Recruiting

Study on Long-Term Kidney Transplant Outcomes in Low-Risk Patients Using Tacrolimus Alone or with Mycophenolate Mofetil

Verified siteRegistered drugNo placebo

Clinical Trials Concierge

Prefer not to search? Our Concierge searches the trials for you.

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 response to a vaccine called Pneumovax 23, which is used to protect against infections caused by a type of bacteria known as pneumococcus. Pneumococcus can lead to serious illnesses such as pneumonia, meningitis, and bloodstream infections. The vaccine contains 23 different types of pneumococcal polysaccharides, which are substances that help the body recognize and fight off these bacteria.

The purpose of the study is to observe the long-term outcomes in patients who have received a kidney transplant and are considered to be at low risk for immune system complications. These patients are being treated with a medication called tacrolimus, either alone or in combination with another drug called mycophenolate mofetil. The study will compare the survival of the transplanted kidney and the overall health of the patients under these different treatment plans.

Participants in the study will receive the Pneumovax 23 vaccine and their response to the vaccine will be measured at various points over several years. This includes checking the levels of antibodies, which are proteins made by the immune system to fight infections, at 3 and 5 years after the initial vaccination, and again after a booster shot given 5 years later. The study will also monitor other health aspects such as kidney function, patient survival, and any episodes of rejection or infections. This research aims to provide valuable information on how well the vaccine works in kidney transplant patients and how it might affect their long-term health.

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
Initial assessment
Upon joining the study, an initial assessment is conducted to confirm eligibility. This includes verifying participation in a previous study related to tacrolimus monotherapy and obtaining written informed consent.
Step 2
Treatment regimen
Participants receive a treatment regimen involving tacrolimus, a medication used to prevent organ rejection. The study compares the effects of tacrolimus alone versus a combination with another medication, mycophenolate mofetil.
Step 3
Vaccination
Participants receive a pneumococcal vaccine, specifically the Pneumovax 23, which is a solution for injection. This vaccine is administered to assess the vaccination response.
Step 4
Monitoring and follow-up
Regular monitoring is conducted to evaluate renal function, patient survival, and any rejection episodes. This includes checking creatinine levels and protein in urine.
Participants are also monitored for infectious complications and any signs of malignancy, including routine dermatology check-ups.
Step 5
Antibody determination
Donor-specific antibodies are measured using a specialized test at 4, 6, and 10 years after transplantation.
Step 6
Vaccination response evaluation
The response to the pneumococcal vaccination is evaluated 3 and 5 years after the initial vaccination, and again 3 weeks and one year after a booster vaccination given 5 years after the initial dose.
Step 7
Study completion
The study is expected to conclude by April 1, 2028, with all data collected and analyzed to assess the long-term outcomes of the treatment regimens.

Who can join the trial?

4 criteria

The patient must have received a kidney transplant and participated in a previous study called "Tacrolimus monotherapy in immunologically low-risk kidney transplant recipients: a pilot randomized-controlled study".
The patient must be able to provide written informed consent, which means they understand the study and agree to participate.
The study is open to both male and female participants.
The study does not include vulnerable populations, which typically refers to groups like children, pregnant women, or those unable to give consent.

Who cannot join the trial?

3 criteria

Individuals who are not considered low-risk kidney transplant recipients. This means that if you have a higher risk of complications after a kidney transplant, you may not be eligible.
Individuals who are not suitable for treatment with tacrolimus or mycophenolate mofetil. These are medications used to help prevent the body from rejecting a transplanted kidney.
Individuals who are part of a vulnerable population. This refers to groups of people who may need special protection or care, such as children, pregnant women, or those with certain disabilities.

Clinical Trials Concierge

Prefer not to search? Our Concierge searches the trials for you.

Tell us about your condition – we search every trial in Europe and connect you with the right site.

We usually reply within a few days

Verified sites

All sites with verified contact details – recruitment status may not be available; ask directly

Erasmus Universitair Medisch Centrum Rotterdam (Erasmus MC)
Responsive
Rotterdam, The Netherlands

Trial locations

Where you can join this trial

Countries are shaded by recruitment status. Click a recruiting country to ask about joining there.

Recruiting

Not finding your country?

Not sure what to do next?

Joining a clinical trial can seem overwhelming. We guide you step by step, so you know exactly what to expect and how we support you through the process.

See the full process and FAQ

Investigated drugs

Tacrolimus
is a medication used to help prevent the body from rejecting a transplanted kidney. It works by suppressing the immune system, which can attack the new organ as if it were a harmful invader. In this trial, tacrolimus is being studied to see how well it works on its own in patients who are considered to be at low risk for transplant rejection.
Mycophenolate mofetil
is another medication used to prevent organ rejection after a kidney transplant. It also suppresses the immune system but works in a different way than tacrolimus. In this trial, mycophenolate mofetil is used in combination with tacrolimus to see if the dual therapy provides better outcomes for low-risk patients compared to using tacrolimus alone.

What is already known about the treatment

Tacrolimus
Tacrolimus is administered orally or intravenously and is primarily used in transplant medicine to prevent organ rejection. It is well-established in medical literature as an effective immunosuppressant. The main therapeutic indication for tacrolimus is to prevent rejection in organ transplant recipients, particularly kidney transplants. At the molecular level, tacrolimus works by inhibiting calcineurin, which in turn reduces the activity of T-cells, a type of immune cell. It is classified pharmacologically as a calcineurin inhibitor.
Mycophenolate Mofetil
Mycophenolate mofetil is taken orally and is used in combination with other medications to prevent organ rejection after a transplant. It is widely recognized in medical literature for its role in immunosuppression. The primary therapeutic use of mycophenolate mofetil is to prevent rejection in kidney, heart, and liver transplants. It works by inhibiting an enzyme needed for the growth of T and B lymphocytes, which are types of white blood cells involved in the immune response. This medication is classified as an immunosuppressant.

Investigated diseases

Vaccination Response – This refers to how the immune system reacts to a vaccine, which is a substance designed to stimulate the body's immune response against diseases. The response can vary based on factors like age, health status, and the type of vaccine. After vaccination, the body typically produces antibodies, which are proteins that help fight off infections. The strength and duration of the immune response can differ, influencing how well and how long a person is protected from the disease. Monitoring vaccination response is important to ensure that the vaccine is effective and to determine if booster shots are needed.