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

Not Applicable

Recruiting

• Conditions: Hemodialysis; Anemia in End Stage Renal Disease

• Registration Number: NCT06906835
• Lead Sponsor: King Chulalongkorn Memorial Hospital

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

Detailed Description

Not available

Study Timeline

• Study Start: 2025-01-31
• Study First Submitted: 2025-03-26
• Study First Submitted QC: 2025-03-26
• Status Verified: 2025-04
• Last Update Submitted: 2025-04-01
• Study First Posted: 2025-04-02
• Last Update Posted: 2025-04-04
• Primary Completion: 2025-08-31
• Study Completion: 2025-09-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 160

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Erythropoietin resistance index (ERI) [non-inferiority]	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 Outcome Measures

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

Trial Locations

Locations (1)

King Chulalongkorn Memorial Hospital; 🇹🇭 Pathumwan, Bangkok, Thailand