The Treatment Effects of Empagliflozin on Renal Outcomes... | NCT06030843

Studies
The Treatment Effects of Empagliflozin on Renal Outcomes in Cardiorenal Syndrome Type 1

NCT06030843

Sponsor

Chulalongkorn University

Status

Recruiting

Last Update Posted

Jun 16, 2026Actual

Enrollment

200Estimated

Phase

Phase 2Phase 3

Conditions

Empagliflozin in Cardiorenal Syndrome Type 1

Interventions

Empagliflozin 10 MG
Placebo

Countries

Thailand

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jun 2026

Overall Recruitment Status or Expanded Access Status

Recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Mar 1, 2025Actual

Primary Completion Date

Nov 30, 2026Estimated

Completion Date

Dec 31, 2026Estimated

First Submitted Date

Sep 3, 2023

First Submission Date that Met QC Criteria

Sep 3, 2023

First Posted Date

Sep 11, 2023Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jun 15, 2026

Last Update Posted Date

Jun 16, 2026Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Yes

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Yes

FDAAA801 Violation

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 2Phase 3

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

200Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Empagliflozin	Experimental	Empagliflozin 10 mg po OD	Drug: Empagliflozin 10 MG
Placebo	Placebo Comparator	Matching placebo	Drug: Placebo

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Empagliflozin 10 MG	Drug	Empagliflozin 10 MG	Empagliflozin
Placebo

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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	30 days

Secondary Outcomes

Measure	Description	Time Frame
In-hospital mortality rate	In-hospital mortality rate	During admission
30-days mortality rate	30-days mortality rate	30 days

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion criteria

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

Exclusion criteria

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
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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Sasipha Tachaboon	Contact	6622564000	73305	sasipha.t@chulahospital.org

Overall Officials

Name	Affiliation	Role
Nattachai Srisawat	Chulalongkorn University	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Faculty of Medicine, Chulalongkorn University	Recruiting	Bangkok	Pathumwan	10330	Thailand

IPD Sharing Statement Module

Plan to Share IPD

Undecided

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

ID	Term
D051437	Renal Insufficiency
D007674	Kidney Diseases
D014570	Urologic Diseases
D052776	Female Urogenital Diseases