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Tegoprubart

Tegoprubart is an innovative drug currently being studied in clinical trials for its potential to prevent kidney transplant rejection. This article explores the ongoing research on Tegoprubart, focusing on its use in kidney transplant patients and its comparison to standard immunosuppressive treatments.

Table of Contents

What is Tegoprubart?

Tegoprubart, also known as AT-1501, is a new drug being studied for use in kidney transplant patients[1]. It is designed to help prevent the body from rejecting a transplanted kidney, a condition known as renal allograft rejection. This drug is currently in the early stages of clinical trials, which means it is being tested to determine its safety and effectiveness in humans.

How Does Tegoprubart Work?

Tegoprubart is a type of drug called a monoclonal antibody. Specifically, it is a humanized IgG1k antibody that targets a protein called CD40L[1]. CD40L plays a role in the immune system’s response to foreign substances, including transplanted organs. By targeting CD40L, tegoprubart aims to prevent the immune system from attacking the new kidney, potentially improving the chances of a successful transplant.

Current Research: The BESTOW Study

The main study currently investigating tegoprubart is called BESTOW (AT-1501-K207)[1]. This is a Phase 2 clinical trial, which means it’s testing the drug in a larger group of people to see how well it works and to further evaluate its safety. Here are some key points about the study:

  • It’s a randomized, open-label study comparing tegoprubart to another drug called tacrolimus, which is currently used to prevent organ rejection.
  • The study aims to enroll about 120 people who are receiving their first kidney transplant.
  • Participants will be randomly assigned to receive either tegoprubart or tacrolimus, along with other standard medications used after kidney transplants.
  • The main goal is to see how well the transplanted kidney is functioning 12 months after the transplant in people who received tegoprubart compared to those who received tacrolimus.

Potential Benefits of Tegoprubart

While the full benefits of tegoprubart are still being studied, researchers hope it might offer several advantages over current treatments[1]:

  • Better kidney function: The study will measure how well the kidneys are working in people who receive tegoprubart compared to those who receive tacrolimus.
  • Lower risk of rejection: Researchers will look at how many people experience rejection of their transplanted kidney with tegoprubart versus tacrolimus.
  • Fewer side effects: The study will compare the safety and tolerability of tegoprubart to tacrolimus.
  • Lower risk of diabetes: One of the study’s goals is to see if tegoprubart leads to fewer cases of new-onset diabetes after transplant compared to tacrolimus.
  • Better overall outcomes: The study will look at overall patient and kidney survival rates with tegoprubart versus tacrolimus.

Who Can Participate in the Study?

The BESTOW study has specific criteria for who can participate[1]. Some key points include:

  • Participants must be 18 years or older.
  • They must be receiving their first kidney transplant from either a living or deceased donor.
  • They must be willing and able to follow the study requirements, including restrictions on certain medications.
  • There are also several conditions that would prevent someone from participating, such as certain medical conditions, previous organ transplants, or use of specific medications.

Study Details

The BESTOW study is divided into three main periods[1]:

  1. Screening: This happens up to 28 days before the transplant.
  2. Transplant: This is the day of the kidney transplant surgery.
  3. Post-transplant Treatment: This lasts for 12 months after the transplant.

Participants will be randomly assigned to one of two groups:

  • Group A will receive tegoprubart through an IV infusion every 21 days, along with other standard medications.
  • Group B will receive tacrolimus twice daily by mouth, along with other standard medications.

Safety Considerations

As with any new medication, there are potential risks and side effects that are still being studied. The BESTOW trial includes several measures to monitor participants’ safety[1]:

  • Regular check-ups and tests to monitor kidney function and overall health.
  • Careful monitoring for side effects or adverse reactions to the medication.
  • Exclusion of people with certain health conditions that might increase their risk of complications.

It’s important to note that tegoprubart is still an experimental drug. While early results may be promising, more research is needed to fully understand its effectiveness and safety profile.

Aspect Details
Study Type Phase 2, multicenter, randomized, open-label, active control study
Participants Approximately 120 de novo kidney transplant recipients
Treatment Arms 1) Tegoprubart 20 mg/kg IV every 21 days
2) Twice daily oral tacrolimus
Common Treatments rATG induction, corticosteroid maintenance, mycophenolate
Primary Endpoint Mean estimated glomerular filtration rate (eGFR) at 12 months
Key Secondary Endpoints – Rate of graft functional impairment at 12 months
– Rate of new onset diabetes after transplant (NODAT) at 12 months
– Patient and graft survival at 12 months
– Rate of biopsy proven acute rejection (BPAR) at 12 months
Eligibility Adults (≥18 years) receiving first kidney transplant, meeting specific health criteria
Study Duration 12 months post-transplant (with possibility of extension)

FAQ

  • What is Tegoprubart? Tegoprubart is an investigational drug being studied for its potential to prevent kidney transplant rejection. It is a humanized monoclonal antibody that targets CD40L, a protein involved in the immune response.
  • How is Tegoprubart administered in the clinical trial? In the clinical trial, Tegoprubart is administered intravenously at a dose of 20 mg/kg. Patients receive it on days 1, 3, 7, 14, 21, 28, and then every 21 days thereafter.
  • What is the main objective of the Tegoprubart clinical trial? The main objective is to assess kidney graft function at 12 months post-transplant in patients treated with Tegoprubart compared to those treated with tacrolimus, which is a standard immunosuppressive drug.
  • Who is eligible to participate in the Tegoprubart clinical trial? Eligible participants are adults (18 years or older) receiving their first kidney transplant from a living or deceased donor. They must meet specific health criteria and be willing to comply with the study requirements.
  • What are some potential benefits of Tegoprubart over current treatments? The study aims to evaluate if Tegoprubart can provide effective immunosuppression while potentially reducing side effects associated with current treatments, such as new-onset diabetes after transplant. However, the full benefits and risks will only be known after the trial is completed.

Ongoing Clinical Trials on Tegoprubart

  • Study on Tegoprubart for Preventing Kidney Transplant Rejection in Patients

    Not recruiting

    2 1 1 1
    Investigated diseases:
    Investigated drugs:
    France Germany Spain

Glossary

  • Tegoprubart: An investigational drug (also known as AT-1501) that is a humanized monoclonal antibody targeting CD40L, being studied for prevention of kidney transplant rejection.
  • Kidney transplant rejection: A condition where the recipient's immune system recognizes the transplanted kidney as foreign and attacks it, potentially leading to loss of kidney function.
  • Immunosuppression: The process of reducing the strength of the body's immune system, often necessary in organ transplantation to prevent rejection of the transplanted organ.
  • Tacrolimus: A standard immunosuppressive drug commonly used to prevent organ rejection in transplant patients.
  • Glomerular Filtration Rate (GFR): A measure of how well the kidneys are filtering waste from the blood, used to assess kidney function.
  • Biopsy Proven Acute Rejection (BPAR): Confirmation of transplant rejection through examination of a small sample of the transplanted kidney tissue.
  • New Onset Diabetes After Transplant (NODAT): The development of diabetes in a patient who did not have diabetes before receiving an organ transplant, often as a side effect of immunosuppressive medications.
  • Rabbit Anti-Thymocyte Globulin (rATG): An immunosuppressive drug used in the induction phase of transplantation to prevent early rejection.
  • Mycophenolate Mofetil (MMF): An immunosuppressive drug often used in combination with other medications to prevent organ rejection in transplant patients.
  • Corticosteroids: A class of steroid hormones used to suppress the immune system and reduce inflammation in transplant patients.

References

  1. http://clinicaltrials.eu/trial/study-on-tegoprubart-for-preventing-kidney-transplant-rejection-in-patients/