AuthorisedTherapeutic confirmatory (Phase III)Interventional

Effect of Empagliflozin in patients with eGFR between 10 and 20 ml/min/1.73m2 - EMPA [10-20]

This research study, called EMPA [10-20], is investigating a new use for a medicine called Jardiance (empagliflozin). It's for adults who have kidney disease and type 2 diabetes. We want to find out if Jardiance can help reduce the amount of protein and a specific protein called albumin in their urine. Too much protein in the urine can be a sign that the kidneys aren't working as well as they should. Participants will either take Jardiance or a dummy pill (placebo) for periods, and we'll check their urine, blood pressure, weight, and blood sugar levels. We'll also carefully watch for any side effects to make sure the treatment is safe.

At a glance

Status

Authorised

Phase

Therapeutic confirmatory (Phase III)

Sponsor

Centre Hospitalier Universitaire De Nice

Enrolment target

Start

05 Mar 2026

Patients with renal impairment and type 2 diabetes.

What is this study about?

This study is all about helping people who have both kidney problems and type 2 diabetes. Type 2 diabetes can sometimes affect the kidneys over time, and this study is looking into a medicine called Jardiance. We already know Jardiance helps with blood sugar, but we want to see if it can also protect the kidneys by reducing the amount of certain proteins found in urine. Finding too much protein in your urine can be a sign that your kidneys are getting damaged, so understanding if a medicine can lower these levels is really important.

Participants in the study will be given either Jardiance or a 'placebo', which looks exactly like Jardiance but doesn't contain any active medicine. This allows doctors to compare the effects of the real medicine against taking nothing extra. By doing this, we can clearly see if any changes we observe are due to Jardiance itself. The study will carefully measure things like how much protein is in the urine, blood pressure, body weight, and blood sugar levels over several weeks.

The main goal is to understand if Jardiance can improve kidney health for people with kidney problems and type 2 diabetes. We also want to make sure the medicine is safe when used in this group of patients. The information gathered from this study will help doctors decide if Jardiance could be a good treatment option for more people in the future.

Key takeaways

This study explores a medicine called Jardiance for people with type 2 diabetes and kidney problems.
It aims to see if Jardiance can reduce protein in the urine, a sign of kidney health.
Participants will take either Jardiance or a dummy pill (placebo).
Regular checks of urine, blood, blood pressure, and weight will be done.
The study helps doctors understand new ways to protect kidneys.
You can leave the study at any time.

Who may be eligible?

This study is looking for adults who are aged 18 or older. You can be any gender to take part.

To be considered, you must have been diagnosed with type 2 diabetes. You also need to have kidney problems, meaning your kidneys are not working as well as they should. Doctors use a specific test called eGFR to measure kidney function, and for this study, your eGFR needs to be between 10 and 20 ml/min/1.73m2. Your doctor will be able to tell you if your kidneys fit this range.

It's important that you meet these specific health requirements so the researchers can understand how the medicine works in people with similar conditions. Your study doctor will review all your medical information to confirm if you are suitable for the study.

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?
Do you have type 2 diabetes?
Do you have kidney problems where your kidney function (eGFR) is between 10 and 20 ml/min?
Are you able to attend regular clinic visits?
Are you willing to provide urine and blood samples?

Answer every question to see your result.

What does participation involve?

If you join this study, you will either receive the medicine Jardiance (10 mg daily) or a 'dummy' pill (placebo) that looks identical. You won't know which one you're taking, and neither will the study team, to make sure the results are fair. The study involves several visits to the clinic over a period of weeks. During these visits, we will take urine samples (usually from your first morning pee) and blood samples, check your blood pressure, and measure your weight. You will have a few rounds of taking either the study medicine or placebo, each lasting for about 6 weeks. After each 6-week period, there will be assessments to see how you are doing. You will need to collect urine over a few days at the start of the study and at certain times during the study. The total time you'll be involved in the study will be explained in detail by the research team.

Potential risks and benefits

Taking part in this study might offer you the potential benefit of closer medical monitoring and access to a new treatment, Jardiance, which could help your kidney health. However, like all medicines, Jardiance can have side effects, and some people may experience them. These might include changes in your blood pressure or blood sugar, or other effects on your body chemistry. The study team will monitor you very closely for any unexpected reactions or issues. Remember, you can choose to leave 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 Jardiance?

Jardiance is a medicine usually used to help people with type 2 diabetes manage their blood sugar, and sometimes to help with heart and kidney health. This study is looking at how it helps people with specific kidney issues.

What is a 'placebo'?

A placebo is a 'dummy' pill that looks just like the real medicine but contains no active ingredients. We use it to compare the effects of the real medicine fairly.

Why do you need urine samples?

We check your urine for specific proteins, like albumin, because high levels can be a sign of kidney problems. We want to see if Jardiance can help reduce these levels.

Will I know if I'm taking the real medicine or the placebo?

No, neither you nor the study team will know during the study. This helps make sure the results are not biased and are as accurate as possible.

How long will I be in the study?

You will participate in several rounds, each lasting about 6 weeks, where you take either Jardiance or the placebo. The study team will provide more specific details about the total duration.