Ignite Creation Date:
2024-05-05 @ 5:22 PM
Last Modification Date:
2024-10-26 @ 9:31 AM
Study NCT ID:
NCT00440466
Status:
COMPLETED
Last Update Posted:
2014-04-21
First Post:
2007-02-26
Brief Title:
PROCRIT Extended Dosing For Maintenance of Hemoglobin in Pre-Dialysis CKD Patients
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-every-two-weeks and Once-every-four-weeks With the Once-weekly Dosing Regimen for 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 every-2-weeks and once every-4-weeks treatment with epoetin alfa a drug that increases red blood cell production in patients with anemia associated with chronic kidney disease is not less effective than treatment with epoetin alfa that is given once a week
Detailed Description:
A consequence of chronic kidney disease is anemia due to decreased production of erythropoietin Anemia is associated with decreased oxygen delivery and utilization and can result in fatigue lethargy decreased cognition and mental acuity and cardiac complicationsThis study was designed to compare 2 dosing regimens once every-2-weeks and once every-4-weeks with the once-weekly dosing regimen Men and women who are diagnosed with anemia associated with chronic kidney disease will participate in this study Approximately 400 patients will be included This is a randomized patients are assigned different treatments based on chance open-label multicenter study of epoetin alfa in patients who are not on dialysis and who are already maintaining anemia with epoetin alfa administered once weekly The study is 40 to 42 weeks in duration All eligible patients will be treated with epoetin alfa according to one of the following 3 regimens once-a-week injection Group 1 or once every-2-weeks injection Group 2 or once every-4-weeks injection Group 3 The maximum volume per injection will not be more than 1 mL therefore some patients may receive more than one injection per dose The study treatment includes a period to convert to the new dosing regimen and a subsequent stable maintenance treatment period After the initial dose hemoglobin will be measured on a weekly basis and used to determine adjustments in dose for each patient The primary hypothesis is that the average change in hemoglobin level in the groups that received epoetin alfa once every 2 weeks or once every 4 weeks is not lower than the change in hemoglobin level in the group that received epoetin alfa only once a week Adverse events will be monitored throughout the study Clinical laboratory examinations vital signs and physical examinations will be conducted routinely to ensure patient safety Approximately 1 mL of epoetin alfa will be injected under the skin either once a week once every 2 weeks or once every 4 weeks maximum doses of 20000 IU once a week 40 000 IU every 2 weeks or 80000 IU every 4 weeks respectively for up to 36 weeks of treatment
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 |
|---|---|---|---|
| EPOAKD3002 | None | None | None |