NESP Pediatric Study

Summary

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.

Timeline

Start

2000-08

Primary completion

2004-11

Completion

2004-11

Outcome

Met primary endpoint

paper These results, and the comparable safety profiles, demonstrate that darbepoetin alfa is non-inferior to rHuEpo in the treatment of anemia in pediatric patients with CKD. PMID 16724235 ↗

paper with a difference of 0.31 g/dl (95% CI: -0.45, 1.07) between the means. PMID 16724235 ↗

Publications

• Results Warady BA, Arar MY, Lerner G, Nakanishi AM, Stehman-Breen C. Darbepoetin alfa for the treatment of anemia in pediatric patients with chronic kidney disease. Pediatr Nephrol. 2006 Aug;21(8):1144-52. doi: 10.1007/s00467-006-0071-0. Epub 2006 May 25.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Darbepoetin alfa	Protein / enzyme biologic	0.42 ug	—
Comparator	rHuEPO	Protein / enzyme biologic	—	—

Indications