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Evaluate efficacy and safety up to 36 months of titrated dose treatment with BAY85-3934 versus epoetin alfa/beta. Titration will be based on the subject's hemoglobin (Hb) response and tolerability of the prior dose. Planned doses include 15, 25, 50, 75, 100,and 150 mg once daily.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Molidustat (BAY85-3934) | Experimental |
| |
| Epoetin alfa/beta | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Molidustat (BAY85-3934) | Drug | Subjects will continue with the same treatment they were receiving in the parent study (16208). BAY85-3934 will be administered daily as oral tablets. Dose assessments will be made every 4 (± 1) weeks. At the scheduled visits, the dose may be titrated on an individualized basis taking into account the subject's Hb response and the tolerability of the previous dose. Total treatment time is up to 36 months. Planned doses include 15, 25, 50, 75, 100, and 150 mg once daily. |
| Measure | Description | Time Frame |
|---|---|---|
| Change in local laboratory hemoglobin level from baseline | Baseline up to 36 months | |
| Number of participants with serious adverse events as a measure of safety and tolerability | Up to 36 months |
| Measure | Description | Time Frame |
|---|---|---|
| Maintenance in hemoglobin target range (10.0 to 11.0 g/dL) | Up to 36 months | |
| Maintenance in hemoglobin target range (9.5 to 11.5 g/dL) | Up to 36 months | |
| Duration of treatment exposure |
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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 |
|---|---|---|---|---|---|---|
| Azusa | California | 91702 | United States | |||
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|
| Epoetin alfa/beta | Biological | Subjects will continue with the same treatment they were receiving in the parent study (16208). Epoetin alfa / beta will be administered as intravenous (IV) or subcutaneous (SC) injections per individual subject regimen according to the local label. Dose assessments will be made every 4 (± 1) weeks. At the scheduled visits,dose may be titrated on an individualized basis taking into account the subject's Hb response and the tolerability of the previous dose.Total treatment time is up to 36 months. |
|
| Up to 36 months |
| Number of subjects requiring titration of dose | Up to 36 months |
| Change of reticulocyte count from baseline of this study | Baseline up to 36 months |
| Change of reticulocyte count from baseline of study 16208 | Baseline up to 36 months |
| Change of red blood cell count from baseline of this study | Baseline up to 36 months |
| Change of red blood cell count from baseline of study 16208 | Baseline up to 36 months |
| Change of hematocrit from baseline of this study | Baseline up to 36 months |
| Change of hematocrit from baseline of study 16208 | Baseline up to 36 months |
| Change of central laboratory hemoglobin level from baseline of this study | Baseline up to 36 months |
| Change of central laboratory hemoglobin level from baseline of study 16208 | Baseline up to 36 months |
| Long Beach |
| California |
| 90813 |
| United States |
| Lynwood | California | 90262 | United States |
| Northridge | California | 91324 | United States |
| San Dimas | California | 91773 | United States |
| Whittier | California | 90602 | United States |
| Whittier | California | 90606 | United States |
| New Port Richey | Florida | 34652 | United States |
| Pembroke Pines | Florida | 33028 | United States |
| Detroit | Michigan | 48202 | United States |
| Creve Coeur | Missouri | 63141 | United States |
| Buffalo | New York | 14215 | United States |
| Cincinnati | Ohio | 45206 | United States |
| Toledo | Ohio | 43615 | United States |
| Oklahoma City | Oklahoma | 73116 | United States |
| Nashville | Tennessee | 37212-8150 | United States |
| Fort Worth | Texas | 76104 | United States |
| Fort Worth | Texas | 76105 | United States |
| Fort Worth | Texas | 76164 | United States |
| Grand Prairie | Texas | 75050 | United States |
| Houston | Texas | 77004 | United States |
| Houston | Texas | 77091 | United States |
| Mansfield | Texas | 76063 | United States |
| Muroran | Hokkaido | 050-0083 | Japan |
| Kuwana | Mie-ken | 511-0061 | Japan |
| Kyoto | 607-8116 | Japan |
| ID | Term |
|---|---|
| D000740 | Anemia |
| D051436 | Renal Insufficiency, Chronic |
| ID | Term |
|---|---|
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D051437 | Renal Insufficiency |
| D007674 | Kidney Diseases |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| C000603972 | molidustat |
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