NCT00527137

NESP Pediatric Study

An Open-label, Randomized, Non-inferiority Study of Novel Erythropoiesis Stimulating Protein (NESP) and Recombinant Human Erythropoietin (rHuEPO) for the Treatment of Anemia in Pediatric Subjects With Chronic Renal Insufficiency (CRI) or End-stage Renal Disease (ESRD) Receiving Dialysis

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 120 (estimated)
• Sponsor: Amgen · Industry
• Sex: —
• Age: —
• Healthy volunteers: Not accepted

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.

Conditions

• Pre-dialysis
• End Stage Renal Disease

Interventions

Type	Name	Description
DRUG	darbepoetin alfa	Dose 100U rHuEPO = 0.42 mcg NESP; adjust as necessary (+/- 25% of the starting dose) to maintain Hb withing 10.0 - 12.5 g/dL
DRUG	rHuEPO	same as previous rHuEPO dose at randomization; adjust as necessary (+/- 25% of the starting dose) to maintain Hb withing 10.0 - 12.5 g/dL

Timeline

• Start date: 2000-08-01
• Primary completion: 2004-11-01
• Completion: 2004-11-01
• First posted: 2007-09-10
• Last updated: 2013-05-08