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

Study acronym: ASSESS
StatusActive, Not Recruiting
PhasePhase 2
SponsorBayer
Started
View on ClinicalTrials.gov ↗

Record History

  1. Enrollment closed, study ongoing Interventions modified · Study sites: 60 to 58 · Eligibility criteria shortened, about 9 words Show 3 more changesShow less
    • Interventions modified
    • Study sites: 60 to 58
    • Eligibility criteria shortened, about 9 words
  2. Primary and study completion moved earlier from Jul 27, 2028 to Nov 29, 2027v7
  3. Eligibility criteria expanded, about 20 words Site details revised at 11 of 60 sitesv6 Show 1 more changeShow less
    • Site details revised at 11 of 60 sites

    See this version in full on ClinicalTrials.gov ↗

  4. Study title expanded, about 11 wordsv5 See this version in full on ClinicalTrials.gov ↗
  5. Study sites revised (60)v4 See this version in full on ClinicalTrials.gov ↗
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  1. Trial status: Not Yet Recruiting to Recruiting Start date changed from estimate of Dec 2, 2025 to Nov 19, 2025 · Study sites revised (60)v3 Show 2 more changesShow less
    • Start date changed from estimate of Dec 2, 2025 to Nov 19, 2025
    • Study sites revised (60)

    See this version in full on ClinicalTrials.gov ↗

  2. Start date: Sep 30, 2025 to Dec 2, 2025v2
  1. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
Bayer
131 trials monitored
See 7 trials at risk
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.
Trial Details
NCT Number NCT07211685
Lead Sponsor Bayer
Conditions Alport Syndrome
Enrollment 60 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov