Ignite Creation Date:
2024-05-05 @ 6:32 PM
Last Modification Date:
2024-10-26 @ 9:34 AM
Study NCT ID:
NCT00495365
Status:
TERMINATED
Last Update Posted:
2011-05-19
First Post:
2007-06-29
Brief Title:
A Dose Conversion Study of Epoetin Alfa in Subjects With the Anemia of Chronic Kidney Disease
Sponsor:
Ortho Biotech Products LP
Organization:
Ortho Biotech Products LP
Study Overview
Official Title:
Evaluation of Dose Conversion From Variable Dosing Intervals of Darbepoetin Alfa to Variable Dosing Intervals of Epoetin Alfa in Patients With the Anemia of Chronic Kidney Disease
Status:
TERMINATED
Status Verified Date:
2010-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
This study was stopped due to slow enrollment
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The purpose of this study was to evaluate hemoglobin stability in subjects who had received darbepoetin alfa for a minimum of 3 months prior to study entry who were then converted to epoetin alfa at the same dosing frequency to maintain a hemoglobin level of 12 plus or minus 1 gdL range 11-13- gdL
Detailed Description:
This was a prospective multicenter study in subjects with chronic kidney disease The study was designed to address hemoglobin stability after drug conversion to epoetin alfa in subjects previously receiving darbepoetin alfa therapy
The study was to enroll approximately 180 subjects with chronic kidney disease Eligible subjects were those with chronic kidney disease who were receiving darbepoetin alfa every two three or four weeks for a period of 3 months or more and who had a stable hemoglobin Hb level at study entry of 12 gdL plus or minus 1 gdL 11-13 gdL Subjects receiving darbepoetin alfa every 2 3 or 4 weeks were switched over to epoetin alfa which they received at the same dosing frequency every 2 3 or 4 weeks upon study entry and throughout the 24 week study period Clinical safety was assessed for the occurrence and severity of adverse events Blood tests Complete Blood Count platelets reticulocyte count iron were assessed at pre-determined intervals throughout the study Vital signs eg Blood pressure were checked at each visit Subjects received epoetin alfa at the same dosing frequency that they had previously received darbepoetin alfa Subjects received 20000 Units U epoetin alfa subcutaneously SC every two weeks 30000 U epoetin alfa SC every 3 weeks or 40000 U epoetin alfa SC every 4 weeks
The study was to enroll approximately 180 subjects with chronic kidney disease Eligible subjects were those with chronic kidney disease who were receiving darbepoetin alfa every two three or four weeks for a period of 3 months or more and who had a stable hemoglobin Hb level at study entry of 12 gdL plus or minus 1 gdL 11-13 gdL Subjects receiving darbepoetin alfa every 2 3 or 4 weeks were switched over to epoetin alfa which they received at the same dosing frequency every 2 3 or 4 weeks upon study entry and throughout the 24 week study period Clinical safety was assessed for the occurrence and severity of adverse events Blood tests Complete Blood Count platelets reticulocyte count iron were assessed at pre-determined intervals throughout the study Vital signs eg Blood pressure were checked at each visit Subjects received epoetin alfa at the same dosing frequency that they had previously received darbepoetin alfa Subjects received 20000 Units U epoetin alfa subcutaneously SC every two weeks 30000 U epoetin alfa SC every 3 weeks or 40000 U epoetin alfa SC every 4 weeks
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