Maintenance intravenous iron in hemodialysis patients to minimize erythropoietin doses: A double-blinded, randomized controlled trial
Phase 3
Completed
- Conditions
- Maintenance hemodialysis patients with no iron deficiency anemiaHemodialysisIron deficiency anemiaIntravenous iron sucroseErythropoietin-stimulating agent
- Registration Number
- TCTR20190707001
- Lead Sponsor
- The Kidney Foundation of Thailand
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- All
- Target Recruitment
- 72
Inclusion Criteria
1. Maintenance hemodialysis patients
2. No problem of iron deficiency anemia
3. Hemoglobin more than 9 mg/dL
4. On erythropoietin-stimulating agent
Exclusion Criteria
1. Life expectancy less than 12 months
2. Trend to Kidney transplant within 12 month
3. Active infection
4. Active malignancy
5. Patient with chronic liver disease
6. Patient with hematologic disease
7. Pregnancy or breast feeding
8. Iron sucrose allergy
9. Hearth failure
10. Hepatitis B,C and HIV infection
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Mean monthly dose of erythropoietin-stimulating agent Dose of erythropoietin-stimulating agent (unit) at 12 months Review dose of Erythropoietin-stimulating agent from opd card
- Secondary Outcome Measures
Name Time Method umber of patient with iron deficiency anemia Number of patients at 12 months Blood for hemoglobin, hematocrit and iron study ,The change of hemoglobin level, hematocrit Hemoglobin level (g/dL) at 12 months Blood for hemoglobin, hematocrit,Mortality rate Number of death at 12 months Review opd card,Side effect of intravenous iron sucrose Number of side effect at 12 months Interview during drug administration ,Quality of life Quality of life (unit) at 12 months Questionair ,Hospitalization Number of hospitalization at 12 months Review opd card,Withholding rate 0-12 month Review opd card