Ignite Creation Date:
2025-12-24 @ 5:39 PM
Ignite Modification Date:
2025-12-28 @ 8:16 PM
Study NCT ID:
NCT00642668
Status:
COMPLETED
Last Update Posted:
2017-07-05
First Post:
2008-03-19
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
A Study of Subcutaneous Mircera for the Maintenance Treatment of Participants With Chronic Renal Anemia
Sponsor:
Hoffmann-La Roche
Organization:
Study Overview
Official Title:
Subcutaneous Treatment of Anemia in Patients With a GFR Below 45 ml/Min/1.73m2 Through Injections With Mircera as Low Frequent as Once Monthly (STABILO)
Status:
COMPLETED
Status Verified Date:
2017-05
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 assessed the efficacy and safety of subcutaneous methoxy polyethylene glycol-epoetin beta (Mircera), a continuous erythropoietin receptor activator (C.E.R.A.), for correction and/or maintenance of hemoglobin levels in participants with chronic kidney disease and renal anemia, who were not treated with erythropoiesis-stimulating agents (ESA) or on dialysis. Eligible participants received monthly subcutaneous injections of methoxy polyethylene glycol-epoetin beta at an initial recommended dose of 1.2 micrograms/kilogram (mcg/kg). The anticipated time on study treatment was 3-10 months, and the target sample size was 200 individuals.
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: