Clinical trial NCT06906835: Comparing Reticulocyte Hemoglobin and Transferrin Saturation to Guide Iron Treatment in People on Dialysis
Official title: Efficacy of Reticulocyte Hemoglobin Equivalent-guided Versus Transferrin Saturation-guided Iron Supplement Protocol in Hemodialysis Patients: A Cluster Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Hemodialysis
Anemia in End Stage Renal Disease
Keywords: Reticulocyte hemoglobin equivalent
Transferrin Saturation
Intravenous Iron Supplementation
Anemia in End Stage Renal Disease
Hemodialysis
Lead sponsor: King Chulalongkorn Memorial Hospital
Sponsor class: OTHER
Collaborators: name: Sysmex Asia Pacific
name: Center of Excellence for Metabolic Bone Disease in CKD patients, Faculty of Medicine, Chulalongkorn University
First posted: 2025-04-02
Enrollment: 160
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Cluster randomization
Primary purpose: TREATMENT

Brief summary: 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


Eligibility criteria: Inclusion Criteria:

* Adult (age 18-80 years)
* 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:

* Serum ferritin \> 800 ng/mL or TSAT \> 40%
* 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

Primary outcomes:
measure: Erythropoietin resistance index (ERI) [non-inferiority]
timeFrame: 6 months
Secondary outcomes:
measure: All cause death
timeFrame: 6 months
measure: Cardiovascular events
timeFrame: 6 months
measure: Blood Transfusions
timeFrame: 6 months
measure: Hospitalizations
timeFrame: 6 months
measure: Incidence of infection
timeFrame: 6 months
Other outcomes:
Locations:
city: Pathumwan
country: Thailand
facility: King Chulalongkorn Memorial Hospital
state: Bangkok
Study officials:
affiliation: Center of Excellence for Metabolic Bone Disease in CKD patients, Chulalongkorn University
name: Paweena Susantitaphong M.D, Ph.D.
role: STUDY_CHAIR
affiliation: Division of Clinical Epidemiology, Department of Medicine, King Chulalongkorn Memorial Hospital, Thai Red Cross
name: Jeerath Phannajit M.D.
role: STUDY_DIRECTOR
affiliation: Division of Nephrology, Department of Medicine, King Chulalongkorn Memorial Hospital
name: Chalermchon Suttaluang M.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.