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

NARecruitingINTERVENTIONAL
Enrollment

160

Participants

Timeline

Start Date

January 31, 2025

Primary Completion Date

August 31, 2025

Study Completion Date

September 30, 2025

Conditions
HemodialysisAnemia in End Stage Renal Disease
Interventions
OTHER

RET-He-Guided Iron Supplementation

"Participants in this arm will receive intravenous (IV) iron therapy guided by reticulocyte hemoglobin equivalent (RET-He) levels.~Iron dosing will follow a protocol based on RET-He values:~* RET-He \< 26 pg: IV iron 100 mg weekly~* RET-He ≥ 26 pg and \< 30 pg: IV iron 100 mg every 2 weeks~* RET-He ≥ 30 pg and ≤ 36 pg: IV iron 100 mg every 4 weeks~* RET-He \> 36 pg or ferritin ≥ 800 ng/mL: Discontinue iron supplementation to prevent iron overload"

OTHER

TSAT-Guided Iron Supplementation

"Participants in this arm will receive IV iron therapy guided by transferrin saturation (TSAT) and serum ferritin, as per the Thai Clinical Practice Guidelines for Anemia in CKD (2021).~Iron dosing will follow this TSAT-based protocol:~* TSAT \< 30% and ferritin \< 200 ng/mL: IV iron 100 mg weekly~* TSAT \< 30% and ferritin 200-500 ng/mL: IV iron 100 mg every 2 weeks~* TSAT \< 30% and ferritin 500-800 ng/mL or TSAT 30-40%: IV iron 100 mg every 4 weeks~* TSAT ≥ 40% or ferritin ≥ 800 ng/mL: Discontinue iron supplementation"

OTHER

Common

"All participants will receive erythropoiesis-stimulating agents (ESAs) according to a standardized dose adjustment protocol based on hemoglobin levels.~Oral iron supplements will be discontinued."

Trial Locations (1)

10330

RECRUITING

King Chulalongkorn Memorial Hospital, Pathumwan

All Listed Sponsors
collaborator

Sysmex Asia Pacific

INDUSTRY

collaborator

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

UNKNOWN

lead

King Chulalongkorn Memorial Hospital

OTHER