Ignite Creation Date:
2024-05-05 @ 5:20 PM
Last Modification Date:
2024-10-26 @ 9:31 AM
Study NCT ID:
NCT00437723
Status:
COMPLETED
Last Update Posted:
2009-05-14
First Post:
2007-02-19
Brief Title:
A Study of NeoRecormon in Patients With Chronic Kidney Disease
Sponsor:
Hoffmann-La Roche
Organization:
Hoffmann-La Roche
Study Overview
Official Title:
An Open-Label Study to Investigate the Effect of NeoRecormon on Hemoglobin Level and Renal Function in Patients With Chronic Kidney Disease Stage 2-4
Status:
COMPLETED
Status Verified Date:
2009-05
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 2 arm study will compare the level of anemia and the decline in renal function between patients receiving NeoRecormon and those not receiving it Patients with chronic kidney disease stage 2-4 and not receiving dialysis will be randomized 21 to a group receiving NeoRecormon at a dose determined by the investigator to achieve and maintain an Hb level of 120-135 gL or to a control group not receiving NeoRecormon The anticipated time on study treatment is 3-12 months and the target sample size is 100 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