NESP Pediatric Study

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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Key information

Conditions

Pre-dialysis Chronic Disease Disease Attributes End Stage Renal Disease Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Kidney Diseases Kidney Failure, Chronic Male Urogenital Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Renal Insufficiency Renal Insufficiency, Chronic Urogenital Diseases Urologic Diseases

Study type

Interventional

Phase

Phase 3

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

darbepoetin alfa

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

rHuEPO

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

Primary outcomes

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 outcomes

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

Sponsors and collaborators

Lead sponsor

Amgen

Industry

Registry information

Official study 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

Important dates

Study start: 2000
Primary completion: 2004
Study completion: 2004
First posted: Sep 10, 2007
Registry last updated: May 8, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed