Optimizing Iron Repletion in Hemodiafiltration : A Randomized Controlled Trial of Two Target Strategies.

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

TCTR

Registry ID

TCTR20260405011

Enrollment

Registered

2026-04-05

Start date

2026-04-13

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 Renal Disease Anemia Iron Deficiency Hemodiafiltration End Stage Renal Disease Anemia Iron Deficiency Hemodiafiltration Intravenous Iron Erythropoiesis Stimulating Agents Ferritin Transferrin Saturation

Interventions

Intravenous iron is given 100 mg every 4 weeks in maintenance online hemodiafiltration patients .Iron is withheld at the conventional ferritin and transferrin saturation target ,Intravenous iron is gi

Experimental Drug,Experimental Drug

Conventional target,High target

Eligibility

Sex/Gender

All

Age

18 Years to 100 Years

Inclusion criteria

Inclusion criteria: Adults aged 18 years or older Receiving maintenance online hemodiafiltration for at least 3 months Ferritin less than 500 ng per mL TSAT less than 30 percent Able to provide informed consent and complete 12 months follow up

Exclusion criteria

Exclusion criteria: Severe infection Severe bleeding Hematologic malignancy Hypersensitivity to intravenous iron Pregnancy or breastfeeding

Design outcomes

Primary

Measure	Time frame
Monthly ESA dose 12 months Monthly dose of erythropoiesis stimulating agent	—

Secondary

Measure	Time frame
Cumulative intravenous iron dose 12 months Total intravenous iron dose administered during follow up,Change in hemoglobin 12 months Change in blood hemoglobin level from baseline,Change in iron parameters 12 months Change in ferritin and transferrin saturation from baseline, Blood transfusion 12 months Need for blood transfusion,Infection 12 months Incidence of infection,Vascular access thrombosis 12 months Incidence of vascular access thrombosis,Hospitalization 12 months Hospitalization for any cause or infection,Cardiovascular events 12 months ncidence of nonfatal myocardial infarction nonfatal stroke or hospitalization for heart failure,Death 12 months All cause mortality	—

Measure

Time frame

Cumulative intravenous iron dose 12 months Total intravenous iron dose administered during follow up,Change in hemoglobin 12 months Change in blood hemoglobin level from baseline,Change in iron parameters 12 months Change in ferritin and transferrin saturation from baseline, Blood transfusion 12 months Need for blood transfusion,Infection 12 months Incidence of infection,Vascular access thrombosis 12 months Incidence of vascular access thrombosis,Hospitalization 12 months Hospitalization for any cause or infection,Cardiovascular events 12 months ncidence of nonfatal myocardial infarction nonfatal stroke or hospitalization for heart failure,Death 12 months All cause mortality

—

Countries

Thailand

Contacts

Public ContactSasiwimon Tangwannawibonn

Thammasat university

sasiwi.tang@gmail.com0804820500

Outcome results

None listed

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