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NCT Number: NCT06906835

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

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

Recruiting

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Key information

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

King Chulalongkorn Memorial Hospital

Pathumwan, Bangkok, 10330, Thailand

Location status: Recruiting

Location contact

Chalermchon Suttaluang

PRINCIPAL_INVESTIGATOR

Jeerath Phannajit M.D.

CONTACT

[email protected]

6622564000 ext. 80901

Jeerath Phannajit M.D.

SUB_INVESTIGATOR

Paweena Susantitaphong M.D., Ph.D.

SUB_INVESTIGATOR

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

RET-He-Guided Iron Supplementation

Other

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

TSAT-Guided Iron Supplementation

Other

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

Common

Other

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.

Primary outcomes

  1. Erythropoietin resistance index (ERI) [non-inferiority]

    Time frame: 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 outcomes

  1. All cause death

    Time frame: 6 months

  2. Cardiovascular events

    Time frame: 6 months

    includes fatal and non-fatal acute coronary syndrome, stroke, and heart failure.

  3. Blood Transfusions

    Time frame: 6 months

    Indication of blood transfusion will be decided by attending physicians for symptomatic anemia.

  4. Hospitalizations

    Time frame: 6 months

    all non-elective admissions will be counted

  5. Incidence of infection

    Time frame: 6 months

Study contacts

Contact information is provided by the study sponsor or research team.

Chalermchon Suttaluang M.D.

CONTACT

[email protected]

Jeerath Jeerath Phannajit M.D.

CONTACT

[email protected]

+6622564000 ext. 80901

Sponsors and collaborators

Lead sponsor

King Chulalongkorn Memorial Hospital

Other

Collaborators

  • Chulalongkorn University
  • Sysmex Asia Pacific

Registry information

Official study title

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

Important dates

Study start
2025
Primary completion
2025
Study completion
2025
First posted
Apr 2, 2025
Registry last updated
Apr 4, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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