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Evaluate efficacy and safety of 16 weeks of titrated dose treatment with BAY85-3934 versus epoetin alfa/beta as measured by hemoglobin (Hb) levels. Fixed starting doses of 25, 50,75 and 150 mg of BAY85-3934 titrated at the scheduled dose control visits. Titration will be based on the subject's Hb response and tolerability of the prior dose. Planned doses include 15, 25, 50, 75, 100,150 and 200 mg/day
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Molidustat (BAY 85-3934)(25mg) | Experimental | Starting dose of 25 mg of BAY85-3934 as once-daily oral tablets. Regular titrations at 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, 100,150 and 200 mg once daily. |
|
| Molidustat (BAY 85-3934)(50mg) | Experimental | Starting dose of 50 mg of BAY85-3934 as once-daily oral tablets. Regular titrations at 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, 100,150 and 200 mg once daily. |
|
| Molidustat (BAY 85-3934) (75mg) | Experimental | Starting dose of 75 mg of BAY85-3934 as once-daily oral tablets. Regular titrations at 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, 100,150 and 200 mg once daily., |
|
| Molidustat (BAY 85-3934) (150mg) | Experimental | Starting dose of 150 mg of BAY85-3934 as once-daily oral tablets. Regular titrations at 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, 150 and 200 mg once daily |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Molidustat (BAY 85-3934) | Drug | Oral doses of BAY85-3934 will be available in multiples of 25,50,75 and 150 mg tablets |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change in local laboratory hemoglobin level from baseline to the average during the last 4 weeks treatment period | Baseline and weeks 14 to 17 |
| Measure | Description | Time Frame |
|---|---|---|
| Mean of the hemoglobin (Hb) levels in the target range (10.0 to 11.0 g/dL) | From week 14 to 17 | |
| Mean of the hemoglobin levels in the target range (9.5 to 11.5 g/dL) | From week 14 to 17 | |
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Inclusion 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 | |||
| 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. |
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|
| Epoetin alfa/beta | Active Comparator | Starting dose at the subject's current weekly dose. Administered IV or SC 3 times per week. Doses will be titrated at the scheduled dose control visits according to the local label. Titration will be based on the subject's Hb response and tolerability of the prior dose. Epoetin alfa may be administered in either the United States (US) or Japan; epoetin beta will only be administered in Japan. |
|
| Epoetin alfa/beta | Biological |
|
| Change from baseline in Hb during active treatment |
| Baseline and weeks 14 to 17 |
| Number of patients with hemoglobin levels outside the target range | From week 14 to 17 |
| Dose level in the evaluation period | Up to 16 weeks |
| Duration of exposure on each dose level | Up to 16 weeks |
| Number of subjects requiring titration of dose | Up to 16 weeks |
| Number of participants with serious adverse events as a measure of safety and tolerability | Up to 16 weeks |
| Long Beach |
| California |
| 90813 |
| United States |
| Los Angeles | California | 90025 | 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 |
| Detroit | Michigan | 48236 | United States |
| Creve Coeur | Missouri | 63141 | United States |
| Eatontown | New Jersey | 07724 | United States |
| Brooklyn | New York | 11212 | United States |
| Buffalo | New York | 14215 | United States |
| Fresh Meadows | New York | 11365 | 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 |
| San Antonio | Texas | 78215 | United States |
| San Antonio | Texas | 78229 | United States |
| Muroran | Hokkaido | 050-0083 | Japan |
| Himeji | Hyōgo | 670-0947 | Japan |
| Kuwana | Mie-ken | 511-0061 | Japan |
| Kyoto | 607-8116 | Japan |
| Nagano | 388-8004 | 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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