Recruiting
Phase 2

BAY 3401016

Sponsor:

Bayer

Code:

NCT07211685

Conditions

Alport Syndrome

Eligibility Criteria

Sex: All

Age: 18 - 45

Healthy Volunteers: Not accepted

Interventions

BAY 3401016

Placebo

Study Details

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 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 function is the presence of excess protein in the urine that is not usually found with healthy kidneys. This condition is known as proteinuria. The study drug, BAY 3401016 (a monoclonal antibody), is a type of medicine that blocks a protein called Semaphorin 3A (Sema3A), which is thought to be involved in causing kidney damage in AS. By blocking the action of the Sema3A protein, BAY 3401016 may prevent proteinuria and slow down the loss in kidney function due to AS.

The main purpose of this study is to learn more about how well BAY 3401016 works in slowing down the loss in kidney function in adults with a rapidly progressing AS.

Conditions

Alport Syndrome

Study ID

NCT07211685

Start date

Nov 19, 2025

Status verified date

Aug, 2026

Completion date

Nov 29, 2027

Anticipated

Primary completion date

Nov 29, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 45

Healthy Volunteers: Not accepted

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), that, in the investigator's judgment, could interfere with or confound the evaluation of local infusion/injection-site reactions to the study intervention.
  • Systolic blood pressure above 140 mmHg
  • Diastolic blood pressure above 90 mmHg

Study Design

Enrollment

60 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: BAY 3401016

BAY 3401016 weekly for 24 weeks in addition to background therapy if eligible

placebo comparator: Placebo

Placebo weekly for 24 weeks in addition to background therapy if eligible

Interventions

BAY 3401016

BAY 3401016

Placebo

Placebo to BAY 3401016

Primary outcome measure

  • Urinary albumin creatinine ratio (UACR) ratio to baseline averaged over 16, 20 and 24 weeks of treatment [ Time Frame: From the start of study intervention, over 16, 20 and 24 weeks of treatment, until the last follow-up visit, 90 days ± 3 days after EoT ]

Central Contacts and Locations

Central contacts

Locations

Nephrology Clinic at The Kirklin Clinic of UAB Hospital

Recruiting

Birmingham, Alabama, United States, 35233

Cardio Renal Institute

Recruiting

Chubbuck, Idaho, United States, 83202

Tufts Medical Center | Nephrology Department

Recruiting

Boston, Massachusetts, United States, 02111

Renal Disease Research Institute | Landry

Recruiting

Dallas, Texas, United States, 75246

St Joseph's Healthcare Hamilton | Cardiology

Recruiting

Hamilton, Ontario, Canada, L8N 4A6

Montreal General Hospital | Nephrology

Recruiting

Montreal, Quebec, Canada, H4A 3J1

Centre hospitalier universitaire de Québec (CHUQ) | Nephrology

Recruiting

Québec, Quebec, Canada, G1R 2J6

More Information

Sponsor

Bayer

Last update posted

Aug 20, 2026

Last verified

Aug, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Bayer on 2026-08-20.