All studies
RecruitingPHASE1, PHASE2INTERVENTIONAL

Safety, Pharmacokinetics, and Efficacy of AT 1501 in Patients Undergoing Kidney Transplant

This study is looking into a new medicine called AT-1501 for people who are having a kidney transplant. The main goal is to find out if AT-1501 is safe to use and if it can help stop the body from rejecting the new kidney. We also want to understand how the medicine acts inside the body. Up to 48 people who are receiving their first kidney transplant will take part. They will receive AT-1501 alongside other standard medicines that are normally given after a transplant to prevent rejection. This research is important because preventing rejection is key to a successful kidney transplant, and new, effective treatments are always being explored to improve patient outcomes.

At a glance

Status
Recruiting
Phase
PHASE1, PHASE2
Sponsor
Eledon Pharmaceuticals
Enrolment target
48
Start
18 Feb 2022
Estimated completion
01 Jan 2027

What is this study about?

When you have a kidney transplant, your body's immune system naturally tries to fight off the new kidney because it sees it as foreign. This is called rejection. To stop this from happening, patients need to take special medicines that calm down the immune system. This study is testing a new medicine called AT-1501, which we hope will be good at preventing this rejection.

The study will involve up to 48 people who are having their first kidney transplant. They will take AT-1501 in combination with other standard medicines that are usually given to prevent rejection, such as rATG, corticosteroids, and mycophenolate. By carefully monitoring these patients, we can learn important things about AT-1501.

We want to find out three main things: is AT-1501 safe to use? How does it move through and act in the body (this is called pharmacokinetics)? And most importantly, does it actually help to prevent the body from rejecting the new kidney? The information we gather will help doctors understand if AT-1501 could be a helpful new treatment option for people with kidney transplants in the future.

Key takeaways

  • New medicine (AT-1501) for kidney transplant patients.
  • Aims to prevent the body from rejecting the new kidney.
  • Study will check safety, how it works, and its effectiveness.
  • Participants will also receive standard anti-rejection medicines.
  • This is for people having their first kidney transplant.

Who may be eligible?

To join this study, you must be at least 18 years old and be having your very first kidney transplant, either from a living or deceased donor. You'll also need to agree to use effective birth control during the study and for about three months after you've finished taking the study medicine.

There are certain reasons why you might not be able to join. For example, if you've had a bone marrow or another organ transplant before, or if you're planning to receive more than one organ. You also can't have previously taken AT-1501 or similar medicines. The type of kidney you're receiving is also important; for instance, if it's expected to be outside the body for too long, or comes from a donor with specific medical situations.

Finally, if you have certain medical conditions, such as taking high doses of steroid medication, a history of blood clots, or if your body already has specific antibodies that could react badly to the new kidney, you won't be able to participate. This helps make sure the study is safe for everyone involved and that the results are clear.

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.

  1. Are you 18 years or older?
  2. Is this your very first kidney transplant?
  3. Are you willing to use birth control during and after the study?
  4. Have you not had other organ transplants before?
  5. Are you not taking high daily doses of steroid medication?
  6. Do you not have a history of blood clots?
Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, you will receive the new medicine AT-1501 along with other standard medicines given after a kidney transplant. You will have regular check-ups at the hospital or clinic. These appointments will involve blood tests to see how the medicine is working and to check for any side effects. Doctors will also closely monitor the health of your new kidney. You'll need to follow specific instructions for taking your medication and attend all scheduled visits over a certain period. The overall duration of your participation will depend on the study's design, including follow-up appointments to track your progress and long-term kidney health.

Potential risks and benefits

Participating in this study might offer the potential benefit of a new medicine that could help prevent your body from rejecting your new kidney. However, like all medicines, AT-1501 may have side effects, and we don't yet know all of them. The study team will closely monitor you for any problems. There's also no guarantee that the medicine will work for everyone, or that you'll directly benefit from taking part. You are free to withdraw from the study at any time, for any reason, without it affecting your medical care.

Locations (9)

Some site locations are approximate. We're improving this — please verify with the trial team before travelling.
  • University of Cincinnati
    Verified postcode
    Cincinnati, United States· Recruiting
  • Royal Prince Alfred Hospital
    Verified postcode
    Camperdown, Australia· Recruiting
  • Royal Adelaide Hospital
    Verified postcode
    Adelaide, Australia· Recruiting
  • Fundação Oswaldo Ramos - Hospital do Rim
    Verified postcode
    São Paulo, Brazil· Recruiting
  • Providence Health Care - St. Paul's Hospital
    Verified postcode
    Vancouver, Canada· Recruiting
  • Vancouver General Hospital
    Verified postcode
    Vancouver, Canada· Recruiting
  • McGill University Health Care Centre
    Verified postcode
    Montreal, Canada· Recruiting
  • Liverpool University Hospitals NHS Foundation Trust - Royal Liverpool University Hospital
    Verified postcode
    Liverpool, United Kingdom· Recruiting
  • Oxford University Hospitals NHS Foundation Trust - John Radcliffe Hospital
    Verified postcode
    Oxford, United Kingdom· Recruiting

Common questions

What is AT-1501?

AT-1501 is a new medicine being tested to see if it can help prevent your body from rejecting a transplanted kidney.

Why is this study important?

This study aims to find better ways to prevent kidney rejection, which is crucial for a successful transplant and a healthy new kidney.

Will I still take my regular transplant medicines?

Yes, you will receive AT-1501 in addition to the standard medicines typically given after a kidney transplant to prevent rejection.

How many people will be in the study?

Up to 48 people who are having their first kidney transplant will take part in this study.

Can I leave the study if I change my mind?

Yes, you can choose to stop participating in the study at any time, and it will not affect your future medical care.

How to find out more

Eledon Pharmaceuticals

Always speak to your GP or specialist before deciding to take part in a study.

Interested in taking part?

Register your interest

Share your details and the research team for "Safety, Pharmacokinetics, and Efficacy of AT 1501 in Patient…" will contact you if you may be eligible. Always speak to your GP before agreeing to take part.

Discussion

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