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Study on Tacrolimus and Sirolimus for Kidney Transplant Patients at High Risk of Cytomegalovirus Infection

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What is this trial about?

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

This clinical trial focuses on patients with advanced chronic kidney disease who have undergone a kidney transplant. The study aims to explore two different treatment approaches to prevent cytomegalovirus (CMV) infection, a common virus that can cause complications after a transplant. The treatments being studied include a combination of tacrolimus and MTOR inhibitors with anticipatory therapy, compared to tacrolimus and mycophenolic acid with universal prophylaxis. The goal is to determine which approach is more effective in preventing CMV infection in patients at high risk after their transplant.

Participants in the study will receive one of the two treatment combinations. The first group will take tacrolimus and MTOR inhibitors, while the second group will take tacrolimus and mycophenolic acid. Both groups will be monitored for their immune response to CMV before the transplant and at 15, 30, and 90 days after the transplant. The study will also track the presence of CMV infection or disease six months after the transplant to evaluate the effectiveness of each treatment approach.

The study will last until the end of 2026, with recruitment starting in mid-2025. Participants will be closely monitored throughout the study to ensure their safety and to gather data on the effectiveness of the treatments. The findings from this study could help improve the management of CMV infection in kidney transplant recipients, potentially leading to better outcomes for patients with advanced chronic kidney disease.

The research process

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

Step 1
Joining the study
Upon joining the study, the participant will be required to sign an informed consent form, indicating agreement to participate in the clinical trial.
Step 2
Initial treatment phase
The participant will receive an immunosuppressive induction treatment with thymoglobulin. This involves between 1 and 5 doses administered through an intravenous infusion.
Step 3
Medication regimen
The participant will begin a medication regimen that includes several drugs:
Mycophenolic acid (Myfortic 180 mg) will be taken orally in the form of gastro-resistant tablets.
Sirolimus (Rapamune 0.5 mg) will be taken orally as coated tablets.
Prednisone (prednisona cinfa 5 mg) will be taken orally as tablets.
Tacrolimus (Advagraf 1 mg) will be taken orally as prolonged-release hard capsules.
Methylprednisolone sodium succinate (Urbason 40 mg) will be administered as an intravenous injection.
Valganciclovir (Valganciclovir Aurovitas 450 mg) will be taken orally as film-coated tablets.
Step 4
Monitoring phase
The participant's CMV-specific cellular immune response will be monitored before transplantation and at 15, 30, and 90 days post-transplantation using a test called Quantiferon-CMV.
Step 5
Evaluation of primary endpoint
The primary endpoint of the study is to assess the presence of CMV infection or disease after renal transplantation. This will be evaluated at 6 months post-transplantation.

Who can join the trial?

4 criteria

Age must be 18 years or older.
Must have a positive test for IgG CMV antibodies. This means your blood test shows you have been exposed to a virus called CMV in the past.
Must receive a specific type of treatment called immunosuppressive induction treatment with thymoglobulin. This involves getting between 1 and 5 doses of a medication that helps prevent your immune system from attacking a new organ after a transplant.
Must agree to participate in the study by signing a form that explains the study and confirms your willingness to join.

Who cannot join the trial?

1 criterion

Patients with advanced chronic renal insufficiency cannot participate. This means if your kidneys are not working well over a long period, you may not be eligible.

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Responsive
Fundacion Para La Investigacion Biomedica Del Hospital Universitario La Paz
Madrid, Spain

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Investigated drugs

Tacrolimus
is a medication used to help prevent the body from rejecting a transplanted organ, such as a kidney. It works by weakening the immune system so that it does not attack the new organ. In this trial, tacrolimus is used as part of a treatment plan for patients who have received a kidney transplant.
MTOR Inhibitors
are a type of medication that helps to prevent organ rejection after a transplant. They work by blocking a specific protein in the body that is involved in cell growth and immune response. This helps to keep the immune system from attacking the transplanted organ. In this study, MTOR inhibitors are used alongside tacrolimus to help protect the new kidney.
Mycophenolic Acid
is another medication used to prevent organ rejection in people who have received a kidney transplant. It works by stopping the immune system from producing cells that can attack the new organ. In this trial, mycophenolic acid is used with tacrolimus as part of a treatment plan to help ensure the transplanted kidney is not rejected by the body.

What is already known about the treatment

Tacrolimus
Tacrolimus is administered orally or intravenously and is used to help prevent organ rejection in patients who have received a kidney transplant. It is currently well-established in medical practice and literature as an immunosuppressant. The main therapeutic indication for tacrolimus is to reduce the body's immune response to the transplanted organ, thereby preventing rejection. At the molecular level, tacrolimus works by inhibiting a protein called calcineurin, which is crucial for activating T-cells, a type of white blood cell involved in the immune response. It is classified pharmacologically as a calcineurin inhibitor.
MTOR inhibitors
MTOR inhibitors are typically administered orally and are used in the context of organ transplantation to prevent rejection. They are recognized in medical literature as effective immunosuppressants. The primary therapeutic use of MTOR inhibitors is to suppress the immune system to prevent the body from attacking the transplanted organ. These inhibitors work by blocking a protein called mTOR, which is involved in cell growth and proliferation, including that of immune cells. They belong to the pharmacological class of immunosuppressants.
Mycophenolic acid
Mycophenolic acid is usually taken orally and is used to prevent organ rejection in kidney transplant patients. It is well-documented in medical literature as an effective immunosuppressant. The main therapeutic indication is to reduce the immune system's activity to prevent it from attacking the transplanted organ. Mycophenolic acid works by inhibiting an enzyme called inosine monophosphate dehydrogenase, which is necessary for the production of DNA in immune cells, thus reducing their proliferation. It is classified as an antimetabolite immunosuppressant.

Investigated diseases

Chronic Kidney Disease – Chronic kidney disease is a long-term condition characterized by a gradual loss of kidney function over time. The kidneys become less effective at filtering waste and excess fluids from the blood, leading to their accumulation in the body. As the disease progresses, symptoms such as fatigue, swelling in the legs and ankles, and changes in urination patterns may occur. In advanced stages, the kidneys may fail to function adequately, necessitating dialysis or transplantation. The progression of the disease can vary, with some individuals experiencing a slow decline in kidney function, while others may progress more rapidly. Chronic kidney disease is often associated with other health conditions, such as high blood pressure and diabetes, which can further impact its progression.