- BAY3401016; Biomarker Study Alport — Recruiting • Phase II • NCT07211685.
- What is being tested: BAY3401016 is being investigated as a potential therapeutic intervention in Alport syndrome, a rare genetic disorder caused by mutations in collagen IV genes (COL4A3, COL4A4, COL4A5) that leads to progressive kidney disease, sensorineural hearing loss, and ocular abnormalities.
- Patient eligibility overview: The study enrolls patients with genetically confirmed Alport syndrome across age groups, with disease severity and renal function status likely determining inclusion criteria to ensure homogeneous patient populations for accurate biomarker evaluation.
- Quick orientation before opening the registry record.
- Checking recruitment status, phase and sponsor at a glance.
- Connecting this trial to nearby guidelines, Drug Science and education.
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. People with AS have a high risk of developing chronic kidney disease (CKD), a condition in which there is progressive loss in kidney function over time. The kidneys soon lose their ability to remove waste products from the body properly, resulting in end-stage kidney disease. A common sign of decreasing kidney…
- : * 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
Use the source registry for the full inclusion and exclusion criteria before discussing referral or enrolment.