EMPASTONE is a research project funded by the Swiss National Science Foundation, which aims to improve treatment for the prevention of kidney stones.
Background: Why do we conduct this study?
Kidney stones are the most common kidney condition worldwide. Around 10% of women and 20% of men are affected. Kidney stones can cause severe pain, require repeated surgery, reduce quality of life and result in high healthcare costs. A particularly significant problem is that kidney stones often recur, 50–80% of those affected develop stones again within 10 years.
There are few medicines available for preventing recurrence, and the evidence regarding their effectiveness is limited. Dietary recommendations for those affected have also been little researched and vary widely across the world.
Studies suggest that certain diabetes medicines, known as SGLT2 inhibitors, may reduce the risk of kidney stones recurring.
With the EMPASTONE study, we now aim to clarify:
- Efficacy of the study drug empagliflozin: Whether and to what extent the SGLT2 inhibitor empagliflozin can reduce the recurrence rate in patients with kidney stones.
- Dietary recommendations: Whether personalised dietary recommendations, based on a 24-hour urine collection and entries in a food diary during the urine collection period, are more effective than general dietary recommendations.
The study drug empagliflozin is currently authorised in Switzerland for the treatment of type 2 diabetes, certain cardiovascular conditions and chronic kidney disease. Empagliflozin has not yet been tested or approved for the prevention of kidney stones. Only when the effectiveness of empagliflozin in preventing kidney stones has been scientifically investigated and proven can it be used to treat kidney stone disease.
Overview of the study: What do we do?
In our study, participants are assigned to different groups at random. This random assignment is known as randomisation. It is important for obtaining reliable results.
Each group receives a different treatment. Ther are 4 groups in our study:
- Group 1 receives the study medication empagliflozin and personalised dietary recommendations.
- Group 2 receives the study medication empagliflozin and general dietary recommendations.
- Group 3 receives a placebo (a dummy drug without an active ingredient) and personalised dietary recommendations.
- Group 4 receives a placebo (a dummy drug without an active ingredient) and general dietary recommendations.
The study is double-blind with regard to the study medication. This means that neither the participants nor the study team know who is receiving the study medication and who is receiving the placebo. This approach is designed to prevent expectations or judgements, whether conscious or unconscious, from influencing the results. Through randomisation and blinding, we can assess the effect of the study drug and the personalised dietary recommendations objectively and reliably.
Funding:
This study is sponsored by Insel Gruppe AG and conducted under the supervision of the University Clinic for Nephrology and Hypertension at Inselspital / University Hospital Bern. The study is funded by the Swiss National Science Foundation (SNSF). The researchers involved receive no direct financial benefit from the conduct of this study. However, indirect benefits such as academic reputation, future funding or career advantages may well exist.
Study results
The overall results of the study will be derived from the data of all participants. The results will be presented in plain language at a patient symposium and published on the study website.
Who can participate?
Adults who have had kidney stones (with a calcium content of at least 50%) at least twice in the last 10 years. Further inclusion criteria apply and will be assessed prior to study enrolment. It is necessary to speak and understand a local language of the respective study centre.
The EMPASTONE study is conducted at the following hospitals: Map of participating centres (click here).
You can find further information at clinicaltrials.gov or humanforschung-schweiz.ch/de