Study to Evaluate Darbepoetin Alfa in Pediatric Subjects With Anemia Due to Chronic Kidney Disease

Amgen

Status and phase

Withdrawn

Phase 1

Conditions

Chronic Kidney Disease

Anemia

Treatments

Drug: Darbepoetin alfa

Study type

Interventional

Funder types

Industry

Identifiers

NCT01428154

20090302

Details and patient eligibility

About

The purpose of this study is to find out more about darbepoetin alfa in children less than 1 year of age with anemia (a decrease in red blood cells) due to kidney failure. This study will see if darbepoetin alfa is safe and well tolerated and whether it causes any side effects by taking blood samples and checking vital signs (heart rate, body temperature, and blood pressure tests) at specific times throughout the study. In addition, the study will evaluate the amount of darbepoetin alfa in the blood over time and look at special markers in the blood to evaluate how darbepoetin alfa works on anemia.

Darbepoetin alfa is approved by the United States Food and Drug Administration (FDA) and European Medicines Agency (EMA) for use in adults, but not for all ages of pediatric subjects. Therefore, studies need to be conducted in pediatric subjects (children) to determine the appropriate dose to use in younger children.

Sex

All

Ages

Under 1 year old

Volunteers

No Healthy Volunteers

Inclusion criteria

Girls and boys between birth and < 1 year of age at the time of enrollment
Body weight ≥ 3 kg at screening and enrollment
Diagnosis of chronic kidney disease stage 3 to 5 with an estimated Glomerular Filtration Rate < 60 mL/min/1.73m2 without dialysis using the updated Schwartz Equation at screening; OR on dialysis at screening
Hemoglobin ≤ 9.0 g/dL within 7 days prior to enrollment
Transferrin saturation ≥ 20% at screening

Exclusion criteria

Premature girls and boys (< 37 weeks of gestation, counting from the first day of the mother's last menstrual period)
Peritoneal dialysis subjects with an episode of peritonitis within 30 days prior to enrollment
History of cardiovascular events or thromboembolism
History of upper or lower gastrointestinal bleeding
History of seizures
Active liver disease or history of liver disease
Uncontrolled hypertension defined as stage 2 hypertension or greater. This is defined as a systolic or diastolic blood pressure value greater than the 99th percentile + 5 mmHg for a subject's age
Major surgery 12 weeks prior to enrollment
Red blood cell transfusions 12 weeks prior to enrollment
Use of any erythropoiesis-stimulating agent within 12 weeks prior to enrollment
Currently receiving antibiotic therapy for systemic infection within 4 weeks prior to enrollment
Current or prior use of immunosuppressants (excluding low-dose corticosteroids, defined as ≤ 0.5 mg/kg per day prednisone or equivalent for ≤ 5 days)
Subject is receiving a dose higher than 0.5 mg/kg per day of prednisone (or equivalent dose of another corticosteroid) for > 5 days within 4 weeks prior to enrollment
Receiving or has received any investigational drug (or is currently using an investigational device) within the 30 days or 5 half-lives (whichever is longer) prior to enrollment
Subject has known hypersensitivity to darbepoetin alfa, r-HuEPO, or to any of the excipients