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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: 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.
Age
1 - 18 years
Sex
ALL
Healthy Volunteers
No
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
Start Date
September 16, 2008
Primary Completion Date
March 3, 2014
Completion Date
March 3, 2014
Last Updated
November 29, 2022
116
ACTUAL participants
Darbepoetin Alfa
DRUG
Placebo
DRUG
Lead Sponsor
Amgen
NCT07241390
NCT05012111
Data Source & Attribution
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