A Phase 3 interventional study of Darbepoetin Alfa and Placebo in Anemia, Chronic Kidney Disease and Kidney Disease, sponsored by Amgen. Terminated at 67 sites in 10 countries. Open to participants aged 1 Year to 18 Years. Per ClinicalTrials.gov, last updated 2022-11-29.
Sponsored by Amgen · Phase 3, Interventional, and Treatment
The primary objectives of this study are the following:
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Exclusion Criteria:
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.
Drug: Darbepoetin Alfa
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.
Drug: Darbepoetin Alfa · Drug: Placebo
Administered by subcutaneous or intravenous injection
Also known as: Aranesp®
Matching placebo solution for subcutaneous or intravenous injection to maintain the blind in the Q2W arm.
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
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
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.
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
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.
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)
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)
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
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.
Number of Participants With Hemoglobin > 12.0, > 13.0, and > 14.0 g/dL During the Study
Time frame: 25 weeks
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
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.
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.
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
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
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.
| Milestone | Darbepoetin Alfa QW | Darbepoetin Alfa Q2W |
|---|---|---|
| Started | 59 | 57 |
| Received treatment | 58 | 56 |
| Completed | 48 | 45 |
| Not completed | 11 | 12 |
| Withdrew: Ineligibility determined | 1 | 1 |
| Withdrew: Adverse event | 0 | 2 |
| Withdrew: Consent withdrawn | 1 | 4 |
| Withdrew: Administrative decision | 1 | 0 |
| Withdrew: Lost to follow-up | 0 | 1 |
| Withdrew: Protocol-specified criteria | 5 | 4 |
| Withdrew: Other | 3 | 0 |
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.
| proportion of participants | Darbepoetin Alfa QW | Darbepoetin Alfa Q2W |
|---|---|---|
| Proportion of Participants Achieving Hemoglobin ≥ 10.0 g/dL | 0.983 (0.908 to 1.000) | 0.839 (0.717 to 0.924) |
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.
| days | Darbepoetin Alfa QW | Darbepoetin Alfa Q2W |
|---|---|---|
| Time to First Hemoglobin Value ≥ 10.0 g/dL | 24.0 (15.0 to 50.0) | 22.0 (14.0 to 41.0) |
| g/dL | Darbepoetin Alfa QW | Darbepoetin Alfa Q2W |
|---|---|---|
| Baseline (n=58, 56) | 8.59 ± 0.84 | 8.73 ± 0.84 |
| Week 1 (n=53, 50) | 8.64 ± 0.90 | 8.65 ± 0.95 |
| Week 2 (n=52, 52) | 8.74 ± 1.09 | 8.96 ± 1.20 |
| Week 3 (n=51, 55) | 9.28 ± 1.27 | 9.09 ± 1.27 |
| Week 4 (n=53, 53) | 9.79 ± 1.30 | 9.55 ± 1.23 |
| Week 5 (n=53, 52) | 10.18 ± 1.29 | 9.87 ± 1.32 |
| Week 6 (n=54, 50) | 10.54 ± 1.43 | 10.19 ± 1.33 |
| Week 7 (n=52, 48) | 10.96 ± 1.53 | 10.17 ± 1.25 |
| Week 8 (n=53, 51) | 11.05 ± 1.37 | 10.47 ± 1.21 |
| Week 9 (n=50, 51) | 11.03 ± 1.48 | 10.60 ± 1.34 |
| Week 10 (n=54, 51) | 11.32 ± 1.33 | 10.60 ± 1.29 |
| Week 11 (n=51, 48) | 11.34 ± 1.33 | 10.73 ± 1.22 |
| Week 12 (n=51, 48) | 11.45 ± 1.25 | 10.87 ± 1.38 |
| Week 13 (n=50, 47) | 11.68 ± 1.19 | 10.82 ± 1.33 |
| Week 14 (n=52, 50) | 11.27 ± 1.28 | 10.92 ± 1.31 |
| Week 15 (n=49, 50) | 11.25 ± 1.13 | 11.00 ± 1.23 |
| Week 16 (n=48, 47) | 11.36 ± 1.19 | 10.86 ± 1.21 |
| Week 17 (n=48, 48) | 11.21 ± 1.23 | 11.05 ± 1.00 |
| Week 18 (n=49, 46) | 11.14 ± 1.20 | 10.91 ± 1.09 |
| Week 19 (n=48, 46) | 11.06 ± 0.91 | 10.91 ± 1.09 |
| Week 20 (n=48, 45) | 11.09 ± 1.03 | 10.76 ± 1.00 |
| Week 21 (n=48, 46) | 11.20 ± 1.04 | 10.64 ± 0.99 |
| Week 22 (n=48, 45) | 11.00 ± 1.19 | 10.58 ± 1.04 |
| Week 23 (n=48, 44) | 10.93 ± 1.10 | 10.50 ± 1.05 |
| Week 24 (n=45, 46) | 10.93 ± 1.16 | 10.43 ± 0.97 |
| Week 25 (n= 32, 31) | 11.13 ± 1.10 | 10.65 ± 0.75 |
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.
| μg/kg | Darbepoetin Alfa QW | Darbepoetin Alfa Q2W |
|---|---|---|
| Weight-adjusted Darbepoetin Alfa Dose at Time of Achieving First Hemoglobin ≥ 10.0 g/dL | 0.48 ± 0.24 | 0.76 ± 0.21 |
Arithmetic means are provided; Withheld doses are counted as 0 μg.
| μg/kg | Darbepoetin Alfa QW | Darbepoetin Alfa Q2W |
|---|---|---|
| Initial Dose (n=58, 56) | 0.45 ± 0.07 | 0.73 ± 0.13 |
| Week 2 (n=55, 0) | 0.45 ± 0.07 | NA ± NA |
| Week 3 (n=55, 52) | 0.44 ± 0.07 | 0.72 ± 0.11 |
| Week 4 (n=54, 0) | 0.40 ± 0.11 | NA ± NA |
| Week 5 (n=54, 51) | 0.43 ± 0.26 | 0.72 ± 0.25 |
| Week 6 (n=54, 0) | 0.42 ± 0.29 | NA ± NA |
| Week 7 (n=54, 51) | 0.38 ± 0.25 | 0.70 ± 0.28 |
| Week 8 (n=53, 1) | 0.34 ± 0.24 | 0.00 ± NA |
| Week 9 (n=52, 52) | 0.32 ± 0.23 | 0.64 ± 0.26 |
| Week 10 (n=55, 3) | 0.33 ± 0.26 | 0.00 ± 0.00 |
| Week 11 (n=54, 50) | 0.32 ± 0.28 | 0.61 ± 0.35 |
| Week 12 (n=54, 2) | 0.26 ± 0.28 | 0.00 ± 0.00 |
| Week 13 (n=54, 50) | 0.24 ± 0.28 | 0.56 ± 0.35 |
| Week 14 (n=53, 4) | 0.21 ± 0.27 | 0.00 ± 0.00 |
| Week 15 (n=52, 48) | 0.31 ± 0.33 | 0.53 ± 0.36 |
| Week 16 (n=50, 5) | 0.35 ± 0.44 | 0.00 ± 0.00 |
| Week 17 (n=51, 47) | 0.29 ± 0.34 | 0.61 ± 0.97 |
| Week 18 (n=50, 3) | 0.32 ± 0.40 | 0.00 ± 0.00 |
| Week 19 (n=50, 46) | 0.31 ± 0.33 | 0.45 ± 0.30 |
| Week 20 (n=48, 4) | 0.35 ± 0.34 | 0.00 ± 0.00 |
| Week 21 (n=48, 46) | 0.38 ± 0.63 | 0.47 ± 0.36 |
| Week 22 (n=48, 3) | 0.38 ± 0.64 | 0.00 ± 0.00 |
| Week 23 (n=47, 44) | 0.39 ± 0.63 | 0.49 ± 0.40 |
| Week 24 (n=46, 1) | 0.41 ± 0.63 | 0.00 ± NA |
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).
| units on a scale | Darbepoetin Alfa QW | Darbepoetin Alfa Q2W |
|---|---|---|
| Week 13 Total Score (n=45, 46) | 4.50 ± 2.19 | 0.58 ± 2.43 |
| Week 13 Psychosocial composite score (n=45, 46) | 5.12 ± 2.16 | -0.41 ± 2.57 |
| Week 13 Physical function score (n=45, 46) | 3.61 ± 3.20 | 2.31 ± 3.35 |
| Week 13 Emotional function score (n=45, 46) | 1.00 ± 3.00 | -3.89 ± 2.74 |
| Week 13 Social function score (n=45, 46) | 6.89 ± 3.54 | 0.76 ± 3.56 |
| Week 13 School function score (n=42, 42) | 7.30 ± 2.47 | 4.17 ± 3.63 |
| Week 25 Total Score (n=38, 41) | 1.90 ± 2.06 | 0.65 ± 2.66 |
| Week 25 Psychosocial composite score (n=38, 41) | 2.52 ± 1.83 | -1.84 ± 3.13 |
| Week 25 Physical function score (n=38, 41) | 0.66 ± 3.89 | 5.18 ± 3.59 |
| Week 25 Emotional function score (n=38, 41) | -0.66 ± 2.61 | -3.51 ± 3.16 |
| Week 25 Social function score (n=38, 41) | 5.13 ± 2.64 | -2.20 ± 4.10 |
| Week 25 School function score (n=36, 37) | 3.90 ± 2.51 | 2.03 ± 3.94 |
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).
| units on a scale | Darbepoetin Alfa QW | Darbepoetin Alfa Q2W |
|---|---|---|
| Week 13 Total Score (n=46, 46) | 2.94 ± 1.70 | -1.23 ± 2.04 |
| Week 13 Psychosocial composite score (n=46, 46) | 2.59 ± 1.92 | -0.45 ± 2.23 |
| Week 13 Physical function score (n=46, 46) | 3.78 ± 2.43 | -2.79 ± 2.59 |
| Week 13 Emotional function score (n=46, 46) | 0.43 ± 2.52 | -0.76 ± 2.79 |
| Week 13 Social function score (n=46, 46) | 3.26 ± 2.93 | -2.28 ± 3.02 |
| Week 13 School function score (n=45, 43) | 2.89 ± 2.98 | 2.44 ± 3.83 |
| Week 25 Total Score (n=40, 42) | 5.00 ± 1.75 | 2.58 ± 1.78 |
| Week 25 Psychosocial composite score (n=40, 42) | 3.81 ± 1.97 | 3.53 ± 2.01 |
| Week 25 Physical function score (n=40, 42) | 7.42 ± 2.48 | 0.74 ± 2.80 |
| Week 25 Emotional function score (n=40, 42) | -0.25 ± 2.51 | 3.93 ± 3.10 |
| Week 25 Social function score (n=40, 42) | 7.00 ± 3.10 | 2.50 ± 2.67 |
| Week 25 School function score (n=40, 39) | 4.25 ± 3.14 | 3.85 ± 3.09 |
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.
| participants | Darbepoetin Alfa QW | Darbepoetin Alfa Q2W |
|---|---|---|
| All adverse events | 48 | 50 |
| Serious adverse events | 16 | 14 |
| Leading to discontinuation of IP | 0 | 2 |
| Leading to discontinuation from study | 0 | 2 |
| Fatal adverse events | 0 | 0 |
| Events of interest | 18 | 20 |
| Treatment-related adverse events (TRAE) | 14 | 16 |
| Treatment-related serious adverse events | 1 | 2 |
| TRAE leading to discontinuation of IP | 0 | 2 |
| TRAE leading to discontinuation from study | 0 | 2 |
| Treatment-related fatal adverse events | 0 | 0 |
| Treatment-related events of interest | 6 | 9 |
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.
| g/dL/week | Darbepoetin Alfa QW | Darbepoetin Alfa Q2W |
|---|---|---|
| Week 2 (n=49, 47) | 0.263 ± 1.09 | 0.350 ± 1.20 |
| Week 3 (n=50, 53) | 0.530 ± 1.27 | 0.200 ± 1.27 |
| Week 4 (n=53, 52) | 0.560 ± 1.30 | 0.513 ± 1.23 |
| Week 5 (n=53, 49) | 0.438 ± 1.29 | 0.117 ± 1.32 |
| Week 6 (n=54, 48) | 0.400 ± 1.43 | 0.231 ± 1.33 |
| Week 7 (n=51, 45) | 0.200 ± 1.53 | 0.100 ± 1.25 |
| Week 8 (n=52, 49) | 0.163 ± 1.37 | 0.300 ± 1.21 |
| Week 9 (n=49, 50) | 0.100 ± 1.48 | 0.089 ± 1.34 |
| Week 10 (n=53, 50) | 0.117 ± 1.33 | 0.000 ± 1.29 |
| Week 11 (n=51, 48) | 0.100 ± 1.33 | 0.138 ± 1.22 |
| Week 12 (n=51, 48) | 0.000 ± 1.25 | 0.200 ± 1.38 |
| Week 13 (n=50, 47) | 0.128 ± 1.19 | -0.064 ± 1.33 |
| Week 14 (n=52, 50) | -0.419 ± 1.28 | 0.023 ± 1.31 |
| Week 15 (n=49, 50) | 0.200 ± 1.13 | 0.128 ± 1.23 |
| Week 16 (n=48, 47) | 0.000 ± 1.19 | -0.100 ± 1.21 |
| Week 17 (n=47, 48) | -0.100 ± 1.23 | 0.139 ± 1.00 |
| Week 18 (n=48, 46) | -0.188 ± 1.20 | 0.094 ± 1.09 |
| Week 19 (n=47, 46) | 0.100 ± 0.91 | -0.100 ± 1.09 |
| Week 20 (n=47, 44) | 0.000 ± 1.03 | -0.050 ± 1.00 |
| Week 21 (n=47, 45) | 0.100 ± 1.04 | -0.140 ± 0.99 |
| Week 22 (n=48, 44) | -0.200 ± 1.19 | 0.000 ± 1.04 |
| Week 23 (n=47, 43) | -0.100 ± 1.10 | 0.000 ± 1.05 |
| Week 24 (n=44, 46) | 0.100 ± 1.16 | 0.050 ± 0.97 |
| Week 25 (n=32, 31) | 0.188 ± 1.10 | 0.000 ± 0.75 |
| participants | Darbepoetin Alfa QW | Darbepoetin Alfa Q2W |
|---|---|---|
| Number of participants with hemoglobin > 12.0 g/dL | 44 | 33 |
| Number of participants with hemoglobin > 13.0 g/dL | 24 | 6 |
| Number of participants with hemoglobin > 14.0 g/dL | 6 | 2 |
The maximum increase between any 2 non-missing hemoglobin measurements over any 2-week period from Day 1.
| g/dL/2 weeks | Darbepoetin Alfa QW | Darbepoetin Alfa Q2W |
|---|---|---|
| Maximum Increase in Hemoglobin Over Any 2 Week Period | 2.06 ± 0.88 | 1.61 ± 0.76 |
| mmHg | Darbepoetin Alfa QW | Darbepoetin Alfa Q2W |
|---|---|---|
| Week 2 (n=55, 54) | 1.7 ± 11.6 | -3.9 ± 11.1 |
| Week 3 (n=55, 56) | 1.1 ± 14.1 | 0.0 ± 12.7 |
| Week 4 (n=55, 54) | 1.3 ± 13.0 | 1.2 ± 11.5 |
| Week 5 (n=55, 52) | 1.1 ± 13.7 | -3.0 ± 13.7 |
| Week 6 (n=54, 51) | 0.2 ± 14.2 | -2.9 ± 12.5 |
| Week 7 (n=54, 52) | -1.0 ± 14.2 | -3.7 ± 13.4 |
| Week 8 (n=55, 52) | 0.5 ± 16.0 | -2.7 ± 13.8 |
| Week 9 (n=54, 52) | 1.0 ± 18.3 | -3.1 ± 14.5 |
| Week 10 (n=55, 52) | -0.2 ± 16.6 | -3.7 ± 14.6 |
| Week 11 (n=54, 51) | -2.0 ± 15.6 | -1.8 ± 15.9 |
| Week 12 (n=55, 49) | -2.4 ± 17.2 | -2.8 ± 15.4 |
| Week 13 (n=53, 50) | 0.5 ± 14.8 | -2.1 ± 14.2 |
| Week 14 (n=54, 50) | -2.3 ± 19.5 | -1.8 ± 15.8 |
| Week 15 (n=53, 50) | 0.1 ± 17.4 | -2.4 ± 13.0 |
| Week 16 (n=50, 48) | 1.9 ± 16.4 | -3.8 ± 16.3 |
| Week 17 (n=51, 47) | 1.0 ± 17.7 | 0.1 ± 10.6 |
| Week 18 (n=50, 46) | 0.5 ± 18.5 | 0.0 ± 15.5 |
| Week 19 (n=50, 47) | 3.4 ± 16.0 | -2.5 ± 14.2 |
| Week 20 (n=48, 46) | -0.9 ± 18.3 | -4.0 ± 13.0 |
| Week 21 (n=49, 46) | 1.9 ± 15.7 | -2.2 ± 15.0 |
| Week 22 (n=48, 46) | -0.6 ± 18.2 | -0.9 ± 15.0 |
| Week 23 (n=47, 45) | -0.6 ± 16.5 | -1.2 ± 15.7 |
| Week 24 (n=46, 46) | 0.0 ± 17.8 | -2.0 ± 11.8 |
| Week 25 (n=34, 32) | -0.5 ± 14.3 | -2.3 ± 12.4 |
| mmHg | Darbepoetin Alfa QW | Darbepoetin Alfa Q2W |
|---|---|---|
| Week 2 (n=55, 54) | 1.4 ± 9.4 | 0.8 ± 11.1 |
| Week 3 (n=55, 56) | 2.2 ± 11.0 | 3.1 ± 10.8 |
| Week 4 (n=55, 54) | 2.8 ± 11.0 | 1.8 ± 12.6 |
| Week 5 (n=55, 52) | 3.0 ± 12.4 | -0.2 ± 11.2 |
| Week 6 (n=54, 51) | 2.6 ± 10.1 | -0.1 ± 11.4 |
| Week 7 (n=54, 52) | 1.2 ± 10.4 | -1.0 ± 12.3 |
| Week 8 (n=55, 52) | 3.9 ± 11.9 | 1.1 ± 15.0 |
| Week 9 (n=54, 52) | 4.8 ± 14.7 | -0.3 ± 12.9 |
| Week 10 (n=55, 52) | 1.5 ± 13.7 | 0.9 ± 15.9 |
| Week 11 (n=54, 51) | 3.9 ± 11.8 | 0.9 ± 14.4 |
| Week 12 (n=55, 49) | 1.6 ± 10.4 | 2.8 ± 13.7 |
| Week 13 (n=54, 50) | 2.7 ± 13.8 | 2.2 ± 10.6 |
| Week 14 (n=54, 50) | 3.4 ± 14.4 | 1.7 ± 12.0 |
| Week 15 (n=53, 50) | 3.7 ± 12.9 | 1.4 ± 11.7 |
| Week 16 (n=50, 48) | 4.6 ± 13.7 | 0.7 ± 11.9 |
| Week 17 (n=51, 47) | 4.1 ± 15.6 | 2.6 ± 10.6 |
| Week 18 (n=50, 46) | 3.0 ± 16.4 | 0.4 ± 11.7 |
| Week 19 (n=50, 47) | 3.7 ± 12.9 | 0.6 ± 12.2 |
| Week 20 (n=48, 46) | 1.7 ± 13.8 | 2.0 ± 13.2 |
| Week 21 (n=49, 46) | 2.9 ± 15.1 | 0.6 ± 12.9 |
| Week 22 (n=48, 46) | 3.2 ± 14.7 | 0.3 ± 13.9 |
| Week 23 (n=47, 45) | 5.0 ± 13.8 | -2.0 ± 14.0 |
| Week 24 (n=46, 46) | 4.0 ± 13.8 | -0.3 ± 12.8 |
| Week 25 (n=34, 32) | 3.0 ± 13.0 | -1.5 ± 10.7 |
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.
| participants | Darbepoetin Alfa QW | Darbepoetin Alfa Q2W |
|---|---|---|
| Number of Participants Who Developed Anti-erythropoiesis Antibodies | 2 | 4 |
Serum concentrations of darbepoetin alfa were measured by an enzyme-linked immunosorbent assay (ELISA).
No measurements were reported for this outcome.
Collected over 25 weeks. Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Darbepoetin Alfa QW | — | 16/58 (27.6%) | 42/58 (72.4%) |
| Darbepoetin Alfa Q2W | — | 14/56 (25%) | 43/56 (76.8%) |
| Event | Darbepoetin Alfa QW | Darbepoetin Alfa Q2W |
|---|---|---|
| HypertensionVascular disorders | 1/58 | 3/56 |
| HyperkalaemiaMetabolism and nutrition disorders | 3/58 | 0/56 |
| PeritonitisInfections and infestations | 0/58 | 2/56 |
| HypotensionVascular disorders | 0/58 | 2/56 |
| Abdominal painGastrointestinal disorders | 2/58 | 1/56 |
| HeadacheNervous system disorders | 2/58 | 0/56 |
| Renal impairmentRenal and urinary disorders | 2/58 | 0/56 |
| Histiocytosis haematophagicBlood and lymphatic system disorders | 0/58 | 1/56 |
| TachycardiaCardiac disorders | 0/58 | 1/56 |
| TinnitusEar and labyrinth disorders | 0/58 | 1/56 |
| Event | Darbepoetin Alfa QW | Darbepoetin Alfa Q2W |
|---|---|---|
| PyrexiaGeneral disorders | 5/58 | 10/56 |
| HeadacheNervous system disorders | 4/58 | 10/56 |
| VomitingGastrointestinal disorders | 10/58 | 9/56 |
| HypertensionVascular disorders | 9/58 | 8/56 |
| Upper respiratory tract infectionInfections and infestations | 3/58 | 7/56 |
| CoughRespiratory, thoracic and mediastinal disorders | 7/58 | 4/56 |
| NasopharyngitisInfections and infestations | 4/58 | 6/56 |
| Abdominal painGastrointestinal disorders | 6/58 | 5/56 |
| PharyngitisInfections and infestations | 2/58 | 5/56 |
| NauseaGastrointestinal disorders | 5/58 | 4/56 |
Efficacy analysis set, including all participants who received ≥ 1 dose of investigational product.
| Age, Continuous(years) | Darbepoetin Alfa QW | Darbepoetin Alfa Q2W | Total |
|---|---|---|---|
| Mean | 12.6 ± 3.6 | 12.8 ± 3.7 | 12.7 ± 3.6 |
| Age, Customized(participants) | Darbepoetin Alfa QW | Darbepoetin Alfa Q2W | Total |
|---|---|---|---|
| 1 - < 6 years | 2 | 1 | 3 |
| 6 - < 12 years | 19 | 18 | 37 |
| 12 - 18 years | 37 | 37 | 74 |
| Sex: Female, Male(Participants) | Darbepoetin Alfa QW | Darbepoetin Alfa Q2W | Total |
|---|---|---|---|
| Female | 23 | 23 | 46 |
| Male | 35 | 33 | 68 |
| Race/Ethnicity, Customized(participants) | Darbepoetin Alfa QW | Darbepoetin Alfa Q2W | Total |
|---|---|---|---|
| White or Caucasian | 30 | 30 | 60 |
| Black or African American | 4 | 5 | 9 |
| Hispanic or Latino | 23 | 20 | 43 |
| Other | 1 | 1 | 2 |
| Dialysis Status(participants) | Darbepoetin Alfa QW | Darbepoetin Alfa Q2W | Total |
|---|---|---|---|
| Not receiving dialysis | 33 | 33 | 66 |
| Receiving hemodialysis | 15 | 14 | 29 |
| Receiving peritoneal dialysis | 10 | 9 | 19 |
| Hemoglobin Concentration(g/dL) | Darbepoetin Alfa QW | Darbepoetin Alfa Q2W | Total |
|---|---|---|---|
| Mean | 8.59 ± 0.84 | 8.73 ± 0.84 | 8.66 ± 0.84 |
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