Ignite Creation Date:
2024-05-05 @ 5:16 PM
Last Modification Date:
2024-10-26 @ 9:30 AM
Study NCT ID:
NCT00422513
Status:
TERMINATED
Last Update Posted:
2011-12-14
First Post:
2007-01-15
Brief Title:
A Study Comparing Mircera and Epoetin Alfa for the Treatment of Anemia in Dialysis Patients With Chronic Kidney Disease
Sponsor:
Hoffmann-La Roche
Organization:
Hoffmann-La Roche
Study Overview
Official Title:
A Randomized Open-label Study Comparing the Pharmacoeconomic Time and Motion Benefit of Mircera and Epoetin Alfa in Patients With Chronic Kidney Disease Stage V on Dialysis
Status:
TERMINATED
Status Verified Date:
2011-11
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Strategic decision unrelated to safety or efficacy
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 time and motion provider time spent on anemia management and effect on hemoglobin Hb levels of methoxy polyethylene glycol-epoetin beta Mircera and epoetin alfa in anemic patients with chronic kidney disease CKD on hemodialysis Patients stable on intravenous iv epoetin alfa will be randomized either to receive standard of care therapy epoetin alfa iv 3 times weekly or to receive Mircera 120-360 micrograms iv monthly After a titration period average time spent on anemia treatment over a 3 month period will be evaluated 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