Comparing two methods to guide iron treatment in dialysis patients with anemia
Efficacy of Reticulocyte Hemoglobin Equivalent-guided Versus Transferrin Saturation-guided Iron Supplement Protocol in Hemodialysis Patients: A Cluster Randomized Controlled Trial
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
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 160 (estimated) |
| Ages | 18 Years to 80 Years |
| Sex | All |
| Sponsor | King Chulalongkorn Memorial Hospital Academic / other |
| Locations | 1 site (Pathumwan, Bangkok) |
| Trial ID | NCT06906835 on ClinicalTrials.gov |
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.
Who should consider this trial
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.
Not a fit: Patients with serum ferritin levels above 800 ng/mL or transferrin saturation above 40% may not benefit from this study.
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 performed: Other studies have explored similar approaches, but this specific comparison of RET-He and TSAT in this patient population is novel.
Eligibility criteria
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 this trial is running
Pathumwan, Bangkok
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.