RecruitingPHASE2INTERVENTIONAL

Phase 2 Study of ALXN2030 in Patients With Antibody-Mediated Rejection After Kidney Transplantation

If you've had a kidney transplant, sometimes your body's immune system can start to attack the new kidney. This is called antibody-mediated rejection (AMR), and it can stop your kidney from working properly. This study is testing a new medicine, called ALXN2030, to see if it can help kidneys recover from this rejection. We’re comparing ALXN2030 against a dummy medicine (placebo) to understand if it works better. The study will also check how safe ALXN2030 is and how your body uses it. Finding better ways to treat AMR could help more people keep their transplanted kidneys working for longer.

At a glance

Status

Recruiting

Phase

PHASE2

Sponsor

Alexion Pharmaceuticals, Inc.

Enrolment target

Start

07 Mar 2025

Estimated completion

07 Nov 2028

Antibody-Mediated Rejection Kidney Transplantation Biopsy-proven Histologic Scores AMR

What is this study about?

When someone receives a kidney transplant, it's a new beginning. However, sometimes the body's immune system mistakenly sees the new kidney as a threat and tries to fight it off. This specific type of reaction is called antibody-mediated rejection (AMR). AMR can damage the kidney and, if not treated, can sometimes lead to the kidney not working properly anymore.

This study is focusing on a new investigational medicine, ALXN2030. Researchers want to see if ALXN2030 can help transplanted kidneys recover when they are experiencing AMR. They will be comparing it to a placebo, which is a dummy medicine with no active ingredients. This helps them understand if any changes are truly due to ALXN2030 or if they might have happened anyway.

The main goal is to check the effectiveness of ALXN2030 by looking at changes in the kidney tissue after 52 weeks, using samples taken from the kidney. The study will also be looking closely at any side effects and how your body responds to the medicine. Finding a new and effective treatment could be very important for people who have had kidney transplants and are facing AMR.

Key takeaways

This study is testing a new drug, ALXN2030, for a kidney transplant problem called antibody-mediated rejection (AMR).
It aims to see if ALXN2030 helps the transplanted kidney recover better than a dummy medicine (placebo).
Participants will have regular check-ups, blood tests, and kidney biopsies.
The study lasts about a year, with a possible extension, and everyone continues their usual anti-rejection medicines.
This research could help improve outcomes for people with kidney transplants in the future.

Who may be eligible?

This study is looking for adults aged 18 to 75 who have had a kidney transplant at least six months ago. Participants must have specific signs of antibody-mediated rejection (AMR) in their transplanted kidney, confirmed by a recent kidney biopsy. This biopsy will show certain markers or features that doctors look for to confirm AMR.

There are also some health requirements, such as a certain level of kidney function and having received specific vaccinations (for meningitis, pneumonia, and Hib) before joining. Your body weight must also be at least 50 kg (about 7 stone 12 pounds).

You wouldn't be able to join if you have other types of kidney rejection or certain kidney conditions. You also can't be taking part in other treatments for rejection or have certain other medical issues that could affect your safety or the study results. The doctors will review all your medical information carefully to see if this study is right for you.

Quick self-check

Are you 18 to 75 years old?
Did you have a kidney transplant at least 6 months ago?
Have tests confirmed you have antibody-mediated rejection (AMR) in your transplanted kidney?
Do you meet specific vaccination requirements (meningitis, pneumonia, Hib)?
Are you generally well enough to take part in a study with regular visits and tests?

This is a guide only — the research team will confirm whether you can take part.

What does participation involve?

If you join this study, you will be randomly assigned to one of three groups: two groups will receive different doses of ALXN2030, and one group will receive a placebo (a dummy medicine). You won't know which group you're in, and neither will your study doctor, until after the main part of the study is over. Everyone in the study will also continue to receive the standard medicines prescribed to help prevent rejection.

The main treatment period will last for 52 weeks (about a year). During this time, you will have regular visits to the clinic for check-ups, blood tests, and two kidney biopsies (at 28 weeks and 52 weeks) to see how your kidney is responding. After the first 52 weeks, if you received ALXN2030, you may be able to continue receiving it for another year in an extension part of the study. If you were in the placebo group, you would then be randomly assigned to receive one of the ALXN2030 doses for the extension period.

There will also be a follow-up period after your last dose of medication to monitor your health. The total time you might be involved in the study, including treatment and follow-up, could be around 104 weeks (two years), or even longer if you enter the extension phase.

Potential risks and benefits

Taking part in any clinical trial has potential benefits and risks. You might benefit from the new treatment if ALXN2030 proves to be effective for antibody-mediated rejection, or you could contribute to developing new treatments for others with kidney transplants. However, there's no guarantee the treatment will help you. There might be side effects from ALXN2030, or from the procedures like biopsies, which will be carefully monitored by the study team. You have the right to withdraw from the study at any time without giving a reason, and this will not affect your usual medical care.

Locations (55)

Research Site
Birmingham, United States· Recruiting
Research Site
Scottsdale, United States· Recruiting
Research Site
Los Angeles, United States· Recruiting
Research Site
Orange, United States· Recruiting
Research Site
Tampa, United States· Recruiting
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Atlanta, United States· Recruiting
Research Site
Kansas City, United States· Recruiting
Research Site
Ann Arbor, United States· Recruiting
Research Site
Detroit, United States· Recruiting
Research Site
Livingston, United States· Recruiting
Research Site
New York, United States· Withdrawn
Research Site
New York, United States· Recruiting

+43 more sites — see the official record for the full list.

Common questions

What is antibody-mediated rejection (AMR)?

AMR is a type of problem where your body's immune system attacks your transplanted kidney, mistaking it for something harmful.

What is ALXN2030?

ALXN2030 is a new medicine being tested to see if it can help transplanted kidneys recover from AMR.

What is a placebo?

A placebo is a 'dummy' medicine that looks like the real drug but contains no active ingredients. It helps researchers see if the real drug is truly effective.

Will I know if I'm getting the real drug?

Neither you nor your study doctor will know if you are receiving ALXN2030 or the placebo until after the main part of the study is finished. This is called a 'double-blind' study.

How long will the study last for me?

The main treatment period is 52 weeks, but with follow-up and a possible extension, your involvement could be around 2 years or longer.

How to find out more

Alexion Pharmaceuticals, Inc. (Sponsor)

clinicaltrials@alexion.com 1-855-752-2356 Official trial record

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