The Effects of Empagliflozin on Renal Outcomes in Post Severe Acute Kidney Injury Survivors
Primary Purpose
Empagliflozin in Post AKI Stage 2-3
Status
Recruiting
Phase
Phase 1
Locations
Thailand
Study Type
Interventional
Intervention
Empagliflozin 10 MG
Placebo
Sponsored by
About this trial
This is an interventional treatment trial for Empagliflozin in Post AKI Stage 2-3 focused on measuring Empagliflozin, AKI
Eligibility Criteria
Inclusion Criteria:
- post AKI stage 2-3
- CrCl > 20
Exclusion Criteria:
- pregnancy
- post kidney transplant
- previous use of SGLT2 Inhibitors
- history of ketoacidosis
Sites / Locations
- Central Chest Institute of ThailandRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
Empagliflozin
Placebo
Arm Description
Outcomes
Primary Outcome Measures
MAKE365
Major adverse kidney events (number of participants with death, renal replacement therapy, New CKD, CKD progression)
Secondary Outcome Measures
Full Information
NCT ID
NCT05360615
First Posted
April 30, 2022
Last Updated
October 27, 2022
Sponsor
Chulalongkorn University
1. Study Identification
Unique Protocol Identification Number
NCT05360615
Brief Title
The Effects of Empagliflozin on Renal Outcomes in Post Severe Acute Kidney Injury Survivors
Official Title
The Effects of Empagliflozin on Renal Outcomes in Post Severe Acute Kidney Injury Survivors
Study Type
Interventional
2. Study Status
Record Verification Date
October 2022
Overall Recruitment Status
Recruiting
Study Start Date
July 1, 2022 (Actual)
Primary Completion Date
June 1, 2024 (Anticipated)
Study Completion Date
July 1, 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Chulalongkorn University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
Effects of Empagliflozin compared with placebo in post severe acute kidney injury survivors, evaluated by MAKE365.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Empagliflozin in Post AKI Stage 2-3
Keywords
Empagliflozin, AKI
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
147 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Empagliflozin
Arm Type
Experimental
Arm Title
Placebo
Arm Type
Placebo Comparator
Intervention Type
Drug
Intervention Name(s)
Empagliflozin 10 MG
Intervention Description
SGLT2 inhibitors
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Placebo
Primary Outcome Measure Information:
Title
MAKE365
Description
Major adverse kidney events (number of participants with death, renal replacement therapy, New CKD, CKD progression)
Time Frame
1 year
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
post AKI stage 2-3
CrCl > 20
Exclusion Criteria:
pregnancy
post kidney transplant
previous use of SGLT2 Inhibitors
history of ketoacidosis
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Sasipha Tachaboon
Phone
022564000
Ext
3679
Email
sasipha_tac@hotmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Nattachai Srisawat
Organizational Affiliation
Chulalongkorn University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Central Chest Institute of Thailand
City
Nonthaburi
State/Province
Mueang Nonthaburi District
ZIP/Postal Code
11000
Country
Thailand
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Peerapat Thanapongsatorn
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Learn more about this trial
The Effects of Empagliflozin on Renal Outcomes in Post Severe Acute Kidney Injury Survivors
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