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

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What is this study about?

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.

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 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 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 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 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 Study?

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 Study?

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

Where you can join this trial?

Verified and Recommended Sites

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Verified Sites

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Other Sites

Site Name	City	Country
Centre Hospitalier De Colmar	Colmar	France
Groupe Hospitalier De La Region De Mulhouse Et Sud Alsace	Mulhouse	France
Centre Hospitalier Lyon Sud	Pierre Benite	France
Centre Hospital Region Metz Thionville	Metz	France
Czokwr Hxttjxrjmeu Rkzjkqzi Dpicpbactofogc	Angers	France
Cxdbtx Hbrpgcgrcnh Uxhgqejkpyybj Dv Dodaj	Dijon	France
Bqociayk Uiwkdxvsgp Hxzzlrpf Cqdbms	Besançon	France
Cghlne Hxgfzgwznnb Rfeupsqr Ufkvqvvwjoyms Do Tfjiy	Tours	France
Cqqx Dv Nzcmr	Vandoeuvre Les Nancy	France
Hfonpepb Utpcpwkdkclpgh Sjkkmuqsko &jzyldk Hknoqdx da Hseglxsnymz	STRASBOURG, Alsace	France

Trial status

Country	Status	Recruitment Start
France	Recruiting	01.06.2025

Trial locations

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.

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 ID:

2024-518493-14-00

Protocol code:

9416

Trial Phase:

Therapeutic use (Phase IV)

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

What is this study about?

Who Can Join the Study?

Who Cannot Join the Study?