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Search / Trial NCT06906835

Comparing Reticulocyte Hemoglobin and Transferrin Saturation to Guide Iron Treatment in People on Dialysis

Launched by KING CHULALONGKORN MEMORIAL HOSPITAL · Mar 26, 2025

Trial Information

Current as of June 26, 2025

Recruiting

Keywords

Reticulocyte Hemoglobin Equivalent Transferrin Saturation Intravenous Iron Supplementation Anemia In End Stage Renal Disease Hemodialysis

ClinConnect Summary

This clinical trial is studying the best way to guide iron treatment for adults with end-stage kidney disease (ESKD) who are undergoing hemodialysis and have anemia. The researchers want to find out if using a specific blood test called reticulocyte hemoglobin (RET-He) to direct iron treatment is just as effective as the more traditional method, which uses transferrin saturation (TSAT). They will look at important health outcomes, like whether patients experience complications such as heart problems, infections, or the need for blood transfusions.

To be eligible for this trial, participants must be adults aged 18 to 80 who have been on hemodialysis for at least six months and have been receiving a medication called erythropoietin to treat anemia. They should have low hemoglobin levels, which is a sign of anemia. During the trial, participants will receive intravenous (IV) iron based on either their RET-He or TSAT levels, and their health will be monitored through blood tests and assessments over six months. This study aims to find the best way to manage anemia in patients on dialysis, helping to improve their overall health outcomes.

Gender

ALL

Eligibility 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

About King Chulalongkorn Memorial Hospital

King Chulalongkorn Memorial Hospital, a leading medical institution in Thailand, is renowned for its commitment to advancing healthcare through innovative research and clinical trials. Affiliated with Chulalongkorn University, the hospital integrates cutting-edge medical practices with a robust academic framework, fostering an environment conducive to pioneering clinical studies. With a focus on improving patient outcomes and contributing to global medical knowledge, the hospital engages in a diverse range of clinical trials across various therapeutic areas, ensuring adherence to the highest ethical standards and regulatory guidelines. Through collaboration with healthcare professionals and researchers, King Chulalongkorn Memorial Hospital aims to enhance the quality of care while driving forward the frontiers of medical science.

Locations

Pathumwan, Bangkok, Thailand

Patients applied

0 patients applied

Trial Officials

Paweena Susantitaphong M.D, Ph.D.

Study Chair

Center of Excellence for Metabolic Bone Disease in CKD patients, Chulalongkorn University

Jeerath Phannajit M.D.

Study Director

Division of Clinical Epidemiology, Department of Medicine, King Chulalongkorn Memorial Hospital, Thai Red Cross

Chalermchon Suttaluang M.D.

Principal Investigator

Division of Nephrology, Department of Medicine, King Chulalongkorn Memorial Hospital

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported