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Study on Everolimus and Mycophenolate Mofetil for Improving COVID-19 Vaccine Response in Kidney Transplant Patients

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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 studying the effects of changing medications in patients who have had a kidney transplant. The study involves two main treatments: everolimus and mycophenolate mofetil (also known as MMF or mycophenolic acid). Everolimus is a medication that helps prevent the body from rejecting a transplanted organ, while mycophenolate mofetil is commonly used to suppress the immune system in transplant patients. The trial aims to see if switching from mycophenolate mofetil to everolimus can improve the body's response to vaccines, specifically the COVID-19 vaccine and the Herpes Zoster vaccine, which is used to prevent shingles.

The purpose of the study is to investigate whether replacing mycophenolate mofetil with everolimus in kidney transplant patients leads to a better immune response to the COVID-19 vaccine. Participants in the study will receive either mycophenolate mofetil or everolimus and will be monitored for their immune response to the vaccines. The study will also look at the levels of antibodies, which are proteins the body makes to fight infections, after vaccination. Additionally, the study will monitor for any side effects or complications that may occur during the trial period.

Participants will be involved in the study for a period of up to 18 months. During this time, they will receive vaccinations and have regular check-ups to assess their health and immune response. The study will also track any changes in kidney function and the occurrence of any adverse events, which are unwanted effects that may happen during the study. The goal is to determine if everolimus can provide a stronger vaccine response while maintaining the health and safety of kidney transplant patients.

The research process

The trial runs in 7 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, you will be asked to provide written consent, confirming your understanding of the study's purpose and any potential risks involved.
You must meet certain criteria, such as being at least 18 years old, having undergone a kidney transplant at least six months prior, and having received three previous COVID-19 vaccinations.
Step 2
Initial assessment
An initial assessment will be conducted to evaluate your current health status and ensure eligibility for the study.
This may include reviewing your medical history and current medications.
Step 3
Medication adjustment
If you are currently taking mycophenolate mofetil (MMF) or mycophenolic acid (MPA), your medication may be adjusted to everolimus.
The dosage of everolimus will be determined by the study team and administered orally in tablet form.
Step 4
Vaccination phase
You will receive a COVID-19 vaccination with the Comirnaty Omicron XBB.1.5 vaccine, administered as an injection.
Additionally, you will receive the Shingrix vaccine for herpes zoster, also administered as an injection.
Step 5
Follow-up assessments
Follow-up assessments will be conducted to measure your body's response to the vaccinations.
These assessments will include blood tests to evaluate antibody levels and immune response.
Step 6
Monitoring and reporting
Throughout the study, you will be monitored for any side effects or adverse reactions to the medications or vaccines.
You will be required to report any symptoms or health changes to the study team.
Step 7
Completion of the study
At the end of the study, a final assessment will be conducted to evaluate your overall health and the effectiveness of the treatment.
You will receive information about the study's findings and any further steps if necessary.

Who can join the trial?

6 criteria

Must be at least 18 years old.
Must be at least 6 months after having a kidney transplant.
Must be eligible for COVID-19 vaccinations as per the vaccine manufacturer's instructions, which means having received 3 previous COVID-19 vaccinations as part of the primary immunization.
Must be able to understand the purpose and risks of the study, and have given written consent to participate (signed informed consent form).
Must be willing to follow the study rules and be available during the study period.
Must be on a maintenance immunosuppressive therapy, which is a treatment to prevent the body from rejecting the transplanted kidney. This includes either a combination of three or two drugs, one of which must be MMF (Mycophenolate Mofetil) or MPA (Mycophenolic Acid) with a minimum daily dose of 1000 mg (MMF) or 720 mg (MPA), and a CNI (Calcineurin Inhibitor), which is another type of medication used to suppress the immune system.

Who cannot join the trial?

4 criteria

Patients who have had a kidney transplantation cannot participate.
Patients currently diagnosed with COVID-19 are not eligible.
Patients with Herpes Zoster, also known as shingles, are excluded.
Patients with impaired immunity, meaning their immune system is not working properly, cannot join the study.

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Verified sites

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Academisch Ziekenhuis Leiden
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Leiden, The Netherlands
Erasmus Universitair Medisch Centrum Rotterdam (Erasmus MC)
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Rotterdam, The Netherlands
Stichting Radboud University Medical Center
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Nijmegen, The Netherlands

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Investigated drugs

Everolimus
is a medication that helps to prevent the body from rejecting a transplanted organ, like a kidney. It works by weakening the immune system so that it does not attack the new organ. In this trial, everolimus is being tested to see if it can improve the body's response to COVID-19 vaccines in people who have had a kidney transplant.
Mycophenolate Mofetil (MMF)
or Mycophenolic Acid (MPA) are medications that are commonly used to prevent organ rejection in transplant patients. They work by suppressing the immune system. In this trial, these medications are being replaced by everolimus to see if this change can lead to a better response to COVID-19 vaccines in kidney transplant patients.

What is already known about the treatment

Everolimus – Everolimus is administered orally in the form of tablets and is currently being studied for its potential to improve vaccine responses in kidney transplant patients. It is primarily used to prevent organ rejection in transplant patients and is being explored for its effects on COVID-19 vaccine efficacy. Everolimus works by inhibiting a protein called mTOR, which plays a role in cell growth and immune response, thereby helping to regulate the immune system. It is classified as an immunosuppressant medication.

Investigated diseases

Kidney Transplantation
Kidney transplantation is a surgical procedure in which a healthy kidney from a donor is placed into a person whose kidneys no longer function properly. After transplantation, the new kidney takes over the work of filtering blood and producing urine. The body may recognize the new kidney as foreign, leading to an immune response. Over time, the transplanted kidney may experience chronic rejection or other complications. The function of the transplanted kidney is monitored through various tests. The progression of kidney function is crucial for the long-term success of the transplant.
COVID-19
COVID-19 is an infectious disease caused by the SARS-CoV-2 virus. It primarily affects the respiratory system, leading to symptoms such as fever, cough, and difficulty breathing. The disease can progress to severe respiratory distress and affect other organs. COVID-19 spreads through respiratory droplets and can lead to widespread outbreaks. The immune response to the virus varies, with some individuals experiencing mild symptoms and others developing severe illness. Long-term effects, known as "long COVID," can occur even after recovery from the acute phase.
Herpes Zoster
Herpes Zoster, also known as shingles, is a viral infection caused by the reactivation of the varicella-zoster virus, which also causes chickenpox. It is characterized by a painful rash that typically appears on one side of the body or face. The rash progresses to blisters that eventually crust over and heal. Pain, itching, or tingling may occur before the rash appears and can persist after the rash has healed. The risk of developing Herpes Zoster increases with age and weakened immune function. Complications can include postherpetic neuralgia, a condition where pain continues after the rash has resolved.
Impaired Immunity
Impaired immunity refers to a weakened or compromised immune system that is less effective at fighting infections and diseases. This condition can result from various factors, including medical treatments, chronic diseases, or genetic disorders. Individuals with impaired immunity are more susceptible to infections and may experience more severe symptoms. The progression of immune impairment can lead to increased vulnerability to opportunistic infections. Monitoring and managing immune function are important to reduce the risk of complications. The condition requires careful management to maintain overall health and prevent infections.