Darbepoetin Treatment of Anemia in Children With Chronic Renal Failure

PHASE3CompletedINTERVENTIONAL
Enrollment

40

Participants

Timeline

Start Date

April 30, 2005

Primary Completion Date

September 30, 2005

Study Completion Date

October 31, 2005

Conditions
Kidney Failure, Chronic
Interventions
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.

Trial Locations (1)

M5G 1X8

The Hospital for Sick Children, Toronto

All Listed Sponsors
lead

The Hospital for Sick Children

OTHER

NCT00213291 - Darbepoetin Treatment of Anemia in Children With Chronic Renal Failure | Biotech Hunter | Biotech Hunter