HemodialysisNCT06906835
Comparing Reticulocyte Hemoglobin and Transferrin Saturation to Guide Iron Treatment in People on Dialysis
A study testing RET-He-Guided Iron Supplementation, TSAT-Guided Iron Supplementation and Common in people with Hemodialysis and Anemia in End Stage Renal Disease, run by King Chulalongkorn Memorial Hospital at 1 site in Thailand.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Hemodialysis, Anemia in End Stage Renal Disease
- What is being tested?
- RET-He-Guided Iron Supplementation, TSAT-Guided Iron Supplementation and Common
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 160 participants
- Where
- 1 siteThailand
- Study dates
- 31 Jan 2025to 30 Sep 2025
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Chalermchon Suttaluang M.D. contact
Thailand1 site, 1 recruiting
- Recruiting
King Chulalongkorn Memorial Hospital
Pathumwan, Bangkok, 10330
Jeerath Phannajit M.D., 6622564000 ext. 80901, jeerath.p@chula.ac.th
Chalermchon Suttaluang
About this study
Official title: Efficacy of Reticulocyte Hemoglobin Equivalent-guided Versus Transferrin Saturation-guided Iron Supplement Protocol in Hemodialysis Patients: A Cluster Randomized Controlled Trial
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:
Read more
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
- Conditions
- Hemodialysis, Anemia in End Stage Renal Disease
- Being tested
- RET-He-Guided Iron Supplementation, TSAT-Guided Iron Supplementation, Common
- Keywords
- Reticulocyte hemoglobin equivalent, Transferrin Saturation, Intravenous Iron Supplementation, Anemia in End Stage Renal Disease, Hemodialysis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RET-He-Guided Iron SupplementationOther
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 SupplementationOther
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
CommonOther
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.
| Study group | Role | What they receive |
|---|---|---|
| RET-He-Guided Iron Supplementation | Experimental | Participants in this arm will receive intravenous (IV) iron therapy guided by reticulocyte hemoglobin equivalent (RET-He) levels. Receives: Other: RET-He-Guided Iron Supplementation; Other: Common |
| TSAT-Guided Iron Supplementation | Active comparator | Participants in this arm will receive IV iron therapy guided by transferrin saturation (TSAT) and serum ferritin. Receives: Other: TSAT-Guided Iron Supplementation; Other: Common |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 6 months
Secondary outcomes (5)
All cause death
Measured: 6 months
Cardiovascular events
includes fatal and non-fatal acute coronary syndrome, stroke, and heart failure.
Measured: 6 months
Blood Transfusions
Indication of blood transfusion will be decided by attending physicians for symptomatic anemia.
Measured: 6 months
Hospitalizations
all non-elective admissions will be counted
Measured: 6 months
Incidence of infection
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Apr 2025
- Study start31 Jan 2025
- Primary completion31 Aug 2025 (estimated)
- Study completion30 Sep 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for HemodialysisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Cluster randomization
- Masking
- None (open label)
- Enrolment
- 160 participants (estimated)
Sponsor and investigators
- Lead sponsor
- King Chulalongkorn Memorial Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Sysmex Asia Pacific, Chulalongkorn University
- Responsible party
- Principal investigator, Jeerath Phannajit, King Chulalongkorn Memorial Hospital
- Investigators
- Paweena Susantitaphong M.D, Ph.D., Study chair, Center of Excellence for Metabolic Bone Disease in CKD patients, Chulalongkorn UniversityJeerath Phannajit M.D., Study director, Division of Clinical Epidemiology, Department of Medicine, King Chulalongkorn Memorial Hospital, Thai Red CrossChalermchon Suttaluang M.D., Principal investigator, Division of Nephrology, Department of Medicine, King Chulalongkorn Memorial Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06906835
- Sponsor's protocol ID
- 0202/67
- Status last verified
- Apr 2025
- First submitted
- 26 Mar 2025
- Last updated
- 4 Apr 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: IPD are planned to be shared with a reasonable and relevant reason, please contact investigator.
Publications
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.
PubMed 32043622Susantitaphong 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.
PubMed 32612843Babitt 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.
PubMed 33839163Wish 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.
PubMed 34805628
Study at a glance
From the registry record, last updated by the sponsor on 4 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Reticulocyte Hemoglobin Equivalent-guided Versus Transferrin Saturation-guided Iron Supplement Protocol in Hemodialysis Patients: A Cluster Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT06906835
- Acronym / sponsor ID
- 0202/67
- Conditions
- Hemodialysis, Anemia in End Stage Renal Disease
- Keywords
- Reticulocyte hemoglobin equivalent, Transferrin Saturation, Intravenous Iron Supplementation, Anemia in End Stage Renal Disease, Hemodialysis
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 160 participants (estimated)
- Lead sponsor
- King Chulalongkorn Memorial HospitalUniversity, hospital or other
- Collaborators
- Sysmex Asia Pacific, Chulalongkorn University
- Study start
- 31 Jan 2025 (actual)
- Primary completion
- 31 Aug 2025 (estimated)
- Study completion
- 30 Sep 2025 (estimated)
- First posted
- 2 Apr 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Cluster randomization
| Arm | Type | Receives |
|---|---|---|
| RET-He-Guided Iron Supplementation | Experimental | Other: RET-He-Guided Iron Supplementation, Other: CommonParticipants in this arm will receive intravenous (IV) iron therapy guided by reticulocyte hemoglobin equivalent (RET-He) levels. |
| TSAT-Guided Iron Supplementation | Active comparator | Other: TSAT-Guided Iron Supplementation, Other: CommonParticipants in this arm will receive IV iron therapy guided by transferrin saturation (TSAT) and serum ferritin. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| RET-He-Guided Iron SupplementationParticipants 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 | Other | RET-He-Guided Iron Supplementation |
| TSAT-Guided Iron SupplementationParticipants 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 | Other | TSAT-Guided Iron Supplementation |
| CommonAll participants will receive erythropoiesis-stimulating agents (ESAs) according to a standardized dose adjustment protocol based on hemoglobin levels. Oral iron supplements will be discontinued. | Other | RET-He-Guided Iron Supplementation, TSAT-Guided Iron Supplementation |
Primary outcome
Erythropoietin resistance index (ERI) [non-inferiority]
Time frame: 6 months
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
5 secondary outcomes
All cause death
Time frame: 6 months
Cardiovascular events
Time frame: 6 months
Blood Transfusions
Time frame: 6 months
Hospitalizations
Time frame: 6 months
Incidence of infection
Time frame: 6 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Apr 2025.
- Background: PubMed 32043622Chinudomwong 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.
- Background: PubMed 32612843Susantitaphong 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.
- Background: PubMed 33839163Babitt 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.
- Background: PubMed 34805628Wish 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.
- Individual participant dataSharing planned: Yes. IPD are planned to be shared with a reasonable and relevant reason, please contact investigator.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Chalermchon Suttaluang M.D. contact
Paweena Susantitaphong M.D, Ph.D. study chair
Center of Excellence for Metabolic Bone Disease in CKD patients, Chulalongkorn University
Jeerath Phannajit M.D. study director
Division of Clinical Epidemiology, Department of Medicine, King Chulalongkorn Memorial Hospital, Thai Red Cross
Chalermchon Suttaluang M.D. principal investigator
Division of Nephrology, Department of Medicine, King Chulalongkorn Memorial Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing RET-He-Guided Iron Supplementation, TSAT-Guided Iron Supplementation and Common in people with Hemodialysis and Anemia in End Stage Renal Disease, run by King Chulalongkorn Memorial Hospital at 1 site in Thailand.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 4 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Thailand. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Jeerath Jeerath Phannajit M.D. (+6622564000 ext. 80901, jeerath.p@chula.ac.th), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Erythropoietin resistance index (ERI) [non-inferiority] (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06906835, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Apr 2025.