NESP Pediatric Study

• Sponsor: Amgen (Industry)
• Overall Status: Completed
• CT.gov ID: NCT00527137
• Collaborator: (none)
• Enrollment: 120
• Arms: 2
• Duration (Months): 51

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Pre-dialysis; End Stage Renal Disease	Drug: darbepoetin alfa; Drug: rHuEPO	Phase 3

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 120 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• 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
• Study Start Date: Aug 1, 2000
• Actual Primary Completion Date: Nov 1, 2004
• Actual Study Completion Date: Nov 1, 2004

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: rHuEPO	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
Experimental: darbepoetin alfa	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

Outcome Measures

Primary Outcome Measures

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 Outcome Measures

1. To determine the safety and tolerability of NESP in the treatment of anemia in the pediatric population with CRI or ESRD [Entire Study]

Eligibility Criteria

Criteria

• Ages Eligible for Study: N/A and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Locations

No locations specified.

Sponsors and Collaborators

• Amgen

Investigators

• Study Director: MD, Amgen

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

• Notice regarding posted summaries of trial results
• To access clinical trial results information click on this link
• FDA-approved Drug Labeling
• AmgenTrials clinical trials website

Publications

None provided.

• Responsible Party: Amgen
• ClinicalTrials.gov Identifier: NCT00527137
• Other Study ID Numbers: 20000100
• First Posted: Sep 10, 2007
• Last Update Posted: May 8, 2013
• Last Verified: May 1, 2013

• Additional relevant MeSH terms: Kidney Diseases; Kidney Failure, Chronic; Darbepoetin alfa

Study Results

No Results Posted as of May 8, 2013