NESP Pediatric Study - Full Text View

Sponsored by:	Amgen
Information provided by:	Amgen
ClinicalTrials.gov Identifier:	NCT00527137

Purpose

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
Pre-Dialysis End Stage Renal Disease	Drug: darbepoetin alfa Drug: rHuEPO	Phase III

MedlinePlus related topics: Anemia

Drug Information available for: Epoetin alfa Erythropoietin Darbepoetin alfa Benzocaine

U.S. FDA Resources

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

Further study details as provided by Amgen:

Primary Outcome Measures:

To demonstrate that NESP is comparable (not inferior) to rHuEPO for the treatment of anemia in pediatric subjects with CRI or ESRD receiving dialysis [ Time Frame: Entire Study ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

To determine the safety and tolerability of NESP in the treatment of anemia in the pediatric population with CRI or ESRD [ Time Frame: Entire Study ] [ Designated as safety issue: Yes ]

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
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
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

Eligibility

Ages Eligible for Study:	1 Year to 18 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00527137

Sponsors and Collaborators

Amgen

Investigators

Study Director:

MD

Amgen

More Information

Notice regarding posted summaries of trial results This link exits the ClinicalTrials.gov site

To access clinical trial results information click on this link This link exits the ClinicalTrials.gov site

FDA-approved Drug Labeling This link exits the ClinicalTrials.gov site

AmgenTrials clinical trials website This link exits the ClinicalTrials.gov site

Publications of Results:

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. Epub 2006 May 25.

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

Study placed in the following topic categories:

Epoetin Alfa
Renal Insufficiency
Urologic Diseases
Renal Insufficiency, Chronic
Darbepoetin alfa

Benzocaine
Anemia
Kidney Failure, Chronic
Kidney Diseases
Kidney Failure

Additional relevant MeSH terms:

Hematinics
Therapeutic Uses
Hematologic Agents
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 14, 2009