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Sponsored by: |
Amgen |
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Information provided by: | Amgen |
ClinicalTrials.gov Identifier: | NCT00527137 |
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.
Condition | Intervention | Phase |
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Pre-Dialysis End Stage Renal Disease |
Drug: darbepoetin alfa Drug: rHuEPO |
Phase III |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Open Label, Parallel Assignment, Safety/Efficacy Study |
Official Title: | 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 |
Estimated Enrollment: | 120 |
Study Start Date: | August 2000 |
Study Completion Date: | November 2004 |
Primary Completion Date: | November 2004 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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rHuEPO: Active Comparator |
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
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darbepoetin alfa: Experimental |
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
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Ages Eligible for Study: | 1 Year to 18 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Responsible Party: | Amgen Inc. ( Global Development Leader ) |
Study ID Numbers: | 20000100 |
Study First Received: | September 6, 2007 |
Last Updated: | April 24, 2008 |
ClinicalTrials.gov Identifier: | NCT00527137 |
Health Authority: | United States: Food and Drug Administration |
Epoetin Alfa Renal Insufficiency Urologic Diseases Renal Insufficiency, Chronic Darbepoetin alfa |
Benzocaine Anemia Kidney Failure, Chronic Kidney Diseases Kidney Failure |
Hematinics Therapeutic Uses Hematologic Agents Pharmacologic Actions |