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NCT Number: NCT07211685

A Study to Learn About How Well BAY 3401016 Works in Adults With Alport Syndrome

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.

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Key information

Conditions

Alport Syndrome Collagen Diseases Congenital Abnormalities Congenital, Hereditary, and Neonatal Diseases and Abnormalities Connective Tissue Diseases Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Kidney Diseases Male Urogenital Diseases Nephritis Nephritis, Hereditary Skin and Connective Tissue Diseases Urogenital Abnormalities Urogenital Diseases Urologic Diseases

Age range

18 year–45 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Clinica de Nefrologia, Urologia y Enfermedades Cardiovasculares S.A., Santa Fe, Santa Fe Province, Argentina

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

BAY 3401016

Biological

BAY 3401016

Placebo

Other

Placebo to BAY 3401016

Primary outcomes

  1. 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

    Progression of kidney disease, including Alport Syndrome (AS), to End-Stage Renal Disease (ESRD) takes years, making it challenging to establish drug efficacy in clinical trials without long follow-ups or large sample sizes. Using surrogate endpoints, such as early changes in albuminuria, can help address this issue. It is tested wether BAY 3401016 has an effect on albuminuria in AS patients. Research shows that albumin overload leads to renal function decline and podocyte injury.

Secondary outcomes

  1. Investigate the safety and tolerability of BAY 3401016 in participants with AS

    Time frame: From the start of study intervention until the last follow-up visit, 90 days ± 3 days after EoT

    Treatment Emergent Adverse Events (TEAEs) and Treatment Emergent Serious Adverse Events (TESAEs)

Study contacts

Contact information is provided by the study sponsor or research team.

Bayer Clinical Trials Contact

CONTACT

[email protected]

(+)1-888-84 22937

Sponsors and collaborators

Lead sponsor

Bayer

Industry

Registry information

Official study title

A Randomized, Double-blind, Placebo-controlled, Parallel Group Phase 2a Study With an Extension Phase to Evaluate the Efficacy and Safety of BAY 3401016 in Participants Aged 18 to 45 With Alport Syndrome

Acronym: ASSESS

Important dates

Study start
2025
Primary completion
2028
Study completion
2028
First posted
Oct 8, 2025
Registry last updated
Jul 2, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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