NESP Pediatric Study - Tabular View

This Tabular View shows the required WHO registration data elements as marked by ^†

Tracking Information

First Received Date ^†

September 6, 2007

Last Updated Date

April 24, 2008

Start Date ^†

August 2000

Current 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 ]

Original Primary Outcome Measures ^†

Same as current

Change History

Complete list of historical versions of study NCT00527137 on ClinicalTrials.gov Archive Site

Current 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 ]

Original Secondary Outcome Measures ^†

Same as current

Descriptive Information

Brief Title ^†

NESP Pediatric 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

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

Study Phase

Phase III

Study Type ^†

Interventional

Study Design ^†

Treatment, Randomized, Open Label, Parallel Assignment, Safety/Efficacy Study

Condition ^†

Pre-Dialysis
End Stage Renal Disease

Intervention ^†

Drug: darbepoetin alfa
Drug: rHuEPO

Study Arms / Comparison Groups

Publications *

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.

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^†

Completed

Estimated Enrollment ^†

120

Completion Date

November 2004

Primary Completion Date

November 2004 (final data collection date for primary outcome measure)

Eligibility 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

Gender

Both

Ages

1 Year to 18 Years

Accepts Healthy Volunteers

Contacts ^††

Location Countries ^†

Expanded Access Status

Administrative Information

NCT ID ^†

NCT00527137

Responsible Party

Global Development Leader, Amgen Inc.

Secondary IDs ^††

Study Sponsor ^†

Amgen

Collaborators ^††

Investigators ^†

Study Director:

Amgen

Information Provided By

Amgen

Verification Date

April 2008

^† Required WHO trial registration data element.
^†† WHO trial registration data element that is required only if it exists.