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Not yet recruitingNAINTERVENTIONAL

Non-Invasive Monitoring of Pediatric Kidney Transplant Recipients and Immunosuppression Personalization: an Open-labeled Multicenter Randomized Controlled Study

This study is for children under 21 who have had a kidney transplant. Currently, doctors often do biopsies (taking small tissue samples) to check if the new kidney is healthy and if the medicines are working well. This research wants to see if new, simpler blood tests called dd-cfDNA and T-Vis can provide the same information. The aim is to reduce the need for biopsies and help doctors give the right amount of medicine to each child, making their recovery smoother and safer.

At a glance

Status
Not yet recruiting
Phase
NA
Sponsor
Assistance Publique - Hôpitaux de Paris
Enrolment target
160
Start
01 Mar 2025
Estimated completion
01 Mar 2029

What is this study about?

When children receive a new kidney, it's really important for doctors to regularly check that the new kidney is working well and that the body isn't trying to reject it. They also need to make sure the medicines given to stop rejection, like tacrolimus, are at the right level to prevent problems. Currently, a common way to do this is by taking small samples from the kidney, called biopsies. While these are very helpful, they do involve a small procedure.

This study, called MONITOR, is exploring new ways to check on the kidney's health and medicine levels that are less invasive. It's looking at using special blood tests: one called 'donor-derived cell-free DNA' (dd-cfDNA) and another for 'virus-specific T cells' (T-Vis). The idea is that these blood tests might be able to tell doctors if the kidney is doing well or if there are any issues, potentially reducing how often children need to have a biopsy.

The researchers also hope that using these blood tests will help doctors fine-tune the amount of anti-rejection medicine each child receives. This is important because too much medicine can have side effects, and too little might not protect the new kidney enough. If successful, this research could lead to a kinder and more personalised way of caring for children after a kidney transplant, making monitoring easier for them and their families.

Key takeaways

  • New study to find better ways to monitor children's kidney transplants.
  • Aims to reduce the need for biopsies using special blood tests.
  • Hopes to personalise anti-rejection medicine doses for each child.
  • Compares new blood test methods with standard care.
  • For children under 21 who have had a single kidney transplant.

Who may be eligible?

This study is looking for young people who have received a single kidney transplant. They need to be under 21 years old at the time of their transplant. The new kidney could have come from either a deceased donor or a living donor.

There are also some important points about who can't join. For example, if you've had other organ transplants besides a kidney, or if you're pregnant, you wouldn't be able to take part. Also, if a biopsy isn't already planned as part of your standard care, you wouldn't be suitable for this study.

Everyone taking part, including parents or legal guardians for younger participants, needs to understand the study well and be happy to follow its steps. You also need to be part of a health insurance system.

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.

  1. Are you under 21 years old and had a kidney transplant?
  2. Was it your first and only organ transplant (just a kidney)?
  3. Are you not pregnant (if applicable)?
  4. Are you and your guardian able to understand and follow study instructions?
  5. Do you currently have health insurance?
Answer every question to see your result.

What does participation involve?

If you join this study, you would be put into one of four groups by chance, like drawing names from a hat. Three groups would have their kidney health monitored using different combinations of the new blood tests (dd-cfDNA, T-Vis, or both). The fourth group would receive the usual care, which includes regular biopsies and blood tests as doctors normally do. The study aims to follow how many biopsies are needed for each group for up to two years and to check the levels of anti-rejection medicine. You would attend regular appointments for blood tests and other checks as required by your specific group.

Potential risks and benefits

Taking part in this study might mean you have fewer biopsies, which could be a benefit as biopsies are invasive. It could also help doctors tailor your medicine doses better, potentially reducing side effects. However, as with any study, there's always a small chance of unforeseen risks, and the new monitoring methods might not be as effective as standard care. You are free to stop participating in the study at any time, for any reason, without it affecting your usual care.

Locations (1)

  • Robert Debré Hospital
    Verified postcode
    Paris, France

Common questions

What is a biopsy?

A biopsy is a procedure where a small piece of tissue is taken from your kidney to be looked at under a microscope. It helps doctors check the health of the kidney.

What are dd-cfDNA and T-Vis tests?

These are special blood tests. dd-cfDNA looks for tiny bits of DNA from the new kidney in your blood, and T-Vis checks certain immune cells, both of which can give clues about how your kidney is doing.

Will I still get my usual care if I join?

Yes, all participants in the study will continue to receive excellent medical care for their kidney transplant. Some will just have different ways of monitoring.

What kind of medicine are they talking about adjusting?

They're referring to anti-rejection medicines, like tacrolimus, which you take to stop your body from attacking the new kidney.

How long does the study last?

The study will follow participants for about two years after randomisation to see the long-term effects of the different monitoring methods.

How to find out more

Julien HOGAN, MD, PhD

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

Interested in taking part?

Register your interest

Share your details and the research team for "Non-Invasive Monitoring of Pediatric Kidney Transplant Recip…" will contact you if you may be eligible. Always speak to your GP before agreeing to take part.

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