Study Treatment Questions

What study treatment will I receive during the study?

You will be placed by chance into 1 of 2 study treatment groups. A computer is used to assign participants to study treatment groups by chance, like flipping a coin. This is called randomization. The Study Group will receive the investigational drug tegoprubart. The Active Control Group will receive the standard-of-care drug, tacrolimus. Both tegoprubart and tacrolimus will be given in combination with other approved immunosuppression medicines.

What does investigational drug mean?

Investigational drug means it is in the testing phase and is not approved by regulatory health authorities to be used to treat a specific disease but is allowed to be used for clinical research purposes.

How does tegoprubart work?

Tegoprubart works by suppressing your immune system. It lessens the chance that your immune system will fight your transplanted kidney.

Are there any side effects from the study treatments?

As with all medicines, there is a chance for side effects, which are unwanted or unintended effects from a medicine. Talk to the study doctor for more information on possible side effects. Your health will be closely monitored throughout the entire study. It is very important to tell the study doctor if you notice any changes in your health or if anything is bothering you.

How long will I be in the study?

The BESTOW Study will last up to 13 months (not including the screening period).

What are the benefits of being in the clinical study?

You may or may not directly benefit from being in the clinical study. However, you will have continuous monitoring from doctors with expertise in kidney transplantation. Any information collected during the study may help doctors learn more about treating others who receive kidney transplants in the future.

Will it cost me anything to be in the study?

There will be no cost to you for the study treatments, visits, tests, or supplies required for the study.

What are the risks of being in the study?

The treatment and procedures involved in this clinical study may include risks that are not possible to predict. Speak to your doctor about the risks involved with participating in this clinical study.

Who is sponsoring the study?

The biotechnology company Eledon Pharmaceuticals is sponsoring the BESTOW Study. They pay the study doctor and study site to run this study.

What if I decide to join the study and then change my mind?

Being in the study is completely voluntary. If you decide to join and then change your mind, you can leave the study at any time.

What medicine is prohibited during the study?

The use of certain medicines is prohibited during participation in the study. These include alternative immunosuppressants, including cyclosporine, sirolimus, and tacrolimus extended-release formulation. Alternative biologic immunosuppressants are also prohibited. Please talk to your study doctor about your current medicines to learn more.

General Clinical Trial Questions

What is a clinical trial?

Clinical trials, also called clinical studies, are research studies that test new medicines.

Why are clinical trials done?

When a new medicine is discovered, it’s first studied in a lab. The most promising medicines are then tested in clinical trials to see if they can safely help people with a specific medical condition.

Why should I join a clinical trial?

Joining a clinical trial is a big decision. You may or may not directly benefit from being in this study, but information learned will help improve treatment for kidney transplant recipients in the future.