Actively Recruiting

Phase Not Applicable
Age: 18Years - 80Years
All Genders
NCT06906835

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

Led by King Chulalongkorn Memorial Hospital · Updated on 2025-04-04

160

Participants Needed

1

Research Sites

34 weeks

Total Duration

On this page

Sponsors

K

King Chulalongkorn Memorial Hospital

Lead Sponsor

S

Sysmex Asia Pacific

Collaborating Sponsor

AI-Summary

What this Trial Is About

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

Official Title

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

Who Can Participate

Age: 18Years - 80Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Adult aged 18 to 80 years
  • End-stage kidney disease on chronic hemodialysis for at least 6 months
  • Receiving erythropoietin therapy for at least 6 months
  • Hemoglobin less than 13.0 g/dL for males or less than 12.0 g/dL for females
Not Eligible

You will not qualify if you...

  • Serum ferritin greater than 800 ng/mL or transferrin saturation greater than 40%
  • Active infection or malignancy
  • Hematologic diseases such as thalassemia major, hemolysis, myelofibrosis, or myelodysplastic disease
  • Use of marrow suppressive or immunosuppressive medications within the past 6 months
  • History of active heart failure or recent myocardial infarction or stroke within the past 6 months
  • History of gastrointestinal or external bleeding or blood transfusion within the past 6 months

AI-Screening

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Trial Site Locations

Total: 1 location

1

King Chulalongkorn Memorial Hospital

Pathumwan, Bangkok, Thailand, 10330

Actively Recruiting

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Research Team

J

Jeerath Jeerath Phannajit M.D.

CONTACT

C

Chalermchon Suttaluang M.D.

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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