RecruitingNAINTERVENTIONAL

Multi-parametric MRI Evaluation of Renal Graft Performance After Living Donor Donation.

This study is investigating how well a donated kidney performs after a living-donor transplant. We're using special MRI scans, known as multi-parametric MRI, to get a detailed picture of the kidney's health, including things like blood flow, oxygen levels, and how flexible the kidney tissue is. Doctors currently use certain measurements to decide if a donated kidney is suitable, but these don't always show the full picture of how well a kidney can adapt. As more older people are donating kidneys, understanding their kidney function in more detail is becoming very important. This research aims to track the health of both the donated kidney in the recipient and the remaining kidney in the donor for up to a year after the transplant. This information could help doctors choose the best kidneys for transplant recipients in the future.

At a glance

Status

Recruiting

Phase

Sponsor

Hospices Civils de Lyon

Enrolment target

Start

07 May 2024

Estimated completion

01 Sep 2029

Renal Insufficiency, Chronic

What is this study about?

When someone needs a kidney transplant, a kidney from a living donor is often the best option. Doctors carefully check the health of potential living donors, especially their kidney function, using a measure called GFR (glomerular filtration rate). This tells them how well the kidneys are cleaning the blood. Sometimes, it's tricky to decide if a kidney from an older donor is suitable because GFR naturally decreases with age. Even though these kidneys can work very well, current tests don't always show how adaptable and healthy they truly are.

This study aims to get a much clearer picture of kidney health using advanced MRI scans. These special scans can give us detailed information about different aspects of the kidney, such as its blood flow, how much oxygen it's getting, and even signs of scarring or inflammation. Think of it like taking a very detailed photograph, but also being able to see how efficiently different parts of the kidney are working. We want to understand how these measurements change over time, both in the kidney that has been transplanted into the recipient and in the kidney that remains in the donor.

The main goal of this research is to see if these advanced MRI scans can help doctors make even better decisions about which kidneys are best for transplant. By understanding how the kidneys are performing at a deeper level, we hope to improve the long-term success of kidney transplants and ensure the best possible outcomes for both donors and recipients.

Key takeaways

This study uses detailed MRI scans to understand kidney health after living donor transplant.
It aims to improve how we select kidneys for transplant.
Both kidney recipients and living donors participate in the study.
It involves several MRI scans, blood/urine tests, and for recipients, a few kidney biopsies over a year.
Participation could help improve future kidney transplant success rates.

Who may be eligible?

To join this study, you need to be an adult (18 years or older).

If you are a recipient, you must have severe, long-lasting kidney disease and be waiting for a kidney transplant from a living donor. If you're a woman, you'll need to be using reliable contraception. You also need to be covered by a national insurance or similar scheme. There are some specific medical reasons why you might not be able to have a kidney biopsy for this study, such as if you're taking certain blood-thinning medications or have very low blood counts.

If you are a donor, you must be healthy enough to donate a kidney, with a GFR (kidney function measure) above a certain level. Like recipients, you need to be an adult, and if you're a woman, you'll need to be using reliable contraception. You also need to be covered by a national insurance or similar scheme. Anyone who has an MRI contraindication (like certain metal implants), weighs over 130 kg, is pregnant or breastfeeding, is in prison, or under certain legal protections cannot take part. Also, if you're already in another study with an ongoing exclusion period, you won't be able to join this one.

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?
If you are a woman, are you using effective contraception?
Do you have any metal implants that make MRI scans unsafe, or do you weigh over 130kg?
Are you able to attend several hospital visits for scans and tests?
If you are a recipient, are you waiting for a living-donor kidney transplant?
If you are a donor, has your doctor told you your kidney function (GFR) is suitable for donation (>60)?

Answer every question to see your result.

What does participation involve?

If you decide to take part, you'll have several visits to the hospital:

**For Recipients:**

* **Before Transplant:** You'll have an MRI scan, and we might take blood and urine samples. * **After Transplant:** You'll have several follow-up appointments. This will include an MRI scan one week after your transplant, then again at 3 months, 6 months, and 12 months. At key points (one week, 3 months, and 12 months), you'll also have a kidney biopsy (a small tissue sample taken from the transplanted kidney), along with blood and urine tests.

**For Donors:**

* **Before Donation:** You'll have an MRI scan, and we'll take blood and urine samples. * **After Donation:** You'll have follow-up appointments with an MRI scan and blood and urine samples at 3 months and 12 months after your donation.

The total duration of your involvement in the study will be about 1 year from the time of your transplant or donation.

Potential risks and benefits

Taking part in this study may offer some benefits, such as gaining a more detailed understanding of your kidney health or the health of your donated kidney through advanced MRI scans. This research could also help improve future kidney donation and transplant matching for others. However, there are some potential risks. MRI scans can be noisy and may cause discomfort if you are claustrophobic. The kidney biopsy is a small medical procedure with a minor risk of bleeding or infection. You will also need to attend several extra hospital visits. It's important to remember that you are free to withdraw from the study at any time without giving a reason, and this will not affect your medical care.

Locations (1)

Hôpital Edouard Herriot, Hospices Civils de Lyon
Verified postcode
Lyon, France· Recruiting

Common questions

What is GFR?

GFR stands for Glomerular Filtration Rate. It's a measure of how well your kidneys are cleaning your blood, essentially how quickly they are filtering out waste products.

What is a multi-parametric MRI?

It's a special type of MRI scan that gives doctors much more detailed information about organs, like kidneys. It can show things beyond just structure, such as blood flow, oxygen levels, and tissue characteristics.

What is a kidney biopsy?

A kidney biopsy is a minor procedure where a very small piece of kidney tissue is taken. This sample is then looked at under a microscope to check for any issues.

Will I have to pay to be part of this study?

No, you will not have to pay to participate in this study. All study-related tests and procedures are covered by the research. Travel expenses might be reimbursed, but you should check with the study team.

Can I still have a transplant or donate a kidney if I don't join the study?

Yes, your decision about joining this study will not affect whether you can receive a kidney transplant or donate a kidney. Your medical care will remain the same.

How to find out more

Sandrine LEMOINE, PU-PH

sandrine.lemoine01@chu-lyon.fr 04 72 11 02 44 Official trial record

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