Ignite Creation Date:
2024-05-05 @ 5:22 PM
Last Modification Date:
2024-10-26 @ 9:31 AM
Study NCT ID:
NCT00442702
Status:
COMPLETED
Last Update Posted:
2011-12-19
First Post:
2007-03-01
Brief Title:
A Study of Subcutaneous Mircera in Patients With Chronic Kidney Disease Not on Dialysis
Sponsor:
Hoffmann-La Roche
Organization:
Hoffmann-La Roche
Study Overview
Official Title:
An Open-label Randomized Multi-center Parallel Group Non-inferiority Study of Subcutaneous Injections of RO0503821 Given Once Monthly vs Darbepoetin Alfa Given According to Local Label in Patients With Chronic Kidney Disease Who Are Not on Dialysis
Status:
COMPLETED
Status Verified Date:
2011-12
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 2 arm study will compare the efficacy and safety of Mircera and darbepoetin alfa in the treatment of anemia in patients with chronic kidney disease who are not on dialysis and who are receiving subcutaneous darbepoetin alfa maintenance therapy Patients will be randomized either to remain on darbepoetin alfa therapy as per local label or to switch to monthly subcutaneous Mircera at a starting dose of 120 200 or 360 micrograms depending on the weekly dose of darbepoetin alfa administered prior to the first dose of Mircera The anticipated time on study treatment is 3-12 months and the target sample size is 100-500 individuals
Detailed Description:
None
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