Chronic Kidney Disease Requiring HemodialysisPhase 2SGLT2-HDNCT06929169
Cardiovascular Effects of SGLT2 Inhibitors in Hemodialysis Patients: A Phase 2 Randomized Study
A Phase 2 study testing iSGLT2 in people with Chronic Kidney Disease Requiring Hemodialysis, run by Maximo Agustin Schiavone at 1 site in Argentina.
Trial summary
Patients with end-stage kidney disease (ESKD) on hemodialysis face an unacceptably high rate of cardiovascular complications, including heart failure, arrhythmias, and sudden cardiac death. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Chronic Kidney Disease Requiring Hemodialysis
- What is being tested?
- iSGLT2
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteArgentina
- Study dates
- May 2025to Aug 2026
- Phase
- Phase 2
- 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 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age ≥18 and ≤70 years
- Diagnosed with end-stage renal disease
- Undergoing online hemodiafiltration for at least 3 months
- Able to provide written informed consent
Who cannot join
- Current immunosuppressive therapy
- Contraindication to cardiac MRI
- Known hypersensitivity or intolerance to SGLT2 inhibitors
- Participation in another interventional clinical trial
- History of diabetic ketoacidosis
- Active substance abuse
Show all 10Show fewer
- Diagnosis of type 1 diabetes mellitus
- History of kidney transplantation
- Acute coronary event within 30 days before enrollment
- Current or recent treatment with an SGLT2 inhibitor
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Argentina1 site, 1 recruiting
- Recruiting
Fresenius Medical Care - CEMIC Saavedra
Buenos Aires, Buenos Aires, C1431FWO
Maximo A, Schiavone, MD, +5491138093510, maximoschiavone@gmail.com
Carlos E. Castellaro, MD, cecastellaro@cemic.edu.ar
About this study
Patients with end-stage kidney disease (ESKD) on hemodialysis face an unacceptably high rate of cardiovascular complications, including heart failure, arrhythmias, and sudden cardiac death. Many of these outcomes are driven by diastolic dysfunction and cardiac fibrosis-conditions that are not adequately addressed by current therapies. SGLT2 inhibitors, originally developed for the treatment of type 2 diabetes, have demonstrated cardiovascular and renal protective effects across multiple patient populations, independent of glycemic control.
This Phase 2, randomized, controlled clinical trial will evaluate the safety and efficacy of SGLT2 inhibitors in patients undergoing maintenance hemodialysis. A total of 80 participants will be randomized to receive either an SGLT2 inhibitor or standard care for 12 months. The primary objective is to determine whether SGLT2 inhibitors improve cardiac function, reduce myocardial fibrosis, and decrease the incidence of intradialytic hypotension. Secondary endpoints include cardiovascular events, hospitalization, and all-cause mortality. The study will also assess changes in key biomarkers and perform advanced cardiac imaging to evaluate structural and functional outcomes.
This trial represents a novel and timely investigation into a class of medications with promising pleiotropic effects, potentially offering new therapeutic options for a high-risk, underserved population.
Read the detailed description
This is a Phase 2, prospective, randomized, open-label, controlled study designed to assess the safety and efficacy of sodium-glucose cotransporter 2 inhibitors (SGLT2i) in patients with end-stage renal disease (ESRD) undergoing maintenance hemodialysis. Despite advances in renal replacement therapy, cardiovascular mortality remains the leading cause of death in this population, often due to heart failure with preserved ejection fraction (HFpEF), arrhythmic events, and myocardial fibrosis. Preclinical models and clinical data in non-dialysis populations suggest that SGLT2 inhibitors exert antifibrotic, anti-inflammatory, and mitochondrial-stabilizing effects that may ameliorate these pathophysiological processes.
A total of 80 eligible patients, aged 18-70 years and receiving online hemodiafiltration for at least 3 months, will be enrolled at Fresenius Medical Center - CEMIC Saavedra (Buenos Aires, Argentina). Participants will be randomized into two parallel groups (intervention vs. control) stratified by age, sex, and dialysis vintage. The intervention group will receive a once-daily SGLT2 inhibitor, while the control group will continue standard care.
Primary outcomes include the incidence and severity of intradialytic hypotension (defined by KDOQI 2020 and HEMO criteria), longitudinal changes in left ventricular mass index (LVMI), ejection fraction, myocardial fibrosis as assessed by cardiac MRI (T1/T2 mapping), and circulating pro-fibrotic biomarkers (e.g., FGF23, procollagen types I and III). Secondary endpoints include major adverse cardiovascular events (MACE), cardiovascular mortality, all-cause mortality, and cause-specific hospitalizations.
Comprehensive phenotyping will be conducted at baseline, months 3, 6, and 12. Assessments include echocardiography, cardiac MRI, 24-hour Holter monitoring, impedance cardiography, pulse wave velocity measurement, and detailed laboratory profiling. Data will be analyzed using appropriate parametric and non-parametric statistical tests, with multivariate regression and survival analysis techniques applied where relevant.
The study complies with ICH-GCP guidelines and the Declaration of Helsinki. The CEMIC institutional review board has granted ethical approval. Informed consent will be obtained from all participants prior to enrollment. The study is funded by institutional and investigator resources, with biomarker assays supported by the lead investigator through his research affiliations with CEMIC and Charité -Universitätsmedizin Berlin.
This study aims to address a critical unmet need in cardio-renal medicine and may lay the groundwork for future therapeutic strategies in dialysis-dependent patients.
- Being tested
- iSGLT2
- Keywords
- SGLT2 Inhibitors, Hemodialysis, Cardiac MRI, Ventricular Remodeling, Heart Failure with Preserved Ejection Fraction, Myocardial Fibrosis, Cardiovascular Disease, Chronic Kidney Disease
- Medical subject headings
- Ventricular Remodeling, Cardiovascular Diseases, Renal Insufficiency, Chronic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
iSGLT2Drug
Also called SGLT2 inhibitor
Participants randomized to the experimental arm will receive a once-daily dose of a sodium-glucose cotransporter 2 inhibitor (SGLT2i), administered orally, in addition to their standard hemodialysis care. The specific agent (e.g., dapagliflozin or empagliflozin) and dose will be selected based on safety data and clinical guidelines applicable to patients with end-stage renal disease (ESRD) on dialysis. The intervention will be maintained for 12 months. Dosing will be monitored by the research team to ensure tolerability and adherence. All patients in the experimental group will undergo comprehensive cardiovascular assessment, including serial cardiac MRI, echocardiography, and measurement of fibrosis-related biomarkers.
This intervention differs from standard care by introducing a pharmacologic agent not routinely administered in the dialysis population, targeting cardiac remodeling, fibrosis, and intradialytic complications.
| Study group | Role | What they receive |
|---|---|---|
| Control | No intervention | Participants in this arm will continue receiving standard hemodialysis treatment, including all routine medical care, medications, and monitoring as per institutional protocols. They will not receive an SGLT2 inhibitor. |
| Drug: iSGLT2 | Experimental | Participants in this arm will receive a sodium-glucose cotransporter 2 inhibitor (SGLT2i) once daily by oral administration, in addition to standard hemodialysis care. The specific agent (e.g., dapagliflozin or empagliflozin) and dose will be selected based on safety data and existing recommendations for patients with end-stage renal disease on dialysis. The intervention will be administered for 12 months. Participants will undergo cardiovascular monitoring, including cardiac MRI, echocardiography, and biomarker assessment at baseline, and months 3, 6, and 12. This arm is designed to evaluate the effects of SGLT2 inhibition on cardiac function, myocardial fibrosis, and intradialytic hypotension. Receives: Drug: iSGLT2 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Left Ventricular Mass Index (LVMI)
LVMI will be measured using cardiac MRI and/or echocardiography at baseline, and at months 3, 6, and 12. The primary outcome will be the change (Δ) in LVMI compared to baseline. Reductions in LVMI will be interpreted as a marker of reverse remodeling and reduced fibrosis.
Measured: Baseline, Month 3, Month 6, and Month 12
Change in Left Ventricular Ejection Fraction (LVEF)
LVEF will be measured by echocardiography at baseline and at months 3, 6, and 12. The primary outcome will be the change from baseline. Improvements will indicate enhancement in global systolic function.
Measured: Baseline, Month 3, Month 6, Month 12
Change in Myocardial Fibrosis as Assessed by Cardiac MRI
Cardiac MRI with T1/T2 mapping will be performed at baseline, and at months 3, 6, and 12. Quantitative measures of myocardial fibrosis will be compared to baseline to assess changes over time.
Measured: Baseline, Month 3, Month 6, Month 12
Change in Pro-fibrotic Biomarkers (FGF23, Procollagen I and III)
Blood levels of FGF23, procollagen type I, and procollagen type III will be measured at baseline and months 3, 6, and 12. The outcome is defined as the change from baseline. These biomarkers reflect myocardial fibrosis activity.
Measured: Baseline, Month 3, Month 6, Month 12
Incidence of Intradialytic Hypotension
Includes new or worsening heart failure, confirmed myocardial infarction, stroke, or clinically significant arrhythmia. Events will be adjudicated based on clinical criteria.
Measured: Baseline through Month 12
Secondary outcomes (4)
Major Adverse Cardiovascular Events (MACE)
Includes new or worsening heart failure, confirmed myocardial infarction, stroke, or clinically significant arrhythmia. Events will be adjudicated based on clinical criteria.
Measured: Baseline through Month 12
Cardiovascular Mortality
Deaths due to cardiovascular causes, including sudden cardiac death, will be recorded and classified according to investigator assessment and clinical documentation.
Measured: Baseline through Month 12
All-Cause Mortality
All deaths occurring during the study period will be recorded regardless of cause. Attribution (cardiac, non-cardiac, unknown) will be documented when possible.
Measured: Baseline through Month 12
Cause-Specific Hospitalizations
Hospitalizations will be recorded and categorized as cardiovascular, infectious, AV-fistula-related, or other. Events will be assessed from enrollment through study completion.
Measured: Baseline through Month 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Apr 2025
- Study startMay 2025 (estimated)
- Primary completionJul 2026 (estimated)
- Study completionAug 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Kidney Disease Requiring 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Maximo Agustin Schiavone
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Maximo Agustin Schiavone, Centro de Educación Medica e Investigaciones Clínicas Norberto Quirno
- Investigators
- Carlos E Castellaro, MD, MSc, Study director, Centro de Educación Medica e Investigaciones Clínicas Norberto Quirno
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06929169
- Sponsor's protocol ID
- PRIISA BA: 8767
- Acronym
- SGLT2-HD
- Status last verified
- Apr 2025
- First submitted
- 8 Apr 2025
- Last updated
- 16 Apr 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 16 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cardiovascular Effects of SGLT2 Inhibitors in Hemodialysis Patients: A Phase 2 Randomized Study
- ClinicalTrials.gov ID
- NCT06929169
- Acronym / sponsor ID
- SGLT2-HD / PRIISA BA: 8767
- Keywords
- SGLT2 Inhibitors, Hemodialysis, Cardiac MRI, Ventricular Remodeling, Heart Failure with Preserved Ejection Fraction, Myocardial Fibrosis, Cardiovascular Disease, Chronic Kidney Disease
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Maximo Agustin SchiavoneUniversity, hospital or other
- Study start
- May 2025 (estimated)
- Primary completion
- Jul 2026 (estimated)
- Study completion
- Aug 2026 (estimated)
- First posted
- 16 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.
Patients with end-stage kidney disease (ESKD) on hemodialysis face an unacceptably high rate of cardiovascular complications, including heart failure, arrhythmias, and sudden cardiac death. Many of these outcomes are driven by diastolic dysfunction and cardiac fibrosis-conditions that are not adequately addressed by current therapies. SGLT2 inhibitors, originally developed for the treatment of type 2 diabetes, have demonstrated cardiovascular and renal protective effects across multiple patient populations, independent of glycemic control.
This Phase 2, randomized, controlled clinical trial will evaluate the safety and efficacy of SGLT2 inhibitors in patients undergoing maintenance hemodialysis. A total of 80 participants will be randomized to receive either an SGLT2 inhibitor or standard care for 12 months. The primary objective is to determine whether SGLT2 inhibitors improve cardiac function, reduce myocardial fibrosis, and decrease the incidence of intradialytic hypotension. Secondary endpoints include cardiovascular events, hospitalization, and all-cause mortality. The study will also assess changes in key biomarkers and perform advanced cardiac imaging to evaluate structural and functional outcomes.
This trial represents a novel and timely investigation into a class of medications with promising pleiotropic effects, potentially offering new therapeutic options for a high-risk, underserved population.
Detailed description
This is a Phase 2, prospective, randomized, open-label, controlled study designed to assess the safety and efficacy of sodium-glucose cotransporter 2 inhibitors (SGLT2i) in patients with end-stage renal disease (ESRD) undergoing maintenance hemodialysis. Despite advances in renal replacement therapy, cardiovascular mortality remains the leading cause of death in this population, often due to heart failure with preserved ejection fraction (HFpEF), arrhythmic events, and myocardial fibrosis. Preclinical models and clinical data in non-dialysis populations suggest that SGLT2 inhibitors exert antifibrotic, anti-inflammatory, and mitochondrial-stabilizing effects that may ameliorate these pathophysiological processes.
A total of 80 eligible patients, aged 18-70 years and receiving online hemodiafiltration for at least 3 months, will be enrolled at Fresenius Medical Center - CEMIC Saavedra (Buenos Aires, Argentina). Participants will be randomized into two parallel groups (intervention vs. control) stratified by age, sex, and dialysis vintage. The intervention group will receive a once-daily SGLT2 inhibitor, while the control group will continue standard care.
Primary outcomes include the incidence and severity of intradialytic hypotension (defined by KDOQI 2020 and HEMO criteria), longitudinal changes in left ventricular mass index (LVMI), ejection fraction, myocardial fibrosis as assessed by cardiac MRI (T1/T2 mapping), and circulating pro-fibrotic biomarkers (e.g., FGF23, procollagen types I and III). Secondary endpoints include major adverse cardiovascular events (MACE), cardiovascular mortality, all-cause mortality, and cause-specific hospitalizations.
Comprehensive phenotyping will be conducted at baseline, months 3, 6, and 12. Assessments include echocardiography, cardiac MRI, 24-hour Holter monitoring, impedance cardiography, pulse wave velocity measurement, and detailed laboratory profiling. Data will be analyzed using appropriate parametric and non-parametric statistical tests, with multivariate regression and survival analysis techniques applied where relevant.
The study complies with ICH-GCP guidelines and the Declaration of Helsinki. The CEMIC institutional review board has granted ethical approval. Informed consent will be obtained from all participants prior to enrollment. The study is funded by institutional and investigator resources, with biomarker assays supported by the lead investigator through his research affiliations with CEMIC and Charité -Universitätsmedizin Berlin.
This study aims to address a critical unmet need in cardio-renal medicine and may lay the groundwork for future therapeutic strategies in dialysis-dependent patients.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control | No intervention | –Participants in this arm will continue receiving standard hemodialysis treatment, including all routine medical care, medications, and monitoring as per institutional protocols. They will not receive an SGLT2 inhibitor. |
| Drug: iSGLT2 | Experimental | Drug: iSGLT2Participants in this arm will receive a sodium-glucose cotransporter 2 inhibitor (SGLT2i) once daily by oral administration, in addition to standard hemodialysis care. The specific agent (e.g., dapagliflozin or empagliflozin) and dose will be selected based on safety data and existing recommendations for patients with end-stage renal disease on dialysis. The intervention will be administered for 12 months. Participants will undergo cardiovascular monitoring, including cardiac MRI, echocardiography, and biomarker assessment at baseline, and months 3, 6, and 12. This arm is designed to evaluate the effects of SGLT2 inhibition on cardiac function, myocardial fibrosis, and intradialytic hypotension. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Age ≥18 and ≤70 years
- Diagnosed with end-stage renal disease
- Undergoing online hemodiafiltration for at least 3 months
- Able to provide written informed consent
Key exclusion criteria (10 listed)
- Current immunosuppressive therapy
- Contraindication to cardiac MRI
- Known hypersensitivity or intolerance to SGLT2 inhibitors
- Participation in another interventional clinical trial
- History of diabetic ketoacidosis
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 |
|---|---|---|
| iSGLT2Also: SGLT2 inhibitorParticipants randomized to the experimental arm will receive a once-daily dose of a sodium-glucose cotransporter 2 inhibitor (SGLT2i), administered orally, in addition to their standard hemodialysis care. The specific agent (e.g., dapagliflozin or empagliflozin) and dose will be selected based on safety data and clinical guidelines applicable to patients with end-stage renal disease (ESRD) on dialysis. The intervention will be maintained for 12 months. Dosing will be monitored by the research team to ensure tolerability and adherence. All patients in the experimental group will undergo comprehensive cardiovascular assessment, including serial cardiac MRI, echocardiography, and measurement of fibrosis-related biomarkers. This intervention differs from standard care by introducing a pharmacologic agent not routinely administered in the dialysis population, targeting cardiac remodeling, fibrosis, and intradialytic complications. | Drug | Drug: iSGLT2 |
Primary outcome
Change in Left Ventricular Mass Index (LVMI)
Time frame: Baseline, Month 3, Month 6, and Month 12
LVMI will be measured using cardiac MRI and/or echocardiography at baseline, and at months 3, 6, and 12. The primary outcome will be the change (Δ) in LVMI compared to baseline. Reductions in LVMI will be interpreted as a marker of reverse remodeling and reduced fibrosis.
Change in Left Ventricular Ejection Fraction (LVEF)
Time frame: Baseline, Month 3, Month 6, Month 12
LVEF will be measured by echocardiography at baseline and at months 3, 6, and 12. The primary outcome will be the change from baseline. Improvements will indicate enhancement in global systolic function.
Change in Myocardial Fibrosis as Assessed by Cardiac MRI
Time frame: Baseline, Month 3, Month 6, Month 12
Cardiac MRI with T1/T2 mapping will be performed at baseline, and at months 3, 6, and 12. Quantitative measures of myocardial fibrosis will be compared to baseline to assess changes over time.
Change in Pro-fibrotic Biomarkers (FGF23, Procollagen I and III)
Time frame: Baseline, Month 3, Month 6, Month 12
Blood levels of FGF23, procollagen type I, and procollagen type III will be measured at baseline and months 3, 6, and 12. The outcome is defined as the change from baseline. These biomarkers reflect myocardial fibrosis activity.
Incidence of Intradialytic Hypotension
Time frame: Baseline through Month 12
Includes new or worsening heart failure, confirmed myocardial infarction, stroke, or clinically significant arrhythmia. Events will be adjudicated based on clinical criteria.
4 secondary outcomes
Major Adverse Cardiovascular Events (MACE)
Time frame: Baseline through Month 12
Cardiovascular Mortality
Time frame: Baseline through Month 12
All-Cause Mortality
Time frame: Baseline through Month 12
Cause-Specific Hospitalizations
Time frame: Baseline through Month 12
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 16 Apr 2025.
- Individual participant dataSharing planned: Undecided
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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.
Carlos E Castellaro, MD, MSc study director
Centro de Educación Medica e Investigaciones Clínicas Norberto Quirno
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing iSGLT2 in people with Chronic Kidney Disease Requiring Hemodialysis, run by Maximo Agustin Schiavone at 1 site in Argentina.
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 10 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 16 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 Argentina. 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.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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 Maximo A Schiavone, MD, MSc (+5491138093510, maximoschiavone@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Left Ventricular Mass Index (LVMI) (time frame: Baseline, Month 3, Month 6, and Month 12). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 16 Apr 2025.