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Study Comparing Immediate and Extended Release Tacrolimus to Reduce Toxicity in Lung Transplant Patients

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 clinical trial is focused on patients who have undergone a lung transplantation. The study is investigating two forms of a medication called tacrolimus, which is commonly used to help prevent the body from rejecting a transplanted lung. The two forms being compared are PROGRAF 1 mg capsule, which is an immediate-release form, and Envarsus 0.75 mg prolonged-release tablets, which is designed to release the medication more slowly over time.

The purpose of the study is to compare the effects of these two forms of tacrolimus on kidney function over a period of two years. Kidney function is an important consideration because tacrolimus can sometimes affect how well the kidneys work. The study will look at the difference in kidney function between the two groups of patients, using a measure called eGFR, which stands for estimated glomerular filtration rate. This measure helps doctors understand how well the kidneys are filtering waste from the blood.

Participants in the study will be randomly assigned to receive either the immediate-release or the prolonged-release form of tacrolimus. They will take the medication orally, meaning by mouth, for up to 24 months. Throughout the study, participants will have their kidney function monitored to see if there are any differences between the two groups. The study aims to find out if one form of the medication is better at reducing potential side effects on the kidneys while still effectively preventing lung transplant rejection.

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 assessment

    Upon joining the study, an initial assessment is conducted to confirm eligibility. This includes verifying that the patient has undergone a single or bilateral lung transplantation and is over 18 years old.

    The patient must be on a stable dose of tacrolimus, taken twice daily, with levels within the target range. Written informed consent is required.

  2. Step 2

    Medication administration

    The patient is administered tacrolimus in one of two forms: PROGRAF 1 mg capsule or Envarsus 0.75 mg prolonged-release tablets. Both are taken orally.

    The choice between immediate release (IR) and prolonged-release (LCP) forms is determined by the study protocol.

  3. Step 3

    Monitoring and follow-up

    Regular monitoring of kidney function is conducted, focusing on the estimated glomerular filtration rate (eGFR). This is calculated using the CKD-EPI creatinine-cystatin C equation.

    The primary goal is to observe any changes in kidney function over a period of two years compared to the baseline measurement.

  4. Step 4

    Completion of study

    The study is expected to conclude by June 30, 2025. At the end of the study, a final assessment of kidney function and overall health is performed.

    The results will help determine the effectiveness of immediate versus extended-release tacrolimus in reducing toxicity related to calcineurin inhibitors in lung transplant patients.

Who can join the trial?

11 criteria

  • Must have had a single or bilateral lung transplantation. This means either one or both lungs have been transplanted.
  • Must be over 18 years old.
  • Must be taking tacrolimus twice a day with stable levels. Tacrolimus is a medication used to prevent organ rejection.
  • Must provide written informed consent, which means agreeing to participate after understanding the study details.
  • Must be a participant in the TransplantLines biobank study at the UMCG, which is a research project collecting health data from transplant patients.
  • For the de novo study (new transplant patients):
  • Must be recruited before the lung transplantation and then put on tacrolimus intravenously, meaning through a vein.
  • Can be randomized, or assigned to a study group, when on a stable daily dosage of tacrolimus.
  • For the conversion study (patients who had a transplant at least a year ago):
  • Must be at least one year after lung transplantation with a stable clinical course and lung function.
  • Must have an eGFR greater than 30 ml/min/1.73m². eGFR is a test that measures kidney function.

Who cannot join the trial?

1 criterion

  • Patients who have not undergone a lung transplantation cannot participate. A lung transplantation is a surgery to replace a diseased lung with a healthy one from a donor.
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Investigated drugs

Tacrolimus: This medication is used to help prevent organ rejection in patients who have received a lung transplant. It works by suppressing the immune system to stop it from attacking the transplanted organ. In this trial, two forms of tacrolimus are being compared: immediate release and extended release. The goal is to see which form is better at reducing kidney-related side effects while still effectively preventing organ rejection.

What is already known about the treatment

Tacrolimus – Tacrolimus is administered orally and is available in both immediate-release and extended-release forms. It is currently used in medicine to prevent organ rejection in patients who have undergone lung transplantation. The main therapeutic indication for tacrolimus is to reduce the risk of organ rejection by suppressing the immune system. At the molecular level, tacrolimus works by inhibiting calcineurin, a protein involved in activating T-cells, which are part of the immune response. It is classified as a calcineurin inhibitor in pharmacology.

Investigated diseases

Lung Transplantation – Lung transplantation is a surgical procedure in which a patient's diseased lungs are replaced with lungs from a donor. This procedure is typically considered for individuals with severe lung diseases that do not respond to other treatments. After the transplant, the body may initially accept the new lungs, but there is a risk of rejection over time. Patients require lifelong monitoring and medication to help prevent rejection and manage their health. The recovery process can be lengthy, involving rehabilitation to improve lung function and overall health. Regular follow-up appointments are necessary to ensure the transplanted lungs are functioning properly.
Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2024-518639-12-00Estimated enrolment140 patientsSponsorUniversitair Medisch Centrum Groningen

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