Empagliflozin in Post AKI Stage 2-3Phase 1NCT05360615
The Effects of Empagliflozin on Renal Outcomes in Post Severe Acute Kidney Injury Survivors
A Phase 1 study testing Empagliflozin 10 MG in people with Empagliflozin in Post AKI Stage 2-3, run by Chulalongkorn University at 1 site in Thailand.
Trial summary
Effects of Empagliflozin compared with placebo in post severe acute kidney injury survivors, evaluated by MAKE365. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Empagliflozin in Post AKI Stage 2-3
- What is being tested?
- Empagliflozin 10 MG
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 147 participants
- Where
- 1 siteThailand
- Study dates
- 1 Jul 2022to 1 Jul 2027
- Phase
- Phase 1
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- post AKI stage 2-3
- CrCl > 20
Who cannot join
- pregnancy
- post kidney transplant
- previous use of SGLT2 Inhibitors
- history of ketoacidosis
Trial locations and contacts
1 site in 1 country.
Thailand1 site
Central Chest Institute of Thailand
Nonthaburi, Mueang Nonthaburi District, 11000
About this study
Effects of Empagliflozin compared with placebo in post severe acute kidney injury survivors, evaluated by MAKE365.
- Conditions
- Empagliflozin in Post AKI Stage 2-3
- Being tested
- Empagliflozin 10 MG, Placebo
- Keywords
- Empagliflozin, AKI
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Empagliflozin 10 MGDrug
SGLT2 inhibitors
PlaceboDrug
Placebo
| Study group | Role | What they receive |
|---|---|---|
| Empagliflozin | Experimental | Not described Receives: Drug: Empagliflozin 10 MG |
| Placebo | Placebo comparator | Not described Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
MAKE365
Major adverse kidney events (number of participants with death, renal replacement therapy, New CKD, CKD progression)
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 May 2022
- Study start1 Jul 2022
- Primary completion1 Jun 2024
- Study completion1 Jul 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Empagliflozin in Post AKI Stage 2-3Studies of the same condition, open and under way.
- More trials run by Chulalongkorn UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 147 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Chulalongkorn University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Nattachai Srisawat ,M.D., Chulalongkorn University
- Investigators
- Nattachai Srisawat, Principal investigator, Chulalongkorn University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05360615
- Sponsor's protocol ID
- IRB.211/65
- Status last verified
- Sep 2026
- First submitted
- 30 Apr 2022
- Last updated
- 29 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 29 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects of Empagliflozin on Renal Outcomes in Post Severe Acute Kidney Injury Survivors
- ClinicalTrials.gov ID
- NCT05360615
- Acronym / sponsor ID
- IRB.211/65
- Conditions
- Empagliflozin in Post AKI Stage 2-3
- Keywords
- Empagliflozin, AKI
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 147 participants (estimated)
- Lead sponsor
- Chulalongkorn UniversityUniversity, hospital or other
- Study start
- 1 Jul 2022 (actual)
- Primary completion
- 1 Jun 2024 (actual)
- Study completion
- 1 Jul 2027 (estimated)
- First posted
- 4 May 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Effects of Empagliflozin compared with placebo in post severe acute kidney injury survivors, evaluated by MAKE365.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Empagliflozin | Experimental | Drug: Empagliflozin 10 MG |
| Placebo | Placebo comparator | Drug: Placebo |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- post AKI stage 2-3
- CrCl > 20
Key exclusion criteria (4 listed)
- pregnancy
- post kidney transplant
- previous use of SGLT2 Inhibitors
- history of ketoacidosis
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Empagliflozin 10 MGSGLT2 inhibitors | Drug | Empagliflozin |
| PlaceboPlacebo | Drug | Placebo |
Primary outcome
MAKE365
Time frame: 1 year
Major adverse kidney events (number of participants with death, renal replacement therapy, New CKD, CKD progression)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Sep 2026.
- Individual participant dataSharing planned: Undecided
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Nattachai Srisawat principal investigator
Chulalongkorn University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Empagliflozin 10 MG in people with Empagliflozin in Post AKI Stage 2-3, run by Chulalongkorn University at 1 site in Thailand.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 29 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Thailand. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
MAKE365 (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Sep 2026.