Benefit of Intravenous iron supplement on anemia and erythropoietin dose in chronic hemodialysis patients
Not Applicable
Active, not recruiting
- Conditions
- PATIENTS END STAGE CHRONIC KIDNEY DISEASE ON DIALYSISiron deficiency,anemia,erythropoietin dose,ferritin,transferrin saturation,hemodialysis
- Registration Number
- TCTR20180903003
- Lead Sponsor
- ็Health Systems Research Intitute
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Active, not recruiting
- Sex
- All
- Target Recruitment
- 200
Inclusion Criteria
1.Age ≥ 18 years at screening
2.Treated with maintenance hemodialysis at least 3 times a week for ≥ 3 months prior to screening
3.Informed consent provided by the study candidate
4.Functional iron deficiency defined as serum ferritin 200-400 ng/mL and transferrin saturation < 30 %
5.Hemoglobin 8-12 g/dL
Exclusion Criteria
1.Active gastrointestinal bleeding
2.Receive blood transfusion during follow up
3.Active infection
4.Iron allergy
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Erythropoietin index 8 months (run-in: 8 weeks + evaluation: 6 months) Erythropoietin dose (unit) per week divided by hemoglobin level (g/dL) at screening: 8 weeks and 6 m
- Secondary Outcome Measures
Name Time Method High sensitivity C reactive protein (hs-CRP) 8 months (run-in: 8 weeks + evaluation: 6 months) hs-CRP at screening (before treatment ) and run-in: 8 weeks and 6 months,Fibroblast growth factor-23 (FGF-23) 8 months (run-in: 8 weeks + evaluation: 6 months) FGF-23 at screening and run-in: 8 weeks and 6 months