Status:
NOT_YET_RECRUITING
BAY3401016; Biomarker Study Alport
Lead Sponsor:
Bayer
Conditions:
Alport Syndrome
Eligibility:
All Genders
18-45 years
Phase:
PHASE2
Brief Summary
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 h...
Eligibility Criteria
Inclusion
- 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
Exclusion
- 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 corticosteroids or urticaria
- Participants with active skin disorders (e.g. atopic dermatitis, severe acne)
- Systolic blood pressure above 140 mmHg
- Diastolic blood pressure above 90 mmHg
Key Trial Info
Start Date :
December 2 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
July 27 2028
Estimated Enrollment :
60 Patients enrolled
Trial Details
Trial ID
NCT07211685
Start Date
December 2 2025
End Date
July 27 2028
Last Update
November 5 2025
Active Locations (60)
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1
Nephrology Clinic at The Kirklin Clinic of UAB Hospital
Birmingham, Alabama, United States, 35233
2
The Peggy and Harold Katz Family Drug Discovery Center - Nephrology
Miami, Florida, United States, 33136
3
Center for Advanced Pediatrics - Nephrology
Atlanta, Georgia, United States, 30329
4
Cardio Renal Institute
Chubbuck, Idaho, United States, 83202