Maintenance intravenous iron in hemodialysis patients to minimize erythropoietin doses: A double-blinded, randomized controlled trial

Maintenance intravenous iron in hemodialysis patients: a double-blinded randomized controlled trial

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

TCTR

Registry ID

TCTR20190707001

Enrollment

Registered

2019-07-07

Start date

2019-07-01

Completion date

Unknown

Last updated

2026-08-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Maintenance hemodialysis patients with no iron deficiency anemia Hemodialysis Iron deficiency anemia Intravenous iron sucrose Erythropoietin-stimulating agent

Interventions

The patients will be prescribed 200 mg per month of iron sucrose intravenously.,The patients will be prescribed 100 mg per month of iron sucrose intravenously.

Active Comparator Drug,Active Comparator Drug

200 mg iron,100 mg iron

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Inclusion criteria

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

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

Design outcomes

Primary

Measure	Time frame
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

Measure	Time frame
Number 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	—

Measure

Time frame

Number 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

—

Countries

Thailand

Contacts

Public ContactPichaya Tantiyavarong

Faculty of Medicine, Thammasat university

pichaya_t@tu.ac.th0897711576

Outcome results

None listed

Source: TCTR (via WHO ICTRP) · Data processed: Aug 9, 2026