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

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

Conditions

• Hemodialysis
• Anemia in End Stage Renal Disease

Interventions

OTHER

RET-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

OTHER

TSAT-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

OTHER

Common

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 & Collaborators

• Sysmex Asia Pacific

  collaborator INDUSTRY

• Center of Excellence for Metabolic Bone Disease in CKD patients, Faculty of Medicine, Chulalongkorn University

  collaborator UNKNOWN

• King Chulalongkorn Memorial Hospital

  lead OTHER

Principal Investigators

• Paweena Susantitaphong M.D, Ph.D. · Center of Excellence for Metabolic Bone Disease in CKD patients, Chulalongkorn University

• Jeerath Phannajit M.D. · Division of Clinical Epidemiology, Department of Medicine, King Chulalongkorn Memorial Hospital, Thai Red Cross

• Chalermchon Suttaluang M.D. · Division of Nephrology, Department of Medicine, King Chulalongkorn Memorial Hospital

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

18 Years

Max Age

80 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2025-01-31

Primary Completion

2025-08-31

Completion

2025-09-30

Countries

• Thailand