Not recruiting

Study of Empagliflozin for Patients with Autosomal Dominant Polycystic Kidney Disease

Verified siteRegistered drugNo placebo

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What is this trial about?

A plain-language summary of the goals, design and what participants do

This clinical trial is focused on studying a condition called Autosomal Dominant Polycystic Kidney Disease (ADPKD). This is a genetic disorder that causes numerous cysts to grow in the kidneys, which can lead to kidney damage over time. The trial will explore the use of a medication called Empagliflozin, which is taken as a 10 mg film-coated tablet. The purpose of the study is to investigate the safety of Empagliflozin in managing kidney growth in patients with ADPKD.

Participants in the study will be randomly assigned to receive either Empagliflozin or a placebo. The study will last for a period of 18 months, during which participants will have regular check-ups to monitor their kidney health and overall well-being. The main focus will be on observing any changes in the size of the kidneys over the course of the treatment.

Throughout the study, participants will be required to attend scheduled visits and undergo various tests to ensure their safety and to gather important data about the effects of the treatment. The study aims to provide valuable insights into the potential benefits of Empagliflozin for individuals living with ADPKD.

The research process

The trial runs in 5 steps – from screening to follow-up. Each step says what happens and what the team monitors.

Step 1
Joining the study
Upon joining the study, the patient will be required to provide evidence of signed written informed consent. This confirms understanding and agreement to participate in the study.
Eligibility criteria include being 18 years or older, having a specific kidney function range, and a diagnosis of autosomal dominant polycystic kidney disease (ADPKD) confirmed by family history, imaging, or genetic testing.
Step 2
Initial assessment
An initial assessment will be conducted to establish baseline measurements. This includes evaluating total kidney volume (TKV) and other relevant health parameters.
Patients currently using tolvaptan must have been on the medication for at least three months prior to the study.
Step 3
Treatment phase
The treatment involves taking either Jardiance 10 mg film-coated tablets or a placebo. The medication is administered orally.
The primary objective is to explore the safety of empagliflozin, the active substance in Jardiance, in managing kidney growth in ADPKD patients.
Step 4
Ongoing monitoring
Throughout the study, regular visits will be scheduled to monitor health status and kidney function. This includes laboratory tests and other study procedures.
Patients must be willing and able to comply with these scheduled visits and procedures.
Step 5
Evaluation of results
The primary endpoint is the relative change from baseline in total kidney volume (TKV) after 18 months of treatment, measured as a percentage per year.
The study is estimated to conclude by January 15, 2027, with recruitment starting on March 15, 2024.

Who can join the trial?

7 criteria

Men and women who are **18 years or older** can participate.
Participants need to have a **kidney function** test result (eGFR) between **25 and 90** if they are between **18 and 50 years old**, or between **25 and 65** if they are **over 50 years old**. eGFR is a test that measures how well your kidneys are working.
Participants must have a diagnosis of **autosomal dominant polycystic kidney disease (ADPKD)**, which is a condition that can be identified through family history, imaging tests like ultrasound or MRI/CT, or genetic testing if needed.
Participants should fall into **Mayo Class I C, D, or E**. This is a way to classify the severity of the kidney condition.
People who are using a medication called **tolvaptan** can join, but they must have been taking it for at least **3 months** before starting the study.
Participants must be willing and able to attend scheduled visits, follow the treatment plan, and undergo laboratory tests and other study procedures.
Participants need to provide **written informed consent**, which means they agree to participate after being informed about the study.

Who cannot join the trial?

4 criteria

Patients who are not diagnosed with autosomal dominant polycystic kidney disease (a genetic disorder that causes cysts to form in the kidneys).
Patients who are outside the specified age range for the study.
Patients who belong to a clinical trial group that is not included in this study.
Patients who are part of a vulnerable population, which means they might need special protection or care.

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Verified sites

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Verified
Medizinische Hochschule Hannover
Hanover, Germany

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Investigated drugs

Empagliflozin is a medication being studied for its potential to slow down kidney growth in patients with Autosomal Dominant Polycystic Kidney Disease (ADPKD). It is commonly used to help control blood sugar levels in people with type 2 diabetes, but in this trial, researchers are exploring its safety and effectiveness for kidney-related issues in ADPKD patients.

Empagliflozin

What is already known about the treatment

Empagliflozin – Empagliflozin is administered orally in tablet form. It is currently being studied for its potential benefits in treating autosomal dominant polycystic kidney disease (ADPKD). The main therapeutic indication under investigation is its ability to slow kidney growth in patients with this condition. At the molecular level, empagliflozin works by inhibiting the sodium-glucose co-transporter 2 (SGLT2) in the kidneys, which reduces glucose reabsorption and promotes glucose excretion in urine. It is classified as an SGLT2 inhibitor, primarily used in the management of type 2 diabetes, but its role in ADPKD is being explored in clinical trials.

Investigated diseases

Autosomal Dominant Polycystic Kidney Disease – This is a genetic disorder characterized by the growth of numerous cysts in the kidneys. These cysts are fluid-filled sacs that can enlarge the kidneys and disrupt their normal function. Over time, the increasing number and size of cysts can lead to a gradual decline in kidney function. The disease is inherited in an autosomal dominant pattern, meaning only one copy of the altered gene is sufficient to cause the disorder. Symptoms often include high blood pressure, back or side pain, and headaches. As the disease progresses, it can lead to complications such as kidney stones and urinary tract infections.