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Study on the Effects of Irbesartan After Acute Kidney Injury in Patients Discharged from ICU

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What is this trial about?

A plain-language summary of the goals, design and what participants do

This clinical trial is focused on studying the effects of a treatment for patients who have experienced acute kidney injury (AKI) and are being discharged from the Intensive Care Unit (ICU). The treatment being tested involves the use of a medication called Irbesartan, which is an angiotensin receptor blocker. This type of medication is commonly used to manage high blood pressure and protect the kidneys. The study will compare the effects of Irbesartan with a placebo to understand its impact on patients' health after they leave the ICU.

The purpose of the study is to evaluate how the treatment affects the heart and overall health of patients during the year following their discharge from the ICU. Participants in the study will receive either Irbesartan or a placebo, and their health will be monitored over the course of a year. The study aims to see if Irbesartan can help reduce the risk of major heart-related events, such as heart attacks or strokes, and improve kidney function in patients who have had AKI.

Throughout the study, researchers will track various health outcomes, including the occurrence of any new episodes of AKI, changes in kidney function, and any heart-related issues. The study will also collect biological samples at the beginning and end of the study to help understand the effects of the treatment. This research is important for finding better ways to support patients recovering from AKI and improve their long-term health outcomes.

The research process

The trial runs in 4 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Joining the study

    Upon joining the study, you will be randomly assigned to receive either the medication Irbesartan or a placebo. A placebo is a substance with no active medication, used to compare effects.

    The medication or placebo will be in the form of a film-coated tablet and will be taken by mouth.

  2. Step 2

    Medication administration

    You will take one tablet of Irbesartan 150 mg or the placebo once daily. This will continue for the duration of the study, which is up to one year after your discharge from the intensive care unit (ICU) or transitional care unit (TCU).

  3. Step 3

    Monitoring and follow-up

    Your health will be monitored throughout the study. This includes regular check-ups to assess your kidney function and overall health.

    You will be evaluated for any major adverse cardiovascular events, such as heart failure, stroke, or heart attack, during the year following your discharge from the ICU or TCU.

  4. Step 4

    End of study assessments

    At the end of the study, your kidney function will be assessed again to determine any changes from the start of the study.

    A biological collection will be taken at the beginning and end of the study to help understand the effects of the treatment.

Who can join the trial?

6 criteria

  • Male or female patients who are 18 years of age or older.
  • Patients who had an acute kidney injury during their stay in the Intensive Care Unit (ICU). Acute kidney injury is a sudden decrease in kidney function.
  • Patients whose kidney function has stabilized for at least 48 hours. This means their kidney function is not getting worse and is either improving or staying the same.
  • Patients who are ready to be discharged from the ICU or Transitional Care Unit (TCU) and this must happen within 30 days after their discharge.
  • Patients must be affiliated with a Social Security System.
  • Women who can have children and men must agree to use effective birth control methods until the end of the study.

Who cannot join the trial?

3 criteria

  • Patients who have not fully or partially recovered from acute kidney injury cannot participate. Acute kidney injury is a sudden episode of kidney failure or damage that happens within a few hours or days.
  • Patients who are not within the specified age range for the study cannot participate. The study is open to certain age groups only.
  • Patients who belong to vulnerable populations, such as those who cannot give consent or are at higher risk, are not eligible.
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Investigated drugs

Angiotensin Receptor Blocker (ARB) is a type of medication used in this clinical trial. It works by blocking certain receptors in the body that are responsible for tightening blood vessels. By doing so, it helps to relax and widen the blood vessels, which can lower blood pressure and improve blood flow. This medication is being studied to see if it can help improve heart and kidney health in patients who have had acute kidney injury and are recovering after being in the Intensive Care Unit (ICU).

What is already known about the treatment

Angiotensin Receptor Blocker (ARB) – This medication is typically taken orally in the form of a tablet. It is currently being studied in clinical trials to assess its effectiveness in improving outcomes for patients who have experienced acute kidney injury and have been discharged from intensive care. The main therapeutic use of ARBs is to help manage high blood pressure and protect the kidneys, especially in patients with heart conditions. At the molecular level, ARBs work by blocking the action of a hormone called angiotensin II, which normally causes blood vessels to tighten. By blocking this hormone, ARBs help relax blood vessels, lowering blood pressure and reducing strain on the heart. They are classified as antihypertensive agents.

Investigated diseases

Acute kidney injury – Acute kidney injury is a sudden episode of kidney failure or kidney damage that happens within a few hours or a few days. It causes a build-up of waste products in the blood and makes it hard for the kidneys to maintain the right balance of fluid in the body. The condition can lead to a decrease in urine output, although occasionally urine output remains normal. Other symptoms may include swelling in the legs, ankles, and around the eyes, as well as fatigue and shortness of breath. The progression of acute kidney injury can vary, with some individuals experiencing a full recovery, while others may develop chronic kidney disease. In severe cases, it can lead to permanent kidney damage.
Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2024-515845-40-00Protocol codeAPHP 200040Estimated enrolment508 patientsSponsorAssistance Publique Hopitaux De Paris

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