Study to Evaluate Darbepoetin Alfa in Pediatric Subjects With Anemia Due to Chronic Kidney Disease (NCT01428154) | Clinical Trial Compass
WithdrawnPhase 1
Study to Evaluate Darbepoetin Alfa in Pediatric Subjects With Anemia Due to Chronic Kidney Disease
Stopped: Difficulty in recruitment. PDCO in the Day 30 summary report agrred to remove the PK study in children \<1 year of age.
0Started 2016-04
Plain-language 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 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.
Who can participate
Age range
1 Year
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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 equivale…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Number of subjects with clinically significant changes in physical examinations, laboratory safety tests, and vital signs
Timeframe: Assessed over 29 days
2
Number of subjects with treatment-emergent adverse events