About this trial
The goal of this clinical trial is to find out which method is better for guiding iron treatment in adult patients with end-stage kidney disease (ESKD) on hemodialysis who have anemia.
The main questions it aims to answer are:
Can using reticulocyte hemoglobin equivalent (RET-He) to guide intravenous (IV) iron treatment be as effective as using transferrin saturation (TSAT)?
Does the method used to guide iron treatment affect outcomes such as death, heart problems, hospitalizations, infections, or the need for blood transfusions?
Researchers will compare RET-He-guided iron treatment with TSAT-guided iron treatment to see if RET-He works just as well and has similar or better outcomes.
Participants will:
Receive IV iron based on either RET-He or TSAT levels
Have blood tests done at the start, 3 months, and 6 months
Have their doses of iron and erythropoietin (a medication to treat anemia) adjusted based on the assigned protocol
Be monitored for clinical outcomes such as hospitalization, heart events, and infections
Eligibility criteria
Qualifiers
Adult (age 18-80 years)
ESKD on chronic hemodialysis ≥ 6 months
EPO therapy ≥ 6 months
Hb < 13.0 g/dL in male, < 12.0 g/dL in female
Disqualifiers
Serum ferritin > 800 ng/mL or TSAT > 40%
Active infection or malignancy
Hematologic disease including thalassemia major, hemolysis, myelofibrosis or myelodysplastic disease
History of marrow suppressive or immunosuppressive medications in past 6 months
Trial design
Treatments tested in this trial
- RET-He-Guided Iron Supplementation
- TSAT-Guided Iron Supplementation
- Common
Treatment groups
Locations
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Sponsors and collaborators
King Chulalongkorn Memorial Hospital
Lead sponsor
Sysmex Asia Pacific
Collaborator
Chulalongkorn University
Collaborator