Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
BAY1213790 · 2 trials · 5 indications
Cumulative incidence risk of the first Composite of MB and CRNMB (ISTH) at month 6 is reported in the table. Descriptive time to composite of MB and CRNMB Events is reported in statistical analysis. Descriptive time to composite of treatment emergent major and CRNMB events \[in alignment with International Society on Thrombosis and Haemostatsis (ISTH) guidelines\] analyses were performed. The cumulative incidence function for the event-of-interest together with the corresponding confidence interval were estimated for each treatment arm using Aalen-Johansen estimators. Cumulative incidence of events up to the day, inclusive.
Cumulative incidence risk of composite of moderate and severe AEs and SAEs at month 6 is reported in the table. Descriptive time to the composite of Moderate and Severe AEs and SAEs is reported in statistical analysis. An AE was any untoward medical occurrence in a patient or clinical study participant, whether or not considered related to the study intervention.
CRNM bleeding: Clinically Relevant Non-Major bleeding
| Arm | Type | Description |
|---|---|---|
| BAY1213790 low dose | EXPERIMENTAL | Participants will receive Osocimab (BAY1213790) 105 mg single loading dose as subcutaneous abdominal injection, followed by monthly maintenance doses of 52.5 mg until the end of the extension treatment period. |
| Placebo low dose | PLACEBO_COMPARATOR | Placebo will be administered subcutaneously in the same manner as Osocimab. |
| BAY1213790 high dose | EXPERIMENTAL | Participants will receive Osocimab (BAY1213790) 210 mg single loading dose as subcutaneous abdominal injection, followed by monthly maintenance doses of 105 mg until the end of the extension treatment period. |
| Placebo high dose | EXPERIMENTAL | Placebo will be administered subcutaneously in the same manner as Osocimab. |
| Dose 1 of BAY1213790 | EXPERIMENTAL | Single intravenous infusion BAY1213790 (Dose 1) |
| Dose 2 of BAY1213790 | EXPERIMENTAL | Single intravenous infusion BAY1213790 (Dose 2) |
| Placebo | PLACEBO_COMPARATOR | Single intravenous infusion placebo |
| Name | Type | Description |
|---|---|---|
| BAY1213790 (Osocimab) | DRUG | Single loading dose as subcutaneous abdominal injection followed by monthly maintenance doses. |
| Placebo | DRUG | Subcutaneous administration in the same manner as Osocimab. |
| BAY1213790 | DRUG | Single intravenous infusion of BAY1213790 (Two different doses) |
| 0.9% sodium chloride solution | DRUG | Single intravenous infusion of Placebo (0.9% sodium chloride solution) |
Inclusion Criteria: * Participants must be at least 18 years of age * Patients with end-stage renal disease on hemodialysis (including hemodiafiltration) for ≥3 months, receiving dialysis at least 9 hours a week and stable in the view of the investigator * Body weight of at least 50 kg * Male and/o...
BAY1213790, also known as osocimab, is an investigational small molecule being studied for use in end-stage renal disease and renal dialysis. It is being evaluated for the prevention of thromboembolic events in adult patients with kidney failure requiring regular hemodialysis or hemodiafiltration.
BAY1213790 is a small molecule that targets Factor XIa, an enzyme involved in blood coagulation. By inhibiting Factor XIa, the drug aims to prevent thromboembolic events without increasing bleeding risk, which is particularly relevant for patients with end-stage renal disease undergoing hemodialysis.
BAY1213790 is being developed by Bayer AG, a German pharmaceutical company traded on the OTC market under the ticker BAYRY. Bayer is conducting clinical trials to evaluate the safety and efficacy of this investigational drug in patients with kidney failure.
BAY1213790 is in Phase 2 clinical development. A Phase 2 study (NCT04523220) has been completed, investigating the safety of low and high doses of osocimab in adult patients with kidney failure requiring regular hemodialysis. The drug is investigational and not yet approved.
BAY1213790 has been studied in two completed clinical trials. NCT03787368 was a Phase 1 pilot study in renal dialysis patients, and NCT04523220 was a Phase 2 study in patients with end-stage renal disease. Both trials were randomized, double-blind, and placebo-controlled.
Yes, BAY1213790 is also known as osocimab. The drug is referred to by both names in clinical research. Osocimab is the generic name used in trial titles, while BAY1213790 is the development code assigned by Bayer AG.