BAY3401016; Biomarker Study Alport (ASSESS)
Actively Recruiting
About This Study
This Phase 2a randomized, double-blind, placebo-controlled study evaluates the efficacy and safety of BAY 3401016 in adults aged 18 to 45 with rapidly progressing Alport Syndrome. The intervention is a monoclonal antibody that targets Semaphorin 3A (Sema3A), a protein implicated in the pathogenesis of glomerular damage and progressive renal decline. The primary objective is to determine if Sema3A inhibition reduces proteinuria and slows the loss of kidney function in this population. Investigators monitor changes in UACR and eGFR to assess the drug's impact on disease progression. The trial includes an initial treatment phase followed by an extension phase to evaluate long-term safety and clinical outcomes.
Who Can Participate?
✓ Inclusion 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
✗ Exclusion Criteria
- •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