Acute Kidney InjuryPhase 2ESS-AKDNCT06528405
The Efficacy and Safety of Sodium-glucose Cotransporter 2 Inhibitors in Patients With Acute Kidney Disease
A Phase 2 study testing dapagliflozin, Other anti-diabetic drug or no anti-diabetic drug and empagliflozin in people with Acute Kidney Injury, run by National Taiwan University Hospital at 1 site in Taiwan.
Trial summary
Acute kidney disease (AKD) happens between 7 and 90 days after an initial kidney injury (AKI). This period is crucial because it can determine whether the condition worsens into chronic kidney disease (CKD). Despite knowing this, there is no proven treatment to improve outcomes for people with AKD. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Acute Kidney Injury
- What is being tested?
- dapagliflozin, Other anti-diabetic drug or no anti-diabetic drug and empagliflozin
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 264 participants
- Where
- 1 siteTaiwan
- Study dates
- 21 Nov 2024to Dec 2027
- Phase
- Phase 2
- 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 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age ≥ 18 years and < 80 years
- Diagnosed with acute kidney disease
- Estimated glomerular filtration rate (eGFR) ≥ 20 mL/min/1.73m²
- Albuminuria > 100 mg/g or proteinuria > 300 mg/g (adjusted by urine creatinine)
- Diagnosed with diabetes or chronic kidney disease
Who cannot join
- Received sodium-glucose cotransporter 2 (SGLT2) inhibitors within 28 days prior to enrollment
- Patients with type 1 diabetes
- Receiving aggressive immunosuppressive therapy for glomerulonephritis
- Obstructive nephropathy
- Polycystic kidney disease
- Malignancy within 3 months or expected to undergo aggressive treatment such as chemotherapy, radiation therapy, immunotherapy, or targeted therapy in the future
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- Pregnant or breastfeeding women
- Clinically assessed as not having recovered from acute kidney injury
- Clinically assessed as at high risk for complications related to SGLT2 inhibitors
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Taiwan1 site, 1 recruiting
- Recruiting
National Taiwan University Hospital
Taipei
Szu-Yu Pan, szuyupan@ntu.edu.tw
About this study
Acute kidney disease (AKD) happens between 7 and 90 days after an initial kidney injury (AKI). This period is crucial because it can determine whether the condition worsens into chronic kidney disease (CKD). Despite knowing this, there is no proven treatment to improve outcomes for people with AKD.
Recent studies have shown that drugs called sodium-glucose cotransporter 2 (SGLT2) inhibitors can slow down the worsening of chronic kidney disease, help with heart failure, and reduce the risk of death. Now, researchers are looking into whether these drugs can also help prevent acute kidney injury (AKI) and improve outcomes for AKD patients.
Read more
Our project will explore the use of SGLT2 inhibitors in patients with AKD, with the belief that these drugs can safely reduce the amount of protein (albumin) in the urine and improve kidney health. To address this, investigators plan to conduct a large, multicenter study in Taiwan. This study will be randomized and placebo-controlled, meaning some patients will receive the SGLT2 inhibitors while others will receive a placebo (a harmless, inactive substance). Investigators will include AKD patients with and without diabetes, focusing on reducing the protein in their urine and monitoring for any serious side effects.
The goal of this trial is to provide strong evidence on whether SGLT2 inhibitors can be an effective treatment for AKD. If successful, this could offer a new strategy to prevent the progression from AKI to CKD and improve the health and outcomes of patients with kidney disease.
- Conditions
- Acute Kidney Injury
- Being tested
- dapagliflozin, Other anti-diabetic drug or no anti-diabetic drug, empagliflozin, canagliflozin
- Keywords
- sodium-glucose cotransporter 2 inhibitor, acute kidney disease, albuminuria
- Medical subject headings
- Acute Kidney Injury, Albuminuria
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
dapagliflozinDrug
Sodium-glucose cotransporter 2 inhibitor for 90 days during the acute kidney disease period.
Other anti-diabetic drug or no anti-diabetic drugOther
Other anti-diabetic drug or no anti-diabetic drug for 90 days during the acute kidney disease period.
Other anti-diabetic drug includes metformin, sulfonylureas, meglitinides, dipeptidyl peptidase-4 inhibitor, insulin, α-glucosidase inhibitors, thiazolidinediones, and glucagon-like peptide-1 receptor agonist.
empagliflozinDrug
Sodium-glucose cotransporter 2 inhibitor for 90 days during the acute kidney disease period.
canagliflozinDrug
Sodium-glucose cotransporter 2 inhibitor for 90 days during the acute kidney disease period.
| Study group | Role | What they receive |
|---|---|---|
| SGLT2i | Experimental | Not described Receives: Drug: dapagliflozin; Drug: empagliflozin; Drug: canagliflozin |
| Control | Placebo comparator | Not described Receives: Other: Other anti-diabetic drug or no anti-diabetic drug |
What is being measured
The primary outcome is the main question the study is designed to answer.
Albuminuria
The changes in albuminuria compared with baseline
Measured: Day 28 and Day 90
Discontinuation of SGLT2i
Development of adverse events leading to discontinuation of SGLT2i
Measured: Day 0 to Day 90
Secondary outcomes (5)
eGFR
The changes in eGFR
Measured: Day 28 to Day 84 or Day 28 to Day 168
Major adverse kidney events
eGFR reduction >50%, dialysis, or death
Measured: Day 0 to Day 180
Major adverse cardiovascular events
hospitalization due to heart failure or death
Measured: Day 0 to Day 180
Death
All-cause mortality
Measured: Day 0 to Day 180
Amputation
Any amputation event
Measured: Day 0 to Day 180
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jul 2024
- Study start21 Nov 2024
- Primary completionJul 2027 (estimated)
- Study completionDec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute Kidney InjuryStudies of the same condition, open and under way.
- More trials run by National Taiwan University HospitalThe 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 264 participants (estimated)
Sponsor and investigators
- Lead sponsor
- National Taiwan University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Chang Gung Memorial Hospital, China Medical University Hospital, National Cheng-Kung University Hospital
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06528405
- Sponsor's protocol ID
- 202404095MINE
- Acronym
- ESS-AKD
- Status last verified
- Dec 2025
- First submitted
- 25 Jul 2024
- Last updated
- 2 Jan 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 2 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Efficacy and Safety of Sodium-glucose Cotransporter 2 Inhibitors in Patients With Acute Kidney Disease
- ClinicalTrials.gov ID
- NCT06528405
- Acronym / sponsor ID
- ESS-AKD / 202404095MINE
- Conditions
- Acute Kidney Injury
- Keywords
- sodium-glucose cotransporter 2 inhibitor, acute kidney disease, albuminuria
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 264 participants (estimated)
- Lead sponsor
- National Taiwan University HospitalUniversity, hospital or other
- Collaborators
- Chang Gung Memorial Hospital, China Medical University Hospital, National Cheng-Kung University Hospital
- Study start
- 21 Nov 2024 (actual)
- Primary completion
- Jul 2027 (estimated)
- Study completion
- Dec 2027 (estimated)
- First posted
- 30 Jul 2024 (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.
Acute kidney disease (AKD) happens between 7 and 90 days after an initial kidney injury (AKI). This period is crucial because it can determine whether the condition worsens into chronic kidney disease (CKD). Despite knowing this, there is no proven treatment to improve outcomes for people with AKD.
Recent studies have shown that drugs called sodium-glucose cotransporter 2 (SGLT2) inhibitors can slow down the worsening of chronic kidney disease, help with heart failure, and reduce the risk of death. Now, researchers are looking into whether these drugs can also help prevent acute kidney injury (AKI) and improve outcomes for AKD patients.
Our project will explore the use of SGLT2 inhibitors in patients with AKD, with the belief that these drugs can safely reduce the amount of protein (albumin) in the urine and improve kidney health. To address this, investigators plan to conduct a large, multicenter study in Taiwan. This study will be randomized and placebo-controlled, meaning some patients will receive the SGLT2 inhibitors while others will receive a placebo (a harmless, inactive substance). Investigators will include AKD patients with and without diabetes, focusing on reducing the protein in their urine and monitoring for any serious side effects.
The goal of this trial is to provide strong evidence on whether SGLT2 inhibitors can be an effective treatment for AKD. If successful, this could offer a new strategy to prevent the progression from AKI to CKD and improve the health and outcomes of patients with kidney disease.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| SGLT2i | Experimental | Drug: dapagliflozin, Drug: empagliflozin, Drug: canagliflozin |
| Control | Placebo comparator | Other: Other anti-diabetic drug or no anti-diabetic drug |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Age ≥ 18 years and < 80 years
- Diagnosed with acute kidney disease
- Estimated glomerular filtration rate (eGFR) ≥ 20 mL/min/1.73m²
- Albuminuria > 100 mg/g or proteinuria > 300 mg/g (adjusted by urine creatinine)
- Diagnosed with diabetes or chronic kidney disease
Key exclusion criteria (9 listed)
- Received sodium-glucose cotransporter 2 (SGLT2) inhibitors within 28 days prior to enrollment
- Patients with type 1 diabetes
- Receiving aggressive immunosuppressive therapy for glomerulonephritis
- Obstructive nephropathy
- Polycystic kidney disease
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 |
|---|---|---|
| dapagliflozinSodium-glucose cotransporter 2 inhibitor for 90 days during the acute kidney disease period. | Drug | SGLT2i |
| Other anti-diabetic drug or no anti-diabetic drugOther anti-diabetic drug or no anti-diabetic drug for 90 days during the acute kidney disease period. Other anti-diabetic drug includes metformin, sulfonylureas, meglitinides, dipeptidyl peptidase-4 inhibitor, insulin, α-glucosidase inhibitors, thiazolidinediones, and glucagon-like peptide-1 receptor agonist. | Other | Control |
| empagliflozinSodium-glucose cotransporter 2 inhibitor for 90 days during the acute kidney disease period. | Drug | SGLT2i |
| canagliflozinSodium-glucose cotransporter 2 inhibitor for 90 days during the acute kidney disease period. | Drug | SGLT2i |
Primary outcome
Albuminuria
Time frame: Day 28 and Day 90
The changes in albuminuria compared with baseline
Discontinuation of SGLT2i
Time frame: Day 0 to Day 90
Development of adverse events leading to discontinuation of SGLT2i
5 secondary outcomes
eGFR
Time frame: Day 28 to Day 84 or Day 28 to Day 168
Major adverse kidney events
Time frame: Day 0 to Day 180
Major adverse cardiovascular events
Time frame: Day 0 to Day 180
Death
Time frame: Day 0 to Day 180
Amputation
Time frame: Day 0 to Day 180
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 2 Jan 2026.
- Individual participant dataSharing planned: Undecided
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing dapagliflozin, Other anti-diabetic drug or no anti-diabetic drug and empagliflozin in people with Acute Kidney Injury, run by National Taiwan University Hospital at 1 site in Taiwan.
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 5 inclusion and 9 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: looking for participants now, as of the sponsor's last update on 2 Jan 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 Taiwan. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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?
Contact Szu-Yu Pan, MD, PhD (+886-23123456 ext. 41845, szuyupan@ntu.edu.tw), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Albuminuria (time frame: Day 28 and Day 90). The study lists 2 primary outcomes in all. 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 2 Jan 2026.