Anemia in End Stage Renal Disease, Hemodialysis
Conditions
Keywords
Reticulocyte hemoglobin equivalent, Transferrin Saturation, Intravenous Iron Supplementation, Anemia in End Stage Renal Disease, Hemodialysis
Brief summary
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
Interventions
OTHERRET-He-Guided Iron Supplementation
Participants 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
OTHERTSAT-Guided Iron Supplementation
Participants 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
OTHERCommon
All participants will receive erythropoiesis-stimulating agents (ESAs) according to a standardized dose adjustment protocol based on hemoglobin levels. Oral iron supplements will be discontinued.
Sponsors
Sysmex Asia Pacific
Center of Excellence for Metabolic Bone Disease in CKD patients, Faculty of Medicine, Chulalongkorn University
King Chulalongkorn Memorial Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
Cluster randomization
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
* 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
Exclusion criteria
* 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 * History of active heart failure and recent myocardial infarction /stroke in past 6 months * History of GI or external bleeding or receiving blood transfusion in past 6 months
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Erythropoietin resistance index (ERI) [non-inferiority] | 6 months | 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| All cause death | 6 months | — |
| Cardiovascular events | 6 months | includes fatal and non-fatal acute coronary syndrome, stroke, and heart failure. |
| Blood Transfusions | 6 months | Indication of blood transfusion will be decided by attending physicians for symptomatic anemia. |
| Hospitalizations | 6 months | all non-elective admissions will be counted |
| Incidence of infection | 6 months | — |
Countries
Thailand
Contacts
Primary ContactJeerath Jeerath Phannajit M.D.
Backup ContactChalermchon Suttaluang M.D.
Outcome results
None listed