NESP Pediatric Study

End Stage Renal Disease Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00527137
• Other study ID #: 20000100
• Status: Completed
• Phase: Phase 3
• First received: September 6, 2007
• Last updated: May 6, 2013
• Start date: August 2000
• Est. completion date: November 2004

Study information

• Verified date: May 2013
• Source: Amgen
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 120
• Est. completion date: November 2004
• Est. primary completion date: November 2004
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• End Stage Renal Disease
• Kidney Diseases
• Kidney Failure, Chronic
• Pre-dialysis

Intervention

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
• 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

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Amgen

References & 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. Epub 2006 May 25. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	To determine the safety and tolerability of NESP in the treatment of anemia in the pediatric population with CRI or ESRD		Entire Study	Yes

External Links

•   AmgenTrials clinical trials website
•   FDA-approved Drug Labeling