Study to Assess Darbepoetin Alfa Dosing for the Correction of Anemia in Pediatric Patients With Chronic Kidney Disease
NCT ID: NCT00436748
Last Updated: 2022-11-29
Study Results
Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.
View full resultsBasic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
TERMINATED
PHASE3
116 participants
INTERVENTIONAL
2008-09-16
2014-03-03
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
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.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Darbepoetin Treatment of Anemia in Children With Chronic Renal Failure
NCT00213291
Study Evaluating Darbepoetin Alfa in Subjects With Chronic Kidney Disease (CKD) Receiving Dialysis
NCT00096915
Phase 2 Study of Darbepoetin Alfa Extended Dosing
NCT00527215
Extension From Weekly to Once Every Other Week Darbepoetin Alfa Administration in Subjects With Chronic Kidney Disease Receiving Dialysis
NCT00436995
Treatment for Subjects With Chronic Kidney Disease (CKD) Not Receiving Dialysis
NCT00111098
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
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.
Darbepoetin Alfa
Administered by subcutaneous or intravenous injection
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.
Darbepoetin Alfa
Administered by subcutaneous or intravenous injection
Placebo
Matching placebo solution for subcutaneous or intravenous injection to maintain the blind in the Q2W arm.
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Darbepoetin Alfa
Administered by subcutaneous or intravenous injection
Placebo
Matching placebo solution for subcutaneous or intravenous injection to maintain the blind in the Q2W arm.
Other Intervention Names
Discover alternative or legacy names that may be used to describe the listed interventions across different sources.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* 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
* 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
1 Year
18 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Amgen
INDUSTRY
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
MD
Role: STUDY_DIRECTOR
Amgen
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Research Site
Birmingham, Alabama, United States
Research Site
Los Angeles, California, United States
Research Site
Los Angeles, California, United States
Research Site
San Diego, California, United States
Research Site
San Francisco, California, United States
Research Site
Stanford, California, United States
Research Site
Washington D.C., District of Columbia, United States
Research Site
Gainesville, Florida, United States
Research Site
Miami, Florida, United States
Research Site
Orlando, Florida, United States
Research Site
Boise, Idaho, United States
Research Site
Chicago, Illinois, United States
Research Site
Iowa City, Iowa, United States
Research Site
Louisville, Kentucky, United States
Research Site
New Orleans, Louisiana, United States
Research Site
Baltimore, Maryland, United States
Research Site
Boston, Massachusetts, United States
Research Site
Kansas City, Missouri, United States
Research Site
Livingston, New Jersey, United States
Research Site
New Brunswick, New Jersey, United States
Research Site
Albuquerque, New Mexico, United States
Research Site
Buffalo, New York, United States
Research Site
New Hyde Park, New York, United States
Research Site
New York, New York, United States
Research Site
The Bronx, New York, United States
Research Site
Valhalla, New York, United States
Research Site
Charlotte, North Carolina, United States
Research Site
Akron, Ohio, United States
Research Site
Cincinnati, Ohio, United States
Research Site
Cleveland, Ohio, United States
Research Site
Cleveland, Ohio, United States
Research Site
Columbus, Ohio, United States
Research Site
Portland, Oregon, United States
Research Site
Portland, Oregon, United States
Research Site
Philadelphia, Pennsylvania, United States
Research Site
Dallas, Texas, United States
Research Site
Houston, Texas, United States
Research Site
San Antonio, Texas, United States
Research Site
Charlottesville, Virginia, United States
Research Site
Norfolk, Virginia, United States
Research Site
Richmond, Virginia, United States
Research Site
Seattle, Washington, United States
Research Site
Edegem, , Belgium
Research Site
Ghent, , Belgium
Research Site
Leuven, , Belgium
Research Site
Jūrmala, , Latvia
Research Site
Vilnius, , Lithuania
Research Site
Mexico City, Mexico City, Mexico
Research Site
Aguascalientes, , Mexico
Research Site
Chihuahua City, , Mexico
Research Site
Puebla City, , Mexico
Research Site
Gdansk, , Poland
Research Site
Lodz, , Poland
Research Site
Szczecin, , Poland
Research Site
San Juan, , Puerto Rico
Research Site
Krasnodar, , Russia
Research Site
Moscow, , Russia
Research Site
Moscow, , Russia
Research Site
Orenburg, , Russia
Research Site
Saint Petersburg, , Russia
Research Site
Samara, , Russia
Research Site
Banská Bystrica, , Slovakia
Research Site
Bratislava, , Slovakia
Research Site
Košice, , Slovakia
Research Site
Birmingham, , United Kingdom
Research Site
Leeds, , United Kingdom
Research Site
London, , United Kingdom
Countries
Review the countries where the study has at least one active or historical site.
References
Explore related publications, articles, or registry entries linked to this study.
Warady BA, Barcia J, Benador N, Jankauskiene A, Olson K, Podracka L, Shavkin A, Srivaths P, Wong CJ, Petersen J. De novo weekly and biweekly darbepoetin alfa dosing in pediatric patients with chronic kidney disease. Pediatr Nephrol. 2018 Jan;33(1):125-137. doi: 10.1007/s00467-017-3758-5. Epub 2017 Aug 17.
Chung EY, Palmer SC, Saglimbene VM, Craig JC, Tonelli M, Strippoli GF. Erythropoiesis-stimulating agents for anaemia in adults with chronic kidney disease: a network meta-analysis. Cochrane Database Syst Rev. 2023 Feb 13;2(2):CD010590. doi: 10.1002/14651858.CD010590.pub3.
Related Links
Access external resources that provide additional context or updates about the study.
AmgenTrials clinical trials website
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
20050256
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.