Empagliflozin in Cardiorenal Syndrome Type 1Phase 2/3TREAT-CRSNCT06030843
The Treatment Effects of Empagliflozin on Renal Outcomes in Cardiorenal Syndrome Type 1
A Phase 2/3 study testing Empagliflozin 10 MG in people with Empagliflozin in Cardiorenal Syndrome Type 1, run by Chulalongkorn University at 1 site in Thailand.
Trial summary
Effects of Empagliflozin compared with placebo in cardiorenal syndrome type 1, evaluated by MAKE30. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Empagliflozin in Cardiorenal Syndrome Type 1
- What is being tested?
- Empagliflozin 10 MG
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 200 participants
- Where
- 1 siteThailand
- Study dates
- 1 Mar 2025to 31 Dec 2026
- Phase
- Phase 2/3
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age 18 years or more
- Hospitalized for the primary diagnosis of acute denovo or decompensated chronic heart regardless of ejection fraction
- AKI KDIGO any stage or urine NGAL ≥ 150 ng/mL
- Must be able to be enrolled into the trial ≤ 12 hours of diagnosis of AKI or elevated urine NGAL
Who cannot join
- Denied to participate in the study
- Cardiogenic shock or unstable hemodynamic (systolic blood pressure of at least 100 mmHg or required inotropic support within last 24 hours)
- Cardiac mechanical support (i.e. extracorporeal membrane oxygenation and intra-aortic balloon pump)
- Acute coronary syndrome
- Diagnosed with cause of AKI other than cardiorenal syndrome (eg. sepsis, nephrotoxic, dehydration)
- Anuria or requiring dialysis or expected to required dialysis within 24 hr
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- Baseline eGFR ≤ 20 ml/min/1.73m2 with or without dialysis initiated
- Heart or kidney transplanted
- Previously received any SGLT2i in the last 3 months before admission
- Allergic to any SGLT2i
- Type 1 diabetes mellitus
- History of ketoacidosis, including diabetic ketoacidosis
- Pregnancy
- Comorbid conditions with an expected survival of less than 1 months such as end-stage liver or heart disease, or uncurable malignancy
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Thailand1 site, 1 recruiting
- Recruiting
Faculty of Medicine, Chulalongkorn University
Bangkok, Pathumwan, 10330
Tanat Lertussavavivat, 6622564000 ext. 73303, lert.tanat@gmail.com
About this study
Effects of Empagliflozin compared with placebo in cardiorenal syndrome type 1, evaluated by MAKE30.
- Being tested
- Empagliflozin 10 MG, Placebo
- Keywords
- Empagliflozin, SGLT2i, Cardiorenal syndrome, ADHF, AKI
- Medical subject headings
- Cardio-Renal Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Empagliflozin 10 MGDrug
Empagliflozin 10 MG
PlaceboDrug
Matching placebo containing Lactose content (0.26 gram)
| Study group | Role | What they receive |
|---|---|---|
| Empagliflozin | Experimental | Empagliflozin 10 mg po OD Receives: Drug: Empagliflozin 10 MG |
| Placebo | Placebo comparator | Matching placebo Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
MAKE30
The composite outcome of death, new dialysis, and sustained loss of kidney function (which was defined as a 25% or greater decline in eGFR from baseline) assess at 30 days following randomization
Measured: 30 days
Secondary outcomes (10)
In-hospital mortality rate
In-hospital mortality rate
Measured: During admission
30-days mortality rate
30-days mortality rate
Measured: 30 days
Initiation of Renal Replacement therapy
Initiation of Renal Replacement therapy
Measured: 30 days
Sustained loss of kidney function defined as a 25% or greater decline in eGFR at 30 days following randomisation compared to baseline eGFR
Sustained loss of kidney function defined as a 25% or greater decline in eGFR at 30 days following randomisation compared to baseline eGFR
Measured: 30 days
Recurrent heart failure
Recurrent heart failure required hospital administration
Measured: 30 days
Vasoactive drug
Vasoactive drug use
Measured: 30 days
Mechanical ventilation
Mechanical ventilation use
Measured: 30 days
Ventricular tachycardia or ventricular fibrillation
Ventricular tachycardia or ventricular fibrillation
Measured: 30 days
Resuscitation following a cardiac arrest
Resuscitation following a cardiac arrest
Measured: 30 days
Reduction of prespecified renal biomarkers
Reduction of prespecified renal biomarkers
Measured: 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Sep 2023
- Study start1 Mar 2025
- Primary completion30 Nov 2026 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Empagliflozin in Cardiorenal Syndrome Type 1Studies of the same condition, open and under way.
- More trials run by Chulalongkorn UniversityThe sponsor's other registered studies.
- 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 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Chulalongkorn University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Nattachai Srisawat ,M.D., Chulalongkorn University
- Investigators
- Nattachai Srisawat, Principal investigator, Chulalongkorn University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06030843
- Sponsor's protocol ID
- IRB 674/66
- Acronym
- TREAT-CRS
- Status last verified
- Jun 2026
- First submitted
- 3 Sep 2023
- Last updated
- 16 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 16 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Treatment Effects of Empagliflozin on Renal Outcomes in Cardiorenal Syndrome Type 1
- ClinicalTrials.gov ID
- NCT06030843
- Acronym / sponsor ID
- TREAT-CRS / IRB 674/66
- Keywords
- Empagliflozin, SGLT2i, Cardiorenal syndrome, ADHF, AKI
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Chulalongkorn UniversityUniversity, hospital or other
- Study start
- 1 Mar 2025 (actual)
- Primary completion
- 30 Nov 2026 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 11 Sep 2023 (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.
Effects of Empagliflozin compared with placebo in cardiorenal syndrome type 1, evaluated by MAKE30.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Empagliflozin | Experimental | Drug: Empagliflozin 10 MGEmpagliflozin 10 mg po OD |
| Placebo | Placebo comparator | Drug: PlaceboMatching placebo |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Age 18 years or more
- Hospitalized for the primary diagnosis of acute denovo or decompensated chronic heart regardless of ejection fraction
- AKI KDIGO any stage or urine NGAL ≥ 150 ng/mL
- Must be able to be enrolled into the trial ≤ 12 hours of diagnosis of AKI or elevated urine NGAL
Key exclusion criteria (14 listed)
- Denied to participate in the study
- Cardiogenic shock or unstable hemodynamic (systolic blood pressure of at least 100 mmHg or required inotropic support within last 24 hours)
- Cardiac mechanical support (i.e. extracorporeal membrane oxygenation and intra-aortic balloon pump)
- Acute coronary syndrome
- Diagnosed with cause of AKI other than cardiorenal syndrome (eg. sepsis, nephrotoxic, dehydration)
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 |
|---|---|---|
| Empagliflozin 10 MGEmpagliflozin 10 MG | Drug | Empagliflozin |
| PlaceboMatching placebo containing Lactose content (0.26 gram) | Drug | Placebo |
Primary outcome
MAKE30
Time frame: 30 days
The composite outcome of death, new dialysis, and sustained loss of kidney function (which was defined as a 25% or greater decline in eGFR from baseline) assess at 30 days following randomization
10 secondary outcomes
In-hospital mortality rate
Time frame: During admission
30-days mortality rate
Time frame: 30 days
Initiation of Renal Replacement therapy
Time frame: 30 days
Sustained loss of kidney function defined as a 25% or greater decline in eGFR at 30 days following randomisation compared to baseline eGFR
Time frame: 30 days
Recurrent heart failure
Time frame: 30 days
Vasoactive drug
Time frame: 30 days
Mechanical ventilation
Time frame: 30 days
Ventricular tachycardia or ventricular fibrillation
Time frame: 30 days
Resuscitation following a cardiac arrest
Time frame: 30 days
Reduction of prespecified renal biomarkers
Time frame: 30 days
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 Jun 2026.
- Individual participant dataSharing planned: Undecided
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.
Nattachai Srisawat principal investigator
Chulalongkorn University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing Empagliflozin 10 MG in people with Empagliflozin in Cardiorenal Syndrome Type 1, run by Chulalongkorn University 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 14 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 Jun 2026. 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined 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.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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 Sasipha Tachaboon (6622564000 ext. 73305, sasipha.t@chulahospital.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
MAKE30 (time frame: 30 days). 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 Jun 2026.