Status:
TERMINATED
Study to Assess Darbepoetin Alfa Dosing for the Correction of Anemia in Pediatric Patients With Chronic Kidney Disease
Lead Sponsor:
Amgen
Conditions:
Anemia
Chronic Kidney Disease
Eligibility:
All Genders
1-18 years
Phase:
PHASE3
Brief Summary
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 ...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
September 16 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 3 2014
Estimated Enrollment :
116 Patients enrolled
Trial Details
Trial ID
NCT00436748
Start Date
September 16 2008
End Date
March 3 2014
Last Update
November 29 2022
Active Locations (67)
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1
Research Site
Birmingham, Alabama, United States, 35233
2
Research Site
Los Angeles, California, United States, 90027
3
Research Site
Los Angeles, California, United States, 90095
4
Research Site
San Diego, California, United States, 92123