Study Complete
Sponsor ID
20000100

NESP Pediatric Study

Sponsor ID
20000100
Clinicaltrials.gov ID
NCT00527137
EUCTIS ID
N/A
EudraCT ID
N/A

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.

Additional Study Details

Phase
Phase 3
Product
darbepoetin alfa
Type
Interventional
Masking
None (Open Label)
Enrollment
120
Additional Study Details

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.