ClinicalTrials.gov
ClinicalTrials.gov Menu

NESP Pediatric Study

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00527137
Recruitment Status : Completed
First Posted : September 10, 2007
Last Update Posted : May 8, 2013
Sponsor:
Information provided by (Responsible Party):
Amgen

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 Type : Interventional  (Clinical Trial)
Estimated 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 : August 2000
Actual Primary Completion Date : November 2004
Actual Study Completion Date : November 2004

Resource links provided by the National Library of Medicine

U.S. FDA Resources

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



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 [ Time Frame: 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 [ Time Frame: Entire Study ]


Information from the National Library of Medicine

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, Learn About Clinical Studies.


Ages Eligible for Study:   Child, Adult, Senior
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00527137


Sponsors and Collaborators
Amgen
Investigators
Study Director: MD Amgen

Additional Information:
Publications of Results:
Responsible Party: Amgen
ClinicalTrials.gov Identifier: NCT00527137     History of Changes
Other Study ID Numbers: 20000100
First Posted: September 10, 2007    Key Record Dates
Last Update Posted: May 8, 2013
Last Verified: May 2013

Additional relevant MeSH terms:
Kidney Diseases
Kidney Failure, Chronic
Urologic Diseases
Renal Insufficiency, Chronic
Renal Insufficiency
Darbepoetin alfa
Epoetin Alfa
Hematinics