Acute Kidney InjuryPhase 3PREVENTS-AKINCT05468203
PREVENTion With Sglt-2 Inhibition of Acute Kidney Injury in Intensive Care
A Phase 3 study testing Dapagliflozin 10mg Tab in people with Acute Kidney Injury, run by The George Institute at 3 sites in Australia.
Trial summary
Background Acute Kidney Injury (AKI) is a potentially life-threatening condition caused by unsafe levels of fluid and waste products accumulating in the body. Often, patients with AKI need treatment with an artificial kidney (called renal replacement therapy or dialysis) to do the work of their kidneys and remove… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Acute Kidney Injury
- What is being tested?
- Dapagliflozin 10mg Tab
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 51 participants
- Where
- 3 sitesAustralia
- Study dates
- 29 Nov 2023to 23 Dec 2025
- Phase
- Phase 3
- Are there results?
- None posted in the registry
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
- Age 18 years or more
- Admitted to ICU within the last 7 days
- Expected to be in the ICU the day after tomorrow
- An arterial or central venous catheter is in situ, or placement is planned for routine management
- Able to receive study treatment orally or via enteral route
- At least one of the following risk factors for AKI:
Show all 16Show fewer
- Required fluid resuscitation, defined as a bolus of fluid prescribed to be given over ≤1 hour to increase or maintain intravascular volume that is in addition to maintenance fluids
- Being treated with continuous vasopressors or inotropes to maintain a systolic blood pressure > 90mmHg, or mean arterial blood pressure > 60mmHg or a MAP target set by the treating clinician for maintaining perfusion
- At least one of the following pre-morbid risk factors:
- Treatment for high blood pressure
- Treatment for type 2 diabetes (minimum diet therapy)
- Atherosclerotic cardiovascular disease
- History of heart failure
- Impaired renal function, defined as an eGFR between 20 - 60 mL/min/1.73m2
- Estimated BMI 30 kg/m2 or more
- Age 60 years or more
Who cannot join
- Met all inclusion criteria more than 24 hours ago
- History of type 1 diabetes mellitus or diabetic ketoacidosis
- COVID-19 infection as the reason for ICU admission
- Requiring renal replacement therapy for intoxication
- eGFR less than 20 mL/min/1.73m2
- Known hypersensitivity to any SGLT-2 inhibitor e.g. dapagliflozin, canagliflozin, empagliflozin, ertugliflozin
Show all 14Show fewer
- Solid organ transplantation within the last 12 months
- Likely to be transferred to another hospital in the next 3 days
- Known or suspected pregnancy
- Death is deemed imminent or inevitable
- Life expectancy is estimated to be less than 90 days
- Patient or the treating clinician declines to participate
- Enrolled in another interventional trial for which co-enrolment is not approved
- Patient has previously been enrolled in the PREVENTS-AKI Study
Trial locations and contacts
3 sites in 1 country.
Australia3 sites
Grampians Health
Ballarat, Victoria, 3350
Austin Health
Heidelberg, Victoria, 3084
Epworth Richmond
Richmond, Victoria, 3121
About this study
Background Acute Kidney Injury (AKI) is a potentially life-threatening condition caused by unsafe levels of fluid and waste products accumulating in the body. Often, patients with AKI need treatment with an artificial kidney (called renal replacement therapy or dialysis) to do the work of their kidneys and remove these dangerous levels of fluid and waste from the body. If left untreated, AKI can become a chronic (long-term) condition that may require treatment for life.
Dapagliflozin is a medication used to treat patients with diabetes, heart disease and long-term (chronic) kidney disease. Recently, Dapagliflozin has been shown to slow the progression of other kidney related complications, however this has not yet been studied in critically ill patients.
Read more
Aim To determine if giving Dapagliflozin (one tablet a day) compared to placebo (a tablet that looks identical but has no active ingredients), decreases injury to the kidneys in patients admitted to the Intensive Care Unit.
Design This study will enrol 3000 patients from 45-50 hospitals worldwide. It is a 'randomised controlled trial' meaning patients will be randomly assigned (like tossing a coin) by a computer to receive either Dapagliflozin or placebo for a maximum of 30 days whilst in the ICU. The study is also a 'double blinded trial' meaning that neither the doctor, the intensive care staff or the patient will know which study treatment they are receiving.
Read the detailed description
Acute kidney injury (AKI) is an increasingly common complication of hospitalisation globally, and a major driver of poor patient outcomes, including higher mortality and reduced quality of life. While numerous studies, including several led by investigators in this grant team, have tested treatments to reduce the impact of AKI, none have been shown to improve outcomes. The absence of any proven therapy highlights a critical unmet need.
A novel class of medicines, inhibitors of the sodium-glucose co-transporter II (SGLT-2 inhibitors), have been shown in recent years to have dramatic effects upon cardiovascular and renal outcomes in patients with heart failure at high risk for renal failure. The evidence suggests that these drugs might prevent AKI from occurring, but this has not been intentionally tested in adequately powered trials. A recently published randomised controlled trial evaluated the use of these drugs in acutely unwell COVID-19 patients and did not raise any safety concern in this acute setting. The trial also showed a numerically lower rate of AKI in those that received the SGLT-2 inhibitor dapagliflozin compared to placebo, but the trial was not sufficiently powered for this outcome.
The PREVENTion with Sglt2 inhibition of Acute Kidney Injury in intensive care (PREVENTS-AKI) trial, will test the effect of dapagliflozin versus placebo upon patients' risk of developing severe AKI in a population admitted to intensive care. This global trial will test the most promising treatment for mitigating the increased risk of AKI. The results will provide the first definitive insight into the prevention of AKI with these agents and will shape global clinical practice in an area where treatments are profoundly lacking.
- Conditions
- Acute Kidney Injury
- Being tested
- Dapagliflozin 10mg Tab, Placebo
- Keywords
- Kidney failure, Sodium Glucose cotransporter-2 inhibitors, Critically ill, Critical Care, ICU
- Medical subject headings
- Acute Kidney Injury, Renal Insufficiency, Critical Illness
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dapagliflozin 10mg TabDrug
Also called SGLT2 inhibitor
Patients will be randomly assigned to receive either dapagliflozin 10 mg or placebo daily while in ICU for up to 30 days
PlaceboDrug
Patients will be randomly assigned to receive either dapagliflozin 10 mg or placebo daily while in ICU for up to 30 days
| Study group | Role | What they receive |
|---|---|---|
| Dapagliflozin | Experimental | Dapaliflozin 10mg tablet administered once daily while in ICU for up to 30 days Receives: Drug: Dapagliflozin 10mg Tab |
| Matched Placebo | Placebo comparator | Matched placebo tablet administered once daily while in ICU for up to 30 days Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Composite outcome: Doubling of serum creatinine from baseline, initiation of renal replacement therapy or death
Proportion of patients experiencing a component of the composite outcome, defined as a doubling of serum creatinine from the study baseline value, initiation of RRT or death
Measured: Within 30 days of randomisation
Secondary outcomes (6)
Doubling of Serum Creatinine
Proportion of patients with a doubling of serum creatinine from baseline value
Measured: Within 30 days of randomisation
Requirement of Renal Replacement Therapy (RRT)
Proportion of patients requiring RRT
Measured: Within 30 days of randomisation
All-cause mortality
Proportion of patients who have died from any cause
Measured: Within 30 days of randomisation
Vasoactive drug therapy
Proportion of patients who were treated with vasoactive drugs
Measured: Within 30 days of randomisation
Mechanical ventilation
Proportion of patients who required mechanical ventilation
Measured: Within 30 days of randomisation
Ventricular tachycardia or ventricular fibrillation
Proportion of patients who experienced ventricular tachycardia or ventricular fibrillation lasting at least 30 seconds whilst in intensive care
Measured: Within 30 days of randomisation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jul 2022
- Study start29 Nov 2023
- Primary completion18 Jul 2025
- Study completion23 Dec 2025
Why it stopped: The vanguard phase is complete. Further phases did not proceed due to funding constraints. A revised methodology is planned, requiring a new protocol and approvals.
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.
- 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 3
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Prospective, international, multi-centre, double blinded, randomised controlled trial
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 51 participants (actual)
Sponsor and investigators
- Lead sponsor
- The George Institute
- Sponsor type
- University, hospital or other
- Collaborators
- University Medical Center Groningen, Australian and New Zealand Intensive Care Society Clinical Trials Group
- Responsible party
- Sponsor
- Investigators
- Martin P Gallagher, MBBS, FRACP, Study director, The George Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05468203
- Sponsor's protocol ID
- GI-RM-7738
- Acronym
- PREVENTS-AKI
- Status last verified
- Mar 2026
- First submitted
- 19 Jul 2022
- Last updated
- 30 Mar 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- PREVENTion With Sglt-2 Inhibition of Acute Kidney Injury in Intensive Care
- ClinicalTrials.gov ID
- NCT05468203
- Acronym / sponsor ID
- PREVENTS-AKI / GI-RM-7738
- Conditions
- Acute Kidney Injury
- Keywords
- Kidney failure, Sodium Glucose cotransporter-2 inhibitors, Critically ill, Critical Care, ICU
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: The vanguard phase is complete. Further phases did not proceed due to funding constraints. A revised methodology is planned, requiring a new protocol and approvals.
- Enrolment
- 51 participants (actual)
- Lead sponsor
- The George InstituteUniversity, hospital or other
- Collaborators
- University Medical Center Groningen, Australian and New Zealand Intensive Care Society Clinical Trials Group
- Study start
- 29 Nov 2023 (actual)
- Primary completion
- 18 Jul 2025 (actual)
- Study completion
- 23 Dec 2025 (actual)
- First posted
- 21 Jul 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.
Background Acute Kidney Injury (AKI) is a potentially life-threatening condition caused by unsafe levels of fluid and waste products accumulating in the body. Often, patients with AKI need treatment with an artificial kidney (called renal replacement therapy or dialysis) to do the work of their kidneys and remove these dangerous levels of fluid and waste from the body. If left untreated, AKI can become a chronic (long-term) condition that may require treatment for life.
Dapagliflozin is a medication used to treat patients with diabetes, heart disease and long-term (chronic) kidney disease. Recently, Dapagliflozin has been shown to slow the progression of other kidney related complications, however this has not yet been studied in critically ill patients.
Aim To determine if giving Dapagliflozin (one tablet a day) compared to placebo (a tablet that looks identical but has no active ingredients), decreases injury to the kidneys in patients admitted to the Intensive Care Unit.
Design This study will enrol 3000 patients from 45-50 hospitals worldwide. It is a 'randomised controlled trial' meaning patients will be randomly assigned (like tossing a coin) by a computer to receive either Dapagliflozin or placebo for a maximum of 30 days whilst in the ICU. The study is also a 'double blinded trial' meaning that neither the doctor, the intensive care staff or the patient will know which study treatment they are receiving.
Detailed description
Acute kidney injury (AKI) is an increasingly common complication of hospitalisation globally, and a major driver of poor patient outcomes, including higher mortality and reduced quality of life. While numerous studies, including several led by investigators in this grant team, have tested treatments to reduce the impact of AKI, none have been shown to improve outcomes. The absence of any proven therapy highlights a critical unmet need.
A novel class of medicines, inhibitors of the sodium-glucose co-transporter II (SGLT-2 inhibitors), have been shown in recent years to have dramatic effects upon cardiovascular and renal outcomes in patients with heart failure at high risk for renal failure. The evidence suggests that these drugs might prevent AKI from occurring, but this has not been intentionally tested in adequately powered trials. A recently published randomised controlled trial evaluated the use of these drugs in acutely unwell COVID-19 patients and did not raise any safety concern in this acute setting. The trial also showed a numerically lower rate of AKI in those that received the SGLT-2 inhibitor dapagliflozin compared to placebo, but the trial was not sufficiently powered for this outcome.
The PREVENTion with Sglt2 inhibition of Acute Kidney Injury in intensive care (PREVENTS-AKI) trial, will test the effect of dapagliflozin versus placebo upon patients' risk of developing severe AKI in a population admitted to intensive care. This global trial will test the most promising treatment for mitigating the increased risk of AKI. The results will provide the first definitive insight into the prevention of AKI with these agents and will shape global clinical practice in an area where treatments are profoundly lacking.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Prospective, international, multi-centre, double blinded, randomised controlled trial
| Arm | Type | Receives |
|---|---|---|
| Dapagliflozin | Experimental | Drug: Dapagliflozin 10mg TabDapaliflozin 10mg tablet administered once daily while in ICU for up to 30 days |
| Matched Placebo | Placebo comparator | Drug: PlaceboMatched placebo tablet administered once daily while in ICU for up to 30 days |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (16 listed)
- Age 18 years or more
- Admitted to ICU within the last 7 days
- Expected to be in the ICU the day after tomorrow
- An arterial or central venous catheter is in situ, or placement is planned for routine management
- Able to receive study treatment orally or via enteral route
Key exclusion criteria (14 listed)
- Met all inclusion criteria more than 24 hours ago
- History of type 1 diabetes mellitus or diabetic ketoacidosis
- COVID-19 infection as the reason for ICU admission
- Requiring renal replacement therapy for intoxication
- eGFR less than 20 mL/min/1.73m2
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 |
|---|---|---|
| Dapagliflozin 10mg TabAlso: SGLT2 inhibitorPatients will be randomly assigned to receive either dapagliflozin 10 mg or placebo daily while in ICU for up to 30 days | Drug | Dapagliflozin |
| PlaceboPatients will be randomly assigned to receive either dapagliflozin 10 mg or placebo daily while in ICU for up to 30 days | Drug | Matched Placebo |
Primary outcome
Composite outcome: Doubling of serum creatinine from baseline, initiation of renal replacement therapy or death
Time frame: Within 30 days of randomisation
Proportion of patients experiencing a component of the composite outcome, defined as a doubling of serum creatinine from the study baseline value, initiation of RRT or death
6 secondary outcomes
Doubling of Serum Creatinine
Time frame: Within 30 days of randomisation
Requirement of Renal Replacement Therapy (RRT)
Time frame: Within 30 days of randomisation
All-cause mortality
Time frame: Within 30 days of randomisation
Vasoactive drug therapy
Time frame: Within 30 days of randomisation
Mechanical ventilation
Time frame: Within 30 days of randomisation
Ventricular tachycardia or ventricular fibrillation
Time frame: Within 30 days of randomisation
Results and safety
The study was stopped early (reason given: The vanguard phase is complete. Further phases did not proceed due to funding constraints. A revised methodology is planned, requiring a new protocol and approvals.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Mar 2026.
Related trials for Acute Kidney Injury
Not yet recruiting
Vitamin C for Acute Kidney Injury in ACLF With Septic Shock: A Randomized Controlled Trial
Acute-on-Chronic Liver Failure (ACLF)
Not yet recruiting
Early Biomarker Kidney Injury Assessment After Acumen Directed Fluid Management in Cardiac Surgery
Renal Injury, Acute Kidney Injury
Recruiting
Acute Kidney Injury and Ultra-endurance Running
AKI (Acute Kidney Injury) Due to Trauma
Recruiting
WIN Ratio Analysis to Determine a Strategy of Non- Invasive SUpport for Respiratory Failure in the EmeRgency Department
Acute Hypoxic Respiratory Failure, Acute Respiratory Distress Syndrome (ARDS)
Not yet recruitingObservational study
Diastolic Shock Index for Predicting Hemodynamic Instability During Continuous Renal Replacement Therapy
Acute Kidney Injury, Hypotension (MeSH: D007022)
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.
Martin P Gallagher, MBBS, FRACP study director
The George Institute
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Dapagliflozin 10mg Tab in people with Acute Kidney Injury, run by The George Institute at 3 sites in Australia.
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 16 inclusion and 14 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: stopped early, as of the sponsor's last update on 30 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Australia. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: The vanguard phase is complete. Further phases did not proceed due to funding constraints. A revised methodology is planned, requiring a new protocol and approvals.). Results are not available in the source record.
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?
Composite outcome: Doubling of serum creatinine from baseline, initiation of renal replacement therapy or death (time frame: Within 30 days of randomisation). 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 30 Mar 2026.