Active not recruitingPHASE1, PHASE2INTERVENTIONAL

Fostamatinib in the Treatment of Chronic Active Antibody Mediated Rejection

This study is investigating a new medication called Fostamatinib for people who have received a kidney transplant. Sometimes, a person's body can see the new kidney as 'foreign' and try to fight it off, which is called rejection. This particular study focuses on a type of rejection that develops over time, called 'chronic active antibody-mediated rejection'. Fostamatinib works by targeting specific cells involved in this type of rejection. Researchers want to find out if Fostamatinib can safely help to prevent this rejection from causing further damage to the transplanted kidney, or even improve it. The study will involve a small number of patients over 12 months.

At a glance

Status

Active not recruiting

Phase

PHASE1, PHASE2

Sponsor

Imperial College London

Enrolment target

Start

08 May 2019

Estimated completion

15 Oct 2025

Renal Transplant Rejection

What is this study about?

When someone receives a kidney transplant, it's a life-changing event. However, sometimes the new kidney faces a big challenge: your own body's defence system, called the immune system, might recognise it as different and start to attack it. This attack is known as 'rejection'. One common type of rejection happens when your body produces special fighter cells called antibodies that target the transplanted kidney and try to damage it. This can cause the kidney to stop working properly over time, which is very serious for transplant patients.

This study is looking at a new drug called Fostamatinib to see if it can help with this specific problem. Scientists have found that a molecule called 'spleen tyrosine kinase' plays a key role in how these damaging antibodies work within your immune cells. Fostamatinib is designed to block this molecule, hopefully stopping the antibodies from harming your new kidney. Think of it like a brake that can slow down or stop the immune system's attack on the kidney.

The main goal of this research is to understand if Fostamatinib is safe for people with a kidney transplant and whether it can effectively treat or prevent the worsening of this type of kidney rejection. By studying a small group of patients, doctors hope to gather important information that could help many more transplant patients in the future.

Key takeaways

This study is testing Fostamatinib for kidney transplant rejection.
It targets a specific type of rejection caused by antibodies.
Participation involves taking the drug for 12 months and having two kidney biopsies.
The goal is to see if the drug is safe and helps protect the transplanted kidney.
This is an early-stage study (Phase 1/2), so fewer patients are involved.
You can withdraw from the study at any time.

Who may be eligible?

To be part of this study, you need to be an adult, at least 18 years old, and have had a kidney transplant. You must also have been diagnosed with a specific type of kidney rejection called 'chronic active antibody-mediated rejection'. Doctors will check your medical records and recent kidney biopsy results to confirm this, and you'll need to be taking a regular anti-rejection medicine called tacrolimus.

There are also some important health checks. You need to be generally stable and healthy, as decided by the study doctor, and understand what the study involves, including the need for kidney biopsies. If you are a woman who could get pregnant, you must not be pregnant or breastfeeding, and you must use effective birth control or already be past menopause or have had certain surgeries.

However, you might not be able to join if you have another type of kidney rejection at the same time, or if you have certain other serious health conditions like heart problems that happened recently, or other significant long-term illnesses that the doctor thinks could interfere with the study or the medication.

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 18 years or older?
Do you have a kidney transplant?
Have you been diagnosed with 'chronic active antibody-mediated rejection'?
Are you currently taking tacrolimus for your transplant?
Are you generally in stable health?
Are you able to attend appointments and have kidney biopsies?

Answer every question to see your result.

What does participation involve?

If you join this study, you'll be given the drug Fostamatinib for 12 months. During this time, you'll have regular check-ups and medical tests. You'll need to have a kidney biopsy twice – once around six months after starting the drug, and again at the end of the 12 months. These biopsies are very important as they allow the doctors to look closely at your kidney tissue under a microscope to see if the rejection has improved or if it has been kept from getting worse. The study will last for up to 52 weeks in total.

Potential risks and benefits

Taking part in this study could potentially offer a benefit if Fostamatinib helps to slow down or improve the rejection of your transplanted kidney, which might help your kidney last longer. However, like all medicines, Fostamatinib may have side effects, and some tests, like biopsies, carry small risks. The study is also designed to learn more about the drug, so there's no guarantee it will directly benefit you. You are free to withdraw from the study at any time, for any reason, without it affecting your usual medical care.

Locations (1)

Some site locations are approximate. We're improving this — please verify with the trial team before travelling.

Imperial College NHS Healthcare Trust
Verified postcode
London, United Kingdom

Common questions

What is 'antibody-mediated rejection'?

It's when your body's immune system, specifically tiny fighter cells called antibodies, sees your new kidney as foreign and starts to attack it, potentially causing damage.

What is Fostamatinib and how does it work?

Fostamatinib is a new drug that aims to block a specific molecule in your immune system that helps cause this type of kidney rejection, hopefully reducing the attack on your kidney.

Will I still need my usual anti-rejection medicines?

Yes, you will need to continue taking your regular anti-rejection medicine, tacrolimus, as part of this study.

What is a kidney biopsy?

A kidney biopsy is a procedure where a small sample of your kidney tissue is taken and looked at under a microscope. It helps doctors see if the rejection is improving or stable.

Will I know if the drug is working?

The information from your kidney biopsies at 6 and 12 months will help doctors see if the rejection is improving or not getting worse. Your study doctor will discuss your results with you.