Active not recruitingPHASE3INTERVENTIONAL

A Study to Learn More About the Effects and Safety of Felzartamab Infusions in Adults With Kidney Transplants Who Have Antibody-Mediated Rejection (AMR)

This study is investigating a new treatment called felzartamab for people who have had a kidney transplant and are now experiencing a problem called antibody-mediated rejection (AMR). AMR happens when the body's natural defence system mistakenly attacks the new kidney, which can stop it from working properly. Felzartamab is an experimental medicine designed to reduce the immune cells that cause this attack. Researchers want to find out if felzartamab can help improve the health of the transplanted kidney and prevent further damage, compared to a dummy treatment (placebo). The study involves adults aged 18 to 75 who have had a kidney transplant at least six months ago and have active AMR. Participants will receive infusions of either felzartamab or a placebo and be monitored for about a year.

At a glance

Status

Active not recruiting

Phase

PHASE3

Sponsor

Biogen

Enrolment target

132

Start

03 Dec 2024

Estimated completion

01 Jun 2027

Antibody-mediated Rejection

What is this study about?

When someone receives a kidney transplant, it can be a life-changing operation. However, sometimes the body's immune system, which usually fights off infections, can see the new kidney as a foreign object and start to attack it. This condition is called antibody-mediated rejection (AMR). In AMR, certain proteins in your immune system, called antibodies, damage the tiny blood vessels in the new kidney, which can make it sick or even stop working.

This study aims to discover if a new medicine, called felzartamab, can help people with AMR protect their transplanted kidney. Felzartamab is a special type of antibody made in a lab. It's designed to target and reduce the immune cells that are making the harmful antibodies. By doing this, researchers hope felzartamab can prevent further damage to the kidney and help it recover. The study will compare felzartamab to a placebo, which looks like the real medicine but contains no active drug, to see how effective it truly is.

Researchers will closely monitor how participants' transplanted kidneys are doing, looking at things like biopsy results (small samples of kidney tissue), urine tests, and overall kidney function. They also want to understand if felzartamab is safe and what side effects it might have. This research is important because it could lead to better ways to manage AMR and help transplanted kidneys last longer for many people.

Key takeaways

This study evaluates felzartamab for antibody-mediated rejection (AMR) in kidney transplant patients.
Felzartamab is a new drug aiming to reduce immune cell attacks on transplanted kidneys.
The study compares felzartamab to a placebo, meaning some participants won't receive the active drug initially.
Participation involves infusions, clinic visits, and health monitoring over about one year.
A main goal is to see if felzartamab helps the kidney tissue look healthier on biopsies.

Who may be eligible?

This study is looking for adults aged between 18 and 75 years old. To be considered, you must have received a kidney transplant at least six months ago. Importantly, you need to have been diagnosed with antibody-mediated rejection (AMR) that is confirmed by a kidney biopsy.

You would not be able to join if you had a blood type mismatch for your transplant or if you've had multiple organ transplants. If your kidney function is rapidly getting worse and you're likely to need dialysis soon, you also wouldn't be able to participate. Additionally, if you've recently received certain specific treatments for AMR, you might need to wait before joining or might not be eligible.

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 an adult between 18 and 75 years old?
Did you have your kidney transplant at least 6 months ago?
Have you been diagnosed with antibody-mediated rejection (AMR) that was confirmed by a kidney biopsy?
Have you *not* had certain specific treatments for AMR within the last 3 months?
Is your kidney function currently stable enough (not rapidly getting worse)?
Did you *not* have a blood type (ABO) incompatible transplant?

Answer every question to see your result.

What does participation involve?

If you decide to take part, your journey will begin with a screening period of up to 42 days to ensure the study is right for you. The study itself has two main parts, lasting about a year in total, with around 21 visits to the study clinic.

In Part A, you'll be randomly assigned to receive either felzartamab or a placebo (a dummy drug). This part is "double blind," meaning neither you nor your study doctor or nurses will know which one you are getting. You'll receive up to 9 doses, given directly into a vein (an "infusion"), over about 24 weeks. The amount of medicine will depend on your body weight.

After Part A, all participants will move to Part B, which is "open label." This means everyone, including you and the study team, will know that you are receiving felzartamab. You'll get up to 9 more infusions over another 28 weeks. Throughout the study, we'll monitor your health with blood and urine tests, heart checks (ECGs), and vital signs measurements. You will also have kidney biopsies at specific times to see how your kidney is responding.

Potential risks and benefits

Taking part in this study could potentially offer you access to a new treatment that might help your kidney rejection. However, there's also a chance you might receive a placebo and not the active drug during the first part of the study. As with any medicine, felzartamab might cause side effects, and some tests, like kidney biopsies, carry their own small risks. Your health will be closely monitored by the study team, but it's important to remember that there's no guarantee of benefit, and your condition could still get worse. You are free to withdraw from the study at any time, for any reason, without it affecting your usual medical care.

Locations (56)

University of Southern California
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Los Angeles, United States
Cedars-Sinai Medical Center
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Los Angeles, United States
UCLA
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Los Angeles, United States
Providence Healthcare
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Orange, United States
Loma Linda
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San Bernardino, United States
California Pacific Medical Center
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San Francisco, United States
University of California, San Francisco
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San Francisco, United States
University of Colorado
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Aurora, United States
University of Chicago
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Chicago, United States
University of Kansas
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Kansas City, United States
Tulane University Health Sciences Center
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New Orleans, United States
Mayo Clinic
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Rochester, United States

Common questions

What is antibody-mediated rejection (AMR)?

AMR is when your body's immune system, which normally fights infections, mistakenly attacks your transplanted kidney. This can cause damage and make the kidney not work as well.

What is felzartamab?

Felzartamab is a new investigational medicine, given as an infusion into a vein. It's designed to target and reduce the immune cells that are causing AMR in transplanted kidneys.

What is a placebo?

A placebo is a dummy treatment that looks exactly like the study drug but contains no active medicine. It helps researchers understand if the real medicine is truly effective.

How long will the study last?

The study will last for about one year, including screening time. You will have approximately 21 visits to the study clinic during this period.

Will I know if I'm getting the study drug or placebo?

During the first part of the study (Part A), neither you nor the doctors will know if you're getting felzartamab or the placebo. In the second part (Part B), everyone will know they are receiving felzartamab.