Ignite Creation Date:
2025-12-24 @ 5:08 PM
Ignite Modification Date:
2025-12-30 @ 9:12 AM
Study NCT ID:
NCT04464850
Status:
UNKNOWN
Last Update Posted:
2020-08-11
First Post:
2020-07-06
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Intravenous Versus Oral Iron Therapy in Hemodialysis Patients
Sponsor:
Chiang Mai University
Organization:
Study Overview
Official Title:
Effects Intravenous Iron and Oral Iron Therapy on Erythropoietin Dose in Maintenance Hemodialysis Patients: An Open-label, Randomized, Controlled Study
Status:
UNKNOWN
Status Verified Date:
2020-08
Last Known Status:
RECRUITING
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:
IVO-IRON
Brief Summary:
This study is aim to compare the efficacy of intravenous versus oral iron therapy regarding the hemoglobin levels, iron status and erythropoietin dosage in maintenance hemodialysis patients
Detailed Description:
Run-in phase: All eligible patients will enter run-in phase for 2 weeks. In this phase, all oral therapy that patients received before enrolment into the study will be discontinued.
Masking: Opened label
Allocation: Block of four randomization into 2 treatment arms: intravenous iron and oral iron
Safety criteria: Study participants who meet the following criteria will be discontinued from the study. All patients data will be analyzed according to intention-to-treat principles.
* Hemoglobin levels \< 6.0 g/dl
* Packed red cells transfusion is required
* Serum ferritin \>1,000 md/dl
Masking: Opened label
Allocation: Block of four randomization into 2 treatment arms: intravenous iron and oral iron
Safety criteria: Study participants who meet the following criteria will be discontinued from the study. All patients data will be analyzed according to intention-to-treat principles.
* Hemoglobin levels \< 6.0 g/dl
* Packed red cells transfusion is required
* Serum ferritin \>1,000 md/dl
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: