CompletedPhase IVInterventional

The OPTIMAL trial: do older adults with kidney transplants benefit from lower doses of anti-rejection tablets?

The OPTIMAL study is investigating the best dose of anti-rejection medicine for people aged 65 and over who have had a kidney transplant. Currently, the amount of medicine given is often based on studies in younger people, but older adults react differently. This can lead to more infections, cancers, and side effects that make life harder. This study will compare a standard higher dose of a medicine called mycophenolate mofetil (MMF) with a slightly lower dose. The aim is to find out if a lower dose can reduce side effects without increasing the risk of the body rejecting the new kidney. It's an important first step to help ensure older transplant patients receive the most effective treatment for a better quality of life.

At a glance

Status

Completed

Phase

Phase IV

Sponsor

North Bristol NHS Trust

Enrolment target

Start

30 Apr 2025

Estimated completion

01 Jun 2026

Kidney transplantation

What is this study about?

When you have a kidney transplant, your body’s natural defence system (immune system) might see the new kidney as a foreign object and try to attack it. This is called 'rejection'. To stop this from happening, transplant patients need to take special medicines, often called anti-rejection medicines, every day.

For older people (aged 65 and up) who receive a kidney transplant, it's a bit different. As we get older, our immune system naturally slows down. This means that older people might not need as much anti-rejection medicine as younger people to prevent rejection. However, the usual doses given to older patients are often based on research done with younger adults. We know that these medicines can have more side effects in older people, such as making them more likely to get infections or develop certain types of cancer, which can really affect their quality of life.

This study, called OPTIMAL, wants to see if giving a slightly lower dose of one common anti-rejection medicine, called mycophenolate mofetil (MMF), could be better for older transplant patients. The researchers want to find out if a lower dose can still prevent rejection effectively, while also reducing those difficult side effects. This is a very important question because there are currently no clear guidelines in the UK about the best dose for older patients, leading to different treatments in different hospitals. The results of this study will help doctors provide the best care for older people with kidney transplants.

Key takeaways

The study explores the best anti-rejection drug dose for older kidney transplant patients.
It compares two common doses of mycophenolate mofetil (MMF).
Aims to reduce side effects like infection, while preventing kidney rejection.
Participation involves no extra hospital visits; data is collected during routine care.
This is likely a low-risk study as both doses are already used in practice.
The results could lead to better guidelines and care for older transplant recipients.

Who may be eligible?

This study is looking for volunteers who are 65 years or older and have recently received a kidney transplant from a deceased donor. Your doctors will be able to tell you if you meet the age requirement for the study.

You would not be able to take part if you've ever had a very bad reaction to the medicine called mycophenolate mofetil (MMF). Also, if you’ve had more than one organ transplant at the same time (like a kidney and a pancreas), or if you can't give your consent to join the study because of your mental capacity, you wouldn't be eligible.

Other reasons you might not be able to join include if your body is very likely to reject the kidney due to specific immune system markers (this is called 'immunologically incompatible'), or if you're taking certain powerful medicines to prevent rejection right after your transplant, or if your treatment plan involves taking less steroid 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 65 years of age or older?
Have you recently received a kidney transplant from a deceased donor?
Have you ever had a severe reaction to mycophenolate mofetil (MMF)? (If yes, you likely can't participate.)
Did you receive only a kidney transplant, not other organs at the same time?
Are you able to provide your consent to take part in the study?

Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, you will be assigned to one of two groups: one receiving a higher dose of mycophenolate mofetil (MMF) (1.5 grams per day) and the other receiving a lower dose (1 gram per day). Both of these doses are already used in hospitals for people with kidney transplants. Your doctor will make sure you are in the correct group and explain your dosage.

Taking part won't mean extra hospital visits for you. All the information and tests needed for the study will be gathered during your regular check-ups with your kidney doctor. This helps to make sure that joining the study doesn’t add any extra burden to your routine care.

The study is planned to run from September 2024 to October 2026. If this initial 'test' study shows it's possible to do, a larger, UK-wide study might happen afterwards.

Potential risks and benefits

Participating in this study has potential benefits, as it could help find the best dose of anti-rejection medication for older kidney transplant patients, leading to better long-term health and quality of life for many. This is a very low-risk trial because it compares two doses of medicine that are already commonly used in hospitals. There's a chance that those on the higher MMF dose might have a slightly higher risk of infections or other side effects, which the study will investigate. Conversely, those on the lower MMF dose might have a slightly higher risk of their body rejecting the kidney, which will also be carefully monitored. However, doctors believe a lower dose might be better tolerated and could reduce infections without increasing rejection. You have the right to withdraw from the study at any time without affecting your medical care.

Locations (1)

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

Not provided at time of registration
City only
-, England

Common questions

What is mycophenolate mofetil (MMF)?

MMF is a common medicine given to people after a kidney transplant to help stop their body from rejecting the new kidney.

Why are you studying older adults specifically?

Older adults react differently to medications, and their immune systems are naturally less active. We want to find the best dose that works for them with the fewest side effects.

Will I have more hospital appointments if I join this study?

No, all the study tests and information will be collected during your regular check-ups at the hospital, so there are no extra visits.

What if I want to stop being part of the study?

You can choose to leave the study at any time, and this will not affect your medical care in any way.

Who is paying for this research?

This study is being funded by the National Institute for Health and Care Research (NIHR) in the UK.

How to find out more

Phillippa (Pippa) Bailey

pippa.bailey@bristol.ac.uk +44 (0)117 3314522 Official trial record

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