NCT06906835Recruiting
Comparing Reticulocyte Hemoglobin and Transferrin Saturation to Guide Iron Treatment in People on Dialysis
Efficacy of Reticulocyte Hemoglobin Equivalent-guided Versus Transferrin Saturation-guided Iron Supplement Protocol in Hemodialysis Patients: A Cluster Randomized Controlled Trial
Source: ClinicalTrials.gov · Last updated 4 Apr 2025 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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
- Status (registry)
- Recruiting
- Study type
- Interventional
- Enrollment
- 160 (estimated)
- First submitted
- 26 Mar 2025
- Start date
- 31 Jan 2025
- Primary completion date
- 31 Aug 2025
- Lead sponsor
- King Chulalongkorn Memorial Hospital
- Diseases
- Chronic kidney disease
- NCT number
- NCT06906835
What you commit to
- Study type: Interventional
- Planned participants: 160
- From 31 Jan 2025 to the primary completion date, 31 Aug 2025
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- History of GI or external bleeding or receiving blood transfusion in past 6 months
Other illness
- 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
Lab values
- Serum ferritin \> 800 ng/mL or TSAT \> 40%
Who the study is looking for
- 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
Age in the registry: 18 years to 80 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| King Chulalongkorn Memorial Hospital Coordinator of this site? Confirm its status | Pathumwan | Thailand | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.