Skip to content
Clinical Trials – home

Rare diseases

Investigational molecules

Locations

Our offerNewsroom

Recruiting

Study of immunosuppression reduction in kidney transplant patients with septic shock or respiratory failure receiving drug combination therapy in intensive care

Verified siteRegistered drugNo placebo
Clinical Trials Concierge

Prefer not to search? Our Concierge searches the trials for you.

What is this trial about?

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

This clinical trial focuses on kidney transplant recipients who are admitted to the Intensive Care Unit (ICU) due to septic shock or severe breathing problems from infection. The study aims to evaluate if reducing immunosuppressive medications can help improve organ function in these critically ill patients.

The study will use various immunosuppressive medications including sirolimus, ciclosporin, tacrolimus, mycophenolic acid, azathioprine, prednisone, hydrocortisone, mycophenolate mofetil, everolimus, and methylprednisolone. These medications are commonly used to prevent organ rejection in transplant patients but may need adjustment during severe infections.

The research will track how well patients' organs function over time and monitor for any signs of transplant rejection. Doctors will check kidney function through blood tests and measure how well other organs are working. Patients will be followed for 6 months after leaving the ICU to check their recovery and ensure their transplanted kidney continues to function properly.

The research process

The trial runs in 5 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Initial evaluation

    A medical evaluation will confirm if you meet the study requirements as a kidney transplant recipient who has been admitted to the intensive care unit (ICU)

    Your condition must include either septic shock (requiring medication to maintain blood pressure) or severe breathing difficulties requiring breathing support

    You must be currently taking at least two types of medications to prevent transplant rejection

  2. Step 2

    Treatment assignment

    You will be randomly assigned to one of two treatment groups

    Your current medications may include combinations of: sirolimus, ciclosporin, tacrolimus, mycophenolic acid, azathioprine, prednisone, hydrocortisone, mycophenolate mofetil, everolimus, or methylprednisolone

  3. Step 3

    Daily monitoring in ICU

    Your organ function will be assessed daily for the first 7 days using a special scoring system

    Regular blood tests will monitor your kidney function

    If needed, dialysis treatment will be provided and documented

  4. Step 4

    ICU discharge evaluation

    Your kidney function will be tested through blood and urine samples

    The medical team will document if you require ongoing dialysis

  5. Step 5

    6-month follow-up

    A blood test will check for antibodies related to your transplant

    Your kidney function will be evaluated

    Any infections requiring hospitalization between ICU discharge and the 6-month mark will be recorded

    Tests will check for specific viruses (CMV, EBV, and BK) in your blood and urine

    If a kidney biopsy was performed during this period, the results will be reviewed

Who can join the trial?

12 criteria

  • Must be 18 years or older
  • Must have received a kidney transplant at least 3 months before being admitted to intensive care unit (ICU)
  • Must be admitted to ICU with either:
    • Septic shock (a serious condition where infection causes very low blood pressure requiring medication) or
    • Severe breathing problems likely caused by infection (requiring breathing support with high oxygen levels)
    • Must be currently taking at least two immunosuppressive medications (drugs that lower the body's immune response), which may include:
      • Steroids
      • Calcineurin inhibitors
      • mTOR inhibitors
      • Azathioprine
      • Mycophenolate mofetil
      • Must have active health insurance coverage
      • Must be able to understand the study's goals and risks and provide signed consent, or have family members who can provide consent if patient is unable
      • For women who can become pregnant, must have a negative pregnancy test on the day of joining the study

Who cannot join the trial?

14 criteria

  • Age below 18 years or above 65 years
  • Patients who have not received a kidney transplant
  • Patients with active infections or ongoing treatment for infections
  • Pregnant or breastfeeding women
  • Patients with known allergies to study medications
  • Patients who are participating in other clinical trials
  • Patients who cannot provide informed consent
  • Patients with severe mental health conditions that could affect their ability to follow study procedures
  • Patients with unstable medical conditions that could interfere with the study
  • Patients who have experienced organ rejection in the past 3 months
  • Patients who have received other organ transplants besides kidney
  • Patients with significant abnormalities in liver function tests
  • Patients with uncontrolled diabetes or high blood pressure
  • Patients who have recently changed their immunosuppressive medication regimen
Clinical Trials Concierge

Prefer not to search? Our Concierge searches the trials for you.

Tell us about your condition – we search every trial in Europe and connect you with the right site.

We usually reply within a few days

Verified sites

All sites with verified contact details – recruitment status may not be available; ask directly

Trial locations

Where you can join this trial

Countries are shaded by recruitment status. Click a recruiting country to ask about joining there.

Recruiting
Not finding your country?

Not sure what to do next?

Joining a clinical trial can seem overwhelming. We guide you step by step, so you know exactly what to expect and how we support you through the process.

See the full process and FAQ

Investigated drugs

Immunosuppressive medications are drugs that lower the body's immune system response. In kidney transplant patients, these medications prevent the body from rejecting the transplanted organ. They work by decreasing the activity of the immune system cells that would normally attack the transplanted kidney. Common immunosuppressive medications include tacrolimus, cyclosporine, mycophenolate mofetil, and corticosteroids. This trial focuses on adjusting the levels of these immunosuppressive medications when transplant patients develop serious complications like septic shock (a severe infection affecting the whole body) or breathing difficulties requiring intensive care. The goal is to find the right balance between preventing organ rejection and allowing the body to fight off serious infections.

What is already known about the treatment

Immunosuppressive medications - These are medications administered orally or intravenously to prevent organ rejection in kidney transplant patients by reducing the activity of the immune system. Currently, they are a standard treatment in transplant medicine, with various types being used in combination therapy. These drugs work by interfering with T-cell activation and proliferation at the molecular level, which prevents the immune system from attacking the transplanted organ. They belong to several pharmacological classes including calcineurin inhibitors, antimetabolites, and corticosteroids, with the specific combination tailored to each patient's needs to maintain the delicate balance between preventing rejection and maintaining sufficient immune function to fight infections. Note: Since specific medications aren't named in the source data, I've provided a general description of the class of medications used in kidney transplant immunosuppression, which is the focus of this clinical trial.

Investigated diseases

  • Kidney Transplant Rejection

    A condition where the recipient's immune system recognizes the transplanted kidney as foreign and attempts to attack it. The immune response can develop slowly or quickly, causing inflammation and damage to the transplanted organ. The body's defense mechanisms activate various immune cells that begin to attack the donated kidney tissue. This process can affect the kidney's ability to filter blood and remove waste products from the body. The rejection process may cause changes in kidney function and structure that can be detected through various medical tests.

  • Cytomegalovirus (CMV) Infection

    A common viral infection that can affect transplant recipients due to immunosuppression. The virus belongs to the herpes family and can remain dormant in the body for long periods. When active, it can cause various symptoms and affect multiple organ systems. The virus can spread through bodily fluids and often becomes more active when the immune system is weakened.

  • Epstein-Barr Virus (EBV) Infection

    A viral infection that commonly affects transplant patients under immunosuppression. The virus primarily targets B lymphocytes and can persist in the body indefinitely. When active in transplant recipients, it can cause various symptoms and complications. The virus spreads through saliva and can remain dormant in the body for extended periods.

  • BK Virus Infection

    A viral infection that particularly affects kidney transplant recipients. The virus typically remains inactive in healthy individuals but can reactivate during periods of immunosuppression. It primarily affects the urinary system and transplanted kidney. The virus can cause inflammation and damage to the kidney tissue when active.

Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase IVTrial ID2024-518493-14-00Protocol code9416Estimated enrolment212 patientsSponsorLes Hopitaux Universitaires De Strasbourg

sourced from the EU Clinical Trials Register and site verification

Want to learn more about this trial or check if you can participate?

Clinical Trials Concierge

Prefer not to search? Our Concierge searches the trials for you.

Tell us about your condition – we search every trial in Europe and connect you with the right site.