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| ID | Type | Description | Link |
|---|---|---|---|
| 2012-002375-33 | EudraCT Number |
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Primary objective was to assess in subjects with CKD: Safety and tolerability of molidustat (BAY 85-3934), effects of molidustat on non-invasive hemodynamics Secondary objectives were to assess: Effects on pharmacodynamic parameters of erythropoiesis (erythropoietin, reticulocytes, erythrocytes, hemoglobin, hematocrit), pharmacokinetics of molidustat, exploratory biomarkers, ie, midregional pro-atrial natriuretic peptide, midregional pro-adrenomedullin, plasma renin activity, and optionally B-type natriuretic peptide, vascular endothelial growth factor, cyclic guanosine monophosphate, cyclic adenosine monophosphate, and noradrenaline
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Molidustat, 80 mg | Experimental | Subjects received a single oral dose of 80 mg BAY 85-3934 in the first period and placebo in the second period, separated by a wash-out period of at least 1 week. |
|
| Molidustat, 120 mg | Experimental | Subjects received a single oral dose of 120 mg BAY 85-3934 in the first period and placebo in the second period, separated by a wash-out period of at least 1 week. |
|
| Molidustat, 40 mg | Experimental | Subjects received a single oral dose of 40 mg BAY 85-3934 in the first period and placebo in the second period, separated by a wash-out period of at least 1 week. This is an optional dose escalation step. |
|
| Molidustat, 160 mg | Experimental | Subjects received a single oral dose of 160 mg BAY 85-3934 in the first period and placebo in the second period, separated by a wash-out period of at least 1 week. This is an optional dose escalation step. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Molidustat (BAY85-3934) | Drug | 20 mg molidustat as a single tablet |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of participants with adverse events | Approximately 9 weeks | |
| Blood pressure | Systolic, diastolic, mean blood pressure | Approximately 9 weeks |
| Heart rate | Approximately 9 weeks | |
| Cmax | Maximum observed drug concentration in measured matrix after single dose administration | Pre-dose and up to 48 h post-dose |
| Cmax/D | Cmax divided by dose | Pre-dose and up to 48 h post-dose |
| AUC | Area under the concentration vs time curve from zero to infinity after single dose | Pre-dose and up to 48 h post-dose |
| AUC/D | AUC divided by dose | Pre-dose and up to 48 h post-dose |
| Heart rate over 1 min | Pre-dose and up to 24 h post-dose | |
| Standing blood pressure procedure | Starting from 2 h post-dose and up to 4 h post-dose | |
| Impedance cardiography |
| Measure | Description | Time Frame |
|---|---|---|
| Change of hematology profile | Hematology profile includes blood concentration of erythropoietin, reticulocytes, erythrocytes, hemoglobin, hematocrit, and exploratory biomarkers. | From baseline to Day 1 after single dose |
| Cmax,norm |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Bayer Study Director | Bayer | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| MĂĽnchen | Bavaria | 81241 | Germany | |||
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 36005278 | Derived | Natale P, Palmer SC, Jaure A, Hodson EM, Ruospo M, Cooper TE, Hahn D, Saglimbene VM, Craig JC, Strippoli GF. Hypoxia-inducible factor stabilisers for the anaemia of chronic kidney disease. Cochrane Database Syst Rev. 2022 Aug 25;8(8):CD013751. doi: 10.1002/14651858.CD013751.pub2. |
| Label | URL |
|---|---|
| Click here to find information about studies related to Bayer Healthcare products conducted in Europe. | View source |
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| Placebo | Drug | Single oral dose of matching placebo will be given in each treatment arm |
|
Stroke volume, heart rate, cardiac index, cardiac output, and total peripheral resistance |
| Pre-dose and up tp 8 h post-dose |
Cmax divided by dose per body weight
| Pre-dose and up to 48 h post-dose |
| AUCnorm | AUC divided by dose per body weight | Pre-dose and up to 48 h post-dose |
| AUC(0-24) | AUC from 0 until 24 h after study drug administration | Pre-dose and up to 24 h post-dose |
| AUC(0-tlast) | AUC from time 0 to the last data point > lower limit of quantification | Pre-dose and up to 48 h post-dose |
| t½ | Half-life associated with the terminal slope | Pre-dose and up to 48 h post-dose |
| tmax | Time to reach Cmax (in case of two identical Cmax values, the first tmax was used) | Pre-dose and up to 48 h post-dose |
| MRT | Mean residence time | Pre-dose and up to 48 h post-dose |
| CL/F | Total body clearance of drug calculated after extravascular administration (eg, apparent oral clearance) | Pre-dose and up to 48 h post-dose |
| Vz/F | Apparent volume of distribution during terminal phase after extravascular administration | Pre-dose and up to 48 h post-dose |
| Geometric mean erythropoietin Cmax | Pre-dose and up to 24 h post-dose |
| Geometric mean reticulocyte count | Pre-dose and up to 24 h post-dose |
| Geometric mean erythrocyte count | Pre-dose and up to 24 h post-dose |
| Geometric mean reticulocytes/erythrocytes values | Pre-dose and up to 24 h post-dose |
| Geometric mean hemoglobin values | Pre-dose and up to 24 h post-dose |
| Geometric mean hematocrit | Pre-dose and up to 24 h post-dose |
| Geometric mean erythropoietin tmax | Pre-dose and up to 24 h post-dose |
| Geometric mean erythropoietin AUC(0-24) | Pre-dose and up to 24 h post-dose |
| Mönchengladbach |
| North Rhine-Westphalia |
| 41061 |
| Germany |
| Kiel | Schleswig-Holstein | 24105 | Germany |
| ID | Term |
|---|---|
| D007674 | Kidney Diseases |
| ID | Term |
|---|---|
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
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| ID | Term |
|---|---|
| C000603972 | molidustat |
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