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

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-80
SponsorKing Chulalongkorn Memorial Hospital

About this 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

Eligibility criteria

Qualifiers

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

Disqualifiers

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

Trial design

Treatments tested in this trial

  • RET-He-Guided Iron Supplementation
  • TSAT-Guided Iron Supplementation
  • Common

Treatment groups

160 Participants
are divided into 2 treatment groups

Locations

1

Map coordinates are unavailable for these locations. Locations are shown below instead.

King Chulalongkorn Memorial HospitalRecruiting10330, Pathumwan, BangkokThailandThailand

Sponsors and collaborators

King Chulalongkorn Memorial Hospital

Lead sponsor

Sysmex Asia Pacific

Collaborator

Chulalongkorn University

Collaborator