Comparing Reticulocyte Hemoglobin and Transferrin Saturation to Guide Iron Treatment in People on… (NCT06906835) | Clinical Trial Compass
RecruitingNot Applicable
Comparing Reticulocyte Hemoglobin and Transferrin Saturation to Guide Iron Treatment in People on Dialysis
Thailand160 participantsStarted 2025-01-31
Plain-language 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
Who can participate
Age range
18 Years – 80 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Erythropoietin resistance index (ERI) [non-inferiority]