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Benefit of Intravenous iron supplement on anemia and erythropoietin dose in chronic hemodialysis patients

Benefit of Intravenous iron supplement on anemia and erythropoietin dose in chronic hemodialysis patients

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
TCTR
Registry ID
TCTR20180903003
Enrollment
Unknown
Registered
2018-09-03
Start date
2014-10-10
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

PATIENTS END STAGE CHRONIC KIDNEY DISEASE ON DIALYSIS iron deficiency&#44

Interventions

Open Label Study to compare the efficacy and safety of intravenous iron supplement between Group A (low ferritin) and Group B (high ferritin) for functional iron deficiency among chronic hemodialysis
400 ng/mL The subjects was follow up and adjust treatment by Feritin level every 3 month (Day 0 &#44
Day 90&#44
Day 180) according to the condition. If Ferritin 200 ng/mL: iron 100 mg iv q 4 week until 3 months ,Open Label Study to compare the efficacy and safety of intravenous iron supplement between Group
700 ng/mL The subjects was follow up and adjust treatment by Feritin level every 3 month (Day 0 &#44
Day 180) according to the condition. If Ferritin 600 ng/mL: iron 100 mg iv q 2 week until 3 months
Active Comparator Drug,Active Comparator Drug
IRON supplement (A), IRON supplement (B)

Sponsors

็Health Systems Research Intitute
Lead Sponsor
Chulalongkorn University
Collaborator

Eligibility

Sex/Gender
All
Age
18 Years to 75 Years

Inclusion criteria

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&#45;400 ng/mL and transferrin saturation < 30 % 5.Hemoglobin 8&#45;12 g/dL

Exclusion criteria

Exclusion criteria: 1.Active gastrointestinal bleeding 2.Receive blood transfusion during follow up 3.Active infection 4.Iron allergy

Design outcomes

Primary

MeasureTime frame
Erythropoietin index 8 months (run&#45;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

MeasureTime frame
High sensitivity C reactive protein (hs&#45;CRP) 8 months (run&#45;in: 8 weeks + evaluation: 6 months) hs&#45;CRP at screening (before treatment ) and run&#45;in: 8 weeks and 6 months,Fibroblast growth factor&#45;23 (FGF&#45;23) 8 months (run&#45;in: 8 weeks + evaluation: 6 months) FGF&#45;23 at screening and run&#45;in: 8 weeks and 6 months—

Countries

Thailand

Contacts

Public ContactAssoc.Prof.Paweena Susantitaphong

Division of Nephrology Department of Medicine Chulalongkorn University

pesancerinus@hotmail.com022564251

Outcome results

None listed

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