Periodic Versus Continuous IV Iron Supplementation in HD Patients
Primary Purpose
Anemia of Chronic Kidney Disease
Status
Completed
Phase
Phase 4
Locations
Greece
Study Type
Interventional
Intervention
Iron Sucrose Supplement
Sponsored by
About this trial
This is an interventional supportive care trial for Anemia of Chronic Kidney Disease focused on measuring iron deficiency, hemodialysis
Eligibility Criteria
Inclusion Criteria:
- Constant rHu-EPO and iron dose for at least 2 months before starting the study
- Hemoglobin ≥ 8,5g/dl and <12,5 g/dl
- Ferritin < 1000 mg/dl
- TSAT < 50%
- CRP < 5 mg/dl
Exclusion Criteria:
- Malignant tumor disease
- Oral iron supplementation
- Active bleeding issues
- Surgical intervention within the last 8 weeks before study inclusion
Sites / Locations
- Papageorgiou General Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
continuous iv administration of iron sucrose
intermittent iv administration of iron sucrose
Arm Description
Prior to the study, all our patients were receiving intravenous iron sucrose in an intermittent mode (every 1-4 weeks).Patients on this arm will receive the same previous dose of iron glucose but in a continuous mode (smaller doses of iron sucrose in every session).
Patients on this arm will continue to receive the same previous intermittent mode of iron sucrose.
Outcomes
Primary Outcome Measures
Change of serum hemoglobin level (g/dl)
Secondary Outcome Measures
Full Information
NCT ID
NCT02787824
First Posted
May 24, 2016
Last Updated
September 19, 2017
Sponsor
Papageorgiou General Hospital
1. Study Identification
Unique Protocol Identification Number
NCT02787824
Brief Title
Periodic Versus Continuous IV Iron Supplementation in HD Patients
Official Title
Periodic Versus Continuous (at Every Session of Hemodialysis) iv Iron Supplementation in Chronic HD Patients
Study Type
Interventional
2. Study Status
Record Verification Date
May 2016
Overall Recruitment Status
Completed
Study Start Date
May 2016 (undefined)
Primary Completion Date
October 2016 (Actual)
Study Completion Date
October 2016 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Papageorgiou General Hospital
4. Oversight
5. Study Description
Brief Summary
The purpose of this study was to compare the efficacy of two regimens of intravenous iron sucrose [continuous (in every hemodialysis session) versus intermittent (every 1-4 weeks)] on the response of rHuEPO in the maintenance phase of its administration in hemodialysis patients.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Anemia of Chronic Kidney Disease
Keywords
iron deficiency, hemodialysis
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
27 (Actual)
8. Arms, Groups, and Interventions
Arm Title
continuous iv administration of iron sucrose
Arm Type
Experimental
Arm Description
Prior to the study, all our patients were receiving intravenous iron sucrose in an intermittent mode (every 1-4 weeks).Patients on this arm will receive the same previous dose of iron glucose but in a continuous mode (smaller doses of iron sucrose in every session).
Arm Title
intermittent iv administration of iron sucrose
Arm Type
Active Comparator
Arm Description
Patients on this arm will continue to receive the same previous intermittent mode of iron sucrose.
Intervention Type
Drug
Intervention Name(s)
Iron Sucrose Supplement
Primary Outcome Measure Information:
Title
Change of serum hemoglobin level (g/dl)
Time Frame
Month 0, 1, 2, 3, 4
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Constant rHu-EPO and iron dose for at least 2 months before starting the study
Hemoglobin ≥ 8,5g/dl and <12,5 g/dl
Ferritin < 1000 mg/dl
TSAT < 50%
CRP < 5 mg/dl
Exclusion Criteria:
Malignant tumor disease
Oral iron supplementation
Active bleeding issues
Surgical intervention within the last 8 weeks before study inclusion
Facility Information:
Facility Name
Papageorgiou General Hospital
City
Thessaloniki
ZIP/Postal Code
56403
Country
Greece
12. IPD Sharing Statement
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Periodic Versus Continuous IV Iron Supplementation in HD Patients
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