NCT06906835 Comparing Reticulocyte Hemoglobin and Transferrin Saturation to Guide Iron Treatment in People on Dialysis
| NCT ID | NCT06906835 |
| Status | Recruiting |
| Phase | — |
| Sponsor | King Chulalongkorn Memorial Hospital |
| Condition | Hemodialysis |
| Study Type | INTERVENTIONAL |
| Enrollment | 160 participants |
| Start Date | 2025-01-31 |
| Primary Completion | 2025-08-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 160 participants in total. It began in 2025-01-31 with a primary completion date of 2025-08-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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
Eligibility Criteria
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
Contact & Investigator
Paweena Susantitaphong M.D, Ph.D.
STUDY CHAIR
Center of Excellence for Metabolic Bone Disease in CKD patients, Chulalongkorn University
Frequently Asked Questions
Who can join the NCT06906835 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 80 Years, studying Hemodialysis. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06906835 currently recruiting?
Yes, NCT06906835 is actively recruiting participants. Contact the research team at jeerath.p@chula.ac.th for enrollment information.
Where is the NCT06906835 trial being conducted?
This trial is being conducted at Pathumwan, Thailand.
Who is sponsoring the NCT06906835 clinical trial?
NCT06906835 is sponsored by King Chulalongkorn Memorial Hospital. The principal investigator is Paweena Susantitaphong M.D, Ph.D. at Center of Excellence for Metabolic Bone Disease in CKD patients, Chulalongkorn University. The trial plans to enroll 160 participants.