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Effect of Continuing Tacrolimus on Access to a Second Kidney Transplant in Patients with Renal Transplant Failure: A Randomized Controlled Trial

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

The study focuses on people whose first renal transplant failure has occurred, meaning the transplanted kidney no longer works. It compares continuing the medication tacrolimus, taken as a prolonged‑release tablet, with stopping all immune‑suppressing drugs after three months.

The purpose is to determine whether maintaining the drug improves the chance of receiving a second kidney transplant. After the first transplant stops working, participants are randomly placed into either the continuation group or the withdrawal group, then start dialysis while waiting for a new organ. Follow‑up visits and blood tests are done regularly for up to three years.

Key outcomes include the proportion of patients who become hyperimmunized (developing a high level of antibodies measured as cPRA ≥ 85 %) that can make a new organ difficult to match, the time spent on dialysis, the rate of receiving a second transplant, and the occurrence of serious infections, cancers, heart problems, and overall survival. These results will be compared between the two groups to see which approach is more effective.

The research process

The trial runs in 8 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Enrollment and Baseline Assessment

    After joining the study, you will undergo a baseline assessment on the day your dialysis starts following renal transplant failure. This assessment records your health status, blood tests, and eligibility for the trial.

    Your medical history, including details of the previous kidney transplant, will be reviewed to confirm that you meet the study criteria.

  2. Step 2

    Randomization to Treatment Groups

    You will be randomly assigned to one of two groups: the maintenance group, which continues taking tacrolimus, or the withdrawal group, which stops the medication after three months.

    The randomization process is performed by the study team and you will be informed of your assigned group without any choice required.

  3. Step 3

    Medication Phase – Continue Tacrolimus (Maintenance Group)

    If you are in the maintenance group, you will take oral Envarsus prolonged‑release tablets containing tacrolimus.

    The prescribed dose is 25.5 mg per day, taken once daily with or without food.

    You will continue this medication for the duration of the study, up to three years, unless your doctor decides to stop it for safety reasons.

  4. Step 4

    Medication Phase – Discontinue Tacrolimus (Withdrawal Group)

    If you are in the withdrawal group, you will also start with the same dose of oral Envarsus prolonged‑release tablets (25.5 mg once daily) for the first three months.

    At the three‑month visit, the study protocol requires you to stop taking tacrolimus. No further doses are given after that point.

  5. Step 5

    Month‑3 Follow‑up Assessment

    Three months after the baseline visit, you will return for a follow‑up appointment.

    The visit includes blood tests to measure antibody levels (cPRA), assessment of any side effects, and confirmation of whether the medication should be continued or stopped according to your group assignment.

  6. Step 6

    Month‑12 Follow‑up Assessment

    One year after enrollment, you will have a second major follow‑up visit.

    During this visit, the study team will evaluate the primary outcome: whether your calculated panel reactive antibody (cPRA) level is 85 % or higher, which indicates a high level of sensitization.

    Additional assessments include dialysis duration, waiting‑list status for a second kidney transplant, and any adverse events that have occurred.

  7. Step 7

    Month‑36 Follow‑up Assessment

    Three years after enrollment, a final follow‑up visit will be performed.

    This visit repeats the evaluations done at month 12, providing long‑term data on antibody levels, transplant eligibility, and overall health.

    The results help determine the impact of continuing versus stopping tacrolimus on access to a new kidney transplant.

  8. Step 8

    Ongoing Safety Monitoring

    Throughout the study, you will be asked to report any serious infections, cancers, cardiovascular problems, or other health concerns.

    The study team will review safety data regularly and may adjust or discontinue treatment if significant risks are identified.

Who can join the trial?

5 criteria

  • You must be 18 years old or older, meaning you are an adult.
  • You must have had a first kidney transplant that has failed – the transplanted kidney no longer works.
  • You must be covered by your country’s social security (national health insurance), which is the public health coverage system.
  • You must sign a written informed consent form, which shows you understand the study and agree to join.
  • Both men and women are allowed to participate.

Who cannot join the trial?

14 criteria

  • Having received more than one organ at the same time (called combined transplantation)
  • Being pregnant or breastfeeding; pregnancy will be checked with a test and women who could become pregnant must use reliable birth control
  • Being a woman who could become pregnant but not using an effective method of birth control
  • Having a positive pregnancy blood test when it is unclear whether menopause has occurred
  • Being under legal guardianship, tutorship, or other court‑ordered protection
  • Having a very high level of antibodies against donor tissue (a cPRA or French TGI score of 85% or more) measured before randomisation
  • Having any cancer (called neoplasia) diagnosed within the past two years, except for common skin cancers such as squamous‑cell or basal‑cell carcinoma
  • Having a past history of lymphoma (a type of blood‑related cancer)
  • Having a severe or opportunistic infection within the last six months (referred to as KTF)
  • Having the transplanted kidney removed within the first three months after the transplant (called early transplantectomy)
  • Not having a plan for a second kidney transplant
  • Planning to receive a kidney from a living donor in less than one year
  • Having lost a previous kidney transplant because medicines were not taken as prescribed (medication nonadherence)
  • Being allergic (having hypersensitivity) to the study drug tacrolimus or any of its inactive ingredients
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Investigated drugs

Envarsus is a prolonged‑release tablet that contains the medicine tacrolimus. It is taken by mouth and works by calming the immune system so it does not attack a transplanted kidney. In the study, patients who keep taking this medication after their first kidney transplant fails are being compared to patients who stop taking any immune‑suppressing drugs.

The other approach in the trial is to stop immunosuppressive therapy altogether after three months. This means patients stop taking medicines that lower the activity of their immune system. The study looks at whether stopping these drugs makes it harder for patients to get a second kidney transplant because their immune system may become stronger and cause a higher risk of rejection.

What is already known about the treatment

  • Envarsus 0.75 mg prolonged-release tablets

    This medication is taken by mouth as a prolonged‑release tablet that slowly releases the drug over time. Tacrolimus is a well‑known immunosuppressant that is widely used and described in medical research. It is mainly prescribed to prevent the body from rejecting a kidney transplant. It works by blocking a protein that activates immune cells, reducing their ability to attack the new kidney, and it belongs to the class of calcineurin inhibitors.

  • Envarsus 1 mg prolonged-release tablets

    This drug is also taken orally as a prolonged‑release tablet that provides a steady dose throughout the day. Tacrolimus is an established immunosuppressive medicine with extensive documentation in the scientific literature. Its primary use is to keep the immune system from rejecting a transplanted kidney. It acts by inhibiting a key protein that triggers immune cell activity, and it is classified as a calcineurin inhibitor.

Investigated diseases

renal transplant failure - Renal transplant failure is the loss of function of a previously transplanted kidney. It occurs when the transplanted organ can no longer filter blood effectively, leading to rising creatinine levels and reduced urine output. The failure can develop gradually due to chronic injury or appear suddenly because of acute rejection or vascular problems. As the transplanted kidney stops working, patients may need to resume dialysis or be considered for another transplant. The condition is monitored by regular blood tests and imaging to track kidney performance.
Trial detailsLast updated 25 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2025-523386-26-00Protocol codePHRC N 2023 GAROUSTEEstimated enrolment200 patientsSponsorUniversity Hospital Of Clermont-Ferrand

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