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

Status

Completed

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00527137

Enrollment

120

Registered

2007-09-10

Start date

2000-08-31

Completion date

2004-11-30

Last updated

2013-05-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

End Stage Renal Disease, Pre-dialysis

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.

Interventions

DRUGdarbepoetin 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

DRUGrHuEPO

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

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Healthy volunteers

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

Design outcomes

Primary

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	Entire Study

Secondary

Measure	Time frame
To determine the safety and tolerability of NESP in the treatment of anemia in the pediatric population with CRI or ESRD	Entire Study

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026