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

NCT06030843 | Recruiting Phase 2 FDA Drug

• 1 other identifier: IRB 674/66
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 1

Brief Summary

Effects of Empagliflozin compared with placebo in cardiorenal syndrome type 1, evaluated by MAKE30.

Conditions

Empagliflozin in Cardiorenal Syndrome Type 1

Keywords

Empagliflozin; SGLT2i; Cardiorenal syndrome; ADHF; AKI

Outcome Measures

Primary Outcomes (1)

• 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 (10)

• In-hospital mortality rate

  During admission

• 30-days mortality rate

  30 days

• Initiation of Renal Replacement therapy

  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

  30 days

• Recurrent heart failure

  30 days

Study Arms (2)

Empagliflozin

EXPERIMENTAL

Empagliflozin 10 mg po OD

Drug: Empagliflozin 10 MG

Placebo

PLACEBO COMPARATOR

Matching placebo

Drug: Placebo

Interventions

Empagliflozin 10 MG DRUG

Empagliflozin 10 MG

Empagliflozin

Placebo DRUG

Matching placebo containing Lactose content (0.26 gram)

Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Chulalongkorn University: lead

Study Sites (1)

Faculty of Medicine, Chulalongkorn University

Bangkok, Pathumwan, 10330, Thailand

RECRUITING

MeSH Terms

Conditions

Cardio-Renal Syndrome

Interventions

empagliflozin

Condition Hierarchy (Ancestors)

Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Heart Failure; Heart Diseases; Cardiovascular Diseases

Study Officials

• Nattachai Srisawat

  Chulalongkorn University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Sasipha Tachaboon

CONTACT

6622564000; sasipha.t@chulahospital.org

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: September 3, 2023
• First Posted: September 11, 2023
• Study Start: March 1, 2025
• Primary Completion: November 30, 2025
• Study Completion (Estimated): December 31, 2026
• Last Updated: August 7, 2025

Record last verified: 2025-08

Locations

TH (1)