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Comparison of Tacrolimus alone versus Tacrolimus, Mycophenolate mofetil and Prednisone combination in elderly kidney transplant patients to reduce infections

Verified siteRegistered drugNo placebo
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What is this trial about?

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

This study focuses on elderly patients who have received a kidney transplant. The research examines whether using a single medication approach with tacrolimus alone works better than the standard treatment that combines three different medications (tacrolimus, mycophenolate mofetil, and prednisone). The purpose is to determine if using fewer medications can reduce the risk of infections and improve quality of life in older transplant recipients.

The medications used in this study are taken by mouth daily. Tacrolimus is a medication that helps prevent the body from rejecting the transplanted kidney by suppressing the immune system. The standard treatment includes two additional immune-suppressing medications: mycophenolate mofetil, which also helps prevent organ rejection, and prednisone, which is a steroid medication that reduces inflammation and suppresses the immune system.

The study will follow participants for three years after their kidney transplant. During this time, researchers will monitor the occurrence of infections, the function of the transplanted kidney, and how well patients feel overall. They will also check how well the transplanted kidney is working through regular medical tests and track any complications that may occur.

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

    Initial medication phase

    After your kidney transplant, you will receive three medications: tacrolimus, mycophenolate mofetil, and prednisone.

    All medications will be taken by mouth according to the prescribed schedule.

    This initial phase begins immediately after your transplant surgery.

  2. Step 2

    Monitoring period

    Your kidney function will be regularly checked through blood tests that measure eGFR (estimated glomerular filtration rate) and 24-hour urine collection.

    Blood tests will be performed to check for the presence of viruses, including cytomegalovirus and BK-virus.

    Additional blood tests will be conducted at 6 months, 1 year, 2 years, and 3 years to monitor your immune system response.

  3. Step 3

    Follow-up visits

    Regular medical appointments will be scheduled to monitor your health status.

    You will complete quality of life assessments during these visits.

    Your kidney transplant function will be evaluated through regular testing.

  4. Step 4

    Study completion

    The study will continue for 3 years after your transplant.

    Final evaluations will include kidney function tests, immune system monitoring, and quality of life assessment.

    The last visit will include comprehensive medical examination and laboratory tests.

Who can join the trial?

6 criteria

  • Patient must be 60 years of age or older
  • Patient must be receiving either a deceased donor or living donor kidney transplant
  • Patient must not have donor-specific anti-HLA antibodies (proteins in the blood that could react against the donor's tissue) at the time of transplantation
  • Previous kidney transplant recipients can participate if they meet all other criteria
  • Both men and women can participate
  • Patient must be able to understand and sign a written informed consent document

Who cannot join the trial?

15 criteria

  • Age below 18 years or above 65 years
  • Previous organ transplants other than current kidney transplant
  • Active or chronic infections (conditions where harmful microorganisms are present in the body)
  • Current pregnancy or breastfeeding
  • Known allergies to immunosuppressive medications (drugs that lower the body's immune response)
  • Severe heart, liver, or lung disease
  • Active cancer or history of cancer in the past 5 years
  • Uncontrolled diabetes (high blood sugar levels)
  • Mental conditions that could affect ability to follow study procedures
  • Participation in other clinical trials within the past 30 days
  • History of substance abuse within the past 2 years
  • Inability to provide informed consent
  • Severe kidney dysfunction (poor kidney function) despite transplantation
  • History of organ rejection episodes in the past 6 months
  • Unstable medical condition that could interfere with study participation
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Investigated drugs

Tacrolimus is an immunosuppressive medication that helps prevent organ rejection after kidney transplantation. It works by weakening the immune system's response to the transplanted kidney, making it less likely for the body to reject the new organ. This medication is being studied as a single-drug therapy approach. Standard triple immunosuppressive therapy includes a combination of three different medications typically used after kidney transplantation to prevent organ rejection. This is the traditional approach that combines multiple medications to suppress the immune system. Note: The trial compares using tacrolimus alone versus the standard combination of three immunosuppressive medications in elderly kidney transplant recipients, with the goal of reducing infection-related complications while maintaining adequate protection against organ rejection.

What is already known about the treatment

Tacrolimus - An immunosuppressive medication administered orally or intravenously, primarily used to prevent organ rejection in kidney transplant recipients. This calcineurin inhibitor works by suppressing T-cell activation in the immune system, thereby reducing the risk of transplant rejection. Tacrolimus belongs to the macrolide class of immunosuppressants and has become a cornerstone of transplant medicine, often prescribed as part of a multi-drug regimen, though recent trials are exploring its effectiveness as monotherapy, particularly in elderly kidney transplant recipients to reduce infection-related complications while maintaining adequate immunosuppression.

Investigated diseases

  • End-stage Kidney Disease

    A condition where the kidneys permanently lose their ability to filter waste from the blood and perform other essential functions. The disease develops gradually as kidney function progressively declines. When kidneys reach this stage, they operate at less than 15% of their normal capacity. This condition leads to fluid retention, electrolyte imbalances, and the build-up of waste products in the body. The disease typically results from other long-term health conditions that damage the kidneys over time.

  • Cytomegalovirus Infection

    A common viral infection that belongs to the herpes virus family. The virus can remain dormant in the body for long periods and may reactivate when the immune system is weakened. In transplant recipients, the virus can become active due to immunosuppression. The infection can affect various organs and tissues in the body.

  • BK Virus Infection

    A common virus that often remains inactive in healthy individuals. The virus typically resides in the urinary tract and kidneys without causing problems in people with normal immune systems. In transplant recipients who take immunosuppressive medications, the virus can reactivate and multiply. The infection primarily affects the urinary system and transplanted kidney.

Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2024-517709-10-00Estimated enrolment304 patientsSponsorErasmus Universitair Medisch Centrum Rotterdam (Erasmus MC)

sourced from the EU Clinical Trials Register and site verification

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