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
1 other identifier
interventional
120
0 countries
N/A
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_3
Started Aug 2000
Typical duration for phase_3
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
August 1, 2000
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 1, 2004
CompletedStudy Completion
Last participant's last visit for all outcomes
November 1, 2004
CompletedFirst Submitted
Initial submission to the registry
September 6, 2007
CompletedFirst Posted
Study publicly available on registry
September 10, 2007
CompletedMay 8, 2013
May 1, 2013
4.3 years
September 6, 2007
May 6, 2013
Conditions
Outcome Measures
Primary Outcomes (1)
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 Outcomes (1)
To determine the safety and tolerability of NESP in the treatment of anemia in the pediatric population with CRI or ESRD
Entire Study
Study Arms (2)
rHuEPO
ACTIVE COMPARATORdarbepoetin alfa
EXPERIMENTALInterventions
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
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
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Amgenlead
Related Publications (1)
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.
PMID: 16724235RESULT
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
MD
Amgen
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 6, 2007
First Posted
September 10, 2007
Study Start
August 1, 2000
Primary Completion
November 1, 2004
Study Completion
November 1, 2004
Last Updated
May 8, 2013
Record last verified: 2013-05