- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00436748
Study to Assess Darbepoetin Alfa Dosing for the Correction of Anemia in Pediatric Patients With Chronic Kidney Disease
November 3, 2022 updated by: Amgen
A Multi-Center, Double-Blind, Randomized Study Evaluating De Novo Weekly and Once Every Two Week Darbepoetin Alfa Dosing for the Correction of Anemia in Pediatric Subjects With Chronic Kidney Disease Receiving and Not Receiving Dialysis
The primary objectives of this study are the following:
- 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
- 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.
Study Overview
Status
Terminated
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
116
Phase
- Phase 3
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Edegem, Belgium, 2650
- Research Site
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Gent, Belgium, 9000
- Research Site
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Leuven, Belgium, 3000
- Research Site
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Jurmala, Latvia, 2015
- Research Site
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Vilnius, Lithuania, 08406
- Research Site
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Aguascalientes, Mexico, 20230
- Research Site
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Chihuahua, Mexico, 31000
- Research Site
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Puebla, Mexico, 72190
- Research Site
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Distrito Federal
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Mexico, Distrito Federal, Mexico, 06720
- Research Site
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Gdansk, Poland, 80-952
- Research Site
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Lodz, Poland, 93-338
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Szczecin, Poland, 70-410
- Research Site
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San Juan, Puerto Rico, 00935
- Research Site
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Krasnodar, Russian Federation, 350033
- Research Site
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Moscow, Russian Federation, 117997
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Moscow, Russian Federation, 107014
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Orenburg, Russian Federation, 460004
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Saint Petersburg, Russian Federation, 198205
- Research Site
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Samara, Russian Federation, 443095
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Banska Bystrica, Slovakia, 974 09
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Bratislava, Slovakia, 833 40
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Kosice, Slovakia, 040 11
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Birmingham, United Kingdom, B4 6NH
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Leeds, United Kingdom, LS1 3EX
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London, United Kingdom, SE1 7EH
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Alabama
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Birmingham, Alabama, United States, 35233
- Research Site
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California
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Los Angeles, California, United States, 90027
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Los Angeles, California, United States, 90095
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San Diego, California, United States, 92123
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San Francisco, California, United States, 94143
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Stanford, California, United States, 94305-5208
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District of Columbia
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Washington, District of Columbia, United States, 20010
- Research Site
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Florida
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Gainesville, Florida, United States, 32610
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Miami, Florida, United States, 33136
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Orlando, Florida, United States, 32806
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Idaho
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Boise, Idaho, United States, 83712
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Illinois
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Chicago, Illinois, United States, 60612
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Iowa
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Iowa City, Iowa, United States, 52242
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Kentucky
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Louisville, Kentucky, United States, 40202
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Louisiana
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New Orleans, Louisiana, United States, 70118
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Maryland
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Baltimore, Maryland, United States, 21287
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Massachusetts
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Boston, Massachusetts, United States, 02115
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Missouri
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Kansas City, Missouri, United States, 64108
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New Jersey
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Livingston, New Jersey, United States, 07039
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New Brunswick, New Jersey, United States, 08901
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New Mexico
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Albuquerque, New Mexico, United States, 87131
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New York
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Bronx, New York, United States, 10467
- Research Site
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Buffalo, New York, United States, 14222
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New Hyde Park, New York, United States, 11040
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New York, New York, United States, 10029
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Valhalla, New York, United States, 10595
- Research Site
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North Carolina
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Charlotte, North Carolina, United States, 28203
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Ohio
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Akron, Ohio, United States, 44308
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Cincinnati, Ohio, United States, 45229
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Cleveland, Ohio, United States, 44195
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Cleveland, Ohio, United States, 44106
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Columbus, Ohio, United States, 43205
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Oregon
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Portland, Oregon, United States, 97239
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Portland, Oregon, United States, 97227
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Pennsylvania
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Philadelphia, Pennsylvania, United States, 19104
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Texas
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Dallas, Texas, United States, 75390
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Houston, Texas, United States, 77030
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San Antonio, Texas, United States, 78229
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Virginia
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Charlottesville, Virginia, United States, 22908
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Norfolk, Virginia, United States, 23507
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Richmond, Virginia, United States, 23219
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Washington
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Seattle, Washington, United States, 98105
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
1 year to 18 years (ADULT, CHILD)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: TRIPLE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
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EXPERIMENTAL: 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.
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Administered by subcutaneous or intravenous injection
Other Names:
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EXPERIMENTAL: 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.
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Administered by subcutaneous or intravenous injection
Other Names:
Matching placebo solution for subcutaneous or intravenous injection to maintain the blind in the Q2W arm.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
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Proportion of Participants Achieving Hemoglobin ≥ 10.0 g/dL
Time Frame: 24 weeks
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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.
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24 weeks
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
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Time to First Hemoglobin Value ≥ 10.0 g/dL
Time Frame: 24 weeks
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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.
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24 weeks
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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.
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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.
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Weight-adjusted Darbepoetin Alfa Dose at Time of Achieving First Hemoglobin ≥ 10.0 g/dL
Time Frame: 24 weeks
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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.
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24 weeks
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Darbepoetin Alfa Weight-Adjusted Dose Over Time
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.
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Arithmetic means are provided; Withheld doses are counted as 0 μg.
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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.
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Change From Baseline at Week 13 and Week 25 in Parent-reported Pediatric Quality of Life Inventory (PedsQL) Scores
Time Frame: Baseline, Week 13 and Week 25 (or end of study visit if earlier than Week 25)
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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).
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Baseline, Week 13 and Week 25 (or end of study visit if earlier than Week 25)
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Change From Baseline at Week 13 and Week 25 in Child Self-reported Pediatric Quality of Life Inventory (PedsQL) Scores
Time Frame: Baseline, Week 13 and Week 25 (or end of study visit if earlier than Week 25)
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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).
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Baseline, Week 13 and Week 25 (or end of study visit if earlier than Week 25)
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Number of Participants With Treatment-emergent Adverse Events
Time Frame: 25 weeks
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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.
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25 weeks
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Hemoglobin Serial Rate of Change (ROC) Over Time
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.
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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.
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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.
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Number of Participants With Hemoglobin > 12.0, > 13.0, and > 14.0 g/dL During the Study
Time Frame: 25 weeks
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25 weeks
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Maximum Increase in Hemoglobin Over Any 2 Week Period
Time Frame: 25 weeks
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The maximum increase between any 2 non-missing hemoglobin measurements over any 2-week period from Day 1.
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25 weeks
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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.
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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.
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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.
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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.
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Number of Participants Who Developed Anti-erythropoiesis Antibodies
Time Frame: 25 weeks
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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.
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25 weeks
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Darbepoetin Alfa Serum Concentrations for Participants Less Than 6 Years of Age
Time Frame: Weeks 1, 2, and 3 before the investigational product dose and 2 days after the first investigational product dose
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Serum concentrations of darbepoetin alfa were measured by an enzyme-linked immunosorbent assay (ELISA).
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Weeks 1, 2, and 3 before the investigational product dose and 2 days after the first investigational product dose
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Helpful Links
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (ACTUAL)
September 16, 2008
Primary Completion (ACTUAL)
March 3, 2014
Study Completion (ACTUAL)
March 3, 2014
Study Registration Dates
First Submitted
February 15, 2007
First Submitted That Met QC Criteria
February 15, 2007
First Posted (ESTIMATE)
February 19, 2007
Study Record Updates
Last Update Posted (ACTUAL)
November 29, 2022
Last Update Submitted That Met QC Criteria
November 3, 2022
Last Verified
November 1, 2022
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 20050256
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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