Ignite Creation Date:
2025-12-24 @ 11:39 PM
Ignite Modification Date:
2025-12-25 @ 9:29 PM
Study NCT ID:
NCT00236951
Status:
COMPLETED
Last Update Posted:
2018-02-20
First Post:
2005-10-10
Is NOT Gene Therapy:
False
Has Adverse Events:
True
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:
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:
Is a FDA Regulated Drug?:
Is a FDA Regulated Device?:
Is an Unapproved Device?:
Is a PPSD?:
Is a US Export?:
Is an FDA AA801 Violation?: