NESP Pediatric Study
Phase 3
Completed
- Conditions
- Pre-dialysisEnd Stage Renal Disease
- Interventions
- Registration Number
- NCT00527137
- Lead Sponsor
- Amgen
- Brief 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Not specified
- Target Recruitment
- 120
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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description rHuEPO rHuEPO - darbepoetin alfa darbepoetin alfa -
- Primary Outcome Measures
Name Time Method To demonstrate that NESP is comparable (not inferior) to rHuEPO for the treatment of anemia in pediatric subjects with CRI or ESRD receiving dialysis Entire Study
- Secondary Outcome Measures
Name Time Method To determine the safety and tolerability of NESP in the treatment of anemia in the pediatric population with CRI or ESRD Entire Study