CompletedNot ApplicableInterventional

Testing the ability to reduce immunosuppression in older renal transplant recipients

When you receive a kidney transplant, you need to take anti-rejection medicines to stop your body attacking the new organ. However, older adults usually have milder immune responses and are at a higher risk of getting severe infections from these strong medicines. This UK study is testing whether people aged 60 and older can safely take lower doses of standard anti-rejection drugs. Half of the participants will receive standard doses, and the other half will receive reduced doses. Doctors will track your health using routine check-ups and advanced blood tests that look for tiny pieces of DNA from the donor kidney. This allows the medical team to spot any early signs of rejection quickly. The goal is to find the right balance: protecting the transplanted kidney while cutting down on dangerous infections.

At a glance

Status

Completed

Phase

Not Applicable

Sponsor

University of London

Enrolment target

106

Start

30 Jun 2022

Estimated completion

30 Aug 2026

Kidney transplant recipients

What is this study about?

After a kidney transplant, patients must take lifelong anti-rejection medicines (immunosuppressants) to stop their immune system from attacking the new organ. Currently, older and younger patients receive similar amounts of these drugs. However, as we get older, our immune systems naturally slow down. Because of this, older recipients face a much higher risk of catching life-threatening infections, but they actually have a lower risk of rejecting their kidney.

Doctors want to know if older adults can safely take lower doses of these medicines. Lowering the dose could help prevent common, serious viruses like cytomegalovirus (CMV), which can cause serious complications in the lungs, eyes, and stomach. At the same time, doctors must be sure the lower dose will still protect the transplanted kidney.

To keep patients safe, researchers are using a new type of blood test. When a transplanted kidney is under stress or facing rejection, it releases tiny fragments of its own genetic code (DNA) into your bloodstream. By measuring this 'donor DNA' alongside regular virus checks, doctors can detect any rejection early and adjust medicine levels before any lasting harm occurs.

Ultimately, this study aims to create personalised treatment plans for older transplant recipients, balancing medicine levels to give people the best quality of life with their new kidney.

Key takeaways

Tests if adults aged 60 and over can safely take lower doses of anti-rejection drugs after a kidney transplant.
Aims to reduce serious infections while keeping the new kidney completely safe.
Uses advanced blood tests to spot any early signs of organ rejection.
Follows your standard post-transplant hospital visits with no extra routine trips required.
Participation is voluntary, and you can withdraw at any time without affecting your NHS care.

Who may be eligible?

This study is open to adults aged 60 and over who are preparing to receive their first single kidney transplant, whether from a living or deceased donor. Because the trial is designed to see if lower doses of medicine are safe, it only includes people who are considered at low risk of early rejection.

You will not be able to take part if you have had an organ transplant before, or if your immune system already has high levels of antibodies that might attack a donor kidney. You may also be excluded if your original kidney disease was caused by specific immune conditions that need standard high-dose therapy, or if you have never been exposed to the Epstein-Barr virus (EBV).

Finally, you must be able to attend regular follow-up clinic appointments every four weeks during the initial monitoring stage, so the care team can keep a close eye on your health.

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.

I am aged 60 or older.
I am waiting for my first-ever kidney transplant.
I am receiving a single kidney (not multiple organs).
I can attend regular hospital check-ups every four weeks after surgery.
I do not have high levels of pre-existing antibodies against donor organs.

Answer every question to see your result.

What does participation involve?

If you join the trial, you will be placed by chance (randomised) into one of two groups: one receives standard doses of anti-rejection medicines, and the other receives a lower dose. You will receive standard post-transplant care, and you will not need to make extra clinic visits beyond what is normally expected after a kidney transplant. During your routine visits, the team will check your healing, test your physical strength, and take a few extra blood samples to look for donor DNA and monitor virus levels. In the first phase, blood checks will happen roughly every four weeks. Your doctors will carefully adjust your medication doses based on your results. The overall study will follow participants through regular clinic check-ups over several years.

Potential risks and benefits

The main benefit of taking part is that receiving a lower dose of medication may reduce your risk of serious infections and other long-term side effects. Even if you receive the standard dose, your participation helps doctors improve post-transplant care for older adults in the future. The primary risk of taking a lower dose is that your body might try to reject the new kidney. To protect you, the team will closely monitor your blood for the earliest signs of rejection so they can raise your dose immediately if needed. Other risks include minor bruising or brief discomfort from routine blood tests. Taking part is entirely voluntary, and you can withdraw from the study at any time without your regular NHS medical care being affected.

Locations (1)

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

Renal Clinic - Royal Free Hospital
City only
London, England

Common questions

Will I have to travel for extra clinic appointments?

No. The trial is designed to fit into your normal schedule of hospital visits following a kidney transplant.

Can I choose whether I get the lower dose or the normal dose?

No. A computer will randomly assign you to either the normal or reduced dose group so the study remains fair and unbiased.

What happens if my body starts to reject the kidney?

The study uses sensitive blood tests to catch rejection early. If there is any sign of rejection, your doctors will increase your anti-rejection medicine straight away.

What is donor DNA and why is it tested?

If a donor kidney becomes irritated or injured, it sheds tiny bits of its DNA into your blood. Finding these pieces early warns doctors of rejection before you feel unwell.

What happens if I decide to leave the trial?

You are free to leave at any time. Your doctors will switch you to the best standard care, and your future treatment will not be compromised.

How to find out more

Reza Motallebzadeh

r.motallebzadeh@ucl.ac.uk +44 2080168089 Official trial record

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