NCT00436748

Study to Assess Darbepoetin Alfa Dosing for the Correction of Anemia in Pediatric Patients With Chronic Kidney Disease

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

• Status: Terminated
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 116 (actual)
• Sponsor: Amgen · Industry
• Sex: All
• Age: 1 Year – 18 Years
• Healthy volunteers: Not accepted

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 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.

Conditions

• Anemia
• Chronic Kidney Disease
• Kidney Disease

Interventions

Type	Name	Description
DRUG	Darbepoetin Alfa	Administered by subcutaneous or intravenous injection
DRUG	Placebo	Matching placebo solution for subcutaneous or intravenous injection to maintain the blind in the Q2W arm.

Timeline

• Start date: 2008-09-16
• Primary completion: 2014-03-03
• Completion: 2014-03-03
• First posted: 2007-02-19
• Last updated: 2022-11-29
• Results posted: 2015-03-31

Locations

67 sites across 10 countries: United States, Belgium, Latvia, Lithuania, Mexico, Poland, Puerto Rico, Russia, Slovakia, United Kingdom