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BAY 3401016 · 1 trial · 1 indication
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.
| Arm | Type | Description |
|---|---|---|
| BAY 3401016 | EXPERIMENTAL | BAY 3401016 weekly for 24 weeks in addition to background therapy if eligible |
| Placebo | PLACEBO_COMPARATOR | Placebo weekly for 24 weeks in addition to background therapy if eligible |
| Name | Type | Description |
|---|---|---|
| BAY 3401016 | BIOLOGICAL | BAY 3401016 |
| Placebo | OTHER | Placebo to BAY 3401016 |
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 h...
BAY 3401016 is an investigational monoclonal antibody being studied for the treatment of Alport Syndrome, a genetic condition affecting the kidneys. It is currently in Phase 2 clinical development and is not yet approved by regulatory authorities.
BAY 3401016 is being developed by Bayer AG, a multinational pharmaceutical company. Bayer's stock is traded over-the-counter under the ticker symbol BAYRY.
BAY 3401016 is currently in Phase 2 clinical development. It is an investigational drug, meaning it has not been approved for commercial use and is still being evaluated in clinical trials.
BAY 3401016 is being studied in a Phase 2 clinical trial with the identifier NCT07211685. This randomized, double-blind, placebo-controlled study is recruiting approximately 60 adults with Alport Syndrome across multiple countries, including the United States, Canada, China, and several European nations.
No, BAY 3401016 is not FDA approved. It is an investigational drug currently in Phase 2 clinical trials for Alport Syndrome, and its safety and efficacy have not yet been established for regulatory approval.