NESP Pediatric Study

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Amgen
ClinicalTrials.gov Identifier:
NCT00527137
First received: September 6, 2007
Last updated: May 6, 2013
Last verified: May 2013
  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 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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

Resource links provided by NLM:


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
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

  Eligibility

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

Sponsors and Collaborators
Amgen
Investigators
Study Director: MD Amgen
  More Information

Additional Information:
Publications:
Responsible Party: Amgen
ClinicalTrials.gov Identifier: NCT00527137     History of Changes
Other Study ID Numbers: 20000100
Study First Received: September 6, 2007
Last Updated: May 6, 2013
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Kidney Diseases
Kidney Failure, Chronic
Urologic Diseases
Renal Insufficiency, Chronic
Renal Insufficiency
Darbepoetin alfa
Epoetin alfa
Hematinics
Hematologic Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on September 16, 2014