Ongoing, recruitingTherapeutic exploratory (Phase II)Interventional

A non-inferiority, randomised and controlled trial to compare the safety, tolerability and preliminary efficacy between standard and Torque Teno virus-guided immunosuppression in stable adult kidney transplant recipients with low immunological risk in the first year after transplantation

This study is for adult kidney transplant patients who are doing well in their first year after surgery and have a low risk of immune problems. Researchers want to see if guiding medication using levels of a virus called Torque Teno virus (TTV) is just as safe and effective as the usual method. The aim is to prevent infections, rejection of the new kidney, and other serious issues. Participants will receive tacrolimus, a common anti-rejection medicine. This is an early-stage study (Phase II) to gather information on safety and how well it works before bigger studies are done.

At a glance

Status

Ongoing, recruiting

Phase

Therapeutic exploratory (Phase II)

Sponsor

Medical University Of Vienna

Enrolment target

260

Start

28 Jun 2022

Post Kidney transplantation

What is this study about?

This study is looking into new ways to manage your medications after a kidney transplant. When you receive a new kidney, you need to take special medicines, like tacrolimus, to stop your body from rejecting it. However, these medicines can also make you more likely to get infections.

In this research, doctors are comparing two different approaches for adult patients who have had a kidney transplant recently (within the last year) and are considered to have a low risk of complications. One group will receive the standard care, while the other group will have their medication adjusted based on the levels of a common virus called Torque Teno virus (TTV) in their blood. Researchers believe that TTV levels might give a clue about how active your immune system is.

The main goal is to find out if using TTV levels to guide medication is as safe and effective as the current standard treatment. They will be watching closely for things like infections, rejection of the new kidney, or other serious problems to see which method works best. This type of research helps doctors find the best ways to care for people with kidney transplants.

Key takeaways

Compares two ways to manage anti-rejection medicine after a kidney transplant.
Investigates if using TTV virus levels to adjust medicine is safe and effective.
For adults who had a kidney transplant within the last year.
Aims to reduce infections and kidney rejection.
Involves regular blood tests and health checks for about one year.
Your choice to join or leave the study will not affect your regular medical care.

Who may be eligible?

This study is looking for adults aged 18 or older who have recently had a kidney transplant. You would be considered if you are in the first year after your transplant and your medical team believes you have a low risk of your body rejecting the new kidney.

Both men and women can take part. The research team will carefully check your full medical history to make sure this study is right for you and safe to join.

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 old or older?
Have you had a kidney transplant in the last year?
Has your doctor told you that you are at low risk for transplant complications?
Are you able to attend regular hospital visits and blood tests?

Answer every question to see your result.

What does participation involve?

If you decide to take part, you will be randomly placed into one of two treatment groups – meaning it's like flipping a coin, so neither you nor your doctor can choose. Both groups will receive tacrolimus, a standard anti-rejection medicine. One group will have their tacrolimus dose guided by TTV virus levels, and the other will receive standard care.

You will have regular hospital visits for blood tests and health checks. Doctors will monitor for infections, any signs of kidney rejection, and how your kidney is working. You will also fill out questionnaires about your health and quality of life. The study will look at how well you take your medication and if there are any side effects. The total duration of your participation in this study would be about one year.

Potential risks and benefits

Taking part in any medical study has potential benefits and risks. A potential benefit could be more personalised care for your anti-rejection medication, especially if the TTV-guided approach proves effective in reducing risks like infection or rejection. However, there are also risks, such as potential side effects from the medication or the possibility that the new approach may not be as effective as standard care. You might need extra blood tests or hospital visits. Remember, your participation is completely voluntary, and you are free to withdraw from the study at any time without explaining why, and this will not affect your future medical care.

Locations (6)

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

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Unverified
Netherlands
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Unverified
Czechia
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Unverified
France
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Unverified
Austria
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Unverified
Germany
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Unverified
Spain

Common questions

What is tacrolimus?

Tacrolimus is a medicine commonly used after an organ transplant to stop your body's immune system from attacking and rejecting the new organ.

What is the Torque Teno virus (TTV)?

TTV is a common virus that most people carry without knowing. Researchers believe its levels in your blood might reflect how active your immune system is, especially after a transplant.

What does 'non-inferiority' mean in a study?

It means the researchers want to show that the new treatment (TTV-guided) is not worse than the standard treatment, rather than necessarily being better.

What is a Phase II study?

Phase II studies are early-stage trials that look at whether a new treatment is safe and if it shows encouraging signs of working, before it's tested in much larger groups of people.

Will my regular kidney care be affected if I join?

The study aims to enhance your care. Your regular medical team will still be involved, and joining the study won't negatively affect your standard treatment or access to care.