Ignite Creation Date:
2024-05-05 @ 5:27 PM
Last Modification Date:
2024-10-26 @ 9:31 AM
Study NCT ID:
NCT00454246
Status:
TERMINATED
Last Update Posted:
2011-12-16
First Post:
2007-03-29
Brief Title:
A Study of Mircera in Hemoglobin Control of Patients Transitioning to Dialysis
Sponsor:
Hoffmann-La Roche
Organization:
Hoffmann-La Roche
Study Overview
Official Title:
A Randomized Open Label Study of the Effect of Intravenous Mircera on Hemoglobin Control in Patients Transitioning From Chronic Kidney Disease Stage 4 Through 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 study will assess the efficacy and safety of methoxy polyethylene glycol-epoetin beta Mircera in the maintenance of hemoglobin levels in patients who have previously received treatment with epoetin alfa or darbepoetin alfa and who are transitioning from chronic kidney disease stage 4 through dialysis Patients will be randomized either to receive Mircera or to remain on their existing therapy the initial monthly dose of subcutaneous sc Mircera 120-360 micrograms will be based on the average weekly dose of epoetin alfa or darbepoetin alfa administered in the week preceding the switch to Mircera At the initiation of dialysis patients in the Mircera group will receive monthly intravenous iv Mircera at a starting dose based on their previous sc dose and those in the control group will receive weekly iv epoetin alfa The anticipated time on study treatment is 1-2 years and the target sample size is 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