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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 | DRUG | 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 small molecule being developed for the treatment of Alport Syndrome, a genetic kidney disorder. It is in Phase 2 clinical development and is not yet approved for any indication. The clinical program is focused on adults 18 years and older with Alport Syndrome.
BAY 3401016 is being developed by Bayer AG, which trades on the OTC market under the ticker BAYRY. Bayer is the sponsor of the Phase 2 study evaluating the compound in Alport Syndrome. The program sits within the nephrology therapeutic area.
BAY 3401016 is in Phase 2 clinical development. It is an investigational small molecule and has not been approved by the FDA or any other regulatory agency. One Phase 2 trial is currently active, and no trials for this compound have been completed.
BAY 3401016 is being studied in one Phase 2 trial, NCT07211685, titled a study to learn about how well BAY 3401016 works in adults with Alport Syndrome. The trial is active but not recruiting, has an enrollment of 60 participants, and is randomized, double-blind, and placebo-controlled.
The Phase 2 trial of BAY 3401016, NCT07211685, is running across multiple countries, including the United States, Argentina, Canada, China, Czechia, France, Germany, India, Italy, Japan, Poland, Portugal, South Korea, Spain, and the United Kingdom. It enrolls adults 18 years and older and does not accept healthy volunteers.