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

King Chulalongkorn Memorial Hospital

Status: Enrolling

Conditions: Hemodialysis; Anemia in End Stage Renal Disease

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

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT06906835

0202/67

Details and patient eligibility

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

Enrollment: 160 estimated patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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160 participants in 2 patient groups

RET-He-Guided Iron Supplementation

Experimental group

Description:

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

Treatment:

Other: Common

Other: RET-He-Guided Iron Supplementation

TSAT-Guided Iron Supplementation

Active Comparator group

Description:

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

Treatment:

Other: Common

Other: TSAT-Guided Iron Supplementation