Ignite Creation Date:
2024-05-05 @ 11:38 AM
Last Modification Date:
2024-10-26 @ 9:10 AM
Study NCT ID:
NCT00090753
Status:
COMPLETED
Last Update Posted:
2012-02-14
First Post:
2004-09-03
Brief Title:
A Study of Intravenous or Subcutaneous Methoxy Polyethylene Glycol-Epoetin Beta RO0503821 Mircera in Chronic Kidney Disease Patients With Renal Anemia
Sponsor:
Hoffmann-La Roche
Organization:
Hoffmann-La Roche
Study Overview
Official Title:
An Open-label Multi-center Study to Document the Efficacy Safety and Tolerability of Long-term Administration of RO0503821 in Patients With Chronic Renal Anemia
Status:
COMPLETED
Status Verified Date:
2012-02
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 study assessed the long-term efficacy safety and tolerability of intravenous iv or subcutaneous sc methoxy polyethylene glycol-epoetin beta in chronic kidney disease patients with renal anemia Eligible patients were those who were receiving stable maintenance therapy with methoxy polyethylene glycol-epoetin beta or erythropoiesis stimulating agents ESAs in Phase II or III clinical studies They continued to receive methoxy polyethylene glycol-epoetin beta or comparator ESAs at the same weekly dose and by the same route of administration sc or iv as in the qualifying studies
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