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

What this Trial Is About

This research aims to determine the best method for guiding iron treatment in adults with end-stage kidney disease (ESKD) who are on hemodialysis and have anemia. The study compares two ways to decide when to give intravenous (IV) iron: using reticulocyte hemoglobin equivalent (RET-He) versus transferrin saturation (TSAT). It also looks at how these methods might affect important outcomes like death, heart problems, hospital stays, infections, and blood transfusions. Participants will be randomly assigned to receive IV iron therapy guided by either RET-He levels or TSAT and ferritin levels. The RET-He group will have iron doses adjusted weekly, biweekly, or monthly based on specific RET-He thresholds, while the TSAT group will follow a similar schedule using TSAT and ferritin values according to Thai guidelines. All participants will also receive erythropoiesis-stimulating agents with doses adjusted based on hemoglobin levels, and oral iron supplements will be stopped. During the study, blood tests will be done at the start, 3 months, and 6 months to monitor hemoglobin, iron levels, and other health markers. Researchers will track clinical outcomes such as hospitalizations, heart events, infections, and blood transfusions. The main measure is the erythropoietin resistance index (ERI) at 6 months. The total study duration for each participant is 6 months, during which safety and treatment effects will be closely monitored.

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