The OPTIMIzE study;OPen label multicenter randomized Trial comparing standard IMmunosuppression with tacrolimus and mycophenolate mofetil with a low exposure tacrolimus regimen In combination with everolimus in de novo renal transplantation in Elderly patients.
This study, called The OPTIMIzE study, is for older patients who have recently had a kidney transplant. Doctors are comparing two different ways of giving medicines that stop the body from rejecting the new kidney. One way is the standard treatment usually given, and the other uses a lower dose of one medicine (tacrolimus) combined with a different medicine called everolimus. The aim is to see if this new combination works better at protecting the new kidney, avoiding side effects, and improving the patient's quality of life. This is a Phase 4 study, which means the medicines are already approved and being used in patients.
At a glance
What is this study about?
When you have a kidney transplant, you need to take special medicines, called immunosuppressants, to stop your body's immune system from attacking and rejecting the new kidney. This study, called OPTIMIzE, is looking at how to give these important medicines to older patients who have just had a kidney transplant.
The research compares two main treatment plans. One is the standard treatment that doctors usually give. The other plan uses a slightly different approach: a lower dose of a common medicine called tacrolimus, combined with another medicine called everolimus. The main goal is to find out if this newer combination of medicines can do a better job of protecting your new kidney over time, while also causing fewer side effects and helping you feel better overall.
The study will carefully check many things, like how well your new kidney is working, whether your body tries to reject it, how often you get infections or other health problems, and how your day-to-day life is affected. By comparing these two treatment approaches, doctors hope to find the best way to help older patients keep their new kidneys healthy for longer and have a better quality of life after a transplant.
Key takeaways
- The study compares two different medicine plans for elderly kidney transplant patients.
- It aims to find the best way to protect new kidneys and improve patient health.
- Participation involves regular clinic visits for monitoring over at least two years.
- All medicines used are already approved and in use.
- Your health and quality of life will be carefully tracked.
Who may be eligible?
This study is open to both men and women of any adult age who have recently received a kidney transplant. The study is specifically designed for elderly patients, which means it will focus on older individuals.
To be considered for this study, you would need to have had a kidney transplant very recently. The medical team will check other specific health details to make sure the study is a safe and suitable option for you.
It's important to remember that even if you fit these general descriptions, the study doctors will go through a full check-up to confirm you meet all the requirements. They will explain everything clearly to you.
- Have I recently had a kidney transplant?
- Am I considered an 'elderly' patient (the study doctors will clarify this)?
- Am I able to attend regular clinic appointments?
- Am I willing to take the study medications as prescribed?
This is a guide only — the research team will confirm whether you can take part.
What does participation involve?
If you decide to take part in this study, you'll be assigned to one of the two treatment groups by chance, like flipping a coin. You'll receive either the standard immunosuppressant medication or the new combination of medicines. You'll have regular visits to your transplant clinic, where doctors will take blood samples, measure your kidney function, and ask you questions about how you're feeling and any side effects you might be experiencing.
These check-ups will happen at specific times, usually at 12 and 24 months after your transplant, but there might be other visits too. During these visits, they'll monitor your overall health, including looking for things like infections, diabetes, or heart problems. They'll also ask about your quality of life and how you're coping. The study will likely follow you for at least two years to understand the long-term effects of the treatments.
Potential risks and benefits
Locations (2)
- —Netherlands
- —Belgium
Common questions
What medicines will I be taking in this study?
You will be taking medicines to prevent your body from rejecting your new kidney. The study compares a standard set of these medicines with a different combination, which includes lower doses of tacrolimus and everolimus.
How long will I be in this study?
The study collects information for at least 24 months (two years) after your kidney transplant, with regular check-ups during that time.
What is the main goal of this study?
The main goal is to see which medication plan works best to keep your new kidney healthy, prevent rejection, and improve your overall well-being and quality of life after a transplant.
Will I know which treatment I'm getting?
This is an 'open label' study, which means both you and your doctors will know which treatment you are receiving.
What if I feel unwell during the study?
Your doctors will closely monitor you throughout the study for any side effects or health changes. You should always tell your medical team about any concerns you have.
How to find out more
Always speak to your GP or specialist before deciding to take part in a study.
Discussion
Community discussion
Powered by our forum at community.patient.info. Please be respectful — this is not medical advice.