Study to Assess Darbepoetin Alfa Dosing for the Correction of Anemia in Pediatric Patients With Chronic Kidney Disease
Stopped early · Phase 3 · Has a placebo group
Conditions studied: Anemia, Chronic Kidney Disease, Kidney Disease
In brief
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.
Key facts
- Study ID
- NCT00436748
- Run by
- Amgen
- People needed
- 116
- Starts
- 2008-09-16
- Expected to finish
- 2014-03-03
- Last updated by the study team
- 2022-11-29
Who can join
Age: 1 and older, up to 18. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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%
You may not qualify if…
- 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
Where it is running
- 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 — Birmingham, Alabama, United States
Full record on ClinicalTrials.gov
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