A Phase II randomised, double-blind, parallel-group, multicentre, international trial to investigate the safety and efficacy of vicadrostat and empagliflozin administered with simultaneous vs staggered initiation in participants with chronic kidney disease at risk of kidney disease progression
Chronic kidney disease causes kidneys to gradually lose their filtering ability over time. Doctors currently use medicines like empagliflozin (Jardiance) to help slow down this damage. Researchers are now testing whether adding a new experimental drug, called vicadrostat, offers extra kidney protection. This trial investigates the best way to start both medicines. Some participants will start both drugs at the same time, while others will start one first and add the second drug later. Researchers will check blood tests, blood pressure, and urine samples over roughly 16 weeks to see how kidney function, potassium levels, and protein leakage change. The trial is open to adults aged 18 and over who have chronic kidney disease and are at risk of their condition getting worse. The findings will help doctors understand how to safely combine these treatments in the future.
At a glance
What is this study about?
Your kidneys act as natural filters, clearing waste and excess fluid from your blood. In chronic kidney disease (CKD), these filters become damaged over time and work less effectively. Without treatment, kidney disease can gradually worsen and lead to kidney failure. Finding new drug combinations that slow or stop this decline is vital for helping people live longer, healthier lives.
Empagliflozin (also known as Jardiance) is an approved tablet widely used to protect the kidneys and heart. Vicadrostat (also known as BI 690517) is a promising new medicine designed to block a hormone that can cause kidney inflammation and scarring. Early research suggests that combining these two treatments may provide stronger kidney protection than using one drug alone.
However, doctors need to know the safest and most effective way to introduce both tablets. Starting two potent kidney medicines at once might cause short-term changes in blood pressure or blood mineral levels, such as potassium. This trial compares starting both drugs simultaneously against a 'staggered' approach, where one tablet is introduced a few weeks after the other.
By comparing these two approaches, researchers hope to discover the smoothest way to protect kidney function without causing avoidable side effects. The results could help shape future NHS and global treatment guidelines for people living with kidney disease.
Key takeaways
- Tests a combination of two kidney-protective medicines: empagliflozin and vicadrostat.
- Compares starting both medicines at the same time versus starting them a few weeks apart.
- Open to adults aged 18 and older living with chronic kidney disease.
- Involves regular blood tests, urine tests, and clinic check-ups over roughly 16 weeks.
- Participation is entirely voluntary and you can withdraw at any time.
Who may be eligible?
This study is open to men and women aged 18 and over who have been diagnosed with chronic kidney disease. Doctors are particularly looking for individuals whose kidney tests show they may be at risk of their kidney function declining further over time.
Because this is a clinical trial, the study team will need to review your overall health and recent lab tests before you can join. This includes checking your kidney filtration rate (eGFR) and the amount of protein in your urine to ensure the trial is safe and suitable for you.
You may not be able to join if you have certain other serious health issues, very unstable blood pressure, or blood potassium levels that are already too high. Women who are pregnant or planning to become pregnant during the trial will also not be able to take part.
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.
- I am aged 18 or older.
- I have been diagnosed with chronic kidney disease.
- My doctor has told me my kidney condition is at risk of progressing.
- I can attend regular clinic appointments for about 16 weeks.
- I am not pregnant and not planning to become pregnant during the study.
What does participation involve?
Taking part in this study lasts approximately 16 weeks. During this time, you will take daily tablets as directed by the clinical team. Depending on which group you are placed into by chance, you will take either empagliflozin, vicadrostat, or a dummy pill (placebo) designed to look identical to vicadrostat.
You will visit the clinic regularly for health monitoring. At these visits, the research team will measure your blood pressure, test your urine for protein leakage, and take small blood samples to measure your kidney filtration rate and potassium levels. Key assessments happen at weeks 6, 12, 14, and 16. The trial team will closely support you throughout your time on the study.
Potential risks and benefits
Locations (8)
- —UnverifiedItaly
- —UnverifiedCzechia
- —UnverifiedPoland
- —UnverifiedSpain
- —UnverifiedFrance
- —UnverifiedGermany
- —UnverifiedBelgium
- —UnverifiedNetherlands
Common questions
What is a placebo and why is it used?
A placebo is an inactive pill that looks just like the real medicine. It helps researchers fairly test whether any changes in health are truly caused by the study drug.
Can I choose whether I start both medicines together?
No. A computer assigns participants by chance to either the simultaneous or staggered start. This ensures the trial results are fair and unbiased.
Will taking part cost me anything?
No. All study medicines, clinic visits, and tests are provided free of charge, and trial sites often help cover reasonable travel expenses.
Can I still take my regular prescription medicines?
Most people can continue their usual medicines, but the study team will review all your prescriptions and supplements beforehand to check they are safe to take together.
What happens if my kidney tests change during the trial?
Your kidney function and potassium levels are checked regularly. If any test results cause concern, the doctor will adjust your treatment or stop the study medicine immediately.
How to find out more
Always speak to your GP or specialist before deciding to take part in a study.
Interested in taking part?
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