Not recruiting

Study on Tegoprubart for Preventing Kidney Transplant Rejection in Patients

Verified siteRegistered drugNo placebo

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What is this trial about?

A plain-language summary of the goals, design and what participants do

This clinical trial is focused on patients undergoing a kidney transplant. The study aims to evaluate the safety and effectiveness of a new treatment called Tegoprubart. Tegoprubart is being compared to an existing medication called Tacrolimus, which is commonly used to prevent the body from rejecting a transplanted kidney. Both Tegoprubart and Tacrolimus are types of medications known as immunosuppressants, which help to reduce the activity of the immune system to prevent it from attacking the new kidney.

The purpose of the study is to assess how well the transplanted kidney functions 12 months after the transplant in patients treated with Tegoprubart compared to those treated with Tacrolimus. Participants in the study will receive either Tegoprubart or Tacrolimus, along with other standard medications used in kidney transplantation, such as Mycophenolate Mofetil and Prednisolone. The study will also include a placebo group to help understand the effects of the treatments being tested. The study will last for up to 12 months, during which participants will have regular check-ups to monitor their kidney function and overall health.

Throughout the study, participants will be closely monitored to ensure their safety and to gather information on how well the treatments are working. The main focus will be on measuring the kidney's ability to filter waste from the blood, known as the estimated glomerular filtration rate (eGFR). Other aspects, such as the rate of kidney function decline and the overall survival of both the patient and the transplanted kidney, will also be evaluated. This study is an important step in finding new and potentially more effective treatments for patients undergoing kidney transplantation.

The research process

The trial runs in 5 steps – from screening to follow-up. Each step says what happens and what the team monitors.

Step 1
Joining the study
Upon joining the study, participants will be informed about the key components of the study and will provide written consent.
Participants must be at least 18 years old and receiving their first kidney transplant.
Step 2
Initial treatment phase
Participants will begin treatment with medications to prevent kidney transplant rejection.
Medications include mycophenolate mofetil and tacrolimus, both administered orally in various forms such as capsules and tablets.
Step 3
Administration of tegoprubart
Participants will receive tegoprubart intravenously. This medication is being evaluated for its safety and effectiveness in preventing kidney transplant rejection.
Step 4
Ongoing treatment and monitoring
Participants will continue to take medications such as prednisolone and antithymocyte immunoglobulin as part of their treatment regimen.
Regular monitoring will occur to assess kidney function and overall health.
Step 5
Evaluation at 12 months
At 12 months post-transplant, the main objective is to assess kidney function, specifically the estimated glomerular filtration rate (eGFR).
Secondary evaluations include the rate of graft functional impairment, new-onset diabetes after transplant (NODAT), and patient and graft survival rates.

Who can join the trial?

7 criteria

Must be able to understand the main parts of the study and be willing to sign a document that shows they agree to participate.
Must be a male or female who is 18 years of age or older.
Must have received their first kidney transplant from either a living or deceased donor.
Must be willing and able to follow the study rules, including not taking certain other medications.
Must agree not to join another study that involves treatment while participating in this one.
If female, must be unable to have children due to surgery or be at least 2 years past menopause. If able to have children, must have a negative pregnancy test before starting the study and agree to use very effective birth control methods during the study and for 120 days after the last dose of the study drug.
If male, must agree to use a very effective birth control method and not donate sperm for 120 days after the last dose of the study drug.

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Verified sites

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

Bellvitge University Hospital
Verified
L'hospitalet De Llobregat, Spain
CHU Grenoble Alpes
Verified
La Tronche, France
Fundacio De Recerca Clinic Barcelona-Institut D’Investigacions Biomediques August Pi I Sunyer
Responsive
Barcelona, Spain

Trial locations

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Investigated drugs

Tegoprubart
is a medication being studied for its potential to improve the function of a transplanted kidney. It is being tested to see if it can help the body accept the new kidney and maintain its function over time.
Tacrolimus
is a medication commonly used to prevent the body from rejecting a transplanted organ, such as a kidney. It works by suppressing the immune system to help the body accept the new organ.

What is already known about the treatment

Tegoprubart
Tegoprubart is administered orally and is currently being studied in clinical trials for its potential use in preventing kidney transplant rejection. It is not yet widely recognized in medical literature as it is still under investigation. The main therapeutic indication for Tegoprubart is the prevention of renal allograft rejection. At the molecular level, it works by modulating the immune response to prevent the body from attacking the transplanted kidney. It is classified pharmacologically as an immunosuppressant.
Tacrolimus
Tacrolimus is an oral medication that is well-established in medical practice and literature for preventing organ transplant rejection. It is commonly used to prevent kidney transplant rejection by suppressing the immune system. Tacrolimus works by inhibiting a specific protein that is crucial for activating immune cells, thereby reducing the risk of the body rejecting the transplanted organ. It is classified as a calcineurin inhibitor, a type of immunosuppressant.

Investigated diseases

Prophylaxis of Renal Allograft Rejection – This condition involves preventing the immune system from attacking a transplanted kidney. After a kidney transplant, the body may recognize the new organ as foreign and attempt to reject it. This rejection can lead to impaired kidney function or even loss of the transplanted organ. The process of rejection can be acute, occurring shortly after the transplant, or chronic, developing over a longer period. Preventive measures are crucial to maintain the health and function of the transplanted kidney. Monitoring and managing the immune response are key aspects of preventing rejection.