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Purpose

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.

Condition

Eligibility

Eligible Ages
Between 18 Years and 45 Years
Eligible Sex
All
Accepts Healthy Volunteers
No

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

Study Design

Phase
Phase 2
Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel Assignment
Intervention Model Description
Two parallel groups (BAY 3401016 and placebo)
Primary Purpose
Treatment
Masking
Double (Participant, Investigator)

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
BAY 3401016 		BAY 3401016 weekly for 24 weeks in addition to background therapy if eligible
  • Biological: BAY 3401016
    BAY 3401016
Placebo Comparator
Placebo 		Placebo weekly for 24 weeks in addition to background therapy if eligible
  • Other: Placebo
    Placebo to BAY 3401016

Recruiting Locations

Cardio Renal Institute
Chubbuck, Idaho 83202

Renal Disease Research Institute | Landry
Dallas, Texas 75246

More Details

Status
Recruiting
Sponsor
Bayer

Study Contact

Bayer Clinical Trials Contact
(+)1-888-84 22937
clinical-trials-contact@bayer.com

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.