Study on the Safety of Rotigotine for Patients with Autosomal Dominant Polycystic Kidney Disease

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What is this study about?

This clinical trial is focused on studying the safety of a medication called rotigotine in patients with a condition known as autosomal dominant polycystic kidney disease (ADPKD). ADPKD is a genetic disorder that causes numerous cysts to form in the kidneys, potentially leading to kidney failure. The treatment being tested is a transdermal patch called Neupro, which delivers rotigotine through the skin. The study will use two different strengths of the patch: 2 mg/24 hours and 4 mg/24 hours.

The main purpose of the study is to evaluate the safety of using the 4 mg/24 hours patch over a period of 24 months. Participants will be monitored for any adverse reactions, including serious ones, that may occur during this time. The study will also look at changes in kidney size using MRI scans, kidney function, blood pressure, quality of life, and other markers related to ADPKD progression. Additionally, the study will assess how well participants adhere to the treatment and their willingness to continue it long-term.

Throughout the study, participants will undergo regular check-ups and tests to monitor their health and the effects of the treatment. The study aims to provide valuable information on the safety and potential benefits of rotigotine for individuals with ADPKD, contributing to better management of this condition in the future.

1 initial assessment

Upon joining the study, an initial assessment is conducted to confirm eligibility. This includes verifying age between 18 to 60 years and checking blood pressure levels to ensure they are within the specified range.

2 medication administration

The medication used in this study is a transdermal patch called Neupro, which contains the active substance rotigotine. The patch is applied to the skin and delivers a dose of 4 mg over 24 hours.

The patch is applied daily for a duration of 24 months.

3 safety monitoring

Throughout the 24-month period, safety is monitored by observing any adverse reactions. This includes both minor and serious reactions, particularly at the site of application or any behavioral changes.

4 regular evaluations

Regular evaluations are conducted to measure changes in kidney size using MRI, assess kidney function through glomerular filtration rate, and monitor blood pressure using a 24-hour blood pressure monitor.

Quality of life is assessed using a specific questionnaire designed for patients with autosomal dominant polycystic kidney disease (ADPKD).

5 urinary markers assessment

Urinary markers related to the progression of ADPKD are evaluated over the 24-month period. These markers include copeptin, cAMP, MCP-1, and AQP-2.

6 treatment compliance

Compliance with the treatment is assessed by calculating the rate of discontinuation over the 24 months.

Participants are also asked if they would be willing to continue the treatment for the rest of their lives.

Who Can Join the Study?

Patients must have ADPKD, which stands for Autosomal Dominant Polycystic Kidney Disease. This is a genetic condition that affects the kidneys.
Patients should be between the ages of 18 and 60 years old.
Patients can have normal blood pressure or high blood pressure, but if they have high blood pressure, it must be controlled. This means their blood pressure readings should be below certain levels when measured over a 24-hour period.
Both male and female patients are eligible to participate.

Who Cannot Join the Study?

Patients who have any other serious health conditions that might interfere with the study.
Patients who are currently participating in another clinical trial.
Patients who have had an allergic reaction to the study medication or similar medications in the past.
Patients who are pregnant or breastfeeding.
Patients who have a history of drug or alcohol abuse.
Patients who are unable to follow the study procedures or attend the required visits.
Patients who have a mental health condition that might affect their ability to participate in the study.
Patients who have a condition that requires treatment with medications that are not allowed in the study.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name	City	Country	Status
Centre Hospitalier Universitaire De Lille	Lille	France

Other Sites

Site Name	City	Country
Centre Hospitalier Universitaire Rouen	Rouen	France
Centre Hospitalier Universitaire Amiens Picardie	Amiens	France
Centre Hospitalier Universitaire De Caen Normandie	Caen	France

Trial status

Country	Status	Recruitment Start
France	Recruiting	01.12.2024

Trial locations

Investigated drugs:

Rotigotine

Rotigotine is a medication used in this trial to assess its safety for patients with autosomal dominant polycystic kidney disease (ADPKD). It is typically used to treat symptoms of Parkinson’s disease and restless legs syndrome by delivering a steady dose through a skin patch. In this study, the focus is on understanding how safe it is for long-term use in individuals with ADPKD.

Investigated diseases:

Congenital cystic kidney disease

Kidney Disease – This term encompasses a range of conditions affecting the kidneys, which are responsible for filtering waste from the blood and balancing fluids in the body. Kidney disease can progress from mild dysfunction to severe impairment, potentially leading to kidney failure. Symptoms may include swelling, fatigue, and changes in urination patterns. Over time, the kidneys may lose their ability to function effectively, necessitating medical intervention. The progression of kidney disease can vary widely depending on the underlying cause and individual health factors.

Trial ID:

2024-515734-32-00

Protocol code:

2022/0345/HP

Trial Phase:

Therapeutic exploratory (Phase II)

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Study on the Safety of Rotigotine for Patients with Autosomal Dominant Polycystic Kidney Disease

What is this study about?

Who Can Join the Study?

Who Cannot Join the Study?