Status:
COMPLETED
Darbepoetin Treatment of Anemia in Children With Chronic Renal Failure
Lead Sponsor:
The Hospital for Sick Children
Conditions:
Kidney Failure, Chronic
Eligibility:
All Genders
1-17 years
Phase:
PHASE3
Brief Summary
This is a study to determine the safety and effectiveness of Darbepoetin (Aranesp) given every 14 to 28 days to treat low red blood cells in children with chronic kidney failure.
Detailed Description
Erythropoietin (EPO) is a glycoprotein synthesized in the kidneys which regulates the rate of proliferation and differentiation of red blood cell precursors. The main cause of anemia in children with ...
Eligibility Criteria
Inclusion
- diagnosis of chronic renal insufficiency or end stage renal disease (ESRD) requiring dialysis
- clinically stable
- hemoglobin of 110-125 g/L in screening period; for naive subjects, hemoglobin \< 110 g/L
- not iron deficient (TSAT \> 19.5%) within 4 weeks of study entry
- stable darbepoetin alpha therapy administered IV or SC q7 to q21 days OR darbepoetin alpha naive
- written informed consent from parent/legal guardian
- less than 18 years old
- weight at least 10 kg
- females of childbearing potential must practice adequate contraception
- availability for follow-up assessments
Exclusion
- scheduled for a living donor kidney transplant within 12 weeks of signing consent
- uncontrolled blood pressure as judged by principal investigator
- change in seizure pattern in past 30 days; grand-mal seizure 12 weeks before enrollment
- current clinical evidence of severe hyperparathyroidism
- major surgery 2 weeks before signing consent
- active inflammatory disease or condition requiring immunosuppressive therapy
- currently receiving antibiotics for active systemic infection
- peritoneal dialysis patient with an episode of peritonitis within the past 30 days
- known HIV antibody positivity
- known antibodies to rHuEPO
- known aluminum toxicity
- known red cell aplasia
- known malignancy
Key Trial Info
Start Date :
April 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
October 1 2005
Estimated Enrollment :
40 Patients enrolled
Trial Details
Trial ID
NCT00213291
Start Date
April 1 2005
End Date
October 1 2005
Last Update
August 26 2013
Active Locations (1)
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1
The Hospital for Sick Children
Toronto, Ontario, Canada, M5G 1X8