Ignite Creation Date:
2025-12-24 @ 2:17 PM
Ignite Modification Date:
2026-02-04 @ 6:25 AM
Study NCT ID:
NCT02198495
Status:
COMPLETED
Last Update Posted:
2020-09-11
First Post:
2014-07-18
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Comparison Study of Two Iron Compounds for Treatment of Anemia in Hemodialysis Patients
Sponsor:
Medical University of Vienna
Organization:
Study Overview
Official Title:
Continuous Versus Periodic Intravenous Iron Supplementation in Maintenance Hemodialysis Patients
Status:
COMPLETED
Status Verified Date:
2020-09
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:
COPEFER
Brief Summary:
Patients with end-stage kidney disease on maintenance hemodialysis frequently require iron supplementation to compensate for ongoing iron losses, and to maintain hemoglobin levels with or without additional use of erythropoiesis-stimulating agents (ESA).
The investigators aim to compare two different intravenous iron preparations, ferric carboxymaltose and iron sucrose in 140 hemodialysis patients. The investigators primary objective is to assess whether both agents are equally effective to maintain a target haemoglobin within 10-12 mg/dl. The investigators will also measure ferritin, transferrin, transferrin saturation, and how much ESA therapy is administered.
Patients will be randomly assigned to either treatment group and followed in parallel over an active study period of 40 weeks.
The investigators aim to compare two different intravenous iron preparations, ferric carboxymaltose and iron sucrose in 140 hemodialysis patients. The investigators primary objective is to assess whether both agents are equally effective to maintain a target haemoglobin within 10-12 mg/dl. The investigators will also measure ferritin, transferrin, transferrin saturation, and how much ESA therapy is administered.
Patients will be randomly assigned to either treatment group and followed in parallel over an active study period of 40 weeks.
Detailed Description:
None
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?: