Ignite Creation Date:
2024-05-05 @ 12:01 PM
Last Modification Date:
2024-10-26 @ 9:18 AM
Study NCT ID:
NCT00213291
Status:
COMPLETED
Last Update Posted:
2013-08-26
First Post:
2005-09-13
Brief Title:
Darbepoetin Treatment of Anemia in Children With Chronic Renal Failure
Sponsor:
The Hospital for Sick Children
Organization:
The Hospital for Sick Children
Study Overview
Official Title:
Extended Dosing of Darbepoetin Alfa Aranesp for the Management of Anemia in Children With Chronic Renal Failure
Status:
COMPLETED
Status Verified Date:
2013-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 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 2Eliminate the 10 day dosing schedule for the administration of Darbepoetin
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 2Eliminate the 10 day dosing schedule for the administration of Darbepoetin
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None