Optimization of Albuminuria-Lowering Therapies for Individual Patients with Type 2 Diabetes Using Empagliflozin and Finerenone in a Pilot Remote Clinical Trial
This study, called a 'pilot remote clinical trial', is for people with type 2 diabetes and a kidney problem called albuminuria. It's testing medicines like Kerendia (finerenone) and Jardiance (empagliflozin) to see how well they lower protein in the urine, which is a sign of kidney damage. A big part of this study is understanding if people can easily participate from home, using digital devices to track their health. Researchers will look at how often people miss blood pressure readings or urine samples, and how well they take their medication. This helps them learn if future studies can be run more conveniently for patients.
At a glance
What is this study about?
This clinical trial is designed for people who have type 2 diabetes and a specific kidney condition called albuminuria. Albuminuria means there's too much protein in your urine, which can be a sign that your kidneys aren't working as well as they should. The study is particularly interested in how two different medicines, empagliflozin (known by the brand name Jardiance) and finerenone (known as Kerendia), work together to reduce this protein in the urine and help protect your kidneys.
A key new aspect of this trial is that it's being run as a 'remote' study. This means participants are doing many of the study activities from their own homes, rather than needing to visit a clinic often. The researchers want to find out how practical and easy this is for people. They'll be looking at things like how well people collect urine samples, take their blood pressure, measure their body weight at home, and keep up with taking their study medication.
While finding out how new treatments help kidneys is important, this study also focuses on proving that remote clinical trials can work well. If successful, it could mean that in the future, it might be easier and more convenient for more people to take part in medical research, as they wouldn't need to travel as much. This type of study (Phase IV) means the medicines are already approved and being used, and researchers are now learning more about how to use them best and how helpful they are in real-world settings.
Key takeaways
- Tests new ways to combine diabetes medicines (Kerendia and Jardiance) to protect kidneys.
- Investigates how well people can take part in a study from their own home.
- Focuses on people with type 2 diabetes and kidney problems (albuminuria).
- Uses digital tools for home measurements like blood pressure and urine samples.
- Aims to make future medical research more accessible and convenient.
Who may be eligible?
To be considered for this study, you need to be an adult, at least 18 years old, and there isn't an upper age limit. Both men and women can take part.
Crucially, you must have been diagnosed with type 2 diabetes. You also need to have a specific kidney problem called albuminuria, which means there's too much protein in your urine. The research team will do tests to confirm this and other health details to make sure the study is a good fit for you and safe.
The study would involve taking specific medicines for your diabetes and kidney condition, and you would need to be able to use digital tools to help with measurements and collecting information from your home.
- Are you 18 years old or older?
- Have you been diagnosed with type 2 diabetes?
- Have you been told you have extra protein in your urine (albuminuria)?
- Are you comfortable using digital tools for health monitoring from home?
- Are you able to regularly provide urine samples from home?
This is a guide only — the research team will confirm whether you can take part.
What does participation involve?
If you join this study, you'll be taking either Kerendia (finerenone), Jardiance (empagliflozin), or possibly both, as film-coated tablets. The study is designed so you can do many of the activities from your home. This includes regular collection of urine samples, which you'll need to send to a lab, and taking your own blood pressure and body weight measurements.
Researchers will regularly check how well you're taking your medication, for example, by counting your pills and looking for traces of the medicine in your urine. You'll also be asked to fill out questionnaires about your experience taking part in the study from home and using digital tools. The exact number of visits, assessments, and the total duration will be explained in detail by the study team, but the aim is to minimise clinic visits by using remote monitoring where possible.
Potential risks and benefits
Locations (1)
- —Netherlands
Common questions
What is albuminuria?
Albuminuria means there's more protein (especially albumin) in your urine than there should be. It can be a sign of kidney damage, especially in people with diabetes.
What are Kerendia and Jardiance?
Kerendia (finerenone) and Jardiance (empagliflozin) are medicines used to treat type 2 diabetes. They can also help protect the kidneys and heart in some people.
What does 'remote clinical trial' mean?
It means you can do a lot of the study activities, like giving samples or taking measurements, from your own home using digital tools, reducing the need for many clinic visits.
Will I know which medicine I'm taking?
The study team will explain how and when you'll know which medicine you're taking. Sometimes, for research accuracy, participants might not know until the study is over.
What if I feel unwell during the study?
The study team will give you clear instructions on who to contact immediately if you feel unwell or have any concerns during the study.
How to find out more
Always speak to your GP or specialist before deciding to take part in a study.
Discussion
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