Ignite Creation Date:
2024-05-05 @ 6:37 PM
Last Modification Date:
2024-10-26 @ 9:35 AM
Study NCT ID:
NCT00517413
Status:
COMPLETED
Last Update Posted:
2016-04-29
First Post:
2007-08-16
Brief Title:
LATINO Study A Study of Mircera for the Maintenance Treatment of Dialysis Patients With Chronic Renal Anemia
Sponsor:
Hoffmann-La Roche
Organization:
Hoffmann-La Roche
Study Overview
Official Title:
A Single-Arm Open-Label Study to Assess the Efficacy Safety and Tolerability of Once-Monthly Administration of Intravenous andor Subcutaneous CERA for the Maintenance of Hemoglobin Levels in Dialysis Patients With Chronic Renal Anemia
Status:
COMPLETED
Status Verified Date:
2016-03
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 single arm study will assess the efficacy and safety of Mircera when administered once monthly subcutaneously or intravenously for the maintenance of hemoglobin levels in dialysis patients with chronic renal anemia Patients currently receiving maintenance treatment with epoetin alfa will receive monthly injections of Mircera with a starting dose 120 200 or 360 micrograms derived from the dose of epoetin alfa they were receiving in the week preceding study start 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