Phase 3 Chronic Kidney Disease Trial, Recruiting NCT07025629 Sponsor: Assistance Publique - Hôpitaux de Paris Condition: Chronic Kidney Disease
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Phase 3 Chronic Kidney Disease Trial, Recruiting

NCT07025629
Recruiting Phase 3

Who may be able to join

AI generated eligibility summary. Written by an AI model from the official source data and checked on a sample basis. It can contain mistakes, so confirm anything important against the original source. How we use AI

Who might be able to join this trial:

  • Adults aged 18 years or older
  • People who needed a breathing machine (mechanical ventilator) and/or heart/blood pressure support medications for more than 24 hours during their ICU stay
  • People whose doctor has decided they are ready to leave the ICU
  • People who have signed the informed consent form agreeing to take part
  • People whose blood test results show certain markers of heart or kidney stress — specifically, elevated heart stress proteins (NT-proBNP above 800 ng/L or BNP above 90 ng/L) and/or a kidney filtering rate (eGFR) between 25 and 90 ml/min/1.73m² at the time of joining the trial

Who may not be able to join:

  • People who are pregnant
  • Women who could become pregnant and who do not agree to use an effective form of contraception throughout the study and until the relevant treatment has left the body (confirm with trial site for the full list of accepted contraception methods)
  • People who are breastfeeding
  • People with a known allergy to the study drug (dapagliflozin) or any of its ingredients
  • People who were already taking dapagliflozin before their ICU admission
  • People with severe liver scarring/failure (classified as Child-Pugh C)
  • People who had or developed a urinary tract infection or a perineal (groin/genital area) infection during their ICU stay, or who have a skin wound near that area (such as a pressure sore near the tailbone) that raises the risk of infection
  • People whose kidney filtering rate (eGFR) is below 25 ml/min/1.73m²
  • People for whom international medical guidelines already strongly recommend dapagliflozin as a standard treatment — this includes certain people with type 2 diabetes not well controlled by current treatment, people with symptomatic chronic heart failure, or people with chronic kidney disease meeting specific criteria who have been on certain blood pressure medications for at least 4 weeks (confirm with trial site)
  • People who do not have national health insurance, or who receive state medical aid (AME)
  • People whose freedom is restricted by a court or administrative order
  • People currently taking part in another interventional clinical trial

Important: Always verify eligibility with the trial site directly before applying.

Based on publicly available eligibility criteria from ClinicalTrials.gov. Verify directly with the trial site before acting. This is not medical advice.

This is a simplified plain English summary of the eligibility criteria. Full criteria are set by the trial investigators and may include additional requirements not shown here. Never self-exclude from a trial based on this summary. Contact the trial site directly to confirm your eligibility.
Last synced 26 July 2026
Phase 3: approximately ~65% of drugs entering this phase reach regulatory approval, based on published industry-wide historical data. This is not specific to this trial.
Phase success rates shown are historical industry-wide averages based on published data. They are not a prediction for this specific trial or your individual situation.

Contact this trial

Principal Investigator: Alexandre Mebazaa, MD-PHD, APHP

Phone: 0142499570

Contact details sourced from ClinicalTrials.gov. Verify directly with the trial site before attending.

GP referral letter

Print a one-page summary to share with your doctor.

Trial details

Status
Recruiting
Phase
Phase 3
Registry
ClinicalTrials.gov
Start date
2 December 2025
Est. completion
15 January 2029

Where this trial is recruiting

🇫🇷 France

Primary endpoints

All-cause mortality; Unscheduled hospital hospitalization for heart failure; Decrease of eGFR by more than 50% from ICU discharge and/or end stage kidney disease defined as an eGFR<15ml/min/1.73m² and/or initiation of renal replacement therapy and/or kidney transplantation

Can't join this trial?

Expanded access pathways

If this trial is not available to you, other access pathways may exist. In Australia, the TGA Special Access Scheme allows access to unapproved therapeutic goods for individual patients.

TGA Special Access Scheme information

Find other recruiting trials on ClinicalTrials.gov

Data last synced from ClinicalTrials.gov: 26 July 2026. Trial status can change. Always verify current status directly with the trial site before making any decision.

Trial recruitment status can change without notice between our nightly data updates. Always contact the trial site directly to confirm current recruitment status before making any decisions or travel arrangements.

View original record on ClinicalTrials.gov