Ignite Creation Date:
2024-05-05 @ 6:38 PM
Last Modification Date:
2024-10-26 @ 9:35 AM
Study NCT ID:
NCT00517881
Status:
TERMINATED
Last Update Posted:
2016-05-27
First Post:
2007-08-16
Brief Title:
Efficacy Safety and Tolerability Study of Subcutaneous CERA in Pre-Dialysis Participants With Chronic Renal Anemia
Sponsor:
Hoffmann-La Roche
Organization:
Hoffmann-La Roche
Study Overview
Official Title:
A Single Arm Open Label Study to Assess the Efficacy Safety and Tolerability of Once Monthly Administration of Subcutaneous CERA for the Maintenance of Haemoglobin Levels in Pre-dialysis Patients With Chronic Renal Anaemia
Status:
TERMINATED
Status Verified Date:
2016-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
The study was terminated due to the slow recruitment rate
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 safety and tolerability of subcutaneous methoxy polyethylene glycol-epoetin beta CERA for maintenance of hemoglobin levels in pre-dialysis participants with chronic renal anemia Participants currently receiving maintenance treatment with subcutaneous darbepoetin alfa will receive monthly subcutaneous injections of CERA with the starting dose of 120 200 or 360 micrograms mcg derived from the dose of darbepoetin alfa or epoetin alfa in the week preceding study start
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
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 2006-006523-40 | EUDRACT_NUMBER | None | None |