Can a diabetes pill shield hearts and kidneys after ICU?
NCT ID NCT07025629
First seen Jun 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time
Summary
This phase 3 trial tests whether the drug dapagliflozin (Farxiga) can reduce deaths and heart or kidney problems in people leaving the intensive care unit (ICU). About 600 adults who needed a breathing machine or blood pressure support will take either the drug or a placebo daily for 12 months. The goal is to see if this simple pill can improve long-term outcomes for ICU survivors.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- Dapagliflozin (Farxiga) 10 mg oral tablet
- What this could lead to
- If it works, this could provide a simple daily pill to protect the heart and kidneys of people leaving the ICU, potentially reducing deaths and hospital readmissions.
- What could go wrong
- This is a phase 3 trial, but it is still testing a new use for an existing drug. The results may not apply to all ICU survivors, and side effects like dehydration or infections are possible.
This is an AI summary of the original study and may miss details. Read our disclaimer.
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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About 600 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Dec 2025
- Expected to finish
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Jan 2029
An estimate. End dates often move.
- 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 \>or= 18 years * Mechanical ventilation and/or vasopressors/inotropes for more than 24h during ICU stay * Patients ready to be discharged from ICU according to physician in charge * Inform consent form signed by the patient * NT-proBNP greater than 800 ng/L or BNP \> 90 ng/L and/or Estimated glomerular filtration rate (eGFR) between 25ml/min/1.73m² and 90ml/min/1.73m² of body-surface area (CKD-EPI formula) at inclusion. Exclusion Criteria: * Pregnancy * Ability to become pregnant and refusal to use effective contraception during all study treatment Women of childbearing potential (WOCBP)\*\* must agree to use adequate contraception according to Recommendations related to contraception and pregnancy testing in clinical trials, by Clinical Trial Facilitation Group (CTFG). The inclusion of WOCBP requires use of a highly effective contraceptive measure : * combined (estrogen and progestogen containing) hormonal contraception associated with inhibition of ovulation * oral * intravaginal * transdermal * progestogen-only hormonal contraception associated with inhibition of ovulation * oral * injectable * implantable * intrauterine device (IUD) * intrauterine hormone-releasing system ( IUS) * bilateral tubal occlusion * vasectomised partner * sexual abstinence The above mentioned risk mitigation measures (contraception) should be maintained during treatment and until the end of relevant systemic exposure. \*\* a woman is considered of childbearing potential (WOCBP), i.e. fertile, following menarche and until becoming post-menopausal unless permanently sterile. Permanent sterilisation methods include hysterectomy, bilateral salpingectomy and bilateral oophorectomy. A postmenopausal state is defined as no menses for 12 months without an alternative medical cause. A high follicle stimulating hormone (FSH) level in the postmenopausal range may be used to confirm a post-menopausal state in women not using hormonal contraception or hormonal replacement therapy. However in the absence of 12 months of amenorrhea, a single FSH measurement is insufficient. * Breast feeding * Known hypersensitivity to dapagliflozin or any of the excipients * Patients treated with dapagliflozin before ICU admission * Patients with severe cirrhosis (Child-Pugh C) * Patients who admitted or who developed during their ICU stay a urinary tract infection or a perineal infection and patients at risk of skin infection near the perineum (e.g., a sacral pressure ulcer) * Estimated glomerular filtration rate (eGFR) below 25 ml per minute per 1.73 m2 of body-surface area (CKD -EPI formula). * Patient for whom treatment with Dapagliflozine is strongly recommended according to recent international guidelines: * patients with type 2 diabetes mellitus adults for whom the treatment is inadequately controlled as an adjunct to diet and exercise: either as monotherapy when metformin is considered inappropriate due to inadequate tolerance, or in addition to other medications for the treatment of type 2 diabetes, * symptomatic chronic heart failure with reduced or preserved left ventricular ejection fraction, * chronic kidney disease, in addition to standard therapy with a glomerular filtration rate (GFR) between 25 and 75 mL/min/1.73m² and a urinary albumin-to-creatinine ratio (ACR) between 200 and 5000 mg/g and treated for at least 4 weeks with an ACE inhibitor or angiotensin 2 receptor blocker (ARB II or sartan). * Patient without national health insurance, and patient on AME (state medical aid) * Persons deprived of liberty by a judicial or administrative decision * Participation in other interventional 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.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
2 sites. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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Hospital Saint Louis
RECRUITINGParis, 75010, France
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Saint Louis Hospital
NOT_YET_RECRUITINGParis, 75010, France
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