Study on Long-Term Safety of Tegoprubart and Tacrolimus for Preventing Kidney Transplant Rejection in Patients

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What is this study about?

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.

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.

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.

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.

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.

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 Study?

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.

Who Cannot Join the Study?

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name	City	Country
Bellvitge University Hospital	L'hospitalet De Llobregat	Spain
Oncopole Claudius Regaud	Toulouse	France
CHU Grenoble Alpes	La Tronche	France

Other Sites

Site Name	City	Country
Hospital Del Mar	Barcelona	Spain
Pellegrin Hospital	Bordeaux	France
Centre Hospitalier Universitaire Rouen	Rouen	France
Hospital Clinic De Barcelona	Barcelona	Spain
Charite Universitaetsmedizin Berlin KöR	Berlin	Germany
Hopital Beaujon	Clichy	France
Cqptvp Hxlrlrsydxa Ea Uiygdksdyfolr Da Lfqvhrr	Limoges	France
Cycuzt Hfzqeffbrtq Rtlayglt Unimabutguiwk Dl Tbpht	Tours	France
Hfcyyybs Uomgzoyievbtx Hkwvompk Tbffb y Pdpjyx Ihsznryd Ctxlvd dbqlgnkhprguzgnsm (hgjf	Badalona	Spain
Heomzhjr Vdat dlqlhihe	Barcelona	Spain

Trial status

Country	Status	Recruitment Start
France	Not recruiting	19.03.2025
Germany	Not recruiting	19.03.2025
Spain	Not recruiting	19.03.2025

Trial locations

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.

Investigated diseases:

Kidney transplant rejection

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.

Trial ID:

2023-503337-21-00

Protocol code:

AT-1501-K209

Trial Phase:

Therapeutic exploratory (Phase II)

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Study on Long-Term Safety of Tegoprubart and Tacrolimus for Preventing Kidney Transplant Rejection in Patients

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