160
Participants
Start Date
January 31, 2025
Primary Completion Date
August 31, 2025
Study Completion Date
September 30, 2025
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"
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"
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."
RECRUITING
King Chulalongkorn Memorial Hospital, Pathumwan
Sysmex Asia Pacific
INDUSTRY
Center of Excellence for Metabolic Bone Disease in CKD patients, Faculty of Medicine, Chulalongkorn University
UNKNOWN
King Chulalongkorn Memorial Hospital
OTHER