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

Phase 1

Recruiting

• Conditions: Empagliflozin in Post AKI Stage 2-3
• Interventions: Drug: Empagliflozin 10 MG; Drug: Placebo

• Registration Number: NCT05360615
• Lead Sponsor: Chulalongkorn University

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2022-04-30
• Study First Submitted QC: 2022-04-30
• Study First Posted: 2022-05-04
• Study Start: 2022-07-01
• Status Verified: 2024-02
• Last Update Submitted: 2024-02-05
• Last Update Posted: 2024-02-07
• Primary Completion: 2024-06-01
• Study Completion: 2024-07-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 147

Inclusion Criteria

• post AKI stage 2-3
• CrCl > 20

Exclusion Criteria

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Empagliflozin	Empagliflozin 10 MG	-
Placebo	Placebo	-

Primary Outcome Measures

Name	Time	Method
MAKE365	1 year	Major adverse kidney events (number of participants with death, renal replacement therapy, New CKD, CKD progression)

Trial Locations

Locations (1)

Central Chest Institute of Thailand; 🇹🇭 Nonthaburi, Mueang Nonthaburi District, Thailand