Trial to Assess the Efficacy of EMPAgliflozin and Personalized Dietary Counseling for Kidney STONE Prevention
This study is for people who have had calcium kidney stones multiple times. Researchers want to find out if a medicine called empagliflozin and personalised diet advice can help prevent new kidney stones. Patients will be split into four groups: some will take empagliflozin, some a dummy pill (placebo), some will get personalised diet advice, and others general diet advice. The study will last for three years. The main goal is to see if these treatments reduce the number of new stones. This research is important because current treatments for preventing kidney stones are limited, and finding new ways could improve people's quality of life.
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¿De qué trata este estudio?
Kidney stones can be very painful and often come back, which can affect people's lives and lead to many hospital visits. While there are some ways to help prevent them, we need more effective treatments. This study is specially designed for people who have calcium kidney stones, which are the most common type.
Researchers are investigating two different approaches to see if they can reduce how often kidney stones return. The first is a medication called empagliflozin. Previous research has hinted that medicines like empagliflozin might help lower the risk of kidney stones. The second approach is personalised diet advice, which means the advice would be tailored specifically to your body's needs based on certain tests, rather than general healthy eating tips.
The study will compare these new approaches against current, standard methods. By looking at a new medication and a more personalised way of giving diet advice, the scientists hope to find better ways to help people avoid the pain and problems that come with recurring kidney stones.
Puntos clave
- Targets frequent calcium kidney stones.
- Tests a new drug (empagliflozin) and special diet advice.
- Participation lasts for three years, with regular check-ups.
- Aims to find better ways to prevent kidney stones from returning.
- You might receive the new drug, a dummy pill, or different types of diet advice.
¿Quién puede ser elegible?
To join this study, you need to be at least 18 years old and have a history of calcium kidney stones. This means you must have had two or more kidney stone episodes in the last 10 years, and your most recent stone must have been made mostly of calcium.
There are also some reasons why you might not be able to join. For example, if your kidney stones are caused by another known medical condition or a rare genetic problem, or if you have certain health issues like severe kidney disease, uncontrolled diabetes (Type 1), heart failure, or are pregnant or breastfeeding. You also can't be taking certain other medications or participating in another clinical trial at the same time.
¿Podría este estudio ser adecuado para ti?
Responde estas preguntas rápidas para ver si puedes ser elegible. Esto es solo una guía: el equipo de investigación toma la decisión final.
- ¿Tienes 18 años o más?
- Have you had at least two calcium kidney stone episodes in the last 10 years?
- Was your last kidney stone mostly made of calcium?
- Do you have good overall health, without serious kidney disease, uncontrolled diabetes (Type 1), or heart failure?
- ¿No estás embarazada o amamantando?
¿En qué consiste la participación?
If you decide to take part in this study, you will be in one of four groups: two groups will receive the study medication (empagliflozin or a dummy pill called a placebo) and two groups will get diet advice (either personalised or general). You'll take a pill once a day for three years. Throughout this time, you'll have regular check-ups with the study team. These check-ups will include medical assessments and monitoring to see how you're doing and if the treatments are working. You will also have scans to check for new kidney stones. The total duration of your participation in the study will be three years.
Riesgos y beneficios potenciales
Locations (21)
- University Hospital Amiens-PicardieCódigo postal verificadoAmiens, France
- Hôpital TenonCódigo postal verificadoParís, Francia
- Hôpital Européen Georges PompidouCódigo postal verificadoParís, Francia
- Charité University Medicine BerlinCódigo postal verificadoBerlín, Alemania
- Università della Campania "Luigi Vanvitelli"Código postal verificadoNápoles, Italia
- Verona University HospitalCódigo postal verificadoVerona, Italy
- Kantonsspital AarauCódigo postal verificadoAarau, Suiza
- Kantonsspital BadenCódigo postal verificadoBaden, Switzerland
- University Hospital BaselCódigo postal verificadoBasel, Switzerland
- Inselspital BernCódigo postal verificadoBern, Switzerland
- Kantonsspital ChurCódigo postal verificadoChur, Switzerland
- Kantonsspital FribourgCódigo postal verificadoFribourg, Switzerland
Preguntas comunes
What kind of kidney stones does this study focus on?
This study is specifically for people with calcium kidney stones, which are the most common type.
How long will I need to be in the study?
If you join, you will be part of the study for three years, taking medication or getting diet advice daily.
Will I definitely get the new medication?
You might get the new medication (empagliflozin) or a dummy pill (placebo), as participants are randomly assigned to groups.
What does 'personalised dietary counselling' mean?
It means you'd get diet advice specifically designed for you, based on assessments of your diet and urine tests.
¿Puedo abandonar el estudio si cambio de opinión?
Yes, you can leave the study at any time, for any reason, without it affecting your medical care.
How often will I receive dietary advice?From the study team
If you participate, you will receive dietary advice a total of 5 times, either from the study physician or from dieticians based on the group you'd be assigned to.
Where can I find further information?From the study team
Further information is available on the study website: https://www.empastone.ch/en/welcome/
How can I participate in the study?From the study team
Please contact the study site you would like to participate in, they are happy to provide any further information. Please note that it is necessary to speak a local language of the respective hospital to participate.
Cómo obtener más información
Daniel G Fuster, Prof MD
Siempre hable con su médico de cabecera o especialista antes de decidir participar en un estudio.
¿Interesado en participar?
Discusión
Discusión comunitaria
Impulsado por nuestro foro en community.patient.info. Por favor, sea respetuoso — esto no es un consejo médico.