A Study to Learn About How Well BAY 3401016 Works in Adults With Alport Syndrome
This study is investigating a new medication called BAY 3401016 for people aged 18 to 45 who have Alport Syndrome. Alport Syndrome is a genetic condition that mainly affects the kidneys, potentially leading to kidney failure. This new medicine is designed to block a protein called Semaphorin 3A (Sema3A), which scientists believe plays a role in causing kidney damage in Alport Syndrome. By blocking this protein, the researchers hope BAY 3401016 might help reduce the amount of protein leaking into the urine (a sign of kidney trouble) and slow down the worsening of kidney function. The main goal is to understand how well this treatment works in slowing down kidney damage in adults with a faster-progressing form of Alport Syndrome.
نظرة سريعة
ما هو موضوع هذه الدراسة؟
Alport Syndrome is a health condition passed down through families that mainly affects the kidneys, but can also cause problems with hearing and eyes. It happens because of changes in certain genes that are important for making a protein called collagen. Collagen is a building block that helps the kidneys work properly.
When someone has Alport Syndrome, their kidneys can gradually lose their ability to filter waste from the blood. This can lead to a condition called chronic kidney disease (CKD) and, over time, might result in kidney failure. A common sign that the kidneys aren't working as well as they should is when too much protein leaks into the urine – this is called proteinuria. Healthy kidneys don't usually let much protein pass through.
This study is testing a new medicine called BAY 3401016. It's a special type of drug designed to block a protein known as Semaphorin 3A (Sema3A). Researchers believe Sema3A might be involved in causing the kidney damage seen in Alport Syndrome. By blocking Sema3A, BAY 3401016 might help to reduce protein in the urine and slow down the rate at which kidney function gets worse. This study aims to find out if this new treatment can indeed help adults with Alport Syndrome keep their kidneys working better for longer.
النقاط الرئيسية
- Tests a new medicine for Alport Syndrome.
- Aims to slow down kidney damage.
- For adults aged 18-45 with Alport Syndrome.
- Will compare the new medicine to a placebo (dummy pill).
- Close medical monitoring if you participate.
من قد يكون مؤهلاً؟
This study is looking for adults between 18 and 45 years old who have Alport Syndrome. This includes men with X-linked Alport Syndrome or men and women with autosomal recessive Alport Syndrome.
To join, your kidneys should still be working reasonably well, but you should also have a certain amount of protein in your urine, which is a sign of kidney problems in Alport Syndrome. Your blood pressure also needs to be within a healthy range.
However, you won't be able to join if you have other types of kidney disease, if you have a serious illness that could affect your safety or the study results, or if you have had cancer. People with severe allergies, certain skin conditions (like eczema or severe acne), or allergies needing specific treatments (like steroids for asthma) are also not suitable for this study.
هل يمكن أن تناسبك هذه الدراسة؟
أجب عن هذه الأسئلة السريعة لترى ما إذا كنت مؤهلاً. هذا دليل فقط - الفريق البحثي هو الذي يتخذ القرار النهائي.
- هل عمرك بين 18 و 45 سنة؟
- Have you been diagnosed with Alport Syndrome (X-linked male or autosomal recessive male or female)?
- Is your kidney function above a certain level (eGFR at least 45 mL/min/1.73m2)?
- Do you have a certain amount of protein in your urine (UACR at least 500mg/g)?
- Is your blood pressure generally well-controlled (below 140/90 mmHg)?
- Do you have any other significant medical conditions or a history of cancer?
ماذا يتضمن المشاركة؟
If you join the study, you would receive either the study medication, BAY 3401016, or a placebo (an inactive substance that looks like the real medicine). You wouldn't know which one you are getting. You would have regular visits to the clinic for health checks, blood tests, urine tests, and to monitor your kidney function and overall health. These visits would help the doctors see how your body is reacting to the treatment and if there are any changes. The total length of your participation in the study, including all follow-up, would be discussed with you by the study team.
المخاطر والفوائد المحتملة
المواقع (51)
- Nephrology Clinic at The Kirklin Clinic of UAB Hospitalالرمز البريدي المؤكدبرمنغهام، الولايات المتحدة
- The Peggy and Harold Katz Family Drug Discovery Center - Nephrologyالرمز البريدي المؤكدميامي، الولايات المتحدة
- Cardio Renal Instituteالرمز البريدي المؤكدChubbuck, United States
- Tufts Medical Center | Nephrology Departmentالرمز البريدي المؤكدبوسطن، الولايات المتحدة
- Renal Disease Research Institute | Landryالرمز البريدي المؤكددالاس، الولايات المتحدة
- Clinica de Nefrologia, Urologia y Enfermedades Cardiovasculares S.A.الرمز البريدي المؤكدSanta Fe, Argentina
- Hospital Británicoالرمز البريدي المؤكدبوينس آيرس، الأرجنتين
- Centro de Educacion Medica e Investigaciones Clinicas "Norberto Quirno" (CEMIC)الرمز البريدي المؤكدبوينس آيرس، الأرجنتين
- Centro de Rehabilitacion Cardiovascular | San Luis, Argentinaالرمز البريدي المؤكدSan Luis, Argentina
- St Joseph's Healthcare Hamilton | Cardiologyالرمز البريدي المؤكدهاميلتون، كندا
- Montreal General Hospital | Nephrologyالرمز البريدي المؤكدمونتريال، كندا
- Centre hospitalier universitaire de Québec (CHUQ) | Nephrologyالرمز البريدي المؤكدكيبك، كندا
أسئلة شائعة
What is Alport Syndrome?
Alport Syndrome is a genetic condition that mainly causes kidney disease, but can also affect hearing and eyesight.
What is the new medicine BAY 3401016 supposed to do?
It aims to block a protein called Sema3A, which is thought to contribute to kidney damage in Alport Syndrome, hopefully slowing down the disease.
هل سأعرف إذا كنت أحصل على الدواء الحقيقي أم حبة وهمية؟
No, you won't know whether you are receiving BAY 3401016 or a placebo (an inactive substance) during the study.
What does 'proteinuria' mean?
Proteinuria means there is too much protein in your urine, which can be a sign that your kidneys are not working properly.
كم مدة الدراسة؟
The full duration of your participation, including all follow-up, would be explained by the study team.
كيفية معرفة المزيد
تحدث دائمًا إلى طبيبك العام أو الأخصائي قبل اتخاذ قرار بالمشاركة في دراسة.
نقاش
مناقشة المجتمع
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