Comparing Reticulocyte Hemoglobin and Transferrin Saturation to Guide Iron Treatment in People on Dialysis

Efficacy of Reticulocyte Hemoglobin Equivalent-guided Versus Transferrin Saturation-guided Iron Supplement Protocol in Hemodialysis Patients: A Cluster Randomized Controlled 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

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