Ignite Creation Date:
2024-05-05 @ 12:03 PM
Last Modification Date:
2024-10-26 @ 9:20 AM
Study NCT ID:
NCT00236951
Status:
COMPLETED
Last Update Posted:
2018-02-20
First Post:
2005-10-10
Brief Title:
Intravenous IV Iron vs No Iron as the Treatment of Anemia in Cancer Patients Undergoing Chemotherapy and Erythropoietin Therapy
Sponsor:
American Regent Inc
Organization:
American Regent Inc
Study Overview
Official Title:
A Phase III Randomized Controlled Study Comparing Iron Sucrose Intravenously to No Iron Treatment of Anemia in Cancer Patients Undergoing Chemotherapy and Erythropoietin Therapy
Status:
COMPLETED
Status Verified Date:
2018-01
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:
To assess the change in hemoglobin levels when iron sucrose was added to a regimen of weekly fixed doses of erythropoietin in patients who had or had not responded to erythropoietin therapy alone
Detailed Description:
This was a two stage randomized controlled study of cancer patients undergoing or planning to undergo chemotherapy After stage one where patients were exposed to an erythropoiesis stimulating agent patients were randomized to receive either IV iron sucrose or no iron supplementation Patients were then followed to safety and efficacy endpoints
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