NCT05360615

Brief Summary

Effects of Empagliflozin compared with placebo in post severe acute kidney injury survivors, evaluated by MAKE365.

Trial Health

75
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
147

participants targeted

Target at P75+ for phase_1

Timeline
2mo left

Started Jul 2022

Longer than P75 for phase_1

Geographic Reach
1 country

1 active site

Status
active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress96%
Jul 2022Jul 2026

First Submitted

Initial submission to the registry

April 30, 2022

Completed
4 days until next milestone

First Posted

Study publicly available on registry

May 4, 2022

Completed
2 months until next milestone

Study Start

First participant enrolled

July 1, 2022

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2024

Completed
2.1 years until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2026

Expected
Last Updated

August 17, 2025

Status Verified

August 1, 2025

Enrollment Period

1.9 years

First QC Date

April 30, 2022

Last Update Submit

August 13, 2025

Conditions

Empagliflozin in Post AKI Stage 2-3

Keywords

EmpagliflozinAKI

Outcome Measures

Primary Outcomes (1)

  • MAKE365

    Major adverse kidney events (number of participants with death, renal replacement therapy, New CKD, CKD progression)

    1 year

Study Arms (2)

Empagliflozin

EXPERIMENTAL
Drug: Empagliflozin 10 MG

Placebo

PLACEBO COMPARATOR
Drug: Placebo

Interventions

Empagliflozin 10 MGDRUG

SGLT2 inhibitors

Empagliflozin
PlaceboDRUG

Placebo

Placebo

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • post AKI stage 2-3
  • CrCl \> 20

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Central Chest Institute of Thailand

Nonthaburi, Mueang Nonthaburi District, 11000, Thailand

Location

MeSH Terms

Interventions

empagliflozin

Study Officials

  • Nattachai Srisawat

    Chulalongkorn University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
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
Assistant Professor.Nattachai Srisawat

Study Record Dates

First Submitted

April 30, 2022

First Posted

May 4, 2022

Study Start

July 1, 2022

Primary Completion

June 1, 2024

Study Completion (Estimated)

July 1, 2026

Last Updated

August 17, 2025

Record last verified: 2025-08

Locations

TH(1)