Study on the Safety and Effects of Setanaxib for Patients with Alport Syndrome

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What is this study about?

This clinical trial is focused on studying Alport syndrome, a genetic condition that affects the kidneys, ears, and eyes. The study will evaluate a treatment called Setanaxib, which is taken as a film-coated tablet. The purpose of the study is to assess the safety and tolerability of Setanaxib compared to a placebo in patients with Alport syndrome.

Participants in the study will be randomly assigned to receive either Setanaxib or a placebo. The study will be conducted over a period of 24 weeks, during which participants will take the medication orally. Throughout the study, various health checks will be performed, including monitoring heart rate, blood pressure, and kidney function. The study will also involve regular blood tests and hearing tests to ensure the safety of the participants.

The trial aims to gather information on how the body processes Setanaxib and its effects on the symptoms of Alport syndrome. By the end of the study, researchers hope to better understand the potential benefits and any side effects of Setanaxib for individuals with this condition.

1 randomization and initial assessment

Upon joining the study, participants are randomly assigned to receive either setanaxib or a placebo. This process is double-blind, meaning neither the participant nor the study team knows which treatment is being administered.

Initial assessments include a review of medical history, a physical examination, and baseline measurements such as blood pressure and heart rate. A urine test is conducted to measure protein levels, and a blood test is performed to assess kidney function.

2 medication administration

Participants take the assigned medication orally in the form of a film-coated tablet. The dosage and frequency are determined by the study protocol, and participants are instructed to follow the prescribed schedule for the duration of the trial.

The study medication is taken alongside any existing treatments for Alport syndrome, such as angiotensin-converting enzyme inhibitors (ACEi) or angiotensin II type I receptor blockers (ARB), which must have been stable for at least 8 weeks prior to the trial.

3 ongoing monitoring and assessments

Throughout the study, participants attend regular visits for monitoring. These visits include physical examinations, blood pressure and heart rate measurements, and laboratory tests to evaluate kidney function and other health indicators.

Participants are monitored for any side effects or adverse events, with particular attention to changes in heart rate, blood pressure, and kidney function. Hearing tests are also conducted to assess any changes in auditory health.

4 final assessment and study completion

At the end of the study period, participants undergo a final assessment. This includes a comprehensive review of health status, laboratory tests, and any changes in symptoms or side effects experienced during the trial.

The study aims to evaluate the safety and tolerability of setanaxib compared to placebo, as well as its effects on kidney function and protein levels in urine.

Who Can Join the Study?

Must be a male or female aged 12 to 50 years. In the EU, the age range is 18 to 50 years.
Must have a diagnosis of Alport syndrome confirmed by genetic testing. This means there is a documented change in a specific gene related to Alport syndrome.
Must weigh at least 40 kg.
Must be willing and able to give informed consent, which means agreeing to participate in the study after understanding what it involves.
Female participants who can have children must use a highly effective method of birth control starting at least 4 weeks before joining the study and continue until 90 days after the last dose of the study medication.
Female participants who can have children must have a negative pregnancy test before starting the study and again before receiving the study medication.
Male participants with female partners who can have children must use a condom and ensure their partner uses a highly effective birth control method. This starts when they agree to join the study and continues until 90 days after the last dose of the study medication.
Male participants must agree not to donate sperm, and female participants must agree not to donate eggs from the start of the study until 90 days after the last dose of the study medication.
Must have a certain level of protein in the urine, measured twice with at least 2 weeks between tests.
Must be taking the highest allowed or tolerated dose of specific blood pressure medications for at least 8 weeks before joining the study.
Must have blood pressure within a certain range based on age and weight for those aged 12 to 17, or below specific levels for those aged 18 and older.
Must have a certain level of kidney function, measured by a test called the estimated glomerular filtration rate (eGFR), which checks how well the kidneys are working.

Who Cannot Join the Study?

Patients who are not diagnosed with Alport syndrome cannot participate. Alport syndrome is a genetic condition that affects the kidneys, ears, and eyes.
Patients who are younger than 18 years old cannot participate.
Patients who are pregnant or breastfeeding cannot participate.
Patients who have participated in another clinical trial within the last 30 days cannot participate.
Patients who have a history of allergic reactions to similar medications cannot participate.
Patients with severe liver or heart problems cannot participate.
Patients who are unable to follow the study procedures cannot participate.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name	City	Country	Status
Medical University Of Vienna	Vienna	Austria
Hopital Necker Enfants Malades	Paris	France

Other Sites

Site Name	City	Country
Fakultni Nemocnice Hradec Kralove	Novy Hradec Kralove	Czechia
University Hospital Olomouc	Olomouc	Czechia
Hospital Edouard Herriot	Lyon	France
Hospital Universitario 12 De Octubre	Madrid	Spain
Univerzitna Nemocnica Martin	Martin	Slovakia
Hospital Universitario Virgen De Las Nieves	Granada	Spain
Fundacio Puigvert	Barcelona	Spain
Hospital Clinic De Barcelona	Barcelona	Spain
Vilniaus universiteto ligonine Santaros klinikos VšĮ	Vilnius	Lithuania
Hospital Universitario Fundacion Jimenez Diaz	Madrid	Spain
Vseobecna Fakultni Nemocnice V Praze	Prague	Czechia
Iisangbke Fby Chipkres Afh Eizhkwnynfye Mpimwyzg	Prague	Czechia
Hcwopwdw Veod dfrduepu	Barcelona	Spain

Trial status

Country	Status	Recruitment Start
Austria	Not recruiting	15.12.2023
Czechia	Not recruiting	15.12.2023
France	Not recruiting	15.12.2023
Lithuania	Not recruiting	15.12.2023
Slovakia	Not recruiting	15.12.2023
Spain	Not recruiting	15.12.2023

Trial locations

Investigated drugs:

Setanaxib

Setanaxib is a medication being studied for its potential to help patients with Alport syndrome. Alport syndrome is a genetic condition that affects the kidneys, ears, and eyes. Setanaxib works by inhibiting certain enzymes called NOX1 and NOX4, which are thought to play a role in the progression of this disease. The trial aims to assess how safe and tolerable setanaxib is for patients, as well as to understand how the body processes the medication and its preliminary effects on the condition.

Investigated diseases:

Alport's syndrome

Alport syndrome – Alport syndrome is a genetic disorder that primarily affects the kidneys, ears, and eyes. It is characterized by progressive kidney disease, hearing loss, and eye abnormalities. The condition is caused by mutations in genes responsible for producing type IV collagen, a protein essential for the normal function of the basement membranes in these organs. Over time, individuals with Alport syndrome may experience worsening kidney function, leading to chronic kidney disease. Hearing loss typically begins in childhood or adolescence and can progress to significant impairment. Eye changes may include abnormalities in the lens or retina, but they usually do not lead to severe vision problems.

Trial ID:

2023-505292-73-00

Protocol code:

GSN000500

NCT ID:

NCT06274489

Trial Phase:

Therapeutic exploratory (Phase II)

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Study on the Safety and Effects of Setanaxib for Patients with Alport Syndrome

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