Kidney shield? diabetes drug tested to prevent ICU kidney failure
NCT ID NCT05468203
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study tested whether dapagliflozin, a drug used for diabetes and chronic kidney disease, could prevent acute kidney injury in critically ill patients in the intensive care unit (ICU). The trial planned to enroll 3,000 adults but was terminated early after only 51 participants. Patients were randomly assigned to receive either dapagliflozin or a placebo daily for up to 30 days while in the ICU.
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Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 3
Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.
- Participants
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51 people
The number who actually took part.
- Started
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Nov 2023
- Finished
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Dec 2025
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: * 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: * 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 Exclusion Criteria: * 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 * 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
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
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Austin Health
Heidelberg, Victoria, 3084, Australia
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Epworth Richmond
Richmond, Victoria, 3121, Australia
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Grampians Health
Ballarat, Victoria, 3350, Australia
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