In short
BAY 3401016 is an investigational protein-based substance being developed by Bayer AG for the treatment of Alport syndrome, a genetic condition that can lead to chronic kidney disease. It has no marketing authorisation and is currently being studied in a Phase 2 clinical trial involving 60 adults. The trial is authorised and is measuring how well the substance reduces albuminuria, a sign of kidney damage, over 24 weeks of treatment.
Key points
- BAY 3401016 is an investigational protein-based therapy with no marketing authorisation.
- It is being tested in a Phase 2 trial for adults with Alport syndrome and chronic kidney disease.
- The authorised trial plans to enrol 60 participants.
- The main measure is the change in urine albumin-to-creatinine ratio (UACR) from baseline.
- The trial compares BAY 3401016 with a placebo over 24 weeks of treatment.
- BAY 3401016 is given as a solution for injection.
What is BAY 3401016?
BAY 3401016 is an investigational protein-based substance. It is classified as a protein of the type "Protein - Other" in the trial registry, meaning it is a biological medicine made from proteins rather than a chemically synthesised small molecule. The substance is being developed by Bayer AG and currently has no marketing authorisation in the product records, which means it is not yet approved as a medicine. It appears under the single name BAY 3401016 in the registry records, with no trade names or other development codes listed.
How does BAY 3401016 work?
The registry records for the trial of BAY 3401016 do not describe its mechanism of action or molecular target. What is known from the trial data is that the substance is being studied for its effect on albuminuria, which is the presence of the protein albumin in the urine and a sign of kidney damage. The primary goal of the trial is to measure whether treatment with BAY 3401016 changes the urine albumin-to-creatinine ratio (UACR), a standard measure of how much albumin leaks into the urine.
Which conditions is BAY 3401016 studied for?
- Alport syndrome — a genetic condition that affects the kidneys, ears and eyes, and can lead to progressive kidney damage.
- Chronic kidney disease — a long-term condition in which the kidneys gradually lose their ability to filter waste from the blood.
The trial registry places BAY 3401016 in the therapeutic area of congenital, hereditary and neonatal diseases and abnormalities, which reflects that Alport syndrome is an inherited condition.
How is BAY 3401016 given?
BAY 3401016 is formulated as a solution for injection. The registry record does not specify the route of administration, stating that it is not applicable in the available data. The trial intervention lists a dose of 99999 mg, which is a placeholder value used in the registry when the actual dose has not been reported. The trial also includes a placebo arm for comparison.
What do the clinical trials show?
There is one clinical trial of BAY 3401016 registered in the EU Clinical Trials Information System. It is a Phase 2, interventional study that has been authorised but is not yet reporting results. The trial is designed to assess the effect of BAY 3401016 on albuminuria in 60 adult participants with Alport syndrome.
The main outcome measure is the mean change in urine albumin-to-creatinine ratio (UACR) from baseline, averaged over weeks 16, 20 and 24 of treatment. UACR is a test that compares the amount of albumin to creatinine in a urine sample; a lower ratio suggests less protein is leaking from the kidneys. The trial compares participants receiving BAY 3401016 with those receiving a placebo, meaning an inactive injection.
The registry record does not list detailed eligibility criteria such as age range beyond adults, kidney function thresholds, or genetic confirmation of Alport syndrome. Participants are adults with Alport syndrome and chronic kidney disease.
What side effects are known?
The registry record for the Phase 2 trial of BAY 3401016 does not report side effects. Because the substance is still investigational and the trial has not published results, no safety information is available from the provided sources.