Comparing Reticulocyte Hemoglobin and Transferrin Saturation to Guide Iron Treatment in People on Dialysis
NCT ID: NCT06906835
Last Updated: 2025-04-04
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
160 participants
INTERVENTIONAL
2025-01-31
2025-09-30
Brief Summary
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The main questions it aims to answer are:
Can using reticulocyte hemoglobin equivalent (RET-He) to guide intravenous (IV) iron treatment be as effective as using transferrin saturation (TSAT)?
Does the method used to guide iron treatment affect outcomes such as death, heart problems, hospitalizations, infections, or the need for blood transfusions?
Researchers will compare RET-He-guided iron treatment with TSAT-guided iron treatment to see if RET-He works just as well and has similar or better outcomes.
Participants will:
Receive IV iron based on either RET-He or TSAT levels
Have blood tests done at the start, 3 months, and 6 months
Have their doses of iron and erythropoietin (a medication to treat anemia) adjusted based on the assigned protocol
Be monitored for clinical outcomes such as hospitalization, heart events, and infections
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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RET-He-Guided Iron Supplementation
Participants in this arm will receive intravenous (IV) iron therapy guided by reticulocyte hemoglobin equivalent (RET-He) levels.
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
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.
TSAT-Guided Iron Supplementation
Participants in this arm will receive IV iron therapy guided by transferrin saturation (TSAT) and serum ferritin.
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.
Interventions
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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.
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
80 Years
ALL
No
Sponsors
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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
Responsible Party
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Jeerath Phannajit
Chief, Division of Clinical Epidemiology, Department of Medicine
Principal Investigators
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Paweena Susantitaphong M.D, Ph.D.
Role: STUDY_CHAIR
Center of Excellence for Metabolic Bone Disease in CKD patients, Chulalongkorn University
Jeerath Phannajit M.D.
Role: STUDY_DIRECTOR
Division of Clinical Epidemiology, Department of Medicine, King Chulalongkorn Memorial Hospital, Thai Red Cross
Chalermchon Suttaluang M.D.
Role: PRINCIPAL_INVESTIGATOR
Division of Nephrology, Department of Medicine, King Chulalongkorn Memorial Hospital
Locations
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King Chulalongkorn Memorial Hospital
Pathumwan, Bangkok, Thailand
Countries
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Central Contacts
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Facility Contacts
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References
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Chinudomwong P, Binyasing A, Trongsakul R, Paisooksantivatana K. Diagnostic performance of reticulocyte hemoglobin equivalent in assessing the iron status. J Clin Lab Anal. 2020 Jun;34(6):e23225. doi: 10.1002/jcla.23225. Epub 2020 Feb 11.
Susantitaphong P, Siribumrungwong M, Takkavatakarn K, Chongthanakorn K, Lieusuwan S, Katavetin P, Tiranathanagul K, Lekhyananda S, Tungsanga K, Vanichakarn S, Eiam-Ong S, Praditpornsilpa K. Effect of Maintenance Intravenous Iron Treatment on Erythropoietin Dose in Chronic Hemodialysis Patients: A Multicenter Randomized Controlled Trial. Can J Kidney Health Dis. 2020 Jun 19;7:2054358120933397. doi: 10.1177/2054358120933397. eCollection 2020.
Babitt JL, Eisenga MF, Haase VH, Kshirsagar AV, Levin A, Locatelli F, Malyszko J, Swinkels DW, Tarng DC, Cheung M, Jadoul M, Winkelmayer WC, Drueke TB; Conference Participants. Controversies in optimal anemia management: conclusions from a Kidney Disease: Improving Global Outcomes (KDIGO) Conference. Kidney Int. 2021 Jun;99(6):1280-1295. doi: 10.1016/j.kint.2021.03.020. Epub 2021 Apr 8.
Wish JB, Anker SD, Butler J, Cases A, Stack AG, Macdougall IC. Iron Deficiency in CKD Without Concomitant Anemia. Kidney Int Rep. 2021 Aug 10;6(11):2752-2762. doi: 10.1016/j.ekir.2021.07.032. eCollection 2021 Nov.
Other Identifiers
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0202/67
Identifier Type: -
Identifier Source: org_study_id
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