Ongoing, recruitingTherapeutic exploratory (Phase II)Interventional

BESTOW: A Phase 2, Multicenter, Randomized, Open-Label Study to Evaluate the Safety and Efficacy of Tegoprubart in Patients Undergoing Kidney Transplantation

This study, called BESTOW, is looking into a new medicine called Tegoprubart. Its main goal is to find out if Tegoprubart can help prevent your body from rejecting a new kidney after a transplant. When you have a kidney transplant, your immune system can sometimes see the new kidney as an invader and try to attack it. Medicines are given to stop this from happening, but they can have side effects. Researchers want to see if Tegoprubart is safe and works better than current treatments, ultimately helping transplanted kidneys last longer and work well. They will measure how well kidneys are working 12 months after the transplant.

At a glance

Status

Ongoing, recruiting

Phase

Therapeutic exploratory (Phase II)

Sponsor

Eledon Pharmaceuticals Inc.

Enrolment target

101

Start

30 Oct 2023

Prophylaxis of Renal Allograft Rejection

What is this study about?

When someone receives a new kidney through a transplant, their body's natural defence system, called the immune system, might try to reject it. This is because the new kidney isn't exactly like their own. To prevent this, people who have kidney transplants are given special medicines to calm down their immune system. These medicines help the new kidney settle in and work properly.

This study, named BESTOW, is testing a new medicine called Tegoprubart. The main purpose is to see if Tegoprubart can do a better job at preventing kidney rejection compared to the usual medicines given after a transplant. Researchers are especially interested in how well the transplanted kidney is working 12 months after the operation. They will also look at how many people keep their new kidney working well, avoid serious problems, and stay healthy.

Finding better ways to prevent kidney rejection is really important. If new medicines like Tegoprubart are safe and effective, they could help people with kidney transplants have healthier lives, with their new kidneys working well for longer. This study is an important step in understanding if Tegoprubart could be a good new option for patients.

Key takeaways

New study testing Tegoprubart for kidney transplant patients.
Aims to prevent the body from rejecting the new kidney.
Compares Tegoprubart to standard anti-rejection medicines.
Focuses on how well the new kidney works after 12 months.
Looking for adults aged 18+ undergoing kidney transplantation.

Who may be eligible?

To join this study, participants generally need to be at least 18 years old. Both men and women are welcome to take part. The study is specifically looking for people who are about to have a kidney transplant.

There might be other health requirements or conditions that would make someone suitable or unsuitable for the study. For example, specific medical history or other ongoing health problems could affect whether you can join.

It's important to remember that joining a clinical trial is a big decision, and you'll need to discuss all the details with your doctor and the study team to make sure it's the right choice for you.

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 18 years old or older?
Are you having a kidney transplant soon?
Are you able to attend regular hospital or clinic visits?
Are you happy to take study medication as instructed?

Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, you will be given one of the study medications, which could be Tegoprubart or a standard anti-rejection medicine. You will need to take these medicines as instructed by the study team. You will have regular visits to the hospital or clinic, which will include examinations, blood tests, and other assessments to check your health and how your new kidney is working.

These visits will help the doctors monitor your progress, check for any side effects, and make sure the medication is working as intended. The study aims to follow participants for at least 12 months after their kidney transplant. The exact number of visits and tests will be explained in detail by the study team, and you'll have ongoing support throughout your participation.

Potential risks and benefits

Participating in any study has potential benefits and risks. You might benefit from receiving a new anti-rejection medicine that could work better than current options, or you'll receive standard care. However, new medicines can have unexpected side effects, and some tests or procedures might cause discomfort. The research team will carefully monitor your health throughout the study. You always have the right to withdraw from the study at any time, for any reason, without it affecting your medical care.

Locations (3)

Some site locations are approximate. We're improving this — please verify with the trial team before travelling.

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Unverified
Spain
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Unverified
France
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Unverified
Germany

Common questions

What is the main goal of this study?

The main goal is to see if a new medicine called Tegoprubart can help prevent your body from rejecting a new kidney after a transplant.

Who can join this study?

Adults aged 18 and over, both men and women, who are having a kidney transplant, might be able to join.

What medicine will I take?

You will either receive the new medicine, Tegoprubart, or one of the standard medicines currently used to prevent rejection.

How long will I be in the study?

The study plans to follow participants for at least 12 months after their kidney transplant to see how well their new kidney is working.

Can I leave the study if I want to?

Yes, you can choose to leave the study at any time, for any reason, and it won't affect your medical care.