RecruitingOBSERVATIONAL

Expanding the Scope of Post-transplant HLA-specific Antibody Detection and Monitoring in Renal Transplant Recipients

This study is exploring a new blood test for kidney transplant patients to detect hidden antibodies that can harm the transplanted kidney. Currently, these antibodies often cause damage without obvious symptoms. Researchers will compare this new test with existing ones to see how well it works and if it can distinguish antibody-related inflammation from other issues like infections. They also want to understand if it's possible to predict which patients might develop these antibodies after a transplant. Another aim is to investigate if kidney transplant patients over 60 are less likely to experience immune reactions like rejection compared to younger patients. The findings could potentially lead to better monitoring methods, personalised medication plans, and reduced side effects from strong medicines.

At a glance

Status

Recruiting

Sponsor

Liverpool University Hospitals NHS Foundation Trust

Enrolment target

282

Start

13 Oct 2023

Estimated completion

13 Oct 2026

Kidney Transplant Renal Transplant Failure Kidney Transplant Rejection Frailty Kidney Transplant; Complications Transplant Dysfunction Diagnosis Renal Transplant

What is this study about?

When you receive a kidney transplant, your body's immune system sometimes sees the new kidney as 'foreign.' This can lead to the production of special proteins called antibodies, which can attack and damage the transplanted kidney. Often, these antibodies don't cause any noticeable symptoms until significant damage has occurred. Currently, doctors usually look for signs of kidney problems, such as changes in blood tests, and if they suspect an issue, they might perform a biopsy (taking a small sample of the kidney) to investigate further. This approach is good because it avoids unnecessary invasive tests, but it means that early, silent damage from antibodies might be missed.

This study is looking at a new blood test that measures something called 'donor-derived cell-free DNA' (dd-cfDNA). This substance can act as an early warning sign of damage to the new kidney, even before symptoms appear or regular blood tests show a problem. The researchers want to see how well this new test works compared to the current methods for detecting antibodies. They're also keen to understand if this test can tell the difference between kidney inflammation caused by these antibodies and inflammation from other issues, like a urine infection.

Another important aspect of this research is to figure out if doctors can predict which transplant patients are more likely to develop these damaging antibodies. This could help tailor monitoring plans more effectively. Furthermore, the study will investigate whether older patients (over 60) have a different immune response, potentially making them less prone to rejection. The hope is that the results of this study could lead to more personalised care for kidney transplant patients, allowing doctors to detect problems earlier, adjust medication appropriately, and potentially reduce the need for strong immunosuppressant drugs and their side effects.

Key takeaways

Exploring a new blood test to detect hidden antibodies after kidney transplant.
Aims to predict who might develop these antibodies.
Investigating if older patients (over 60) have better protection against rejection.
Could lead to earlier detection of kidney damage.
May result in more personalised treatment plans.
Could potentially reduce strong medication side effects in the future.

Who may be eligible?

This study is looking for adult kidney transplant patients. For the new blood test part, suitable participants include those who had their transplant within the last year, or those who are about to have one or recently had one (within six months). This specific group is for patients who had a 'high-risk' transplant, meaning there was a higher chance of their body reacting to the new kidney, for example, if they had a second transplant.

For the parts of the study looking at older patients and predicting who might develop antibodies, any adult patient who is having a kidney transplant or has just had one (within 72 hours) might be eligible. It's important that all participants are able to understand the study and give their consent to take part.

Quick self-check

Are you an adult (18 years or older)?
Have you had a kidney transplant recently, or are you about to have one?
Were you able to understand and agree to take part in the study?
If your transplant already happened, was it within the last 12 months? (Especially if it was considered a 'high-risk' transplant)
If you are having a transplant soon, are you unsensitized (meaning you didn't have certain antibodies before the transplant)?

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

What does participation involve?

This study involves having a new blood test alongside your usual follow-up appointments and existing antibody tests. You won't need to take any new medication as part of this study. The amount of extra blood drawn will be small, typically taken during your routine blood tests. The study will monitor your health and kidney function over time, aligning with your standard post-transplant care. The total duration of your participation will depend on which part of the study you are eligible for, but it aims to integrate seamlessly with your existing medical care, without requiring many additional visits.

Potential risks and benefits

Participating in this study might not directly benefit you, but the information gathered could help improve care for future kidney transplant patients. There are minimal risks involved, primarily those associated with drawing blood, such as minor bruising or discomfort. All procedures will be performed by experienced medical staff. You are free to withdraw from the study at any time without affecting your medical care.

Locations (1)

Liverpool University Hospitals NHS Foundation Trust
Liverpool, United Kingdom· Recruiting

Common questions

What is an antibody in the context of a kidney transplant?

After a kidney transplant, your body's immune system might create special proteins called antibodies that can see your new kidney as 'foreign' and potentially attack it, even without you feeling unwell.

Why is it important to detect these antibodies early?

Detecting these antibodies early can help doctors understand if your new kidney is at risk and allow them to adjust your treatment to prevent or reduce damage before it becomes serious.

What is 'donor-derived cell-free DNA'?

This is tiny bits of DNA from the donated kidney that can be found in your blood. Higher levels can sometimes be an early sign that the new kidney might be experiencing some damage or rejection.

Will taking part in this study change my current medication?

No, this study will not involve changes to your current medication or your standard post-transplant care. It is focused on testing new diagnostic methods.

Is this study safe?

Yes, the main procedure involves drawing a small amount of blood, which is a very common and generally safe medical procedure. Any risks are minimal and will be discussed with you.

How to find out more

George E Nita, MBChB MSc MRCSEd

george.nita@liverpoolft.nhs.uk 01517062000 Official trial record

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