RecruitingNot ApplicableNCT06906835

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

Sponsor

King Chulalongkorn Memorial Hospital

Enrollment

160 participants

Start Date

Jan 31, 2025

Study Type

INTERVENTIONAL

Conditions

Hemodialysis Anemia in End Stage Renal Disease

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

Eligibility

Min Age: 18 YearsMax Age: 80 Years

Inclusion Criteria4

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 Criteria6

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

Interested in this trial?

Get notified about updates and connect with the research team.

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.