Ongoing, recruitingTherapeutic use (Phase IV)Interventional

Evolution of proteinuria in renal transplant patients treated with Dapagliflozin for nephroprotection. DAPAGREFFE

This study, called DAPAGREFFE, is exploring how a medicine named Dapagliflozin (you might know it as Forxiga) works in people who have received a kidney transplant. The main goal is to find out if this medicine can help protect the transplanted kidney. Researchers will measure a specific protein in urine to see if it decreases after taking the medicine for six months. This could be a sign that the kidneys are working better. The study also looks at other aspects of kidney health, potential side effects, and how the medicine interacts with other treatments people might be taking after a transplant. It's for adults aged 18 and over, including both men and women.

At a glance

Status

Ongoing, recruiting

Phase

Therapeutic use (Phase IV)

Sponsor

Centre Hospitalier Universitaire De Montpellier

Enrolment target

Start

13 Oct 2023

chronic renal failure

What is this study about?

Imagine your kidneys as a very important filter for your body. When someone has a kidney transplant, they receive a new kidney to help their body filter waste properly. Sometimes, even with a new kidney, there can be ongoing issues, and doctors look for ways to keep these new kidneys as healthy as possible for as long as possible.

This study is focusing on a medicine called Dapagliflozin, which you might also know by its brand name, Forxiga. It's usually given as a 10 mg tablet. Doctors want to see if this medicine can help protect the transplanted kidneys. They will do this by checking for a specific protein in the patient's urine, called albumin. If the level of this protein goes down, especially by a certain amount, it could mean the kidney is being better protected or is working more efficiently.

Over six months, the researchers will closely watch these protein levels. They'll also look at other important things like how well the kidney is filtering overall, if there are any serious kidney problems, and how the medicine might affect things like blood pressure, weight, or interact with other medicines people take after a transplant. They will also keep a careful eye out for any side effects, such as infections or other common issues with this type of medication. This is a "Phase IV" study, which means the medicine is already approved for some uses, and doctors are now studying it in more detail for this specific group of patients.

Key takeaways

The study explores if Dapagliflozin helps protect transplanted kidneys.
It measures a protein in urine as a sign of kidney health.
The study lasts at least six months with clinic visits.
Researchers will monitor side effects and interaction with other medications.
It's for adults (18+) with chronic kidney issues after a transplant.

Who may be eligible?

To be considered for this study, you need to be an adult, aged 18 years or older – there's no upper age limit. The study is open to both men and women.

You would also need to have received a kidney transplant and be experiencing what doctors call 'chronic renal failure.' This simply means your kidneys aren't working as well as they should be, even after the transplant.

Beyond these general points, medical staff would check your full health history to make sure the study is right and safe for you, and that you meet all the specific requirements set by the research team.

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?
Are your kidneys currently not working as well as they should (chronic renal failure)?
Are you able to attend regular clinic visits for about six months?

Answer every question to see your result.

What does participation involve?

If you join this study, you would be prescribed the medicine Dapagliflozin, usually as a 10 mg tablet, which you would take regularly. You would have several visits to the clinic over a period of at least six months. During these visits, the research team would carry out various assessments.

Potential risks and benefits

Participating in this study might offer the potential benefit of a new treatment that could help protect your transplanted kidney. However, like all medicines, Dapagliflozin can have side effects, which the study team would monitor closely. These could include infections or changes to your blood sugar and blood pressure, among others. You would be fully informed of all potential risks before deciding to join, and you are always free to withdraw from the study at any time, for any reason, without it affecting your usual medical care.

Locations (1)

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

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Unverified
France

Common questions

What is Dapagliflozin (Forxiga)?

It's a medicine that helps the body get rid of sugar and salt through urine, and it's being studied to see if it can help protect transplanted kidneys.

What does 'protein in urine' mean for my kidney?

A high level of certain proteins in your urine can sometimes be a sign that your kidneys are not filtering as well as they should be. This study wants to see if the medicine can reduce that protein.

How long will I be in this study?

The main part of the study involves taking the medicine and being monitored for at least six months.

Will I still take my other medications?

Yes, the study will also look at how Dapagliflozin interacts with the other medicines you take, especially those to prevent transplant rejection.

What if I experience side effects?

The study team will carefully monitor you for any side effects, and you should tell them immediately if you feel unwell. You can leave the study at any time if you wish.