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A Randomized Controlled Trial Comparing the Withholding Rates of Maintenance Intravenous Iron Administration between 100 mg every 2 weeks and 200 mg every 4 weeks in Hemodialysis Patients with Absolute Iron Deficiency

A Randomized Controlled Trial Comparing the Withholding Rates of Maintenance Intravenous Iron Administration between 100 mg every 2 weeks and 200 mg every 4 weeks in Hemodialysis Patients with Absolute Iron Deficiency

Status
Recruiting
Phases
Phase 2
Study type
Interventional
Source
TCTR
Registry ID
TCTR20251231008
Enrollment
60
Registered
2025-12-31
Start date
2025-12-01
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

End-stage kidney disease on maintenance hemodialysis

Interventions

Intravenous iv iron 200 mg post Hemodialysis session every 4 wks,Intravenous iv iron 100 mg post Hemodialysis session every 2 wks
Experimental Drug,Experimental Drug
Iron iv 200 mg q 4 wks,Iron iv 100 mg q 2 wks

Sponsors

King Taksin Memorial Hospital Research Grant
Lead Sponsor

Eligibility

Sex/Gender
All
Age
20 Years to 74 Years

Inclusion criteria

Inclusion criteria: 1. Aged over 20 years who have been receiving hemodialysis more than 3 months. 2. not responded to oral iron therapy for 3 months. 3. History of absolute iron deficiency and have completed an intravenous iron loading dose of 1,000 mg and continued maintenance dose 100 mg every 4 weeks for no more than 4 months. Before enrollment, hemoglobin level more than 9 g/dL. 4. Serum ferritin levels between 200 to 800 ng/mL and TSAT between 20 to 40%. 5. Patient provide written informed consent and voluntarily participate in the study.

Exclusion criteria

Exclusion criteria: 1. History of blood loss or received blood transfusion within 4 months prior to enrollment. 2. Anemia from other causes. 3. Cancer who are currently receiving treatment. 4. Active infection. 5. Pregnant or breastfeeding patients.

Design outcomes

Primary

MeasureTime frame
Iron overload every 3 month Ferritin more than 800 ng/mL , TSAT more than 40%

Secondary

MeasureTime frame
EPO dose , mortality rate , Hb level , cardiovascular mortality, infection-related events , vascular access thrombosis every 3 months patient record form

Countries

Thailand

Contacts

Public ContactOran Chalapipat

Nephrology Outpatient Clinic , Taksin Hospital

chalapipat@yahoo.com024370123

Outcome results

None listed

Source: TCTR (via WHO ICTRP) · Data processed: Aug 10, 2026