Ignite Creation Date:
2025-12-25 @ 2:22 AM
Ignite Modification Date:
2025-12-27 @ 5:53 AM
Study NCT ID:
NCT02453334
Status:
COMPLETED
Last Update Posted:
2021-05-11
First Post:
2015-05-21
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Can Iron Lessen Anemia Due to Cancer and Chemotherapy: A Study to Investigate the Efficacy and Safety of Injectafer®
Sponsor:
American Regent, Inc.
Organization:
Study Overview
Official Title:
IRON CLAD: Can Iron Lessen Anemia Due to Cancer and Chemotherapy: A Multi-center, Randomized, Double-blinded, Controlled Study to Investigate the Efficacy and Safety of Injectafer® (Ferric Carboxymaltose Injection) in Adults
Status:
COMPLETED
Status Verified Date:
2021-05
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:
IRON CLAD
Brief Summary:
Phase III, multicenter, randomized, double-blinded, prospective study with two parallel treatment groups. Patients who present to the hematologist/oncologist and satisfy all inclusion and exclusion criteria will be eligible for participation in this 18-week study.
Detailed Description:
This is a Phase III, multicenter, randomized, double-blinded, prospective study with two parallel treatment groups. Patients who present to the hematologist/oncologist and satisfy all inclusion and exclusion criteria will be eligible for participation in this 18-week study. Subjects who meet all inclusion criteria and no exclusion criteria, will be randomized into the trial (Group A or B).
Study Oversight
Has Oversight DMC:
False
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?: