Study on the Safety and Effectiveness of Regtivex and Tocilizumab in Patients Receiving HLA-Mismatched Living Donor Kidney Transplants

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What is this study about?

This clinical trial is focused on studying treatments for patients undergoing a kidney transplant from a living donor. The study involves two main treatments: RegTivex-04, which is a type of cell therapy using expanded regulatory T cells, and Tocilizumab, a medication given as an injection. These treatments are combined with a donor bone marrow infusion. The purpose of the study is to evaluate the safety and effectiveness of these treatments in patients who receive a kidney from a donor with a different tissue type, known as HLA-mismatched.

Participants in the study will receive the treatments and be monitored for their health and the function of their new kidney. The study will look at how well the treatments work in helping the body accept the new kidney and whether they can safely reduce the need for other medications that suppress the immune system. The study will also check for any changes in the immune system that might indicate a better acceptance of the new kidney.

The study will take place over several years, with regular check-ups to assess the health of the participants and the success of the kidney transplant. The goal is to find out if these treatments can help improve the outcomes for kidney transplant patients, making the process safer and more effective.

1 joining the study

Upon joining the study, the patient provides written informed consent. This is a necessary step to confirm understanding and agreement to participate in the trial.

2 pre-transplant preparation

The patient is prepared for a kidney transplant from a living donor. The donor is not HLA-identical, meaning their tissue type does not completely match the patient’s, but the kidney is ABO-compatible, which means the blood types are compatible.

3 transplant procedure

The kidney transplant is performed. This involves the surgical placement of the donor kidney into the patient’s body.

4 administration of medications

After the transplant, the patient receives regtivex and tocilizumab as part of the treatment. Regtivex is administered through intravenous infusion, while tocilizumab is given as a subcutaneous injection using a pre-filled syringe containing 162 mg of the solution.

5 monitoring and follow-up

The patient’s health and kidney function are closely monitored. This includes checking for any signs of graft-versus-host disease (GVHD), impaired kidney function, or other complications. The goal is to ensure the safety and effectiveness of the treatment.

6 assessment of chimerism

Within the first month after the transplant, the levels of chimerism are assessed. Chimerism refers to the presence of donor cells in the patient’s body, which is an important indicator of how well the transplant is being accepted.

7 long-term follow-up

The study continues to monitor the patient for up to 12 months post-transplant to evaluate the long-term safety and efficacy of the treatment. This includes assessing kidney function and any potential rejection episodes.

Who Can Join the Study?

For recipients (study and control group): Patient has provided written informed consent.
For donors (study group only): Participant is 18 years or older.
For donors (study group only): Participant is suitable to donate bone marrow according to the guidelines of the Department of Blood Group Serology and Transfusion Medicine.
For donors (study group only): WOCBP (Women of Childbearing Potential) must not be pregnant at inclusion (i.e., negative pregnancy test).
For donors (control group only): Participant has provided written informed consent to donate blood for immune monitoring analyses.
For donors (control group only): Participant is 18 years or older.
For recipients (study and control group): Patient is 18 years or older.
For recipients (study and control group): Patient is a planned recipient of a living donor kidney transplant.
For recipients (study and control group): Patient is a planned recipient of an ABO-compatible kidney graft. (ABO compatibility means the blood types of the donor and recipient are compatible.)
For recipients (study and control group): Patient is a planned recipient of a kidney graft from a donor that is not HLA-identical. (HLA-identical means having the same human leukocyte antigens, which are proteins on cells that help the immune system recognize foreign substances.)
For recipients (study and control group): Patient is negative for DSA. (DSA stands for donor-specific antibodies, which are antibodies that target the donor’s cells.)
For recipients (study and control group): WOCBP must have a negative pregnancy test at inclusion.
For recipients (study and control group): WOCBP must be using an adequate method of contraception to avoid pregnancy throughout the study and for up to 12 weeks after the study in such a manner that the risk of pregnancy is minimized.
For donors (study group only): Participant has provided written informed consent.

Who Cannot Join the Study?

Individuals who have had a kidney transplantation from a deceased donor cannot participate. This study is only for those receiving a kidney from a living donor.
Participants must be within a certain age range. If you are outside this range, you cannot join the study.
Both males and females can participate, but certain health conditions or vulnerabilities may exclude you from the study.
If you are part of a vulnerable population, which means you might need extra protection or care, you may not be eligible.

Where you can join this trial?

Verified and Recommended Sites

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Verified Sites

Site Name	City	Country	Status
Medical University Of Vienna	Vienna	Austria

Other Sites

No sites found in this category

Trial status

Country	Status	Recruitment Start
Austria	Not recruiting	01.08.2024

Trial locations

Investigated drugs:

Tocilizumab

Tocilizumab is a medication used in this trial to help reduce inflammation. It works by blocking a specific protein in the body that can cause inflammation and is often used in conditions where the immune system is overactive. In this trial, it is used to help manage the immune response in kidney transplant recipients.

Regulatory T Cell Therapy involves using specialized cells from the recipient that are expanded in a laboratory setting. These cells, known as regulatory T cells, help control the immune system and prevent it from attacking the transplanted kidney. This therapy aims to promote tolerance to the new organ and reduce the risk of rejection.

Donor Bone Marrow Infusion is a procedure where bone marrow cells from the kidney donor are given to the recipient. This is done to help the recipient’s body accept the new kidney by promoting a state of mixed chimerism, where both donor and recipient cells coexist, potentially reducing the need for long-term immunosuppressive drugs.

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. This condition arises when the kidneys are unable to filter waste from the blood effectively, leading to the accumulation of harmful substances in the body. The transplanted kidney takes over the function of filtering blood, helping to maintain a balance of fluids and electrolytes. Over time, the body may attempt to reject the new kidney, which is why immunosuppressive medications are often required to prevent this. The success of the transplant can be influenced by various factors, including the compatibility of the donor kidney and the recipient’s immune response. Regular monitoring and medical follow-up are essential to ensure the transplanted kidney functions well.

Trial ID:

2024-513459-34-00

Protocol code:

Trex001

Trial Phase:

Human Pharmacology (Phase I) – Other

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Study on the Safety and Effectiveness of Regtivex and Tocilizumab in Patients Receiving HLA-Mismatched Living Donor Kidney Transplants

What is this study about?

Who Can Join the Study?

Who Cannot Join the Study?