RecruitingNAINTERVENTIONAL

Efficiency of Everolimus for the Treatment of Kidney Transplanted Patients Presenting a Missing Self-induced NK-mediated Rejection

This study is investigating a new approach to treat kidney transplant rejection. Sometimes, the body's natural killer (NK) cells can attack a transplanted kidney, even if there are no typical signs of rejection. This happens when the kidney cells are 'missing' certain markers, making them look unfamiliar to the body. This study wants to see if a medicine called Everolimus, which works by affecting the immune system, can help stop this specific type of NK cell-mediated rejection. Researchers will involve kidney transplant patients who show signs of this condition and monitor their kidney function and health to understand if Everolimus can improve the long-term success of their transplant. The goal is to find better ways to keep transplanted kidneys working well for longer.

At a glance

Status

Recruiting

Phase

Sponsor

Hospices Civils de Lyon

Enrolment target

Start

03 Dec 2020

Estimated completion

03 Dec 2027

Kidney Transplant Failure and Rejection

What is this study about?

When someone receives a new kidney, their body's immune system naturally tries to protect itself. Sometimes, this can lead to the immune system attacking the transplanted kidney, which is called rejection. Traditionally, doctors have focused on two main types of rejection, both involving specific immune cells (T cells and B cells). However, recent research has found another way rejection can happen, involving different immune cells called 'natural killer' (NK) cells. These NK cells can mistakenly attack the new kidney if its cells are 'missing' certain identifying markers, making them seem foreign or unhealthy.

This study aims to explore this new type of rejection in kidney transplant patients. It’s based on earlier findings that suggested a particular group of medicines, called mTOR inhibitors (one of which is Everolimus), might be effective in preventing this NK cell-related rejection. The researchers want to test this idea in real-life patients to see if Everolimus can help protect transplanted kidneys from this specific type of attack.

By understanding and treating this 'missing self' rejection, the hope is to improve the long-term success of kidney transplants. Keeping a transplanted kidney working well for as long as possible is very important for patients' health and quality of life. This research could lead to new treatment options for transplant patients in the future.

Key takeaways

This study investigates a new type of kidney transplant rejection.
It focuses on natural killer (NK) cells and a 'missing self' problem.
The treatment being tested is a medicine called Everolimus.
The goal is to improve the long-term success of transplanted kidneys.
Participation involves taking Everolimus and having regular health checks for 6 months.

Who may be eligible?

To be considered for this study, you need to be an adult kidney transplant patient, aged 18 or older. Doctors will look at your kidney biopsy results to see if you have certain types of inflammation and mild long-term damage, and if you have this specific 'missing self' feature on your transplanted kidney. It's also important that you don't have certain antibodies (called 'donor specific antibodies') that usually cause rejection, as this study is focused on a different type of rejection.

There are also some reasons why you wouldn't be able to join. For example, if you have a history of not tolerating Everolimus or similar medicines well, or if you have severe long-term damage to your kidney. If your urine shows a high level of protein, or if you do have the typical donor specific antibodies, you would also not be able to take part in this specific trial. These rules ensure the study focuses on the patients for whom this new treatment type is most relevant.

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?
Do you have a kidney transplant?
Has your doctor mentioned a specific type of inflammation or mild damage on your kidney biopsy?
Have you been told you don't have typical 'donor specific antibodies'?
Do you tolerate Everolimus or similar medicines well?

Answer every question to see your result.

What does participation involve?

If you are eligible and choose to take part, you would be given the study medication, Everolimus, for a period of 6 months. This medicine would be added to your current medication, which would include a calcineurin inhibitor and corticosteroids. During these 6 months, you would have regular check-ups to monitor your kidney function through blood tests and urine tests. Doctors would also look at your kidney cells to see how they are responding to the treatment. The research team will regularly check the activity of your NK cells to understand the effects of the treatment. The total duration of the active treatment part of the study is 6 months, with ongoing monitoring likely after this period to fully assess the long-term impact.

Potential risks and benefits

Participating in this study might offer a potential benefit of an improved way to manage a specific type of kidney transplant rejection, potentially helping your transplanted kidney last longer. However, like all medicines, Everolimus can have side effects, and adding a new medication might increase the risk of certain health issues. The research team will explain all known risks associated with Everolimus and how they will monitor your health throughout the study. You would be fully informed about these potential risks and benefits before deciding to take part, and you are free to withdraw from the study at any time without affecting your usual medical care.

Locations (1)

Service de transplantation, néphrologie et immunologie clinique, Hôpital Edouard Herriot (HCL)
Verified postcode
Lyon, France· Recruiting

Common questions

What is 'missing self' rejection?

'Missing self' rejection is a type of natural killer (NK) cell-driven attack on a transplanted kidney, where the kidney cells lack certain identifying markers.

What is Everolimus?

Everolimus is a medicine that helps to suppress the immune system, preventing it from attacking the transplanted organ. It's an 'mTOR inhibitor'.

How long would I take the study drug?

If you join the study, you would take Everolimus for 6 months, in addition to your current anti-rejection medications.

What kind of tests will I have?

You would have tests to check your kidney function, look at the kidney tissue, and observe the activity of your NK cells.

Can I leave the study at any time?

Yes, you can choose to leave the study at any point without it affecting your regular medical care.

How to find out more

Alice KOENIG, MD

alice.koenig@chu-lyon.fr 472110178 Official trial record

Always speak to your GP or specialist before deciding to take part in a study.