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New treatment option for Alport Syndrome
Official title A Study to Learn About How Well BAY 3401016 Works in Adults With Alport Syndrome
ClinicalTrials.gov ID: NCT07211685
What this study is testing
What is BAY 3401016?
BAY 3401016 is an investigational medicine, being studied as a potential treatment for alport syndrome.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- Alport syndrome (AS) is a rare genetic condition that causes kidney disease, hearing loss, and eye abnormalities that occur due to changes in specific genes (COL4A3, COL4A4, and COL4A5). These genes help in producing an important protein called collagen.
- Phase 2: a mid-size study of how well it works
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 45
You may be able to join if
- Participants must be 18 to 45 years of age inclusive
- Participants with AS, either XLAS (male) or ARAS (male or female)
- eGFR ≥ 45 mL/min/1.73m2
- UACR ≥ 500mg/g
You likely can't join if
- Chronic kidney disease is different from AS
- Clinically significant illness that could have influence on the safety of the participant and/or interfere with the study objectives
- History or current existence of malignancy
- Participants with history of severe allergies, multiple drug allergies or non-allergic drug reactions including allergies affecting the lower...
- Participants with active skin disorders (e.g. atopic dermatitis, severe acne)
- Systolic blood pressure above 140 mmHg
See the full eligibility criteria
- Participants must be 18 to 45 years of age inclusive
- Participants with AS, either XLAS (male) or ARAS (male or female)
- eGFR ≥ 45 mL/min/1.73m2
- UACR ≥ 500mg/g
- Chronic kidney disease is different from AS
- Clinically significant illness that could have influence on the safety of the participant and/or interfere with the study objectives
- History or current existence of malignancy
- Participants with history of severe allergies, multiple drug allergies or non-allergic drug reactions including allergies affecting the lower respiratory tract - allergic asthma, allergies requiring therapy with...
- Participants with active skin disorders (e.g. atopic dermatitis, severe acne)
- Systolic blood pressure above 140 mmHg
- Diastolic blood pressure above 90 mmHg
The study team makes the final eligibility decision.
Where it's taking place
- Birmingham, Alabama, United States
- Miami, Florida, United States
- Atlanta, Georgia, United States
- Chubbuck, Idaho, United States
- Boston, Massachusetts, United States
- Dallas, Texas, United States
- Santa Fe, Santa Fe Province, Argentina
- Buenos Aires, Argentina
- San Luis, Argentina
- Hamilton, Ontario, Canada
- London, Ontario, Canada
- Whitby, Ontario, Canada
- Montreal, Quebec, Canada
- Québec, Canada
- Beijing, Beijing Municipality, China
- Chongqing, Chongqing Municipality, China
- Guangzhou, Guangdong, China
- Wuhan, Hubei, China
- Hangzhou, Zhejiang, China
- Hradec Králové, Hradec Králové Region, Czechia
+ 38 more site(s).
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 45 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Birmingham, Alabama, United States; Miami, Florida, United States; Atlanta, Georgia, United States; Chubbuck, Idaho, United States; Boston, Massachusetts, United States; Dallas, Texas, United States and 52 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.