Ignite Creation Date:
2024-05-05 @ 5:14 PM
Last Modification Date:
2024-10-26 @ 9:29 AM
Study NCT ID:
NCT00413894
Status:
COMPLETED
Last Update Posted:
2016-02-15
First Post:
2006-12-19
Brief Title:
A Study of Intravenous Mircera for the Treatment of Anemia in Dialysis Patients
Sponsor:
Hoffmann-La Roche
Organization:
Hoffmann-La Roche
Study Overview
Official Title:
An Open Label Study of the Effect of Intravenous Mircera on Hemoglobin Levels in Anemic Patients With Chronic Kidney Disease Who Are on Dialysis and Who Have Previously Received Epoetin Alfa or Beta or Darbepoetin Alfa Treatment
Status:
COMPLETED
Status Verified Date:
2016-01
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 intravenous Mircera administered with pre-filled syringes for the treatment of anemia in patients with chronic kidney disease who are on dialysis and who have previously received treatment with epoetin alfa or beta or darbepoetin alfa Patients will receive monthly intravenous injections of Mircera with the starting dose derived from the dose of epoetin alfa or beta or darbepoetin 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 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