RecruitingPHASE2INTERVENTIONAL

Clinical Trial With Donor Modified Immune Cells in Living Donor Kidney Transplantation

This study is testing a new treatment called MIC for people who are receiving a kidney transplant from a living donor. The main goal is to see if MIC is safe and effective in helping the body accept the new kidney, possibly reducing the need for strong anti-rejection medications. Patients getting a kidney transplant and their donors will be put into different groups by chance. Some will get the new MIC treatment, and others will receive standard care, which includes usual anti-rejection medicines. Researchers will follow all participants for one year to closely monitor how well the new kidney is working and if there are any side effects. After the main study, everyone will be monitored for another two years to track their long-term health, as is common with advanced new medical products.

At a glance

Status

Recruiting

Phase

PHASE2

Sponsor

TolerogenixX GmbH

Enrolment target

126

Start

04 May 2022

Estimated completion

01 Dec 2028

Kidney Transplantation

What is this study about?

Imagine you need a new kidney, and someone close to you is willing to donate one. This is a very special gift. After a kidney transplant, your body’s immune system naturally tries to protect you by attacking what it sees as foreign – the new kidney. To stop this, you need to take special medicines called 'immunosuppressants' for the rest of your life. These medicines are very important, but they can also have side effects, and sometimes they don't fully prevent the body from rejecting the new kidney.

This study is looking at a new treatment called MIC. MIC is made from immune cells taken from the kidney donor's blood. The idea is that these special cells might help the recipient's body 'learn' to accept the new kidney, potentially reducing the amount or strength of other anti-rejection medicines needed. This could mean fewer side effects and a healthier future for the new kidney.

Researchers want to find out two main things: first, is MIC safe? And second, how well does it work compared to the usual anti-rejection treatments? By safely reducing the need for strong anti-rejection drugs, this new approach could potentially make kidney transplants even more successful and improve the quality of life for people who receive new kidneys.

Key takeaways

This study is for adults getting a living donor kidney transplant.
It tests a new treatment (MIC) from donor cells to help prevent rejection.
The goal is to improve transplant success and reduce anti-rejection medicine side effects.
Participants are randomly assigned to MIC or standard care.
Close monitoring will occur for one year, with longer-term follow-up for 2 more years.

Who may be eligible?

This study is looking for adults who are getting their very first kidney transplant from a living donor. Both the person donating the kidney and the person receiving it must be at least 18 years old. The recipient must be under 70 years of age.

There are also specific medical requirements. For example, your blood type needs to match or be compatible with your donor’s blood, and certain tests that look for your body’s reaction to the donor's cells must be negative. You also need to not have certain severe reactions or antibodies against the donor's tissue. At the time of screening, you'll need a negative COVID-19 test result.

For women who could become pregnant, there are specific requirements to ensure you are not pregnant before the study starts and to use effective birth control methods during the study. Both donors and recipients must be able to understand what the study involves and agree to take part by signing a consent form.

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 having your first kidney transplant from a living donor?
Are you between 18 and 69 years old?
Is your donor at least 18 years old?
Does your blood type match or is it compatible with your donor's?
Are you prepared to use effective birth control if you could get pregnant?

Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, both you (the recipient) and your kidney donor will be randomly placed into one of three groups. This is like flipping a coin to decide who gets which treatment, meaning some will get the new MIC treatment and others will receive standard care. For those in the MIC group, blood cells will be collected from your donor in a special procedure before the transplant. Then, after your kidney transplant, you will receive the MIC treatment as a single injection into your vein.

About a week after the transplant, your standard anti-rejection medicines will begin. Everyone in the study will have regular check-ups at the hospital for one year to see how you are doing, how well your new kidney is working, and to check for any side effects. Because MIC is an advanced treatment, you will also be monitored for an additional two years after the initial one-year follow-up. This longer-term monitoring helps researchers understand the full effects of the treatment.

Potential risks and benefits

Taking part in this study might mean you are among the first to receive a new treatment that could potentially reduce the need for strong anti-rejection medicines, which could improve your kidney's long-term health and your overall quality of life. However, as with any new treatment, there are potential risks, and we don't yet know all the possible side effects of MIC. You will be closely monitored by a medical team, and they will explain all known risks to you. Remember, joining a study is always your choice, and you have the right to withdraw at any time without it affecting your medical care.

Locations (8)

Medizinische Klinik mit Schwerpunkt Nephrologie und Internistische Intensivmedizin Charité - Universitätsmedizin Berlin
Verified postcode
Berlin, Germany· Not yet recruiting
Universitätsklinikum Hamburg-Eppendorf, Universitäres Transplantations Centrum
Verified postcode
Hamburg, Germany· Recruiting
Innere Medizin V; Klinik für Hämatologie, Onkologie, Rheumatologie; Universitätsklinikum Heidelberg
Verified postcode
Heidelberg, Germany· Recruiting
Medizinische Klinik, Innere Medizin X Nephrologie - Nierenzentrum Universitätsklinikum Heidelberg
Verified postcode
Heidelberg, Germany· Recruiting
Transplantationszentrum München; Ludwig-Maximilians-Universität
Verified postcode
Munich, Germany· Recruiting
Klinikum rechts der Isar, Abteilung Nephrologie, Technische Universität München
Verified postcode
Munich, Germany· Not yet recruiting
Universitätsklinikum Münster, Transplantationsnephrologie
Verified postcode
Münster, Germany· Recruiting
Klinik für Nieren-, Hochdruck- und Autoimmunerkrankungen; Transplantationszentrum Stuttgart
Verified postcode
Stuttgart, Germany· Recruiting

Common questions

What is MIC?

MIC is a new treatment made from your kidney donor's immune cells. It's designed to help your body accept the new kidney.

Will I still need anti-rejection medicines?

Yes, all participants will receive anti-rejection medicines. The study is investigating if MIC allows for a lower dose of these medicines.

How long will I be in the study?

You will have regular visits for one year after your transplant, and then your health will be monitored for an additional two years.

Is this a new type of transplant?

No, this is a standard living donor kidney transplant, but with an additional new treatment being tested alongside it.

Can I choose which treatment group I'm in?

No, participants are randomly assigned to a treatment group to ensure the study results are fair and unbiased.

How to find out more

Matthias Schaier, Prof.Dr.med.

schaier@tolerogenixx.com +49 162 2638 005 Official trial record

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