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

NCT06906835 | Recruiting

• 1 other identifier: 0202/67
• Study Type: interventional
• Target: 160
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

Reticulocyte hemoglobin equivalent; Transferrin Saturation; Intravenous Iron Supplementation; Anemia in End Stage Renal Disease; Hemodialysis

Outcome Measures

Primary Outcomes (1)

• Erythropoietin resistance index (ERI) [non-inferiority]

  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 Outcomes (5)

• All cause death

  6 months

• Cardiovascular events

  6 months

• Blood Transfusions

  6 months

• Hospitalizations

  6 months

• Incidence of infection

  6 months

Study Arms (2)

RET-He-Guided Iron Supplementation

EXPERIMENTAL

Participants in this arm will receive intravenous (IV) iron therapy guided by reticulocyte hemoglobin equivalent (RET-He) levels.

Other: RET-He-Guided Iron Supplementation; Other: Common

TSAT-Guided Iron Supplementation

ACTIVE COMPARATOR

Participants in this arm will receive IV iron therapy guided by transferrin saturation (TSAT) and serum ferritin.

Other: TSAT-Guided Iron Supplementation; Other: Common

Interventions

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

RET-He-Guided Iron Supplementation

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

TSAT-Guided 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.

RET-He-Guided Iron Supplementation; TSAT-Guided Iron Supplementation

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• King Chulalongkorn Memorial Hospital: lead
• Sysmex Asia Pacific: collaborator
• Center of Excellence for Metabolic Bone Disease in CKD patients, Faculty of Medicine, Chulalongkorn University: collaborator

Study Sites (1)

King Chulalongkorn Memorial Hospital

Pathumwan, Bangkok, 10330, Thailand

RECRUITING

Related Publications (4)

• Chinudomwong P, Binyasing A, Trongsakul R, Paisooksantivatana K. Diagnostic performance of reticulocyte hemoglobin equivalent in assessing the iron status. J Clin Lab Anal. 2020 Jun;34(6):e23225. doi: 10.1002/jcla.23225. Epub 2020 Feb 11.

  PMID: 32043622 BACKGROUND

• Susantitaphong P, Siribumrungwong M, Takkavatakarn K, Chongthanakorn K, Lieusuwan S, Katavetin P, Tiranathanagul K, Lekhyananda S, Tungsanga K, Vanichakarn S, Eiam-Ong S, Praditpornsilpa K. Effect of Maintenance Intravenous Iron Treatment on Erythropoietin Dose in Chronic Hemodialysis Patients: A Multicenter Randomized Controlled Trial. Can J Kidney Health Dis. 2020 Jun 19;7:2054358120933397. doi: 10.1177/2054358120933397. eCollection 2020.

  PMID: 32612843 BACKGROUND

• Babitt JL, Eisenga MF, Haase VH, Kshirsagar AV, Levin A, Locatelli F, Malyszko J, Swinkels DW, Tarng DC, Cheung M, Jadoul M, Winkelmayer WC, Drueke TB; Conference Participants. Controversies in optimal anemia management: conclusions from a Kidney Disease: Improving Global Outcomes (KDIGO) Conference. Kidney Int. 2021 Jun;99(6):1280-1295. doi: 10.1016/j.kint.2021.03.020. Epub 2021 Apr 8.

  PMID: 33839163 BACKGROUND

• Wish JB, Anker SD, Butler J, Cases A, Stack AG, Macdougall IC. Iron Deficiency in CKD Without Concomitant Anemia. Kidney Int Rep. 2021 Aug 10;6(11):2752-2762. doi: 10.1016/j.ekir.2021.07.032. eCollection 2021 Nov.

  PMID: 34805628 BACKGROUND

Study Officials

• Paweena Susantitaphong M.D, Ph.D.

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

  STUDY CHAIR

• Jeerath Phannajit M.D.

  Division of Clinical Epidemiology, Department of Medicine, King Chulalongkorn Memorial Hospital, Thai Red Cross

  STUDY DIRECTOR

• Chalermchon Suttaluang M.D.

  Division of Nephrology, Department of Medicine, King Chulalongkorn Memorial Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Jeerath Jeerath Phannajit M.D.

CONTACT

+6622564000; jeerath.p@chula.ac.th

Chalermchon Suttaluang M.D.

CONTACT

chonharrychon@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Chief, Division of Clinical Epidemiology, Department of Medicine

Model Details: Cluster randomization

Study Record Dates

• First Submitted: March 26, 2025
• First Posted: April 2, 2025
• Study Start: January 31, 2025
• Primary Completion: August 31, 2025
• Study Completion: September 30, 2025
• Last Updated: April 4, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP

Locations

TH (1)