AuthorisedPhase III and phase IV (Integrated)Interventional

Long-term outcomes in immunologically low-risk kidney transplant recipients using tacrolimus

Doctors are studying kidney transplant patients who have a lower chance of their body rejecting the new kidney. The main goal is to see how these patients fare over many years. Researchers will look at things like how their new kidney is working, their overall health, and if they have any rejection problems. They will also keep an eye on infections. A special part of the study is checking how well these patients respond to the pneumonia vaccine (Pneumovax 23) a few years after their transplant and after a booster shot. This helps us understand what long-term care is best for kidney transplant patients.

At a glance

Status

Authorised

Phase

Phase III and phase IV (Integrated)

Sponsor

Erasmus Universitair Medisch Centrum Rotterdam (Erasmus MC)

Enrolment target

Start

27 Jan 2025

Vaccination response

What is this study about?

This research is designed to follow kidney transplant patients who are considered to have a lower risk of their body rejecting the new kidney. The main aim is to understand their health and well-being over a long period. This is important because while kidney transplants can greatly improve someone's life, there are still many questions about the best way to care for patients in the years following their surgery.

Doctors will be carefully checking several key areas. They'll look at how well the kidney is functioning, how long patients live, and whether they experience any episodes where their body tries to reject the new organ. They will also track any infections patients get and if they develop any new cancers, including skin cancer, which can sometimes be a concern after a transplant.

A special focus of this study is on how well these patients' immune systems respond to vaccinations. Specifically, they'll be checking the response to the pneumonia vaccine (Pneumovax 23). This helps doctors learn if the vaccine offers good protection over time for transplant patients, which is vital for keeping them healthy and preventing serious illnesses.

Key takeaways

Looks at long-term health of kidney transplant patients.
Focuses on patients with lower risk of rejection.
Checks how well kidneys work and overall patient survival.
Monitors for infections and new cancers.
Evaluates immune response to pneumonia vaccine over time.
Aims to improve future care for transplant recipients.

Who may be eligible?

To take part in this study, you must be at least 18 years old. There is no upper age limit, so people of all adult ages can be considered.

Both men and women can join this study. The researchers want to get a broad picture of how kidney transplant patients recover and thrive long-term, regardless of their gender.

Could this study suit you?

Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.

Are you 18 years old or older?
Have you had a kidney transplant?
Are you considered 'low-risk' for your body rejecting the kidney?
Are you able to attend appointments for multiple years after your transplant?

Answer every question to see your result.

What does participation involve?

If you take part in this study, you will have regular check-ups and assessments over many years after your kidney transplant. These will involve blood tests to check your kidney function and look for specific antibodies, as well as urine tests. You will also have routine dermatology check-ups to screen for skin cancer. The study involves monitoring your response to a pneumonia vaccine (Pneumovax 23) at specific times after your transplant and after a booster dose. The total duration of your participation will be many years, as the study is looking at long-term outcomes.

Potential risks and benefits

Taking part in this study could help doctors learn more about how to give the best long-term care to kidney transplant patients, which might benefit future patients. The study involves standard medical tests like blood and urine samples, which carry very low risks, such as a small bruise from a blood draw. The pneumonia vaccine is a standard vaccine, but like all medicines, it can have side effects, usually mild, such as soreness at the injection site. You have the right to withdraw from the study at any time without giving a reason, and this will not affect your usual medical care.

Locations (1)

Some site locations are approximate. We're improving this — please verify with the trial team before travelling.

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Unverified
Netherlands

Common questions

What is the main purpose of this study?

The study aims to understand how kidney transplant patients with a lower risk of rejection fare over many years, looking at their kidney health, survival, and immune responses to vaccines.

What is 'Pneumovax 23'?

Pneumovax 23 is a vaccine that helps protect against pneumonia, a serious lung infection. The study is checking how well transplant patients respond to it.

What does 'immunologically low-risk' mean?

This means your immune system is less likely to strongly fight against or reject the new kidney, which is a good thing for transplant success.

Will I have to take any new medication for this study?

The study mentions 'Pneumovax 23, solution for injection', which is a vaccine. It does not mention new daily medications for your transplant care beyond what you might already be taking.

How long will I be involved in the study?

This is a long-term study, so your involvement will span several years after your kidney transplant, with check-ups at specific intervals.