Ignite Creation Date:
2025-12-24 @ 9:49 PM
Ignite Modification Date:
2025-12-30 @ 7:26 PM
Study NCT ID:
NCT00364832
Status:
COMPLETED
Last Update Posted:
2016-12-20
First Post:
2006-08-15
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
A Study of Subcutaneous (sc) Mircera in Dialysis Patients With Chronic Renal Anemia.
Sponsor:
Hoffmann-La Roche
Organization:
Study Overview
Official Title:
An Open-label, Multicenter, Randomized Study to Determine Dose Conversion Factors at Different Frequencies of Administration After Switching From Maintenance Treatment With Subcutaneous Epoetin Alfa or Beta to Maintenance Treatment With Subcutaneous RO0503821 in Dialysis Patients With Chronic Renal Anemia
Status:
COMPLETED
Status Verified Date:
2016-10
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 will determine the appropriate dose and frequency of administration of sc Mircera maintenance therapy in dialysis patients with chronic renal anemia who were previously receiving sc epoetin alfa or beta. 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:
Is a FDA Regulated Drug?:
Is a FDA Regulated Device?:
Is an Unapproved Device?:
Is a PPSD?:
Is a US Export?:
Is an FDA AA801 Violation?: