Kidney Failure, Chronic Clinical Trial
Official title:
Extended Dosing of Darbepoetin Alfa (Aranesp) for the Management of Anemia in Children With Chronic Renal Failure
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.
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 chronic renal failure is deficiency of EPO production as a result of
declining renal function. Recombinant human EPO (rHuEPO) is a synthetic erythropoietin that
is structurally and functionally similar to naturally occuring EPO. Treatment of anemia
using rHuEPO has been associated with an improvement in the quality of life for patients,
likely attributable to an increased production in hemoglobin and a reduction of dilatation
of the heart. Recently, an analogue of EPO with two extra oligosaccharide chins, darbepoetin
alfa, has been described as having a more prolonged effect requiring less frequent dosing.
There are currently no data available on the efficacy of darbepoetin alfa administered every
14-28 days for children. The most common dosing schedules in the clinical trial at HSC are
every 7, 10, and 14 days. Due to reports of increased pain associated with the SC injection,
and confusion of caregivers when the 10 day dosing schedule is necessary, the goals of the
current proposal are to: 1) Decrease the frequency of SC injections and 2)Eliminate the 10
day dosing schedule for the administration of Darbepoetin.
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Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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