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

April 1, 2025 updated by: Jeerath Phannajit, King Chulalongkorn Memorial Hospital

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

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

160

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Thailand
    • Bangkok
      • Pathumwan, Bangkok, Thailand, 10330
        • Recruiting
        • King Chulalongkorn Memorial Hospital
        • Contact:
        • Contact:
          • Chalermchon Suttaluang
        • Contact:
          • Jeerath Phannajit M.D.
        • Contact:
          • Paweena Susantitaphong M.D., Ph.D.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: RET-He-Guided Iron Supplementation
Participants in this arm will receive intravenous (IV) iron therapy guided by reticulocyte hemoglobin equivalent (RET-He) levels.
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: 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.
Active Comparator: TSAT-Guided Iron Supplementation
Participants in this arm will receive IV iron therapy guided by transferrin saturation (TSAT) and serum ferritin.
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.

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
6 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Incidence of infection
Time Frame: 6 months
6 months
All cause death
Time Frame: 6 months
6 months
Cardiovascular events
Time Frame: 6 months
includes fatal and non-fatal acute coronary syndrome, stroke, and heart failure.
6 months
Blood Transfusions
Time Frame: 6 months
Indication of blood transfusion will be decided by attending physicians for symptomatic anemia.
6 months
Hospitalizations
Time Frame: 6 months
all non-elective admissions will be counted
6 months

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
(Pre-specified subgroup analyses)
Time Frame: 6 months
- Patients with and without thalassemia trait will be separately analyzed
6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

King Chulalongkorn Memorial Hospital

Collaborators

Sysmex Asia Pacific
Center of Excellence for Metabolic Bone Disease in CKD patients, Faculty of Medicine, Chulalongkorn University

Investigators

  • Study Chair: Paweena Susantitaphong M.D, Ph.D., Center of Excellence for Metabolic Bone Disease in CKD patients, Chulalongkorn University
  • Study Director: Jeerath Phannajit M.D., Division of Clinical Epidemiology, Department of Medicine, King Chulalongkorn Memorial Hospital, Thai Red Cross
  • Principal Investigator: Chalermchon Suttaluang M.D., Division of Nephrology, Department of Medicine, King Chulalongkorn Memorial Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 31, 2025

Primary Completion (Estimated)

August 31, 2025

Study Completion (Estimated)

September 30, 2025

Study Registration Dates

First Submitted

March 26, 2025

First Submitted That Met QC Criteria

March 26, 2025

First Posted (Actual)

April 2, 2025

Study Record Updates

Last Update Posted (Actual)

April 4, 2025

Last Update Submitted That Met QC Criteria

April 1, 2025

Last Verified

April 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 0202/67

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

IPD are planned to be shared with a reasonable and relevant reason, please contact investigator.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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