Ignite Creation Date:
2024-05-05 @ 5:22 PM
Last Modification Date:
2024-10-26 @ 9:31 AM
Study NCT ID:
NCT00442416
Status:
TERMINATED
Last Update Posted:
2016-08-17
First Post:
2007-03-01
Brief Title:
A Study of Subcutaneous Mircera for the Treatment of Anemia in Peritoneal Dialysis Patients
Sponsor:
Hoffmann-La Roche
Organization:
Hoffmann-La Roche
Study Overview
Official Title:
A Two-arm Randomized Open-label Multicenter Study of Safety and Efficacy of Monthly Injections of RO0503821 Versus Epoetin Alfa in Peritoneal Dialysis Patients Who Self Inject or Receive In-center Injections
Status:
TERMINATED
Status Verified Date:
2016-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Strategic decision unrelated to safety or efficacy
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This 2 arm study will compare the efficacy of monthly Mircera and epoetin alfa in peritoneal dialysis patients who self-inject at home or receive in-centre injections The safety of subcutaneous sc Mircera and injection site reactions and patient satisfaction will also be assessed Eligible patients will be randomized either to receive monthly sc injections of Mircera and will be switched from sc epoetin alfa at a starting dose of 120-360 micrograms or to remain on standard of care sc epoetin alfa Dose adjustments will be permitted to reachmaintain a hemoglobin level of 10-12gdL The anticipated time on study treatment is 3-12 months and the target sample size is 380 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