Study Complete
Sponsor ID
20000100
NESP Pediatric Study
Study Details
Open-label, randomized study of NESP in pediatric subjects 18 years of age or younger. Subjects will receive study drug (NESP or rHuEPO) for 28 weeks after a 2 week screening and baseline period. During the study, procedures include bloodwork for laboratory assessments and vital signs. Dose titration determined by hemoglobin values taken weekly during the study. Antibody samples taken at baseline and during the end of study assessments. A physical examination and laboratory tests will conclude the study.
Protocol Summary
Primary Outcome Measures
To demonstrate that NESP is comparable (not inferior) to rHuEPO for the treatment of anemia in pediatric subjects with CRI or ESRD receiving dialysis
Timeframe: Entire Study
Secondary Outcome Measures
To determine the safety and tolerability of NESP in the treatment of anemia in the pediatric population with CRI or ESRD
Timeframe: Entire Study
Locations
No locations found.