RecruitingPHASE3INTERVENTIONAL

Low-dose Arginine-vasopressin Supplementation on Post-transplant Acute Kidney Injury After Liver Transplantation (AVENIR Trial)

This study, called the AVENIR Trial, is looking for better ways to protect kidneys after a liver transplant. Liver transplants are major operations, and sometimes the kidneys can be damaged during or after the surgery. This can lead to serious long-term health problems. Researchers want to see if a medication called arginine-vasopressin (AVP) can help prevent this kidney damage. AVP is a naturally occurring hormone that helps control blood pressure. The study will compare AVP with another common medication, norepinephrine, which is currently used to help stabilize blood pressure during surgery. By finding a way to better protect kidneys, the aim is to improve recovery and long-term health for people having liver transplants.

At a glance

Status

Recruiting

Phase

PHASE3

Sponsor

Assistance Publique - Hôpitaux de Paris

Enrolment target

304

Start

16 Apr 2025

Estimated completion

16 May 2027

Acute Kidney Injury Post Liver Transplantation

What is this study about?

When someone has a liver transplant, it's a big operation, and sometimes the kidneys can get a bit stressed during the surgery. This stress can lead to something called acute kidney injury (AKI), which means the kidneys don't work as well as they should for a while. For some people, this can even turn into longer-term kidney problems. Doctors are always looking for ways to stop this from happening, to help patients recover better and have fewer health issues later on.

This study, called the AVENIR Trial, is testing a new approach. It's looking at a medication called arginine-vasopressin, or AVP for short. AVP is actually a hormone your body makes naturally, and it plays a role in controlling blood pressure. The doctors think that giving a small amount of AVP during the liver transplant operation might help protect the kidneys. They believe it might help blood flow to the kidneys in a helpful way, preventing damage.

The main goal of this research is to see if AVP is better than the standard treatment, a medication called norepinephrine, at preventing kidney injury after a liver transplant. Both medications help manage blood pressure during surgery, but researchers want to know if AVP has a special benefit for kidney protection. If AVP proves to be effective, it could become a new way to improve care for people undergoing liver transplants.

Key takeaways

The study aims to reduce kidney damage after liver transplants.
It compares two medications during surgery: AVP and norepinephrine.
You won't know which treatment you receive (double-blind study).
Close monitoring of your kidney health will be part of the study.
Participation is voluntary, and you can withdraw anytime.

Who may be eligible?

To join this study, you need to be an adult (18 years or older) who is scheduled to have a liver transplant. You must be able to understand the study information and give your informed consent, which means you agree to take part after having all your questions answered.

There are some reasons why you might not be able to join. For example, if your liver transplant is an emergency, or if you're already scheduled to have a kidney transplant at the same time as your liver transplant. You also can't join if you have very poor kidney function already, or if you have epilepsy. If you are pregnant or breastfeeding, you won't be able to take part either.

It's also important that you haven't recently taken part in another clinical trial where you received a new treatment, and you must not be allergic to any of the study medications. The medical team will check all these points carefully to see if this study is suitable for you.

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?
Are you scheduled for a liver transplant?
Do you *not* need an emergency liver transplant due to very sudden and severe liver failure?
Are you *not* having a kidney transplant at the same time as your liver transplant?
Do you *not* have very poor kidney function already (e.g., on dialysis)?
Are you *not* pregnant or breastfeeding?

Answer every question to see your result.

What does participation involve?

If you decide to take part, you'll be randomly assigned to receive one of two medications during your liver transplant surgery: either arginine-vasopressin (AVP) or norepinephrine. Both medications will be given continuously through a drip (infusion) into your vein. The medical team will carefully adjust the dose to maintain your blood pressure at a safe level for your surgery and recovery. You won't know which medication you are receiving, and neither will your doctors, to ensure the results are as fair as possible.

After your surgery, the research team will closely monitor your kidney function and overall health. This will involve regular blood tests and other assessments, just like what would normally happen after a liver transplant, but with some extra checks for the study. There will be follow-up appointments after you leave the hospital, typically for a few weeks or months, to continue monitoring your recovery and kidney health. The total duration of your active participation, meaning when you're being monitored for the study, will be outlined by the research team.

Potential risks and benefits

Taking part in this study may offer potential benefits, such as receiving one of the best available treatments to manage blood pressure during your transplant, with the potential for better kidney protection. However, we don't yet know if AVP is better than the current standard. Both medications used in this study are used in clinical practice, but like all medications, they can have side effects. Your care team will monitor you very closely for any potential issues. You have the right to withdraw from the study at any time, for any reason, without it affecting your usual medical care.

Locations (1)

URC Lariboisière-Fernand Widal-saint Louis
Verified postcode
Paris, France· Recruiting

Common questions

What is acute kidney injury (AKI) and why is it important?

AKI means your kidneys suddenly stop working as well as they should. After a major surgery like a liver transplant, it can lead to longer hospital stays and sometimes ongoing kidney problems, so preventing it is very important.

What is Arginine-vasopressin (AVP)?

AVP is a hormone your body usually makes. It helps control your blood pressure and water balance. In this study, we're giving a small extra amount during surgery to see if it protects your kidneys.

Will I know if I'm getting AVP or norepinephrine?

No, you won't. This is a 'double-blind' study, meaning neither you nor your doctors will know which medication you're receiving. This helps make the study results fair.

Does taking part affect my regular liver transplant care?

No, your medical team will still provide you with the best possible care for your liver transplant, regardless of whether you are in the study or not. The study adds extra monitoring and a specific medication strategy.

What if I change my mind about participating?

You are free to leave the study at any time, for any reason, without it affecting your medical care for your liver transplant or any other health needs.

How to find out more

Jacques DURANTEAU, Pr

jacques.duranteau@aphp.fr 01 45 21 34 41 Official trial record

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