Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
BAY85-3934 · 5 trials · 2 indications
An adverse event (AE) was any untoward medical occurrence in a subject who received study drug without regard to possibility of causal relationship. An serious adverse event (SAE) was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly; medically important serious event. TEAEs were defined as AEs/SAEs that started or worsened after the study drug treatment.
Heart rate was observed in all treatment groups in supine position.
Heart rate was assessed over 1 minute from the Electrocardiogram (ECG) recording.
SBP, DBP was observed in all treatment groups in supine phase.
Electrocardiograms were recorded and analyzed by an electronic ECG reading system.
Laboratory parameters include hematology, coagulation, serum chemistry, urinalysis.
Cmax refers to the highest measured drug concentration after a single dose which is obtained by collecting a series of blood samples and measuring the concentrations of drug in each sample. Geometric mean and percentage geometric coefficient of variation (%CV) were reported.
Cmax/D is defined as maximum observed drug concentration divided by dose. Cmax refers to the highest measured drug concentration after single dose which is obtained by collecting a series of blood samples and measuring the concentrations of drug in each sample. Geometric mean and percentage geometric coefficient of variation (%CV) were reported.
AUC is a measure of systemic drug exposure after single dose, which is obtained by collecting a series of blood samples and measuring the concentrations of drug in each sample. AUC is defined as area under concentration versus time curve from time 0 (pre-dose) to extrapolated infinite time. Geometric mean and percentage geometric coefficient of variation (%CV) were reported.
AUC is a measure of systemic drug exposure after single dose, which is obtained by collecting a series of blood samples and measuring the concentrations of drug in each sample. AUC is defined as area under concentration versus time curve from time 0 (pre-dose) to extrapolated infinite time. AUC/D is defined as area under the concentration versus time curve from zero to infinity divided by dose. Geometric mean and percentage geometric coefficient of variation (%CV) were reported.
Cmax,md defined as maximum observed drug concentration after multiple dose. Cmax,md refers to the highest measured drug concentration in the dosing interval which is obtained by collecting a series of blood samples and measuring the concentrations of drug in each sample. Geometric mean and percentage geometric coefficient of variation (%CV) were reported.
Cmax,md/D is defined as maximum observed drug concentration divided by dose after multiple dose administration. Cmax,md refers to the highest measured drug concentration within the dosing interval which is obtained by collecting a series of blood samples and measuring the concentrations of drug in each sample. Geometric mean and percentage geometric coefficient of variation (%CV) were reported.
AUC(0-24)md is defined as area under the concentration versus time curve from 0 to 24 hour after multiple dose. Geometric mean and percentage geometric coefficient of variation (%CV) were reported.
AUC(0-24)md/D is defined as area under the concentration versus time curve from 0 to 24 hour divided by dose after multiple dose. Geometric mean and percentage geometric coefficient of variation (%CV) were reported.
| Arm | Type | Description |
|---|---|---|
| BAY85-3934 (25mg OD) | EXPERIMENTAL | 25 mg once daily (OD) of BAY85-3934 Morning: 1 tablet BAY85-3934 25 mg and 2 tablets matching placebo Evening: 3 tablets matching placebo |
| BAY85-3934 (50mg OD) | EXPERIMENTAL | 50 mg OD of BAY85-3934 Morning: 2 tablets BAY85-3934 25 mg and 1 tablet matching placebo Evening: 3 tablets matching placebo |
| BAY85-3934 (75mg OD) | EXPERIMENTAL | 75 mg OD of BAY85-3934 Morning: 3 tablets BAY85-3934 25 mg Evening: 3 tablets matching placebo |
| BAY85-3934 (25mg BID) | EXPERIMENTAL | 25 mg twice daily (BID) of BAY85-3934 Morning and evening: 1 tablet BAY85-3934 25 mg and 2 tablets matching placebo |
| BAY85-3934 (50mg BID) | EXPERIMENTAL | 50 mg BID of BAY85-3934 Morning and evening: 2 tablets BAY85-3934 25 mg and 1 tablet matching placebo |
| Placebo BID | PLACEBO_COMPARATOR | Placebo BID Morning and evening: 3 tablets of placebo matching BAY85-3934 25 mg |
| BAY85-3934 (25mg) | EXPERIMENTAL | Fixed starting dose of 25 mg of BAY85-3934 oral tablet (once daily dose) titrated at the scheduled dose control visits. Titration occuring every 4-weeks will be based on the subject's hemoglobin (Hb) response and tolerability of the prior dose. Total treatment time is 16 weeks. Planned doses include 15, 25, 50, 75, 100, and 150 mg once daily. |
| BAY85-3934 (50mg) | EXPERIMENTAL | Fixed starting dose of 50 mg of BAY85-3934 oral tablet (once daily dose) titrated at the scheduled dose control visits. Titration occuring every 4-weeks will be based on the subject's Hb response and tolerability of the prior dose. Total treatment time is 16 weeks. Planned doses include 15, 25, 50, 75, 100, and 150 mg once daily. |
| BAY85-3934 (75mg) | EXPERIMENTAL | Fixed starting doses of 75 mg of BAY85-3934 oral tablet (once daily dose) titrated at the scheduled dose control visits. Titration occuring every 4-weeks will be based on the subject's Hb response and tolerability of the prior dose. Total treatment time is 16 weeks. Planned doses include 15, 25, 50, 75, 100, and 150 mg once daily. |
| Darbepoetin alfa | ACTIVE_COMPARATOR | Darbepoetin (intravenous or subcutaneous) will be administered according to the local label and titrated at the scheduled dose control visits. Titration will be based on the subject's Hb response and tolerability of the prior dose. |
| Arm 1 | EXPERIMENTAL | - |
| Arm 2 | PLACEBO_COMPARATOR | - |
| Placebo | PLACEBO_COMPARATOR | - |
| Molidustat (BAY85-3934) 5 mg | EXPERIMENTAL | - |
| Molidustat (BAY85-3934) 10 mg | EXPERIMENTAL | - |
| Molidustat (BAY85-3934) 25 mg | EXPERIMENTAL | - |
| Molidustat (BAY85-3934) 50 mg | EXPERIMENTAL | - |
| Molidustat (BAY85-3934) 75 mg | EXPERIMENTAL | - |
| Arm 3 | EXPERIMENTAL | - |
| Name | Type | Description |
|---|---|---|
| BAY85-3934 | DRUG | 25mg Tablet |
| Placebo | DRUG | Matching placebo tablet |
| Darbepoetin alfa | BIOLOGICAL | - |
Inclusion Criteria: * Women without childbearing potential * Male or female subjects ≥ 18 years of age with anemia of chronic kidney disease (CKD) at screening * Estimated glomerular filtration rate of \< 60 mL/min/1.73 m2 (Modification of Diet in Renal Disease \[MDRD\] or the formula according to ...
BAY85-3934 is an investigational small molecule being developed for the treatment of anemia, including anemia associated with chronic kidney disease. It is currently in Phase 2 clinical development and has not been approved by regulatory authorities.
BAY85-3934 is being developed by Bayer AG, a multinational pharmaceutical company. Bayer's stock is traded over-the-counter under the ticker symbol BAYRY.
BAY85-3934 is in Phase 2 clinical development. It has completed five clinical trials, including Phase 1 and Phase 2 studies, but it remains investigational and is not yet approved for any use.
BAY85-3934 has been studied in five completed trials. Notable ones include NCT01318551, a single-dose study in healthy and renally impaired subjects; NCT01332942, a dose escalation study in patients with renal anemia; NCT01458028, a pharmacokinetic study; and NCT02021409, a Phase 2 maintenance study in pre-dialysis chronic kidney disease patients.
No alternative names for BAY85-3934 have been disclosed. It is identified solely by its development code BAY85-3934 in clinical trial registries and scientific literature.