NESP Pediatric Study

Amgen

Status and phase: Completed; Phase 3

Conditions: Pre-dialysis; End Stage Renal Disease

Treatments: Drug: darbepoetin alfa; Drug: rHuEPO

Study type: Interventional

Funder types: Industry

Identifiers

NCT00527137

20000100

Details and patient eligibility

About

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.

Enrollment: 120 estimated patients

Sex

Volunteers: No Healthy Volunteers

Inclusion criteria

• 1 to 18 years of age
• ESRD receiving dialysis or CRI with eGFR less than 30 mL/min
• Baseline hemoglobin 9.5 - 12.5 g/dL and iron replete
• Stable rHuEPO therapy for 8 weeks

Exclusion criteria

• Scheduled for a living-related kidney transplant
• Uncontrolled blood pressure
• seizure activity
• Hyperparathyroidism
• Major surgery within 12 weeks or active inflammatory disease
• Currently receiving antibiotics
• Clinical evidence of malignancy
• Pregnant or breast-feeding

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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120 participants in 2 patient groups

rHuEPO

Active Comparator group

Treatment:

Drug: rHuEPO

darbepoetin alfa

Experimental group

Treatment:

Drug: darbepoetin alfa