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
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
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
Parallel
RET-He-Guided Iron Supplementation
Other interventionParticipants in this arm will receive intravenous (IV) iron therapy guided by reticulocyte hemoglobin equivalent (RET-He) levels. Iron dosing will follow a protocol based on RET-He values: * RET-He \< 26 pg: IV iron 100 mg weekly * RET-He ≥ 26 pg and \< 30 pg: IV iron 100 mg every 2 weeks * RET-He ≥ 30 pg and ≤ 36 pg: IV iron 100 mg every 4 weeks * RET-He \> 36 pg or ferritin ≥ 800 ng/mL: Discontinue iron supplementation to prevent iron overload
TSAT-Guided Iron Supplementation
Other interventionParticipants in this arm will receive IV iron therapy guided by transferrin saturation (TSAT) and serum ferritin, as per the Thai Clinical Practice Guidelines for Anemia in CKD (2021). Iron dosing will follow this TSAT-based protocol: * TSAT \< 30% and ferritin \< 200 ng/mL: IV iron 100 mg weekly * TSAT \< 30% and ferritin 200-500 ng/mL: IV iron 100 mg every 2 weeks * TSAT \< 30% and ferritin 500-800 ng/mL or TSAT 30-40%: IV iron 100 mg every 4 weeks * TSAT ≥ 40% or ferritin ≥ 800 ng/mL: Discontinue iron supplementation
Common
Other interventionAll participants will receive erythropoiesis-stimulating agents (ESAs) according to a standardized dose adjustment protocol based on hemoglobin levels. Oral iron supplements will be discontinued.
Erythropoietin resistance index (ERI) [non-inferiority]
The erythropoietin resistance index (ERI, Unit/week/g/dL) is calculated by dividing the weekly body-weight-adjusted epoetin dose (international units per kilogram per week) by the hemoglobin concentration (grams per deciliter) The pre-specified non-inferiority margin is 20% (approx. 160 Unit/week/g/dL) Pre-specified subgroup analysis will be conducted: Patients with and without thalassemia trait will be separately analyzed
All cause death
Cardiovascular events
includes fatal and non-fatal acute coronary syndrome, stroke, and heart failure.
Blood Transfusions
Indication of blood transfusion will be decided by attending physicians for symptomatic anemia.
Hospitalizations
all non-elective admissions will be counted
Map coordinates are unavailable for these locations. Locations are shown below instead.
ThailandClick on the lead sponsor to view all of their trials.
King Chulalongkorn Memorial Hospital
Lead sponsor
Sysmex Asia Pacific
Collaborator
Chulalongkorn University
Collaborator
