Iron Deficiency in CKD Without Concomitant Anemia.
Jay B Wish, Stefan D Anker, Javed Butler...
https://pubmed.ncbi.nlm.nih.gov/34805628/Actively Recruiting
Led by King Chulalongkorn Memorial Hospital · Updated on 2025-04-04
160
Participants Needed
1
Research Sites
4 weeks
Total Duration
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.
CONDITIONS
Comparing Reticulocyte Hemoglobin and Transferrin Saturation to Guide Iron Treatment in People on Dialysis
J
Jeerath Jeerath Phannajit M.D.
C
Chalermchon Suttaluang M.D.
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King Chulalongkorn Memorial Hospital
Lead Sponsor
Sysmex Asia Pacific
Collaborating Sponsor
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Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 6 months
Participants receive intravenous iron therapy guided by either reticulocyte hemoglobin equivalent or transferrin saturation levels. Iron dosing varies based on specific biomarker thresholds. All participants also receive erythropoiesis-stimulating agents with dose adjustments based on hemoglobin levels. Oral iron supplements are discontinued during this period.
Regular visits as per dialysis and treatment protocol
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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Lead Sponsor
Sysmex Asia Pacific
Collaborating Sponsor