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

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What is this study about?

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.

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.

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.

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.

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.

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 Study?

  • 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 Study?

  • 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.

Where you can join this trial?

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Other Sites

Site Name City Country Status
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Want to learn more about this study or check if you can participate? Contact us.

Trial status

Country Status Recruitment Start
Spain Spain
Recruiting
01.06.2025

Trial locations

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.

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.

Trial ID:
2025-520854-12-00
Protocol code:
TIMTOR
Trial Phase:
Therapeutic confirmatory (Phase III)

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