- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00527137
NESP Pediatric Study
May 6, 2013 updated by: Amgen
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Anticipated)
120
Phase
- Phase 3
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
No
Description
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 Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: 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
|
Active Comparator: 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
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
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
|
Entire Study
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
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
|
Entire Study
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
August 1, 2000
Primary Completion (Actual)
November 1, 2004
Study Completion (Actual)
November 1, 2004
Study Registration Dates
First Submitted
September 6, 2007
First Submitted That Met QC Criteria
September 6, 2007
First Posted (Estimate)
September 10, 2007
Study Record Updates
Last Update Posted (Estimate)
May 8, 2013
Last Update Submitted That Met QC Criteria
May 6, 2013
Last Verified
May 1, 2013
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 20000100
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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