Not recruiting

Study on Long-Term Safety of Tegoprubart and Tacrolimus 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 studying the long-term safety and effectiveness of a treatment called tegoprubart in people who have received a kidney transplant. The main goal is to see how well this treatment works over time in preventing the body from rejecting the new kidney. The study involves using tegoprubart along with other medications like mycophenolate mofetil or mycophenolate sodium, which are commonly used to help prevent organ rejection.

Participants in this study will receive tegoprubart through an intravenous (IV) infusion, which means it will be given directly into a vein. The study will monitor participants over a long period to check for any side effects and to see how well the kidney is functioning. The study will also compare the results with those of other treatments to ensure the best possible outcomes for kidney transplant recipients.

Throughout the study, researchers will keep track of any health changes, including side effects and how well the kidney is working. This will help determine the safety and effectiveness of tegoprubart in the long term. The study aims to provide valuable information that could improve the care and treatment of people who have received a kidney transplant.

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
Introduction to the study
Upon joining the study, the participant will receive information about the trial's purpose, which is to evaluate the long-term safety and effectiveness of tegoprubart in kidney transplant recipients.
The participant will be informed about the medications involved, including tegoprubart administered intravenously at a dose of 20 mg/kg, along with either mycophenolate mofetil or mycophenolate sodium.
Step 2
Medication administration
The participant will receive tegoprubart intravenously. The specific dosage is 20 mg/kg, and the administration will be part of a regimen that includes other medications.
Additional medications include Prograf in various forms: 1 mg, 0.5 mg, and 5 mg hard capsules, as well as a 5 mg/ml concentrate for infusion. AT-1501 is also administered intravenously.
Step 3
Monitoring and assessments
Throughout the study, the participant's health will be monitored for any side effects or adverse events related to the treatment.
Regular assessments will include checking vital signs and laboratory measures, as well as evaluating kidney transplant medication side effects using a specific symptom scale at baseline and at 12, 24, 36, and 48 months.
Step 4
Evaluation of outcomes
The study will assess the safety of the treatment by tracking any serious adverse events and changes in health indicators.
Efficacy will be evaluated by measuring participant and graft survival rates, as well as kidney function, at specified intervals throughout the study.
Step 5
Completion of the study
The study is expected to conclude by February 28, 2030. Participants will continue to be monitored until the end of the study period.
Final assessments will be conducted to determine the long-term safety and effectiveness of the treatment regimen.

Who can join the trial?

5 criteria

You must have successfully completed a previous related study to be considered for this study.
You need to understand the main parts of the study and be willing to sign a document that shows you agree to participate.
You must agree not to join another study that involves treatment while you are part of this study.
If you are a woman, you must either be unable to have children due to surgery or be at least two years past menopause. If you can have children, you need to have a negative pregnancy test before starting the study. You and your partner must agree to use very effective birth control methods from the start of the study until 120 days after the last dose of the study drug.
If you are a man, you 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
Centre Hospitalier Et Universitaire De Limoges
Verified
Limoges, France

Trial locations

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Investigated drugs

Tegoprubart
is a medication being studied for its long-term safety and effectiveness in people who have received a kidney transplant. It is given through an intravenous (IV) infusion, which means it is administered directly into the bloodstream through a vein.
Mycophenolate Mofetil (MMF)
is a medication used to help prevent the body from rejecting a transplanted kidney. It works by suppressing the immune system, which is the body's defense against foreign substances.
Mycophenolate Sodium (MPS)
is another form of mycophenolate used for the same purpose as MMF. It also helps prevent the rejection of a transplanted kidney by weakening the immune system's response.

What is already known about the treatment

Tegoprubart – This medication is administered intravenously and is currently being studied in clinical trials for its long-term safety and effectiveness in kidney transplant recipients. It is primarily used to prevent the rejection of a transplanted kidney. Tegoprubart works by modulating the immune system to reduce the likelihood of the body attacking the new organ. It is classified as an immunosuppressant.

Investigated diseases

Prophylaxis of Renal Allograft Rejection – This condition involves measures taken to prevent the immune system from attacking a newly 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 damage or loss of the transplanted kidney. The process of rejection can be acute, occurring shortly after the transplant, or chronic, developing over a longer period. Preventive strategies are crucial to ensure the transplanted kidney functions properly and remains healthy. These strategies typically involve the use of medications to suppress the immune response.