Ignite Creation Date:
2024-05-05 @ 5:24 PM
Last Modification Date:
2024-10-26 @ 9:31 AM
Study NCT ID:
NCT00440557
Status:
COMPLETED
Last Update Posted:
2014-05-07
First Post:
2007-02-26
Brief Title:
An Efficacy and Safety Study of Epoetin Alfa for Initiation and Maintenance Treatment of Patients With Anemia Associated With Chronic Kidney Disease
Sponsor:
Johnson Johnson Pharmaceutical Research Development LLC
Organization:
Johnson Johnson Pharmaceutical Research Development LLC
Study Overview
Official Title:
A Randomized Open Label Multicenter Study of Epoetin Alfa Comparing Two Extended-Dosing Regimens Once-Weekly and Every-Two-Weeks With the Three-Times-Weekly Dosing Regimen for Initiation and Maintenance Treatment in Anemic Subjects With Chronic Kidney Disease
Status:
COMPLETED
Status Verified Date:
2014-04
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:
The purpose of this study is to demonstrate that once weekly and once every-2-weeks treatment with epoetin alfa in patients with anemia associated with chronic kidney disease is not less effective than the approved treatment with epoetin alfa that is given 3 times weekly with respect to changes in hemoglobin
Detailed Description:
This is a open-label all people know the identity of the intervention randomized the study medication is assigned by chance multicenter study designed to show that 2 alternative dosing regimens once weekly and once every-2-weeks given at doses equivalent to 50 IUkg 3 times a week are not inferior to the 3-times-weekly dosing regimen Approximately 375 patients with anemia will be enrolled in this study Patients will be randomly assigned to receive epoetin alfa by subcutaneous SC injection according to one of the following 3 regimens 3 times weekly Group 1 once weekly Group 2 or once every 2 weeks Group 3 for 22 weeks Thereafter patients in Group 1 will be switched to the once-weekly dosing regimen for an additional 22 weeks and patients in Groups 2 and 3 will continue their current treatment for an additional 22 weeks The total duration of the open-label treatment phase is 44 weeks which will include initiation and maintenance treatment periods with the goal of increasing then maintaining the hemoglobin level between 110 and 119 gdL inclusive and a safety period to assess longer exposure to epoetin alfa treatment and any period of hemoglobin instability during the transition from 3-times-weekly to once-weekly dosing Starting doses of epoetin alfa in the 3-times-weekly once-weekly and every-2-weeks groups will be 50 IUkg 10000 IU and 20000 IU respectively thereafter adjusted according to weekly hemoglobin concentrations Safety evaluations will include assessment of adverse events laboratory tests physical examinations and vital signs
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 |
|---|---|---|---|
| EPOAKD3001 | OTHER | Johnson Johnson Pharmaceutical Research and Development LLC | None |