Status:
WITHDRAWN
Study to Evaluate Darbepoetin Alfa in Pediatric Subjects With Anemia Due to Chronic Kidney Disease
Lead Sponsor:
Amgen
Conditions:
Anemia
Chronic Kidney Disease
Eligibility:
All Genders
Up to 1 years
Phase:
PHASE1
Brief Summary
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 darbe...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
April 1 2016
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 1 2016
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT01428154
Start Date
April 1 2016
End Date
November 1 2016
Last Update
June 17 2016
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