The Effects of Empagliflozin on Renal Outcomes in Post Severe Acute Kidney Injury Survivors

August 13, 2025 updated by: Nattachai Srisawat ,M.D., Chulalongkorn University
Effects of Empagliflozin compared with placebo in post severe acute kidney injury survivors, evaluated by MAKE365.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

147

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Thailand
    • Mueang Nonthaburi District
      • Nonthaburi, Mueang Nonthaburi District, Thailand, 11000
        • Central Chest Institute of Thailand

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • post AKI stage 2-3
  • CrCl > 20

Exclusion Criteria:

  • pregnancy
  • post kidney transplant
  • previous use of SGLT2 Inhibitors
  • history of ketoacidosis

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: Placebo
Drug: Placebo
Placebo
Experimental: Empagliflozin
Drug: Empagliflozin 10 MG
SGLT2 inhibitors

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
MAKE365
Time Frame: 1 year
Major adverse kidney events (number of participants with death, renal replacement therapy, New CKD, CKD progression)
1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Chulalongkorn University

Investigators

  • Principal Investigator: Nattachai Srisawat, Chulalongkorn University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 1, 2022

Primary Completion (Actual)

June 1, 2024

Study Completion (Estimated)

July 1, 2026

Study Registration Dates

First Submitted

April 30, 2022

First Submitted That Met QC Criteria

April 30, 2022

First Posted (Actual)

May 4, 2022

Study Record Updates

Last Update Posted (Actual)

August 17, 2025

Last Update Submitted That Met QC Criteria

August 13, 2025

Last Verified

August 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IRB.211/65

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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