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| Name | Class |
|---|---|
| Sysmex Asia Pacific | INDUSTRY |
| Chulalongkorn University | OTHER |
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The goal of this clinical trial is to find out which method is better for guiding iron treatment in adult patients with end-stage kidney disease (ESKD) on hemodialysis who have anemia.
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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| RET-He-Guided Iron Supplementation | Experimental | Participants in this arm will receive intravenous (IV) iron therapy guided by reticulocyte hemoglobin equivalent (RET-He) levels. |
|
| TSAT-Guided Iron Supplementation | Active Comparator | Participants in this arm will receive IV iron therapy guided by transferrin saturation (TSAT) and serum ferritin. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| RET-He-Guided Iron Supplementation | Other | 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:
|
| Measure | Description | Time Frame |
|---|---|---|
| Erythropoietin resistance index (ERI) [non-inferiority] | The erythropoietin resistance index (ERI, Unit/week/g/dL) is calculated by dividing the weekly body-weight-adjusted epoetin dose (international units per kilogram per week) by the hemoglobin concentration (grams per deciliter) The pre-specified non-inferiority margin is 20% (approx. 160 Unit/week/g/dL) Pre-specified subgroup analysis will be conducted: Patients with and without thalassemia trait will be separately analyzed | 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| All cause death | 6 months | |
| Cardiovascular events | includes fatal and non-fatal acute coronary syndrome, stroke, and heart failure. | 6 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Jeerath Jeerath Phannajit M.D. | Contact | +6622564000 | 80901 | jeerath.p@chula.ac.th |
| Chalermchon Suttaluang M.D. | Contact | chonharrychon@gmail.com |
| Name | Affiliation | Role |
|---|---|---|
| Paweena Susantitaphong M.D, Ph.D. | Center of Excellence for Metabolic Bone Disease in CKD patients, Chulalongkorn University | Study Chair |
| Jeerath Phannajit M.D. | Division of Clinical Epidemiology, Department of Medicine, King Chulalongkorn Memorial Hospital, Thai Red Cross |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| King Chulalongkorn Memorial Hospital | Recruiting | Pathumwan | Bangkok | 10330 | Thailand |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 32043622 | Background | 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. | |
| 32612843 | Background | 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. |
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IPD are planned to be shared with a reasonable and relevant reason, please contact investigator.
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Cluster randomization
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| TSAT-Guided Iron Supplementation | Other | 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:
|
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| Common | Other | 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. |
|
| Blood Transfusions | Indication of blood transfusion will be decided by attending physicians for symptomatic anemia. | 6 months |
| Hospitalizations | all non-elective admissions will be counted | 6 months |
| Incidence of infection | 6 months |
| Study Director |
| Chalermchon Suttaluang M.D. | Division of Nephrology, Department of Medicine, King Chulalongkorn Memorial Hospital | Principal Investigator |
| 33839163 | Background | 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. |
| 34805628 | Background | 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. |