Comparing two methods to guide iron treatment in dialysis patients with anemia
Official title: Efficacy of Reticulocyte Hemoglobin Equivalent-guided Versus Transferrin Saturation-guided Iron Supplement Protocol in Hemodialysis Patients: A Cluster Randomized Controlled Trial
Run by King Chulalongkorn Memorial Hospital · NCT06906835 · Data updated 2026-11-12
This study is testing whether using a new method to guide iron treatment can help adults with kidney disease and anemia feel better compared to the standard method.
Quick facts
| Study type | Interventional |
|---|---|
| Ages | 18 Years to 80 Years |
| Sex | All |
| Enrollment | 160 (estimated) |
| Sponsor | King Chulalongkorn Memorial Hospital Academic / other |
| Locations | 1 site (Pathumwan, Bangkok) |
| Status | Recruiting |
| Started | January 31, 2025 |
| Main results expected | August 31, 2025 |
| Study ends | September 30, 2025 |
| Registry record updated | April 4, 2025 |
| Trial ID | NCT06906835 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates are adults aged 18-80 with end-stage kidney disease on chronic hemodialysis for at least 6 months and experiencing anemia.
✕Probably not a fit
Patients with serum ferritin levels above 800 ng/mL or transferrin saturation above 40% may not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This clinical trial aims to determine whether using reticulocyte hemoglobin equivalent (RET-He) is as effective as transferrin saturation (TSAT) for guiding intravenous iron treatment in adults with end-stage kidney disease (ESKD) undergoing hemodialysis and experiencing anemia. Participants will receive iron supplementation based on either RET-He or TSAT levels, with blood tests conducted at the start, 3 months, and 6 months to monitor their condition. The study will evaluate clinical outcomes such as mortality, heart problems, hospitalizations, infections, and the need for blood transfusions to assess the effectiveness of each method.
Why it matters
Potential benefit: If successful, this study could lead to improved iron treatment protocols for dialysis patients, potentially enhancing their overall health outcomes.
How similar studies have gone: Other studies have explored similar approaches, but this specific comparison of RET-He and TSAT in this patient population is novel.
Who can join: the full rules
Show full inclusion / exclusion 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
Where it's running
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King Chulalongkorn Memorial Hospital
Pathumwan, Bangkok, Thailand Recruiting
Study contacts
- Principal investigator: Chalermchon Suttaluang M.D. — Division of Nephrology, Department of Medicine, King Chulalongkorn Memorial Hospital
- Study coordinator: Jeerath Jeerath Phannajit M.D.
- Email: jeerath.p@chula.ac.th
- Phone: +6622564000
Similar studies
Other studies for the same condition or treatment. Recruiting studies are listed first.
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Nurse-led dialysis self-management program for distress in adults on hemodialysis
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-
Repeated brief limb ischemia to see its effect on blood pressure and inflammation in people with kidney disease
This study tests whether short, repeated episodes of limb ischemia can influence blood pressure, heart rate, and inflammation in adults with chronic kidney disease who may be on hemodialysis.
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A small trial tests whether a 4-week mindfulness meditation program in addition to usual care can improve sleep quality and reduce stress and symptoms in adults on hemodialysis.
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Progressive muscle relaxation to ease depression and fatigue during hemodialysis
This trial will try whether guided progressive muscle relaxation can reduce depression and fatigue in people receiving hemodialysis.
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Multispecies synbiotic in people on hemodialysis
This pilot study tests whether a multispecies synbiotic can alter gut microbes and reduce gut-derived toxins in adults on maintenance hemodialysis over 12 weeks.
How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.