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

20050256

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.

2008-09-16

2014-03-03

2014-03-03

Terminated

Early phase I

116

Inclusion Criteria: * 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 Criteria: * 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

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE3'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR']}}, 'enrollmentInfo': {'count': 116, 'type': 'ACTUAL'}}

2022-11-29