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

September 6, 2007
May 6, 2013
August 2000
November 2004   (final data collection date for primary outcome measure)
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 ]
To demonstrate that NESP is comparable (not inferior) to rHuEPO for the treatment of anemia in pediatric subjects with CRI or ESRD receiving dialysis
Complete list of historical versions of study NCT00527137 on ClinicalTrials.gov Archive Site
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 ]
To determine the safety and tolerability of NESP in the treatment of anemia in the pediatric population with CRI or ESRD
Not Provided
Not Provided
 
NESP Pediatric Study
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

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.

Not Provided
Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
  • Pre-dialysis
  • End Stage Renal Disease
  • 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
  • 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
  • Active Comparator: rHuEPO
    Intervention: Drug: rHuEPO
  • Experimental: darbepoetin alfa
    Intervention: Drug: darbepoetin alfa
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 ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
120
November 2004
November 2004   (final data collection date for primary outcome measure)

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
Not Provided
Not Provided
No
Contact information is only displayed when the study is recruiting subjects
Not Provided
 
NCT00527137
20000100
Not Provided
Amgen
Amgen
Not Provided
Study Director: MD Amgen
Amgen
May 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP