Study to Assess Darbepoetin Alfa Dosing for the Correction of Anemia in Pediatric Patients with Chronic Kidney Disease
Study Details
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.
Protocol Summary
Proportion of Participants Achieving Hemoglobin ≥ 10.0 g/dL
Timeframe: 24 weeks
Time to First Hemoglobin Value ≥ 10.0 g/dL
Timeframe: 24 weeks
Hemoglobin Concentration Over Time
Timeframe: Baseline and Weeks 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 21, 22, 23, 24 and 25.
Weight-adjusted Darbepoetin Alfa Dose at Time of Achieving First Hemoglobin ≥ 10.0 g/dL
Timeframe: 24 weeks
Darbepoetin Alfa Weight-Adjusted Dose (μg/kg) Over Time
Timeframe: Day 1 (initial dose) and Weeks 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 21, 22, 23, 24 and 25.
Change From Baseline at Week 13 and Week 25 in Parent-reported Pediatric Quality of Life Inventory (PedsQL) Scores
Timeframe: Baseline, Week 13 and Week 25 (or end of study visit if earlier than Week 25)
Change From Baseline at Week 13 and Week 25 in Child Self-reported Pediatric Quality of Life Inventory (PedsQL) Scores
Timeframe: Baseline, Week 13 and Week 25 (or end of study visit if earlier than Week 25)
Number of Participants with Adverse Events
Timeframe: 25 weeks
Hemoglobin Serial Rate of Change (ROC) Over Time
Timeframe: Weeks 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 21, 22, 23, 24 and 25.
Number of Participants with Hemoglobin > 12.0, > 13.0, and > 14.0 g/dL During the Study
Timeframe: 25 weeks
Maximum Increase in Hemoglobin Over Any 2 Week Period
Timeframe: 25 weeks
Change from Baseline in Systolic Blood Pressure Over Time
Timeframe: Baseline and Weeks 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 21, 22, 23, 24 and 25.
Change from Baseline in Diastolic Blood Pressure Over Time
Timeframe: Baseline and Weeks 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 21, 22, 23, 24 and 25.
Number of Participants who Developed Anti-erythropoiesis Antibodies
Timeframe: 25 weeks
Darbepoetin Alfa Serum Concentrations for Participants Less than 6 Years of Age
Timeframe: Weeks 1,2, and 3 before the investigational product dose and 2 days after the first investigational product dose