Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
BAY3283142 · 6 trials · 6 indications
AUC(0-tlast) will be used as main parameter, if mean AUC cannot be reliably determined in all participants.
| Arm | Type | Description |
|---|---|---|
| Arm 1 | PLACEBO_COMPARATOR | Placebo OD and sham titration after 14 days and after 28 days |
| Arm 2 | EXPERIMENTAL | BAY3283142 (dose 1) OD and sham titration after 14 days and after 28 days |
| Arm 3 | EXPERIMENTAL | BAY3283142 (dose 2) OD and sham titration after 14 days and after 28 days |
| Arm 4 | EXPERIMENTAL | BAY3283142 (dose 2) OD and uptitration to dose 3 OD after 14 days and sham titration after 28 days |
| Arm 5 | EXPERIMENTAL | BAY3283142 (dose 2) OD and uptitration to dose 3 OD after 14 days and to dose 4 OD after 28 days |
| Arm 6 | EXPERIMENTAL | BAY3283142 (dose 3) OD and uptitration to dose 5 OD after 14 days and sham titration after 28 days |
| Treatment scheme 1 | EXPERIMENTAL | The Participants will receive either BAY3283142 or placebo once a day. The treatment scheme consists of 3 dose steps. Treatment will start with the low dose for 7 days , followed for 14 days at the middle dose and 14 days on the high dose. |
| Treatment scheme 2 | EXPERIMENTAL | (if treatment scheme 1 is safe and well-tolerated) Participants will receive either BAY3283142 or placebo once a day. The treatment scheme consists of 3 dose steps. Treatment will start with the low dose for 7 days , followed for 14 days at the middle dose and 7 days on the very high dose. |
| Treatment scheme 3 | EXPERIMENTAL | (if treatment scheme 1 is safe and well-tolerated) Participants will receive either BAY3283142 or placebo twice a day. The treatment scheme consists of 3 dose steps. Treatment will start with the low dose for 7 days , followed for 14 days at the middle dose and 7 days on the very high dose. |
| Treatment scheme 4 | EXPERIMENTAL | (if treatment scheme 1 is not safe and well-tolerated) Participants will receive either BAY3283142 or placebo twice a day. The treatment scheme consists of 3 dose steps. Treatment will start with the low dose for 7 days , followed for 14 days at the middle dose and 14 days on the high dose. |
| Dose step 1 | EXPERIMENTAL | Participants will receive a low dose of BAY3283142 on Day 1 followed by 1 day without dosing and a multiple dose phase for 7 days. |
| Dose step 2 | EXPERIMENTAL | Participants will receive a high dose of BAY3283142 on Day 1 followed by 1 day without dosing and a multiple dose phase for 7 days. |
| Placebo | PLACEBO_COMPARATOR | Participants will receive placebo on Day 1 followed by 1 day without dosing and a multiple dose phase for 7 days. |
| Group 1: Mild hepatic impairment | EXPERIMENTAL | Participants with mild hepatic impairment. |
| Group 2: Moderate hepatic impairment | EXPERIMENTAL | Participants with moderate hepatic impairment. |
| Group 3 and 4: Normal hepatic function (control group) | EXPERIMENTAL | Control group(s) of age-, weight-, and gender-matched participants with normal hepatic function. |
| BAY3283142 (low dose) | EXPERIMENTAL | Participants will receive BAY3283142 as single low dose on Day 1 followed by multiple doses for 7 days from Day 3 to Day 9. |
| BAY3283142 (medium dose) | EXPERIMENTAL | Participants will receive BAY3283142 as single medium dose on Day 1 followed by multiple doses for 7 days from Day 3 to Day 9 (optional arm). |
| BAY3283142 (high dose) | EXPERIMENTAL | Participants will receive BAY3283142 as single high dose on Day 1 followed by multiple doses for 7 days from Day 3 to Day 9. |
| Matching placebo | PLACEBO_COMPARATOR | Participants will receive a BAY3283142 matching placebo as single dose on Day 1 followed by multiple doses for 7 days from Day 3 to Day 9. |
| Up-titration Scheme 1 | EXPERIMENTAL | Participants will receive 12 days treatment in total. |
| Up-titration Scheme 2 | EXPERIMENTAL | Participants will receive 12 days treatment in total. |
| Up-titration Scheme 3 | EXPERIMENTAL | Participants will receive 12 days treatment in total. |
| Name | Type | Description |
|---|---|---|
| BAY3283142 | DRUG | Tablet, intake orally once daily |
| Placebo | DRUG | Matching with BAY3283142 |
| Placebo to BAY3283142 | DRUG | oral administration |
Inclusion Criteria: * Participant must be ≥18 years of age * eGFR (Chronic Kidney Disease Epidemiology Collaboration formula) ≥20 and ≤75 mL/min /1.73 m\^2 at Screening Note: One re-assessment of eGFR based on central laboratory values is allowed during the Screening period" * UACR ≥200 mg/g and \<...
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BAY3283142 is an investigational small molecule being developed for chronic kidney disease. It is currently in Phase 2 clinical development and has not been approved by regulatory authorities. The drug is being studied in patients with chronic kidney disease, including those with hypertension and other related conditions.
BAY3283142 is being developed by Bayer AG, a multinational pharmaceutical company. Bayer's stock is traded on the OTC market under the ticker symbol BAYRY. The company is conducting clinical trials to evaluate the safety, tolerability, and pharmacokinetics of this investigational drug for chronic kidney disease.
BAY3283142 is currently in Phase 2 clinical development for chronic kidney disease. The drug is investigational and has not received regulatory approval. Bayer has completed six Phase 1 trials with a total enrollment of 1425 participants, and the program is now advancing into later-stage clinical testing.
BAY3283142 has completed six Phase 1 clinical trials. These include studies in patients with mild to moderate hypertension (NCT05491642), Japanese healthy male participants (NCT05800444), participants with reduced liver function (NCT06402721), and healthy Chinese participants (NCT06487845). All trials have been completed with no active studies currently ongoing.
BAY3283142 is a small molecule therapeutic being studied for chronic kidney disease. The specific molecular target of the drug has not been disclosed in the available clinical trial information. The ongoing clinical development program is focused on evaluating the drug's safety, tolerability, and how it moves through the body.