality of Life Inventory (PedsQL) Scores | Week 25 Physical function score (n=40, 42) | 7.42 units on a scale | Standard Error 2.48 |
| Darbepoetin Alfa QW | Change From Baseline at Week 13 and Week 25 in Child Self-reported Pediatric Quality of Life Inventory (PedsQL) Scores | Week 13 Emotional function score (n=46, 46) | 0.43 units on a scale | Standard Error 2.52 |
| Darbepoetin Alfa QW | Change From Baseline at Week 13 and Week 25 in Child Self-reported Pediatric Quality of Life Inventory (PedsQL) Scores | Week 25 Emotional function score (n=40, 42) | -0.25 units on a scale | Standard Error 2.51 |
| Darbepoetin Alfa QW | Change From Baseline at Week 13 and Week 25 in Child Self-reported Pediatric Quality of Life Inventory (PedsQL) Scores | Week 13 Social function score (n=46, 46) | 3.26 units on a scale | Standard Error 2.93 |
| Darbepoetin Alfa QW | Change From Baseline at Week 13 and Week 25 in Child Self-reported Pediatric Quality of Life Inventory (PedsQL) Scores | Week 13 Psychosocial composite score (n=46, 46) | 2.59 units on a scale | Standard Error 1.92 |
| Darbepoetin Alfa QW | Change From Baseline at Week 13 and Week 25 in Child Self-reported Pediatric Quality of Life Inventory (PedsQL) Scores | Week 25 School function score (n=40, 39) | 4.25 units on a scale | Standard Error 3.14 |
| Darbepoetin Alfa QW | Change From Baseline at Week 13 and Week 25 in Child Self-reported Pediatric Quality of Life Inventory (PedsQL) Scores | Week 13 School function score (n=45, 43) | 2.89 units on a scale | Standard Error 2.98 |
| Darbepoetin Alfa Q2W | Change From Baseline at Week 13 and Week 25 in Child Self-reported Pediatric Quality of Life Inventory (PedsQL) Scores | Week 25 School function score (n=40, 39) | 3.85 units on a scale | Standard Error 3.09 |
| Darbepoetin Alfa Q2W | Change From Baseline at Week 13 and Week 25 in Child Self-reported Pediatric Quality of Life Inventory (PedsQL) Scores | Week 13 Total Score (n=46, 46) | -1.23 units on a scale | Standard Error 2.04 |
| Darbepoetin Alfa Q2W | Change From Baseline at Week 13 and Week 25 in Child Self-reported Pediatric Quality of Life Inventory (PedsQL) Scores | Week 13 Psychosocial composite score (n=46, 46) | -0.45 units on a scale | Standard Error 2.23 |
| Darbepoetin Alfa Q2W | Change From Baseline at Week 13 and Week 25 in Child Self-reported Pediatric Quality of Life Inventory (PedsQL) Scores | Week 13 Physical function score (n=46, 46) | -2.79 units on a scale | Standard Error 2.59 |
| Darbepoetin Alfa Q2W | Change From Baseline at Week 13 and Week 25 in Child Self-reported Pediatric Quality of Life Inventory (PedsQL) Scores | Week 13 Social function score (n=46, 46) | -2.28 units on a scale | Standard Error 3.02 |
| Darbepoetin Alfa Q2W | Change From Baseline at Week 13 and Week 25 in Child Self-reported Pediatric Quality of Life Inventory (PedsQL) Scores | Week 13 School function score (n=45, 43) | 2.44 units on a scale | Standard Error 3.83 |
| Darbepoetin Alfa Q2W | Change From Baseline at Week 13 and Week 25 in Child Self-reported Pediatric Quality of Life Inventory (PedsQL) Scores | Week 25 Total Score (n=40, 42) | 2.58 units on a scale | Standard Error 1.78 |
| Darbepoetin Alfa Q2W | Change From Baseline at Week 13 and Week 25 in Child Self-reported Pediatric Quality of Life Inventory (PedsQL) Scores | Week 25 Psychosocial composite score (n=40, 42) | 3.53 units on a scale | Standard Error 2.01 |
| Darbepoetin Alfa Q2W | Change From Baseline at Week 13 and Week 25 in Child Self-reported Pediatric Quality of Life Inventory (PedsQL) Scores | Week 25 Physical function score (n=40, 42) | 0.74 units on a scale | Standard Error 2.8 |
| Darbepoetin Alfa Q2W | Change From Baseline at Week 13 and Week 25 in Child Self-reported Pediatric Quality of Life Inventory (PedsQL) Scores | Week 25 Emotional function score (n=40, 42) | 3.93 units on a scale | Standard Error 3.1 |
| Darbepoetin Alfa Q2W | Change From Baseline at Week 13 and Week 25 in Child Self-reported Pediatric Quality of Life Inventory (PedsQL) Scores | Week 25 Social function score (n=40, 42) | 2.50 units on a scale | Standard Error 2.67 |
| Darbepoetin Alfa Q2W | Change From Baseline at Week 13 and Week 25 in Child Self-reported Pediatric Quality of Life Inventory (PedsQL) Scores | Week 13 Emotional function score (n=46, 46) | -0.76 units on a scale | Standard Error 2.79 |
Secondary
Change From Baseline at Week 13 and Week 25 in Parent-reported Pediatric Quality of Life Inventory (PedsQL) Scores
The PedsQL is a health-related quality of life (HRQOL) questionnaire that can be used to measure quality of life in children ≥ 2 years old. The 23-item PedsQL 4.0 includes physical functioning (8 items), emotional functioning (5 items), social functioning (5 items), and school functioning (5 items). Separate questionnaires for ages 2 to 4 (toddler), 5-7, 8-12, and 13-18 years are used for parent proxy-reporting, which assesses parents' perceptions of their child's HRQOL. The instructions ask how much of a problem each item has been during the past 1 month; each item is answered on a 5-point scale: 0 = never a problem; 1 = almost never a problem; 2 = sometimes a problem; 3 = often a problem; 4 = almost always a problem. Scores from the 4 subscales, the total score, and the psychosocial composite score were generated using standard algorithms. Each item's score in the questionnaire was converted to a 0 to 100 scale (with higher scores indicating better HRQOL).
Time frame: Baseline, Week 13 and Week 25 (or end of study visit if earlier than Week 25)
Population: Efficacy analysis set with available data for each score at each time point (indicated by n).
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Darbepoetin Alfa QW | Change From Baseline at Week 13 and Week 25 in Parent-reported Pediatric Quality of Life Inventory (PedsQL) Scores | Week 13 School function score (n=42, 42) | 7.30 units on a scale | Standard Error 2.47 |
| Darbepoetin Alfa QW | Change From Baseline at Week 13 and Week 25 in Parent-reported Pediatric Quality of Life Inventory (PedsQL) Scores | Week 13 Total Score (n=45, 46) | 4.50 units on a scale | Standard Error 2.19 |
| Darbepoetin Alfa QW | Change From Baseline at Week 13 and Week 25 in Parent-reported Pediatric Quality of Life Inventory (PedsQL) Scores | Week 13 Psychosocial composite score (n=45, 46) | 5.12 units on a scale | Standard Error 2.16 |
| Darbepoetin Alfa QW | Change From Baseline at Week 13 and Week 25 in Parent-reported Pediatric Quality of Life Inventory (PedsQL) Scores | Week 13 Physical function score (n=45, 46) | 3.61 units on a scale | Standard Error 3.2 |
| Darbepoetin Alfa QW | Change From Baseline at Week 13 and Week 25 in Parent-reported Pediatric Quality of Life Inventory (PedsQL) Scores | Week 13 Emotional function score (n=45, 46) | 1.00 units on a scale | Standard Error 3 |
| Darbepoetin Alfa QW | Change From Baseline at Week 13 and Week 25 in Parent-reported Pediatric Quality of Life Inventory (PedsQL) Scores | Week 13 Social function score (n=45, 46) | 6.89 units on a scale | Standard Error 3.54 |
| Darbepoetin Alfa QW | Change From Baseline at Week 13 and Week 25 in Parent-reported Pediatric Quality of Life Inventory (PedsQL) Scores | Week 25 Total Score (n=38, 41) | 1.90 units on a scale | Standard Error 2.06 |
| Darbepoetin Alfa QW | Change From Baseline at Week 13 and Week 25 in Parent-reported Pediatric Quality of Life Inventory (PedsQL) Scores | Week 25 Psychosocial composite score (n=38, 41) | 2.52 units on a scale | Standard Error 1.83 |
| Darbepoetin Alfa QW | Change From Baseline at Week 13 and Week 25 in Parent-reported Pediatric Quality of Life Inventory (PedsQL) Scores | Week 25 Physical function score (n=38, 41) | 0.66 units on a scale | Standard Error 3.89 |
| Darbepoetin Alfa QW | Change From Baseline at Week 13 and Week 25 in Parent-reported Pediatric Quality of Life Inventory (PedsQL) Scores | Week 25 Emotional function score (n=38, 41) | -0.66 units on a scale | Standard Error 2.61 |
| Darbepoetin Alfa QW | Change From Baseline at Week 13 and Week 25 in Parent-reported Pediatric Quality of Life Inventory (PedsQL) Scores | Week 25 Social function score (n=38, 41) | 5.13 units on a scale | Standard Error 2.64 |
| Darbepoetin Alfa QW | Change From Baseline at Week 13 and Week 25 in Parent-reported Pediatric Quality of Life Inventory (PedsQL) Scores | Week 25 School function score (n=36, 37) | 3.90 units on a scale | Standard Error 2.51 |
| Darbepoetin Alfa Q2W | Change From Baseline at Week 13 and Week 25 in Parent-reported Pediatric Quality of Life Inventory (PedsQL) Scores | Week 13 School function score (n=42, 42) | 4.17 units on a scale | Standard Error 3.63 |
| Darbepoetin Alfa Q2W | Change From Baseline at Week 13 and Week 25 in Parent-reported Pediatric Quality of Life Inventory (PedsQL) Scores | Week 25 School function score (n=36, 37) | 2.03 units on a scale | Standard Error 3.94 |
| Darbepoetin Alfa Q2W | Change From Baseline at Week 13 and Week 25 in Parent-reported Pediatric Quality of Life Inventory (PedsQL) Scores | Week 25 Physical function score (n=38, 41) | 5.18 units on a scale | Standard Error 3.59 |
| Darbepoetin Alfa Q2W | Change From Baseline at Week 13 and Week 25 in Parent-reported Pediatric Quality of Life Inventory (PedsQL) Scores | Week 13 Total Score (n=45, 46) | 0.58 units on a scale | Standard Error 2.43 |
| Darbepoetin Alfa Q2W | Change From Baseline at Week 13 and Week 25 in Parent-reported Pediatric Quality of Life Inventory (PedsQL) Scores | Week 25 Total Score (n=38, 41) | 0.65 units on a scale | Standard Error 2.66 |
| Darbepoetin Alfa Q2W | Change From Baseline at Week 13 and Week 25 in Parent-reported Pediatric Quality of Life Inventory (PedsQL) Scores | Week 13 Psychosocial composite score (n=45, 46) | -0.41 units on a scale | Standard Error 2.57 |
| Darbepoetin Alfa Q2W | Change From Baseline at Week 13 and Week 25 in Parent-reported Pediatric Quality of Life Inventory (PedsQL) Scores | Week 25 Social function score (n=38, 41) | -2.20 units on a scale | Standard Error 4.1 |
| Darbepoetin Alfa Q2W | Change From Baseline at Week 13 and Week 25 in Parent-reported Pediatric Quality of Life Inventory (PedsQL) Scores | Week 13 Physical function score (n=45, 46) | 2.31 units on a scale | Standard Error 3.35 |
| Darbepoetin Alfa Q2W | Change From Baseline at Week 13 and Week 25 in Parent-reported Pediatric Quality of Life Inventory (PedsQL) Scores | Week 25 Psychosocial composite score (n=38, 41) | -1.84 units on a scale | Standard Error 3.13 |
| Darbepoetin Alfa Q2W | Change From Baseline at Week 13 and Week 25 in Parent-reported Pediatric Quality of Life Inventory (PedsQL) Scores | Week 13 Emotional function score (n=45, 46) | -3.89 units on a scale | Standard Error 2.74 |
| Darbepoetin Alfa Q2W | Change From Baseline at Week 13 and Week 25 in Parent-reported Pediatric Quality of Life Inventory (PedsQL) Scores | Week 25 Emotional function score (n=38, 41) | -3.51 units on a scale | Standard Error 3.16 |
| Darbepoetin Alfa Q2W | Change From Baseline at Week 13 and Week 25 in Parent-reported Pediatric Quality of Life Inventory (PedsQL) Scores | Week 13 Social function score (n=45, 46) | 0.76 units on a scale | Standard Error 3.56 |
Secondary
Change From Baseline in Diastolic Blood Pressure Over Time
Time frame: Baseline and Weeks 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 21, 22, 23, 24 and 25.
Population: Safety analyis set with available data at each time point (indicated by n).
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Darbepoetin Alfa QW | Change From Baseline in Diastolic Blood Pressure Over Time | Week 24 (n=46, 46) | 4.0 mmHg | Standard Deviation 13.8 |
| Darbepoetin Alfa QW | Change From Baseline in Diastolic Blood Pressure Over Time | Week 7 (n=54, 52) | 1.2 mmHg | Standard Deviation 10.4 |
| Darbepoetin Alfa QW | Change From Baseline in Diastolic Blood Pressure Over Time | Week 8 (n=55, 52) | 3.9 mmHg | Standard Deviation 11.9 |
| Darbepoetin Alfa QW | Change From Baseline in Diastolic Blood Pressure Over Time | Week 9 (n=54, 52) | 4.8 mmHg | Standard Deviation 14.7 |
| Darbepoetin Alfa QW | Change From Baseline in Diastolic Blood Pressure Over Time | Week 10 (n=55, 52) | 1.5 mmHg | Standard Deviation 13.7 |
| Darbepoetin Alfa QW | Change From Baseline in Diastolic Blood Pressure Over Time | Week 11 (n=54, 51) | 3.9 mmHg | Standard Deviation 11.8 |
| Darbepoetin Alfa QW | Change From Baseline in Diastolic Blood Pressure Over Time | Week 6 (n=54, 51) | 2.6 mmHg | Standard Deviation 10.1 |
| Darbepoetin Alfa QW | Change From Baseline in Diastolic Blood Pressure Over Time | Week 2 (n=55, 54) | 1.4 mmHg | Standard Deviation 9.4 |
| Darbepoetin Alfa QW | Change From Baseline in Diastolic Blood Pressure Over Time | Week 3 (n=55, 56) | 2.2 mmHg | Standard Deviation 11 |
| Darbepoetin Alfa QW | Change From Baseline in Diastolic Blood Pressure Over Time | Week 4 (n=55, 54) | 2.8 mmHg | Standard Deviation 11 |
| Darbepoetin Alfa QW | Change From Baseline in Diastolic Blood Pressure Over Time | Week 5 (n=55, 52) | 3.0 mmHg | Standard Deviation 12.4 |
| Darbepoetin Alfa QW | Change From Baseline in Diastolic Blood Pressure Over Time | Week 12 (n=55, 49) | 1.6 mmHg | Standard Deviation 10.4 |
| Darbepoetin Alfa QW | Change From Baseline in Diastolic Blood Pressure Over Time | Week 13 (n=54, 50) | 2.7 mmHg | Standard Deviation 13.8 |
| Darbepoetin Alfa QW | Change From Baseline in Diastolic Blood Pressure Over Time | Week 14 (n=54, 50) | 3.4 mmHg | Standard Deviation 14.4 |
| Darbepoetin Alfa QW | Change From Baseline in Diastolic Blood Pressure Over Time | Week 15 (n=53, 50) | 3.7 mmHg | Standard Deviation 12.9 |
| Darbepoetin Alfa QW | Change From Baseline in Diastolic Blood Pressure Over Time | Week 16 (n=50, 48) | 4.6 mmHg | Standard Deviation 13.7 |
| Darbepoetin Alfa QW | Change From Baseline in Diastolic Blood Pressure Over Time | Week 17 (n=51, 47) | 4.1 mmHg | Standard Deviation 15.6 |
| Darbepoetin Alfa QW | Change From Baseline in Diastolic Blood Pressure Over Time | Week 18 (n=50, 46) | 3.0 mmHg | Standard Deviation 16.4 |
| Darbepoetin Alfa QW | Change From Baseline in Diastolic Blood Pressure Over Time | Week 19 (n=50, 47) | 3.7 mmHg | Standard Deviation 12.9 |
| Darbepoetin Alfa QW | Change From Baseline in Diastolic Blood Pressure Over Time | Week 20 (n=48, 46) | 1.7 mmHg | Standard Deviation 13.8 |
| Darbepoetin Alfa QW | Change From Baseline in Diastolic Blood Pressure Over Time | Week 21 (n=49, 46) | 2.9 mmHg | Standard Deviation 15.1 |
| Darbepoetin Alfa QW | Change From Baseline in Diastolic Blood Pressure Over Time | Week 22 (n=48, 46) | 3.2 mmHg | Standard Deviation 14.7 |
| Darbepoetin Alfa QW | Change From Baseline in Diastolic Blood Pressure Over Time | Week 23 (n=47, 45) | 5.0 mmHg | Standard Deviation 13.8 |
| Darbepoetin Alfa QW | Change From Baseline in Diastolic Blood Pressure Over Time | Week 25 (n=34, 32) | 3.0 mmHg | Standard Deviation 13 |
| Darbepoetin Alfa Q2W | Change From Baseline in Diastolic Blood Pressure Over Time | Week 24 (n=46, 46) | -0.3 mmHg | Standard Deviation 12.8 |
| Darbepoetin Alfa Q2W | Change From Baseline in Diastolic Blood Pressure Over Time | Week 6 (n=54, 51) | -0.1 mmHg | Standard Deviation 11.4 |
| Darbepoetin Alfa Q2W | Change From Baseline in Diastolic Blood Pressure Over Time | Week 13 (n=54, 50) | 2.2 mmHg | Standard Deviation 10.6 |
| Darbepoetin Alfa Q2W | Change From Baseline in Diastolic Blood Pressure Over Time | Week 7 (n=54, 52) | -1.0 mmHg | Standard Deviation 12.3 |
| Darbepoetin Alfa Q2W | Change From Baseline in Diastolic Blood Pressure Over Time | Week 19 (n=50, 47) | 0.6 mmHg | Standard Deviation 12.2 |
| Darbepoetin Alfa Q2W | Change From Baseline in Diastolic Blood Pressure Over Time | Week 8 (n=55, 52) | 1.1 mmHg | Standard Deviation 15 |
| Darbepoetin Alfa Q2W | Change From Baseline in Diastolic Blood Pressure Over Time | Week 14 (n=54, 50) | 1.7 mmHg | Standard Deviation 12 |
| Darbepoetin Alfa Q2W | Change From Baseline in Diastolic Blood Pressure Over Time | Week 9 (n=54, 52) | -0.3 mmHg | Standard Deviation 12.9 |
| Darbepoetin Alfa Q2W | Change From Baseline in Diastolic Blood Pressure Over Time | Week 22 (n=48, 46) | 0.3 mmHg | Standard Deviation 13.9 |
| Darbepoetin Alfa Q2W | Change From Baseline in Diastolic Blood Pressure Over Time | Week 10 (n=55, 52) | 0.9 mmHg | Standard Deviation 15.9 |
| Darbepoetin Alfa Q2W | Change From Baseline in Diastolic Blood Pressure Over Time | Week 15 (n=53, 50) | 1.4 mmHg | Standard Deviation 11.7 |
| Darbepoetin Alfa Q2W | Change From Baseline in Diastolic Blood Pressure Over Time | Week 23 (n=47, 45) | -2.0 mmHg | Standard Deviation 14 |
| Darbepoetin Alfa Q2W | Change From Baseline in Diastolic Blood Pressure Over Time | Week 20 (n=48, 46) | 2.0 mmHg | Standard Deviation 13.2 |
| Darbepoetin Alfa Q2W | Change From Baseline in Diastolic Blood Pressure Over Time | Week 16 (n=50, 48) | 0.7 mmHg | Standard Deviation 11.9 |
| Darbepoetin Alfa Q2W | Change From Baseline in Diastolic Blood Pressure Over Time | Week 2 (n=55, 54) | 0.8 mmHg | Standard Deviation 11.1 |
| Darbepoetin Alfa Q2W | Change From Baseline in Diastolic Blood Pressure Over Time | Week 25 (n=34, 32) | -1.5 mmHg | Standard Deviation 10.7 |
| Darbepoetin Alfa Q2W | Change From Baseline in Diastolic Blood Pressure Over Time | Week 3 (n=55, 56) | 3.1 mmHg | Standard Deviation 10.8 |
| Darbepoetin Alfa Q2W | Change From Baseline in Diastolic Blood Pressure Over Time | Week 17 (n=51, 47) | 2.6 mmHg | Standard Deviation 10.6 |
| Darbepoetin Alfa Q2W | Change From Baseline in Diastolic Blood Pressure Over Time | Week 4 (n=55, 54) | 1.8 mmHg | Standard Deviation 12.6 |
| Darbepoetin Alfa Q2W | Change From Baseline in Diastolic Blood Pressure Over Time | Week 21 (n=49, 46) | 0.6 mmHg | Standard Deviation 12.9 |
| Darbepoetin Alfa Q2W | Change From Baseline in Diastolic Blood Pressure Over Time | Week 5 (n=55, 52) | -0.2 mmHg | Standard Deviation 11.2 |
| Darbepoetin Alfa Q2W | Change From Baseline in Diastolic Blood Pressure Over Time | Week 11 (n=54, 51) | 0.9 mmHg | Standard Deviation 14.4 |
| Darbepoetin Alfa Q2W | Change From Baseline in Diastolic Blood Pressure Over Time | Week 18 (n=50, 46) | 0.4 mmHg | Standard Deviation 11.7 |
| Darbepoetin Alfa Q2W | Change From Baseline in Diastolic Blood Pressure Over Time | Week 12 (n=55, 49) | 2.8 mmHg | Standard Deviation 13.7 |
Secondary
Change From Baseline in Systolic Blood Pressure Over Time
Time frame: Baseline and Weeks 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 21, 22, 23, 24 and 25.
Population: Safety analyis set with available data at each time point (indicated by n).
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Darbepoetin Alfa QW | Change From Baseline in Systolic Blood Pressure Over Time | Week 8 (n=55, 52) | 0.5 mmHg | Standard Deviation 16 |
| Darbepoetin Alfa QW | Change From Baseline in Systolic Blood Pressure Over Time | Week 3 (n=55, 56) | 1.1 mmHg | Standard Deviation 14.1 |
| Darbepoetin Alfa QW | Change From Baseline in Systolic Blood Pressure Over Time | Week 4 (n=55, 54) | 1.3 mmHg | Standard Deviation 13 |
| Darbepoetin Alfa QW | Change From Baseline in Systolic Blood Pressure Over Time | Week 5 (n=55, 52) | 1.1 mmHg | Standard Deviation 13.7 |
| Darbepoetin Alfa QW | Change From Baseline in Systolic Blood Pressure Over Time | Week 6 (n=54, 51) | 0.2 mmHg | Standard Deviation 14.2 |
| Darbepoetin Alfa QW | Change From Baseline in Systolic Blood Pressure Over Time | Week 7 (n=54, 52) | -1.0 mmHg | Standard Deviation 14.2 |
| Darbepoetin Alfa QW | Change From Baseline in Systolic Blood Pressure Over Time | Week 2 (n=55, 54) | 1.7 mmHg | Standard Deviation 11.6 |
| Darbepoetin Alfa QW | Change From Baseline in Systolic Blood Pressure Over Time | Week 9 (n=54, 52) | 1.0 mmHg | Standard Deviation 18.3 |
| Darbepoetin Alfa QW | Change From Baseline in Systolic Blood Pressure Over Time | Week 10 (n=55, 52) | -0.2 mmHg | Standard Deviation 16.6 |
| Darbepoetin Alfa QW | Change From Baseline in Systolic Blood Pressure Over Time | Week 11 (n=54, 51) | -2.0 mmHg | Standard Deviation 15.6 |
| Darbepoetin Alfa QW | Change From Baseline in Systolic Blood Pressure Over Time | Week 12 (n=55, 49) | -2.4 mmHg | Standard Deviation 17.2 |
| Darbepoetin Alfa QW | Change From Baseline in Systolic Blood Pressure Over Time | Week 13 (n=53, 50) | 0.5 mmHg | Standard Deviation 14.8 |
| Darbepoetin Alfa QW | Change From Baseline in Systolic Blood Pressure Over Time | Week 14 (n=54, 50) | -2.3 mmHg | Standard Deviation 19.5 |
| Darbepoetin Alfa QW | Change From Baseline in Systolic Blood Pressure Over Time | Week 15 (n=53, 50) | 0.1 mmHg | Standard Deviation 17.4 |
| Darbepoetin Alfa QW | Change From Baseline in Systolic Blood Pressure Over Time | Week 16 (n=50, 48) | 1.9 mmHg | Standard Deviation 16.4 |
| Darbepoetin Alfa QW | Change From Baseline in Systolic Blood Pressure Over Time | Week 17 (n=51, 47) | 1.0 mmHg | Standard Deviation 17.7 |
| Darbepoetin Alfa QW | Change From Baseline in Systolic Blood Pressure Over Time | Week 18 (n=50, 46) | 0.5 mmHg | Standard Deviation 18.5 |
| Darbepoetin Alfa QW | Change From Baseline in Systolic Blood Pressure Over Time | Week 19 (n=50, 47) | 3.4 mmHg | Standard Deviation 16 |
| Darbepoetin Alfa QW | Change From Baseline in Systolic Blood Pressure Over Time | Week 20 (n=48, 46) | -0.9 mmHg | Standard Deviation 18.3 |
| Darbepoetin Alfa QW | Change From Baseline in Systolic Blood Pressure Over Time | Week 21 (n=49, 46) | 1.9 mmHg | Standard Deviation 15.7 |
| Darbepoetin Alfa QW | Change From Baseline in Systolic Blood Pressure Over Time | Week 22 (n=48, 46) | -0.6 mmHg | Standard Deviation 18.2 |
| Darbepoetin Alfa QW | Change From Baseline in Systolic Blood Pressure Over Time | Week 23 (n=47, 45) | -0.6 mmHg | Standard Deviation 16.5 |
| Darbepoetin Alfa QW | Change From Baseline in Systolic Blood Pressure Over Time | Week 24 (n=46, 46) | 0.0 mmHg | Standard Deviation 17.8 |
| Darbepoetin Alfa QW | Change From Baseline in Systolic Blood Pressure Over Time | Week 25 (n=34, 32) | -0.5 mmHg | Standard Deviation 14.3 |
| Darbepoetin Alfa Q2W | Change From Baseline in Systolic Blood Pressure Over Time | Week 24 (n=46, 46) | -2.0 mmHg | Standard Deviation 11.8 |
| Darbepoetin Alfa Q2W | Change From Baseline in Systolic Blood Pressure Over Time | Week 2 (n=55, 54) | -3.9 mmHg | Standard Deviation 11.1 |
| Darbepoetin Alfa Q2W | Change From Baseline in Systolic Blood Pressure Over Time | Week 14 (n=54, 50) | -1.8 mmHg | Standard Deviation 15.8 |
| Darbepoetin Alfa Q2W | Change From Baseline in Systolic Blood Pressure Over Time | Week 3 (n=55, 56) | 0.0 mmHg | Standard Deviation 12.7 |
| Darbepoetin Alfa Q2W | Change From Baseline in Systolic Blood Pressure Over Time | Week 20 (n=48, 46) | -4.0 mmHg | Standard Deviation 13 |
| Darbepoetin Alfa Q2W | Change From Baseline in Systolic Blood Pressure Over Time | Week 4 (n=55, 54) | 1.2 mmHg | Standard Deviation 11.5 |
| Darbepoetin Alfa Q2W | Change From Baseline in Systolic Blood Pressure Over Time | Week 15 (n=53, 50) | -2.4 mmHg | Standard Deviation 13 |
| Darbepoetin Alfa Q2W | Change From Baseline in Systolic Blood Pressure Over Time | Week 5 (n=55, 52) | -3.0 mmHg | Standard Deviation 13.7 |
| Darbepoetin Alfa Q2W | Change From Baseline in Systolic Blood Pressure Over Time | Week 23 (n=47, 45) | -1.2 mmHg | Standard Deviation 15.7 |
| Darbepoetin Alfa Q2W | Change From Baseline in Systolic Blood Pressure Over Time | Week 6 (n=54, 51) | -2.9 mmHg | Standard Deviation 12.5 |
| Darbepoetin Alfa Q2W | Change From Baseline in Systolic Blood Pressure Over Time | Week 16 (n=50, 48) | -3.8 mmHg | Standard Deviation 16.3 |
| Darbepoetin Alfa Q2W | Change From Baseline in Systolic Blood Pressure Over Time | Week 7 (n=54, 52) | -3.7 mmHg | Standard Deviation 13.4 |
| Darbepoetin Alfa Q2W | Change From Baseline in Systolic Blood Pressure Over Time | Week 21 (n=49, 46) | -2.2 mmHg | Standard Deviation 15 |
| Darbepoetin Alfa Q2W | Change From Baseline in Systolic Blood Pressure Over Time | Week 8 (n=55, 52) | -2.7 mmHg | Standard Deviation 13.8 |
| Darbepoetin Alfa Q2W | Change From Baseline in Systolic Blood Pressure Over Time | Week 17 (n=51, 47) | 0.1 mmHg | Standard Deviation 10.6 |
| Darbepoetin Alfa Q2W | Change From Baseline in Systolic Blood Pressure Over Time | Week 9 (n=54, 52) | -3.1 mmHg | Standard Deviation 14.5 |
| Darbepoetin Alfa Q2W | Change From Baseline in Systolic Blood Pressure Over Time | Week 25 (n=34, 32) | -2.3 mmHg | Standard Deviation 12.4 |
| Darbepoetin Alfa Q2W | Change From Baseline in Systolic Blood Pressure Over Time | Week 10 (n=55, 52) | -3.7 mmHg | Standard Deviation 14.6 |
| Darbepoetin Alfa Q2W | Change From Baseline in Systolic Blood Pressure Over Time | Week 18 (n=50, 46) | 0.0 mmHg | Standard Deviation 15.5 |
| Darbepoetin Alfa Q2W | Change From Baseline in Systolic Blood Pressure Over Time | Week 11 (n=54, 51) | -1.8 mmHg | Standard Deviation 15.9 |
| Darbepoetin Alfa Q2W | Change From Baseline in Systolic Blood Pressure Over Time | Week 22 (n=48, 46) | -0.9 mmHg | Standard Deviation 15 |
| Darbepoetin Alfa Q2W | Change From Baseline in Systolic Blood Pressure Over Time | Week 12 (n=55, 49) | -2.8 mmHg | Standard Deviation 15.4 |
| Darbepoetin Alfa Q2W | Change From Baseline in Systolic Blood Pressure Over Time | Week 19 (n=50, 47) | -2.5 mmHg | Standard Deviation 14.2 |
| Darbepoetin Alfa Q2W | Change From Baseline in Systolic Blood Pressure Over Time | Week 13 (n=53, 50) | -2.1 mmHg | Standard Deviation 14.2 |
Secondary
Darbepoetin Alfa Serum Concentrations for Participants Less Than 6 Years of Age
Serum concentrations of darbepoetin alfa were measured by an enzyme-linked immunosorbent assay (ELISA).
Time frame: Weeks 1, 2, and 3 before the investigational product dose and 2 days after the first investigational product dose
Population: Due to the low number of participants \<6 years of age summary concentration analyses were not performed.
Secondary
Darbepoetin Alfa Weight-Adjusted Dose Over Time
Arithmetic means are provided; Withheld doses are counted as 0 μg.
Time frame: Day 1 (initial dose) and Weeks 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 21, 22, 23, 24 and 25.
Population: Efficacy analyis set with available data at each time point (indicated by n). Numbers \> 0 on non-darbepoetin alfa dosing weeks for the Q2W group reflect participants who did not receive the assigned placebo dose (eg, dose withheld per investigator decision based on hemoglobin value or missed visit).
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Darbepoetin Alfa QW | Darbepoetin Alfa Weight-Adjusted Dose Over Time | Week 7 (n=54, 51) | 0.38 μg/kg | Standard Deviation 0.25 |
| Darbepoetin Alfa QW | Darbepoetin Alfa Weight-Adjusted Dose Over Time | Week 8 (n=53, 1) | 0.34 μg/kg | Standard Deviation 0.24 |
| Darbepoetin Alfa QW | Darbepoetin Alfa Weight-Adjusted Dose Over Time | Week 22 (n=48, 3) | 0.38 μg/kg | Standard Deviation 0.64 |
| Darbepoetin Alfa QW | Darbepoetin Alfa Weight-Adjusted Dose Over Time | Week 3 (n=55, 52) | 0.44 μg/kg | Standard Deviation 0.07 |
| Darbepoetin Alfa QW | Darbepoetin Alfa Weight-Adjusted Dose Over Time | Initial Dose (n=58, 56) | 0.45 μg/kg | Standard Deviation 0.07 |
| Darbepoetin Alfa QW | Darbepoetin Alfa Weight-Adjusted Dose Over Time | Week 2 (n=55, 0) | 0.45 μg/kg | Standard Deviation 0.07 |
| Darbepoetin Alfa QW | Darbepoetin Alfa Weight-Adjusted Dose Over Time | Week 4 (n=54, 0) | 0.40 μg/kg | Standard Deviation 0.11 |
| Darbepoetin Alfa QW | Darbepoetin Alfa Weight-Adjusted Dose Over Time | Week 5 (n=54, 51) | 0.43 μg/kg | Standard Deviation 0.26 |
| Darbepoetin Alfa QW | Darbepoetin Alfa Weight-Adjusted Dose Over Time | Week 6 (n=54, 0) | 0.42 μg/kg | Standard Deviation 0.29 |
| Darbepoetin Alfa QW | Darbepoetin Alfa Weight-Adjusted Dose Over Time | Week 9 (n=52, 52) | 0.32 μg/kg | Standard Deviation 0.23 |
| Darbepoetin Alfa QW | Darbepoetin Alfa Weight-Adjusted Dose Over Time | Week 10 (n=55, 3) | 0.33 μg/kg | Standard Deviation 0.26 |
| Darbepoetin Alfa QW | Darbepoetin Alfa Weight-Adjusted Dose Over Time | Week 11 (n=54, 50) | 0.32 μg/kg | Standard Deviation 0.28 |
| Darbepoetin Alfa QW | Darbepoetin Alfa Weight-Adjusted Dose Over Time | Week 12 (n=54, 2) | 0.26 μg/kg | Standard Deviation 0.28 |
| Darbepoetin Alfa QW | Darbepoetin Alfa Weight-Adjusted Dose Over Time | Week 13 (n=54, 50) | 0.24 μg/kg | Standard Deviation 0.28 |
| Darbepoetin Alfa QW | Darbepoetin Alfa Weight-Adjusted Dose Over Time | Week 14 (n=53, 4) | 0.21 μg/kg | Standard Deviation 0.27 |
| Darbepoetin Alfa QW | Darbepoetin Alfa Weight-Adjusted Dose Over Time | Week 15 (n=52, 48) | 0.31 μg/kg | Standard Deviation 0.33 |
| Darbepoetin Alfa QW | Darbepoetin Alfa Weight-Adjusted Dose Over Time | Week 16 (n=50, 5) | 0.35 μg/kg | Standard Deviation 0.44 |
| Darbepoetin Alfa QW | Darbepoetin Alfa Weight-Adjusted Dose Over Time | Week 17 (n=51, 47) | 0.29 μg/kg | Standard Deviation 0.34 |
| Darbepoetin Alfa QW | Darbepoetin Alfa Weight-Adjusted Dose Over Time | Week 18 (n=50, 3) | 0.32 μg/kg | Standard Deviation 0.4 |
| Darbepoetin Alfa QW | Darbepoetin Alfa Weight-Adjusted Dose Over Time | Week 19 (n=50, 46) | 0.31 μg/kg | Standard Deviation 0.33 |
| Darbepoetin Alfa QW | Darbepoetin Alfa Weight-Adjusted Dose Over Time | Week 20 (n=48, 4) | 0.35 μg/kg | Standard Deviation 0.34 |
| Darbepoetin Alfa QW | Darbepoetin Alfa Weight-Adjusted Dose Over Time | Week 21 (n=48, 46) | 0.38 μg/kg | Standard Deviation 0.63 |
| Darbepoetin Alfa QW | Darbepoetin Alfa Weight-Adjusted Dose Over Time | Week 23 (n=47, 44) | 0.39 μg/kg | Standard Deviation 0.63 |
| Darbepoetin Alfa QW | Darbepoetin Alfa Weight-Adjusted Dose Over Time | Week 24 (n=46, 1) | 0.41 μg/kg | Standard Deviation 0.63 |
| Darbepoetin Alfa Q2W | Darbepoetin Alfa Weight-Adjusted Dose Over Time | Week 16 (n=50, 5) | 0.00 μg/kg | Standard Deviation 0 |
| Darbepoetin Alfa Q2W | Darbepoetin Alfa Weight-Adjusted Dose Over Time | Week 7 (n=54, 51) | 0.70 μg/kg | Standard Deviation 0.28 |
| Darbepoetin Alfa Q2W | Darbepoetin Alfa Weight-Adjusted Dose Over Time | Week 11 (n=54, 50) | 0.61 μg/kg | Standard Deviation 0.35 |
| Darbepoetin Alfa Q2W | Darbepoetin Alfa Weight-Adjusted Dose Over Time | Week 8 (n=53, 1) | 0.00 μg/kg | — |
| Darbepoetin Alfa Q2W | Darbepoetin Alfa Weight-Adjusted Dose Over Time | Week 21 (n=48, 46) | 0.47 μg/kg | Standard Deviation 0.36 |
| Darbepoetin Alfa Q2W | Darbepoetin Alfa Weight-Adjusted Dose Over Time | Week 19 (n=50, 46) | 0.45 μg/kg | Standard Deviation 0.3 |
| Darbepoetin Alfa Q2W | Darbepoetin Alfa Weight-Adjusted Dose Over Time | Week 22 (n=48, 3) | 0.00 μg/kg | Standard Deviation 0 |
| Darbepoetin Alfa Q2W | Darbepoetin Alfa Weight-Adjusted Dose Over Time | Week 12 (n=54, 2) | 0.00 μg/kg | Standard Deviation 0 |
| Darbepoetin Alfa Q2W | Darbepoetin Alfa Weight-Adjusted Dose Over Time | Week 3 (n=55, 52) | 0.72 μg/kg | Standard Deviation 0.11 |
| Darbepoetin Alfa Q2W | Darbepoetin Alfa Weight-Adjusted Dose Over Time | Week 24 (n=46, 1) | 0.00 μg/kg | — |
| Darbepoetin Alfa Q2W | Darbepoetin Alfa Weight-Adjusted Dose Over Time | Week 17 (n=51, 47) | 0.61 μg/kg | Standard Deviation 0.97 |
| Darbepoetin Alfa Q2W | Darbepoetin Alfa Weight-Adjusted Dose Over Time | Initial Dose (n=58, 56) | 0.73 μg/kg | Standard Deviation 0.13 |
| Darbepoetin Alfa Q2W | Darbepoetin Alfa Weight-Adjusted Dose Over Time | Week 13 (n=54, 50) | 0.56 μg/kg | Standard Deviation 0.35 |
| Darbepoetin Alfa Q2W | Darbepoetin Alfa Weight-Adjusted Dose Over Time | Week 2 (n=55, 0) | NA μg/kg | — |
| Darbepoetin Alfa Q2W | Darbepoetin Alfa Weight-Adjusted Dose Over Time | Week 23 (n=47, 44) | 0.49 μg/kg | Standard Deviation 0.4 |
| Darbepoetin Alfa Q2W | Darbepoetin Alfa Weight-Adjusted Dose Over Time | Week 4 (n=54, 0) | NA μg/kg | — |
| Darbepoetin Alfa Q2W | Darbepoetin Alfa Weight-Adjusted Dose Over Time | Week 14 (n=53, 4) | 0.00 μg/kg | Standard Deviation 0 |
| Darbepoetin Alfa Q2W | Darbepoetin Alfa Weight-Adjusted Dose Over Time | Week 5 (n=54, 51) | 0.72 μg/kg | Standard Deviation 0.25 |
| Darbepoetin Alfa Q2W | Darbepoetin Alfa Weight-Adjusted Dose Over Time | Week 18 (n=50, 3) | 0.00 μg/kg | Standard Deviation 0 |
| Darbepoetin Alfa Q2W | Darbepoetin Alfa Weight-Adjusted Dose Over Time | Week 6 (n=54, 0) | NA μg/kg | — |
| Darbepoetin Alfa Q2W | Darbepoetin Alfa Weight-Adjusted Dose Over Time | Week 15 (n=52, 48) | 0.53 μg/kg | Standard Deviation 0.36 |
| Darbepoetin Alfa Q2W | Darbepoetin Alfa Weight-Adjusted Dose Over Time | Week 9 (n=52, 52) | 0.64 μg/kg | Standard Deviation 0.26 |
| Darbepoetin Alfa Q2W | Darbepoetin Alfa Weight-Adjusted Dose Over Time | Week 20 (n=48, 4) | 0.00 μg/kg | Standard Deviation 0 |
| Darbepoetin Alfa Q2W | Darbepoetin Alfa Weight-Adjusted Dose Over Time | Week 10 (n=55, 3) | 0.00 μg/kg | Standard Deviation 0 |
Secondary
Hemoglobin Concentration Over Time
Time frame: Baseline and Weeks 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 21, 22, 23, 24 and 25.
Population: Efficacy analyis set with available data at each time point (indicated by n).
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Darbepoetin Alfa QW | Hemoglobin Concentration Over Time | Week 4 (n=53, 53) | 9.79 g/dL | Standard Deviation 1.3 |
| Darbepoetin Alfa QW | Hemoglobin Concentration Over Time | Week 25 (n= 32, 31) | 11.13 g/dL | Standard Deviation 1.1 |
| Darbepoetin Alfa QW | Hemoglobin Concentration Over Time | Baseline (n=58, 56) | 8.59 g/dL | Standard Deviation 0.84 |
| Darbepoetin Alfa QW | Hemoglobin Concentration Over Time | Week 1 (n=53, 50) | 8.64 g/dL | Standard Deviation 0.9 |
| Darbepoetin Alfa QW | Hemoglobin Concentration Over Time | Week 2 (n=52, 52) | 8.74 g/dL | Standard Deviation 1.09 |
| Darbepoetin Alfa QW | Hemoglobin Concentration Over Time | Week 3 (n=51, 55) | 9.28 g/dL | Standard Deviation 1.27 |
| Darbepoetin Alfa QW | Hemoglobin Concentration Over Time | Week 24 (n=45, 46) | 10.93 g/dL | Standard Deviation 1.16 |
| Darbepoetin Alfa QW | Hemoglobin Concentration Over Time | Week 5 (n=53, 52) | 10.18 g/dL | Standard Deviation 1.29 |
| Darbepoetin Alfa QW | Hemoglobin Concentration Over Time | Week 6 (n=54, 50) | 10.54 g/dL | Standard Deviation 1.43 |
| Darbepoetin Alfa QW | Hemoglobin Concentration Over Time | Week 7 (n=52, 48) | 10.96 g/dL | Standard Deviation 1.53 |
| Darbepoetin Alfa QW | Hemoglobin Concentration Over Time | Week 8 (n=53, 51) | 11.05 g/dL | Standard Deviation 1.37 |
| Darbepoetin Alfa QW | Hemoglobin Concentration Over Time | Week 9 (n=50, 51) | 11.03 g/dL | Standard Deviation 1.48 |
| Darbepoetin Alfa QW | Hemoglobin Concentration Over Time | Week 10 (n=54, 51) | 11.32 g/dL | Standard Deviation 1.33 |
| Darbepoetin Alfa QW | Hemoglobin Concentration Over Time | Week 11 (n=51, 48) | 11.34 g/dL | Standard Deviation 1.33 |
| Darbepoetin Alfa QW | Hemoglobin Concentration Over Time | Week 12 (n=51, 48) | 11.45 g/dL | Standard Deviation 1.25 |
| Darbepoetin Alfa QW | Hemoglobin Concentration Over Time | Week 13 (n=50, 47) | 11.68 g/dL | Standard Deviation 1.19 |
| Darbepoetin Alfa QW | Hemoglobin Concentration Over Time | Week 14 (n=52, 50) | 11.27 g/dL | Standard Deviation 1.28 |
| Darbepoetin Alfa QW | Hemoglobin Concentration Over Time | Week 15 (n=49, 50) | 11.25 g/dL | Standard Deviation 1.13 |
| Darbepoetin Alfa QW | Hemoglobin Concentration Over Time | Week 16 (n=48, 47) | 11.36 g/dL | Standard Deviation 1.19 |
| Darbepoetin Alfa QW | Hemoglobin Concentration Over Time | Week 17 (n=48, 48) | 11.21 g/dL | Standard Deviation 1.23 |
| Darbepoetin Alfa QW | Hemoglobin Concentration Over Time | Week 18 (n=49, 46) | 11.14 g/dL | Standard Deviation 1.2 |
| Darbepoetin Alfa QW | Hemoglobin Concentration Over Time | Week 19 (n=48, 46) | 11.06 g/dL | Standard Deviation 0.91 |
| Darbepoetin Alfa QW | Hemoglobin Concentration Over Time | Week 20 (n=48, 45) | 11.09 g/dL | Standard Deviation 1.03 |
| Darbepoetin Alfa QW | Hemoglobin Concentration Over Time | Week 21 (n=48, 46) | 11.20 g/dL | Standard Deviation 1.04 |
| Darbepoetin Alfa QW | Hemoglobin Concentration Over Time | Week 22 (n=48, 45) | 11.00 g/dL | Standard Deviation 1.19 |
| Darbepoetin Alfa QW | Hemoglobin Concentration Over Time | Week 23 (n=48, 44) | 10.93 g/dL | Standard Deviation 1.1 |
| Darbepoetin Alfa Q2W | Hemoglobin Concentration Over Time | Week 17 (n=48, 48) | 11.05 g/dL | Standard Deviation 1 |
| Darbepoetin Alfa Q2W | Hemoglobin Concentration Over Time | Week 24 (n=45, 46) | 10.43 g/dL | Standard Deviation 0.97 |
| Darbepoetin Alfa Q2W | Hemoglobin Concentration Over Time | Week 11 (n=51, 48) | 10.73 g/dL | Standard Deviation 1.22 |
| Darbepoetin Alfa Q2W | Hemoglobin Concentration Over Time | Week 25 (n= 32, 31) | 10.65 g/dL | Standard Deviation 0.75 |
| Darbepoetin Alfa Q2W | Hemoglobin Concentration Over Time | Week 22 (n=48, 45) | 10.58 g/dL | Standard Deviation 1.04 |
| Darbepoetin Alfa Q2W | Hemoglobin Concentration Over Time | Baseline (n=58, 56) | 8.73 g/dL | Standard Deviation 0.84 |
| Darbepoetin Alfa Q2W | Hemoglobin Concentration Over Time | Week 12 (n=51, 48) | 10.87 g/dL | Standard Deviation 1.38 |
| Darbepoetin Alfa Q2W | Hemoglobin Concentration Over Time | Week 1 (n=53, 50) | 8.65 g/dL | Standard Deviation 0.95 |
| Darbepoetin Alfa Q2W | Hemoglobin Concentration Over Time | Week 18 (n=49, 46) | 10.91 g/dL | Standard Deviation 1.09 |
| Darbepoetin Alfa Q2W | Hemoglobin Concentration Over Time | Week 2 (n=52, 52) | 8.96 g/dL | Standard Deviation 1.2 |
| Darbepoetin Alfa Q2W | Hemoglobin Concentration Over Time | Week 13 (n=50, 47) | 10.82 g/dL | Standard Deviation 1.33 |
| Darbepoetin Alfa Q2W | Hemoglobin Concentration Over Time | Week 3 (n=51, 55) | 9.09 g/dL | Standard Deviation 1.27 |
| Darbepoetin Alfa Q2W | Hemoglobin Concentration Over Time | Week 21 (n=48, 46) | 10.64 g/dL | Standard Deviation 0.99 |
| Darbepoetin Alfa Q2W | Hemoglobin Concentration Over Time | Week 4 (n=53, 53) | 9.55 g/dL | Standard Deviation 1.23 |
| Darbepoetin Alfa Q2W | Hemoglobin Concentration Over Time | Week 14 (n=52, 50) | 10.92 g/dL | Standard Deviation 1.31 |
| Darbepoetin Alfa Q2W | Hemoglobin Concentration Over Time | Week 5 (n=53, 52) | 9.87 g/dL | Standard Deviation 1.32 |
| Darbepoetin Alfa Q2W | Hemoglobin Concentration Over Time | Week 19 (n=48, 46) | 10.91 g/dL | Standard Deviation 1.09 |
| Darbepoetin Alfa Q2W | Hemoglobin Concentration Over Time | Week 6 (n=54, 50) | 10.19 g/dL | Standard Deviation 1.33 |
| Darbepoetin Alfa Q2W | Hemoglobin Concentration Over Time | Week 15 (n=49, 50) | 11.00 g/dL | Standard Deviation 1.23 |
| Darbepoetin Alfa Q2W | Hemoglobin Concentration Over Time | Week 7 (n=52, 48) | 10.17 g/dL | Standard Deviation 1.25 |
| Darbepoetin Alfa Q2W | Hemoglobin Concentration Over Time | Week 23 (n=48, 44) | 10.50 g/dL | Standard Deviation 1.05 |
| Darbepoetin Alfa Q2W | Hemoglobin Concentration Over Time | Week 8 (n=53, 51) | 10.47 g/dL | Standard Deviation 1.21 |
| Darbepoetin Alfa Q2W | Hemoglobin Concentration Over Time | Week 16 (n=48, 47) | 10.86 g/dL | Standard Deviation 1.21 |
| Darbepoetin Alfa Q2W | Hemoglobin Concentration Over Time | Week 9 (n=50, 51) | 10.60 g/dL | Standard Deviation 1.34 |
| Darbepoetin Alfa Q2W | Hemoglobin Concentration Over Time | Week 20 (n=48, 45) | 10.76 g/dL | Standard Deviation 1 |
| Darbepoetin Alfa Q2W | Hemoglobin Concentration Over Time | Week 10 (n=54, 51) | 10.60 g/dL | Standard Deviation 1.29 |
Secondary
Hemoglobin Serial Rate of Change (ROC) Over Time
Calculated using the serial method as the change in hemoglobin from the previous non-missing hemoglobin level divided by number of days in between, and then multiplied by 7.
Time frame: Weeks 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 21, 22, 23, 24 and 25.
Population: Safety analyis set with available data at each time point (indicated by n).
| Arm | Measure | Group | Value (MEDIAN) | Dispersion |
|---|---|---|---|---|
| Darbepoetin Alfa QW | Hemoglobin Serial Rate of Change (ROC) Over Time | Week 2 (n=49, 47) | 0.263 g/dL/week | Full Range 1.09 |
| Darbepoetin Alfa QW | Hemoglobin Serial Rate of Change (ROC) Over Time | Week 13 (n=50, 47) | 0.128 g/dL/week | Full Range 1.19 |
| Darbepoetin Alfa QW | Hemoglobin Serial Rate of Change (ROC) Over Time | Week 7 (n=51, 45) | 0.200 g/dL/week | Full Range 1.53 |
| Darbepoetin Alfa QW | Hemoglobin Serial Rate of Change (ROC) Over Time | Week 14 (n=52, 50) | -0.419 g/dL/week | Full Range 1.28 |
| Darbepoetin Alfa QW | Hemoglobin Serial Rate of Change (ROC) Over Time | Week 4 (n=53, 52) | 0.560 g/dL/week | Full Range 1.3 |
| Darbepoetin Alfa QW | Hemoglobin Serial Rate of Change (ROC) Over Time | Week 15 (n=49, 50) | 0.200 g/dL/week | Full Range 1.13 |
| Darbepoetin Alfa QW | Hemoglobin Serial Rate of Change (ROC) Over Time | Week 8 (n=52, 49) | 0.163 g/dL/week | Full Range 1.37 |
| Darbepoetin Alfa QW | Hemoglobin Serial Rate of Change (ROC) Over Time | Week 16 (n=48, 47) | 0.000 g/dL/week | Full Range 1.19 |
| Darbepoetin Alfa QW | Hemoglobin Serial Rate of Change (ROC) Over Time | Week 21 (n=47, 45) | 0.100 g/dL/week | Full Range 1.04 |
| Darbepoetin Alfa QW | Hemoglobin Serial Rate of Change (ROC) Over Time | Week 17 (n=47, 48) | -0.100 g/dL/week | Full Range 1.23 |
| Darbepoetin Alfa QW | Hemoglobin Serial Rate of Change (ROC) Over Time | Week 9 (n=49, 50) | 0.100 g/dL/week | Full Range 1.48 |
| Darbepoetin Alfa QW | Hemoglobin Serial Rate of Change (ROC) Over Time | Week 18 (n=48, 46) | -0.188 g/dL/week | Full Range 1.2 |
| Darbepoetin Alfa QW | Hemoglobin Serial Rate of Change (ROC) Over Time | Week 5 (n=53, 49) | 0.438 g/dL/week | Full Range 1.29 |
| Darbepoetin Alfa QW | Hemoglobin Serial Rate of Change (ROC) Over Time | Week 19 (n=47, 46) | 0.100 g/dL/week | Full Range 0.91 |
| Darbepoetin Alfa QW | Hemoglobin Serial Rate of Change (ROC) Over Time | Week 10 (n=53, 50) | 0.117 g/dL/week | Full Range 1.33 |
| Darbepoetin Alfa QW | Hemoglobin Serial Rate of Change (ROC) Over Time | Week 20 (n=47, 44) | 0.000 g/dL/week | Full Range 1.03 |
| Darbepoetin Alfa QW | Hemoglobin Serial Rate of Change (ROC) Over Time | Week 22 (n=48, 44) | -0.200 g/dL/week | Full Range 1.19 |
| Darbepoetin Alfa QW | Hemoglobin Serial Rate of Change (ROC) Over Time | Week 3 (n=50, 53) | 0.530 g/dL/week | Full Range 1.27 |
| Darbepoetin Alfa QW | Hemoglobin Serial Rate of Change (ROC) Over Time | Week 23 (n=47, 43) | -0.100 g/dL/week | Full Range 1.1 |
| Darbepoetin Alfa QW | Hemoglobin Serial Rate of Change (ROC) Over Time | Week 11 (n=51, 48) | 0.100 g/dL/week | Full Range 1.33 |
| Darbepoetin Alfa QW | Hemoglobin Serial Rate of Change (ROC) Over Time | Week 24 (n=44, 46) | 0.100 g/dL/week | Full Range 1.16 |
| Darbepoetin Alfa QW | Hemoglobin Serial Rate of Change (ROC) Over Time | Week 6 (n=54, 48) | 0.400 g/dL/week | Full Range 1.43 |
| Darbepoetin Alfa QW | Hemoglobin Serial Rate of Change (ROC) Over Time | Week 25 (n=32, 31) | 0.188 g/dL/week | Full Range 1.1 |
| Darbepoetin Alfa QW | Hemoglobin Serial Rate of Change (ROC) Over Time | Week 12 (n=51, 48) | 0.000 g/dL/week | Full Range 1.25 |
| Darbepoetin Alfa Q2W | Hemoglobin Serial Rate of Change (ROC) Over Time | Week 25 (n=32, 31) | 0.000 g/dL/week | Full Range 0.75 |
| Darbepoetin Alfa Q2W | Hemoglobin Serial Rate of Change (ROC) Over Time | Week 21 (n=47, 45) | -0.140 g/dL/week | Full Range 0.99 |
| Darbepoetin Alfa Q2W | Hemoglobin Serial Rate of Change (ROC) Over Time | Week 2 (n=49, 47) | 0.350 g/dL/week | Full Range 1.2 |
| Darbepoetin Alfa Q2W | Hemoglobin Serial Rate of Change (ROC) Over Time | Week 3 (n=50, 53) | 0.200 g/dL/week | Full Range 1.27 |
| Darbepoetin Alfa Q2W | Hemoglobin Serial Rate of Change (ROC) Over Time | Week 4 (n=53, 52) | 0.513 g/dL/week | Full Range 1.23 |
| Darbepoetin Alfa Q2W | Hemoglobin Serial Rate of Change (ROC) Over Time | Week 5 (n=53, 49) | 0.117 g/dL/week | Full Range 1.32 |
| Darbepoetin Alfa Q2W | Hemoglobin Serial Rate of Change (ROC) Over Time | Week 6 (n=54, 48) | 0.231 g/dL/week | Full Range 1.33 |
| Darbepoetin Alfa Q2W | Hemoglobin Serial Rate of Change (ROC) Over Time | Week 7 (n=51, 45) | 0.100 g/dL/week | Full Range 1.25 |
| Darbepoetin Alfa Q2W | Hemoglobin Serial Rate of Change (ROC) Over Time | Week 8 (n=52, 49) | 0.300 g/dL/week | Full Range 1.21 |
| Darbepoetin Alfa Q2W | Hemoglobin Serial Rate of Change (ROC) Over Time | Week 9 (n=49, 50) | 0.089 g/dL/week | Full Range 1.34 |
| Darbepoetin Alfa Q2W | Hemoglobin Serial Rate of Change (ROC) Over Time | Week 10 (n=53, 50) | 0.000 g/dL/week | Full Range 1.29 |
| Darbepoetin Alfa Q2W | Hemoglobin Serial Rate of Change (ROC) Over Time | Week 11 (n=51, 48) | 0.138 g/dL/week | Full Range 1.22 |
| Darbepoetin Alfa Q2W | Hemoglobin Serial Rate of Change (ROC) Over Time | Week 12 (n=51, 48) | 0.200 g/dL/week | Full Range 1.38 |
| Darbepoetin Alfa Q2W | Hemoglobin Serial Rate of Change (ROC) Over Time | Week 13 (n=50, 47) | -0.064 g/dL/week | Full Range 1.33 |
| Darbepoetin Alfa Q2W | Hemoglobin Serial Rate of Change (ROC) Over Time | Week 14 (n=52, 50) | 0.023 g/dL/week | Full Range 1.31 |
| Darbepoetin Alfa Q2W | Hemoglobin Serial Rate of Change (ROC) Over Time | Week 15 (n=49, 50) | 0.128 g/dL/week | Full Range 1.23 |
| Darbepoetin Alfa Q2W | Hemoglobin Serial Rate of Change (ROC) Over Time | Week 16 (n=48, 47) | -0.100 g/dL/week | Full Range 1.21 |
| Darbepoetin Alfa Q2W | Hemoglobin Serial Rate of Change (ROC) Over Time | Week 17 (n=47, 48) | 0.139 g/dL/week | Full Range 1 |
| Darbepoetin Alfa Q2W | Hemoglobin Serial Rate of Change (ROC) Over Time | Week 18 (n=48, 46) | 0.094 g/dL/week | Full Range 1.09 |
| Darbepoetin Alfa Q2W | Hemoglobin Serial Rate of Change (ROC) Over Time | Week 19 (n=47, 46) | -0.100 g/dL/week | Full Range 1.09 |
| Darbepoetin Alfa Q2W | Hemoglobin Serial Rate of Change (ROC) Over Time | Week 22 (n=48, 44) | 0.000 g/dL/week | Full Range 1.04 |
| Darbepoetin Alfa Q2W | Hemoglobin Serial Rate of Change (ROC) Over Time | Week 23 (n=47, 43) | 0.000 g/dL/week | Full Range 1.05 |
| Darbepoetin Alfa Q2W | Hemoglobin Serial Rate of Change (ROC) Over Time | Week 24 (n=44, 46) | 0.050 g/dL/week | Full Range 0.97 |
| Darbepoetin Alfa Q2W | Hemoglobin Serial Rate of Change (ROC) Over Time | Week 20 (n=47, 44) | -0.050 g/dL/week | Full Range 1 |
Secondary
Maximum Increase in Hemoglobin Over Any 2 Week Period
The maximum increase between any 2 non-missing hemoglobin measurements over any 2-week period from Day 1.
Time frame: 25 weeks
Population: Safety analysis set
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Darbepoetin Alfa QW | Maximum Increase in Hemoglobin Over Any 2 Week Period | 2.06 g/dL/2 weeks | Standard Deviation 0.88 |
| Darbepoetin Alfa Q2W | Maximum Increase in Hemoglobin Over Any 2 Week Period | 1.61 g/dL/2 weeks | Standard Deviation 0.76 |
Secondary
Number of Participants Who Developed Anti-erythropoiesis Antibodies
Participants who were negative for anti-erythropoiesis antibodies at Baseline (pre-dose) and who developed anti-erythropoiesis antibodies during the study. Serum samples were tested using Amgen's Surface Plasmon Resonance Immunoassay (SPRIA) method.
Time frame: 25 weeks
Population: Safety analysis set with both pre and postdose immunoassay antibody results
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Darbepoetin Alfa QW | Number of Participants Who Developed Anti-erythropoiesis Antibodies | 2 participants |
| Darbepoetin Alfa Q2W | Number of Participants Who Developed Anti-erythropoiesis Antibodies | 4 participants |
Secondary
Number of Participants With Hemoglobin > 12.0, > 13.0, and > 14.0 g/dL During the Study
Time frame: 25 weeks
Population: Safety analysis set
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Darbepoetin Alfa QW | Number of Participants With Hemoglobin > 12.0, > 13.0, and > 14.0 g/dL During the Study | Number of participants with hemoglobin > 12.0 g/dL | 44 participants |
| Darbepoetin Alfa QW | Number of Participants With Hemoglobin > 12.0, > 13.0, and > 14.0 g/dL During the Study | Number of participants with hemoglobin > 13.0 g/dL | 24 participants |
| Darbepoetin Alfa QW | Number of Participants With Hemoglobin > 12.0, > 13.0, and > 14.0 g/dL During the Study | Number of participants with hemoglobin > 14.0 g/dL | 6 participants |
| Darbepoetin Alfa Q2W | Number of Participants With Hemoglobin > 12.0, > 13.0, and > 14.0 g/dL During the Study | Number of participants with hemoglobin > 12.0 g/dL | 33 participants |
| Darbepoetin Alfa Q2W | Number of Participants With Hemoglobin > 12.0, > 13.0, and > 14.0 g/dL During the Study | Number of participants with hemoglobin > 13.0 g/dL | 6 participants |
| Darbepoetin Alfa Q2W | Number of Participants With Hemoglobin > 12.0, > 13.0, and > 14.0 g/dL During the Study | Number of participants with hemoglobin > 14.0 g/dL | 2 participants |
Secondary
Number of Participants With Treatment-emergent Adverse Events
A serious adverse event (SAE) is defined as an adverse event that meets at least one of the following serious criteria: • is fatal, • is life threatening, • requires in-patient hospitalization or prolongation of existing hospitalization, • results in persistent or significant disability/incapacity, • is a congenital anomaly/birth defect, and/or • other significant medical hazard. The investigator assessed whether the adverse event was related to the investigational product (IP). Events of interest included hypertension, ischemic heart disease, cardiac failure, cerebrovascular disorders, convulsions, embolic and thrombotic events, embolic and thrombotic events: venous, embolic and thrombotic events: arterial, embolic and thrombotic events: vessel type unspecified and mixed arterial and venous, dialysis vascular access thrombosis, antibody-mediated pure red cell aplasia, hypersensitivity, lack of efficacy-effect, and malignancies.
Time frame: 25 weeks
Population: Safety analysis set including all participants who received ≥ 1 dose of investigational product.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Darbepoetin Alfa QW | Number of Participants With Treatment-emergent Adverse Events | All adverse events | 48 participants |
| Darbepoetin Alfa QW | Number of Participants With Treatment-emergent Adverse Events | Treatment-related adverse events (TRAE) | 14 participants |
| Darbepoetin Alfa QW | Number of Participants With Treatment-emergent Adverse Events | Leading to discontinuation from study | 0 participants |
| Darbepoetin Alfa QW | Number of Participants With Treatment-emergent Adverse Events | Treatment-related serious adverse events | 1 participants |
| Darbepoetin Alfa QW | Number of Participants With Treatment-emergent Adverse Events | Leading to discontinuation of IP | 0 participants |
| Darbepoetin Alfa QW | Number of Participants With Treatment-emergent Adverse Events | TRAE leading to discontinuation of IP | 0 participants |
| Darbepoetin Alfa QW | Number of Participants With Treatment-emergent Adverse Events | Fatal adverse events | 0 participants |
| Darbepoetin Alfa QW | Number of Participants With Treatment-emergent Adverse Events | TRAE leading to discontinuation from study | 0 participants |
| Darbepoetin Alfa QW | Number of Participants With Treatment-emergent Adverse Events | Serious adverse events | 16 participants |
| Darbepoetin Alfa QW | Number of Participants With Treatment-emergent Adverse Events | Treatment-related fatal adverse events | 0 participants |
| Darbepoetin Alfa QW | Number of Participants With Treatment-emergent Adverse Events | Treatment-related events of interest | 6 participants |
| Darbepoetin Alfa QW | Number of Participants With Treatment-emergent Adverse Events | Events of interest | 18 participants |
| Darbepoetin Alfa Q2W | Number of Participants With Treatment-emergent Adverse Events | Treatment-related events of interest | 9 participants |
| Darbepoetin Alfa Q2W | Number of Participants With Treatment-emergent Adverse Events | Leading to discontinuation of IP | 2 participants |
| Darbepoetin Alfa Q2W | Number of Participants With Treatment-emergent Adverse Events | All adverse events | 50 participants |
| Darbepoetin Alfa Q2W | Number of Participants With Treatment-emergent Adverse Events | Serious adverse events | 14 participants |
| Darbepoetin Alfa Q2W | Number of Participants With Treatment-emergent Adverse Events | Leading to discontinuation from study | 2 participants |
| Darbepoetin Alfa Q2W | Number of Participants With Treatment-emergent Adverse Events | Fatal adverse events | 0 participants |
| Darbepoetin Alfa Q2W | Number of Participants With Treatment-emergent Adverse Events | Events of interest | 20 participants |
| Darbepoetin Alfa Q2W | Number of Participants With Treatment-emergent Adverse Events | Treatment-related adverse events (TRAE) | 16 participants |
| Darbepoetin Alfa Q2W | Number of Participants With Treatment-emergent Adverse Events | Treatment-related serious adverse events | 2 participants |
| Darbepoetin Alfa Q2W | Number of Participants With Treatment-emergent Adverse Events | TRAE leading to discontinuation of IP | 2 participants |
| Darbepoetin Alfa Q2W | Number of Participants With Treatment-emergent Adverse Events | TRAE leading to discontinuation from study | 2 participants |
| Darbepoetin Alfa Q2W | Number of Participants With Treatment-emergent Adverse Events | Treatment-related fatal adverse events | 0 participants |
Secondary
Time to First Hemoglobin Value ≥ 10.0 g/dL
The time from study Day 1 to the day a participant first achieved hemoglobin ≥ 10.0 g/dL for participants who achieved hemoglobin ≥ 10.0 g/dL.
Time frame: 24 weeks
Population: Efficacy analysis set responders (participants with at least 1 postbaseline hemoglobin ≥ 10.0 g/dL)
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Darbepoetin Alfa QW | Time to First Hemoglobin Value ≥ 10.0 g/dL | 24.0 days |
| Darbepoetin Alfa Q2W | Time to First Hemoglobin Value ≥ 10.0 g/dL | 22.0 days |
Secondary
Weight-adjusted Darbepoetin Alfa Dose at Time of Achieving First Hemoglobin ≥ 10.0 g/dL
The darbepoetin alfa dose at the time a participant achieved a first hemoglobin level ≥ 10.0 g/dL, divided by the participant's weight measured at the closest study week prior to the dosing, post dialysis.
Time frame: 24 weeks
Population: Efficacy analysis set responders (participants with at least 1 postbaseline hemoglobin ≥ 10.0 g/dL) for whom dosing data were available.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Darbepoetin Alfa QW | Weight-adjusted Darbepoetin Alfa Dose at Time of Achieving First Hemoglobin ≥ 10.0 g/dL | 0.48 μg/kg | Standard Deviation 0.24 |
| Darbepoetin Alfa Q2W | Weight-adjusted Darbepoetin Alfa Dose at Time of Achieving First Hemoglobin ≥ 10.0 g/dL | 0.76 μg/kg | Standard Deviation 0.21 |