NESP Pediatric Study

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

120 participants

Study Classification

INTERVENTIONAL

Study Start Date

2000-08-31

Study Completion Date

2004-11-30

Brief Summary

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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.

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Detailed Description

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Conditions

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Pre-dialysis End Stage Renal Disease

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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rHuEPO

Group Type ACTIVE_COMPARATOR

rHuEPO

Intervention Type DRUG

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

darbepoetin alfa

Group Type EXPERIMENTAL

darbepoetin alfa

Intervention Type DRUG

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

Interventions

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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

Intervention Type 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

Intervention Type DRUG

Eligibility Criteria

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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

Eligible Sex

Accepts Healthy Volunteers

No