Efficacy of Reticulocyte Hemoglobin Equivalent-guided Versus Transferrin Saturation-guided Iron Supplement Protocol in Hemodialysis Patients: A Cluster Randomized Controlled Trial

Status: Recruiting
Location: See location...
Intervention Type: Other
Study Type: Interventional
Study Phase: Not Applicable
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
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 80
Healthy Volunteers: f
View:

• 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

Locations
Other Locations
Thailand
King Chulalongkorn Memorial Hospital
RECRUITING
Pathumwan
Contact Information
Primary
Jeerath Jeerath Phannajit M.D.
jeerath.p@chula.ac.th
+6622564000
Backup
Chalermchon Suttaluang M.D.
chonharrychon@gmail.com
Time Frame
Start Date: 2025-01-31
Estimated Completion Date: 2025-09-30
Participants
Target number of participants: 160
Treatments
Experimental: RET-He-Guided Iron Supplementation
Participants in this arm will receive intravenous (IV) iron therapy guided by reticulocyte hemoglobin equivalent (RET-He) levels.
Active_comparator: TSAT-Guided Iron Supplementation
Participants in this arm will receive IV iron therapy guided by transferrin saturation (TSAT) and serum ferritin.
Related Therapeutic Areas
Sponsors
Collaborators: Sysmex Asia Pacific, Center of Excellence for Metabolic Bone Disease in CKD patients, Faculty of Medicine, Chulalongkorn University
Leads: King Chulalongkorn Memorial Hospital

This content was sourced from clinicaltrials.gov