Active not recruitingPHASE2INTERVENTIONAL

A Study to Test Whether Vicadrostat in Combination With Empagliflozin Helps People With Chronic Kidney Disease

This study is investigating a new medicine called vicadrostat, when given alongside empagliflozin, for adults who have chronic kidney disease that is at risk of getting worse. Some people who have recently taken a specific kidney medicine (SGLT2 inhibitor) or have certain other health conditions cannot join. Participants will be randomly placed into one of two groups. Both groups will take medicines daily as tablets for 3 months. One group takes both study medicines together from the start, while the other takes empagliflozin with a dummy pill (placebo) first, and then adds vicadrostat later. Doctors will regularly test kidney function and monitor overall health. The study lasts about 4.5 months in total, including follow-up visits.

At a glance

Status

Active not recruiting

Phase

PHASE2

Sponsor

Boehringer Ingelheim

Enrolment target

492

Start

18 Jul 2025

Estimated completion

20 Aug 2026

Chronic Kidney Disease

What is this study about?

This research study is looking at a new medicine called vicadrostat and how it works when combined with an existing medicine, empagliflozin, for people living with chronic kidney disease (CKD). CKD means your kidneys aren't working as well as they should, and for some, it can get worse over time. The main goal of this study is to find out if this combination of medicines can help slow down the progression of kidney disease.

Chronic kidney disease can affect your quality of life and lead to other health problems, so finding new and effective treatments is very important. This study is trying to understand if giving vicadrostat and empagliflozin together from the start, or adding vicadrostat after a period of just taking empagliflozin, makes a difference in how well the treatment works. This information could help doctors in the future decide the best way to prescribe these medicines.

While this is a research study, participants will have their kidney health closely monitored by medical professionals. The study medicine, vicadrostat, is still being investigated, meaning we are still learning about how well it works and its full effects. Empagliflozin is an approved medication for kidney disease and other conditions. The doctors running this study are committed to ensuring participant safety and will carefully watch for any changes in health.

Key takeaways

A research study for adults with chronic kidney disease.
Investigating a new medicine, vicadrostat, combined with empagliflozin.
Participants take daily tablets for 3 months, with regular health checks.
Compares starting medicines at the same time versus adding one later.
Total study involvement is about 4.5 months.
Participation is voluntary, and you can withdraw at any time.

Who may be eligible?

This study is looking for adults aged 18 or over who have chronic kidney disease that doctors believe is at risk of getting worse. You would need to have had specific kidney function test results within the last year and at the start of the study to show your kidneys are working within a certain range. You should also be taking a stable dose of a common blood pressure medicine (either an ACE inhibitor or an ARB) for at least 4 weeks before the study starts, and not plan to change this during the study.

However, there are reasons why you might not be able to join. For example, if you have taken a specific type of kidney medicine called an SGLT2 inhibitor within 4 weeks of the study starting, you wouldn't be eligible. Also, if you've recently taken certain other heart or kidney medicines (like MRAs, aldosterone synthase inhibitors, or potassium-sparing diuretics), or if you need to take them during the study, you wouldn't be able to participate.

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 chronic kidney disease that is at risk of getting worse?
Are you currently taking a stable dose of an ACE inhibitor or ARB medicine (common blood pressure medicines)?
Have you avoided taking an SGLT2 inhibitor (a specific type of kidney medicine) in the last 4 weeks?
Have you avoided taking certain other heart or kidney medicines in the last 2 weeks?

Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, you will be involved for about 4.5 months in total. Over this time, you will need to attend several visits at the study site. During these visits, doctors and nurses will check your general health, take blood and urine samples to measure your kidney function, and ask you about any changes in how you are feeling. You will be given either the study medicines (vicadrostat and empagliflozin) or empagliflozin with a dummy pill (placebo) to take every day as tablets. The placebo looks just like the real medicine but contains no active drug. You will be randomly assigned to one of two groups, meaning you have an equal chance of being in either group. Throughout the study, the medical team will regularly monitor your health and keep track of any unwanted effects from the medicines.

Potential risks and benefits

Taking part in any clinical study involves both potential benefits and potential risks. You might benefit from closer medical monitoring and possibly receive a new treatment that could help your kidney condition. However, there's no guarantee that the study medicine will work for you, and like all medicines, vicadrostat and empagliflozin can have side effects. Some people might experience side effects that are unexpected or uncomfortable. Your health will be carefully watched throughout the study. It's very important to remember that you are free to leave the study at any time, for any reason, without it affecting your medical care.

Locations (157)

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

Apogee Clinical Research
Verified postcode
Huntsville, United States
Orange County Clinical Trials
Verified postcode
Anaheim, United States
North America Research Institute
Verified postcode
San Dimas, United States
Valiance Clinical Research-Tarzana-68237
Verified postcode
Tarzana, United States
Amicis Research Center - Valencia
Verified postcode
Valencia, United States
Focus Clinical Research
Verified postcode
West Hills, United States
Clinical Research of Brandon LLC
Verified postcode
Brandon, United States
Hillcrest Medical Research
Verified postcode
DeLand, United States
Encore Medical Research
Verified postcode
Hollywood, United States
Finlay Medical Research Corp
Verified postcode
Miami, United States
Total Research Group, LLC
Verified postcode
Miami, United States
San Marcus Research Clinic, Inc.
Verified postcode
Miami Lakes, United States

Common questions

What is chronic kidney disease?

Chronic kidney disease means your kidneys are damaged and can't filter blood as well as they should, which can lead to health problems over time.

What is a 'placebo'?

A placebo is a dummy pill that looks exactly like the study medicine but contains no active drug. It helps researchers understand the true effects of the actual medicine.

How long will I be taking the study medicines?

You will be taking the study medicines (or empagliflozin with a placebo) for about 3 months, as part of a total study involvement of around 4.5 months.

Will I know which group I'm in?

No, you will be randomly assigned to one of two groups, and initially, neither you nor the study doctors will know which treatment you are receiving (this is called 'blinded').

What happens after the study ends?

After your final study visit, your participation in the study will conclude. Your regular doctor will then continue to manage your kidney disease as before.