Not yet recruitingOBSERVATIONAL

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This study, called NovoStart, is investigating a specific medicine called Envarsus, given once a day, to help prevent organ rejection in people who have recently had a kidney transplant. Doctors want to see how effective and safe this medicine is in a real-world setting. They will compare it to other forms of the same medication that are taken twice a day or a different once-a-day version. The study involves patients in France and aims to understand if starting Envarsus right after a transplant can improve long-term outcomes, using special tools to predict how well the new kidney will work. It's designed to help doctors find the best ways to care for kidney transplant patients.

At a glance

Status

Not yet recruiting

Sponsor

Chiesi SAS

Enrolment target

165

Start

01 May 2025

Estimated completion

31 Dec 2027

Chronic Renal Disease

What is this study about?

When someone receives a kidney transplant, their body's immune system can sometimes try to reject the new organ. To prevent this, patients usually need to take special medicines called immunosuppressants. This study, named NovoStart, is looking closely at one of these medicines, called Envarsus, which is a once-a-day tablet.

The main goal is to understand how well Envarsus works and if it's safe when it's given to patients right after their kidney transplant. Researchers want to see if it helps prevent the new kidney from being rejected. They'll also compare patients taking Envarsus to those taking other versions of the same medicine – some taken twice a day, and another once-a-day type – to get a clearer picture of its benefits.

This study is happening in 13 hospitals across France and is considered a "real-world" study, meaning it looks at how the medicine works in everyday hospital settings, not just in very controlled lab conditions. The results will help doctors make better decisions about which medicines to use for kidney transplant patients to help their new kidney last longer and work well.

Key takeaways

This study evaluates a once-daily kidney transplant medicine called Envarsus.
It aims to improve long-term kidney health by preventing organ rejection.
The study is a 'real-world' observation in French hospitals.
It compares Envarsus to other standard anti-rejection medications.
Results could help doctors make better treatment choices for transplant patients.

Who may be eligible?

To join this study, you must be at least 18 years old and have recently received a kidney transplant from either a living or deceased donor. You also need to be starting the Envarsus medicine within 24 hours of your transplant. It's important that you are willing for your health information to be used for the study and are covered by a social security plan.

There are several reasons why you might not be able to join. For example, if you have a medical condition that means you shouldn't take Envarsus, or if you've had certain complex transplants (like a kidney and heart transplant together). If you've had weight-loss surgery or have stomach problems that might stop your body from absorbing the medicine properly, you also wouldn't be able to take part.

Additionally, if you are pregnant or breastfeeding, or if you have Parkinson's disease or similar conditions causing shakes, this study wouldn't be suitable. People who are already taking part in another medical study involving a new medicine, or those under legal guardianship, also cannot 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 or older?
Have you recently had a kidney transplant (from living or deceased donor)?
Will you be starting Envarsus medicine within 24 hours of your transplant?
Do you have social security coverage?
Are you not pregnant or breastfeeding?
Do you not have any conditions that would prevent you from taking Envarsus?

Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, you will be given the Envarsus medicine once daily, starting soon after your kidney transplant. Your doctors will regularly check your health, the levels of the medicine in your blood, and how well your new kidney is working. This will likely involve regular hospital visits, blood tests, and check-ups, similar to the care you would already receive after a kidney transplant. The study will carefully record your progress and any effects of the medication. The exact number of visits and the duration of your participation would be fully explained by the study team.

Potential risks and benefits

Taking part in this study may offer the benefit of receiving close monitoring of your health and new kidney function. You would be helping doctors learn more about the best ways to use a key medicine after kidney transplantation, potentially improving care for future patients. As with any medicine, Envarsus has potential side effects, and some people may react differently. The study involves collecting your health information. You are free to withdraw from the study at any time without affecting your medical care.

Locations (1)

Chru Tours
Verified postcode
Tours, France

Common questions

What is the main goal of this study?

The main goal is to see how well a once-daily medicine called Envarsus works and if it's safe for people who have just had a kidney transplant.

What is Envarsus?

Envarsus is a special medicine taken once a day to help stop your body from rejecting a new kidney after a transplant.

Where is this study taking place?

This study is being conducted in 13 hospitals across France that perform kidney transplants.

Will I get different treatment if I join this study?

You will receive Envarsus starting soon after your transplant, and your doctors will closely monitor your health, similar to standard post-transplant care, but with specific data collection for the study.

Can I leave the study at any time?

Yes, you are completely free to leave the study at any point without it affecting your medical care.

How to find out more

Philippe GATAULT, MD

philippe.gatault@univ-tours.fr 247366392 Official trial record

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