Darbepoetin Treatment of Anemia in Children With Chronic Renal Failure
|Study Design:||Allocation: Non-Randomized
Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Extended Dosing of Darbepoetin Alfa (Aranesp) for the Management of Anemia in Children With Chronic Renal Failure|
- The safety of darbepoetin when administered at an increased dosing interval [ Time Frame: 40 weeks ] [ Designated as safety issue: Yes ]
- Safety and tolerability of darbepoetin [ Time Frame: 40 weeks ] [ Designated as safety issue: Yes ]
- Proportion of subjects who receive red blood cell transfusions [ Time Frame: 40 weeks ] [ Designated as safety issue: No ]
- Percentage of Hb data points that exceed upper target of 125 g/L [ Time Frame: 16-36 weeks ] [ Designated as safety issue: No ]
- Incidence of anti-erythropoietin antibody formation [ Time Frame: 40 weeks ] [ Designated as safety issue: No ]
|Study Start Date:||April 2005|
|Estimated Study Completion Date:||October 2005|
|Primary Completion Date:||September 2005 (Final data collection date for primary outcome measure)|
Drug: darbepoetin alfa
Darbepoetin alfa will be administered by SC/IV injection every 14-28 days. Patients starting on the 14 day dose regimen will receive two times their baseline weekly dose; patients on the 28 day schedule will receive four times their average weekly dose. The exception to a Q14 or Q28 dosing schedule will be for patients requiring 10 mcg every 10 days. These patients will go to 20 mcg Q21 days before extending to the Q28 day schedule. Naive patients will start on a dose of 0.9 mcg/kg every 14 days. Study subjects who are successfully treated for 12 weeks on the 14 day schedule may be enrolled in the 28 day schedule study.
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00213291
|The Hospital for Sick Children|
|Toronto, Ontario, Canada, M5G 1X8|
|Principal Investigator:||Denis F Geary, MD||The Hospital For Sick Children, Toronto Canada|