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Sponsor opened Phase 2 Study.
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Subjects who received tesevatinib in Study KD019-101 and completed 24 months of treatment will continue on the dose of tesevatinib they were receiving at 24 months on the KD019-101 study.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 50mg Daily | Experimental | One 50mg tesevatinib tablet per day |
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| 100mg Daily | Experimental | Two 50mg tesevatinib tablets per day |
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| 150mg M/Th | Experimental | Three 50mg tesevatinib tablets every Monday and Thursday. |
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| 150mg MWF | Experimental | Three 50mg tesevatinib tablets every Monday, Wednesday and Friday. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| tesevatinib | Drug |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| Monitor Longitudinal Changes in Estimated Glomerular Filtration Rate | Monitor longitudinal changes in estimated glomerular filtration rate (eGFR) in subjects with ADPKD when treated with tesevatinib. | 37 Months |
| Measure | Description | Time Frame |
|---|---|---|
| Monitor Longitudinal Changes in Total Kidney Volume | Monitor longitudinal changes from baseline in total kidney volume (TKV) in subjects with ADPKD when treated with tesevatinib. | 37 Months |
| Number of Subjects Experiencing Adverse Events as a Measure of Safety and Tolerability |
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Inclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| UCLA Medical Center | Los Angeles | California | 90025 | United States | ||
| Beth Israel Deaconess Medical Center |
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Extension Study, participants to be followed at the dose of tesevatinib they were receiving in Study KD019-101.
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To evaluate the long term safety and tolerability of tesevatinib in subjects with ADPKD when treated with tesevatinib. |
| 37 Months |
| Boston |
| Massachusetts |
| 02215 |
| United States |
| Washington University School of Medicine | St Louis | Missouri | 63110 | United States |
| Cleveland Clinic | Cleveland | Ohio | 44195 | United States |
| University of Virginia - Nephrology Clinical Research Center | Charlottesville | Virginia | 22908 | United States |
| Medical College of Wisconsin | Milwaukee | Wisconsin | 53226 | United States |
| ID | Term |
|---|---|
| D016891 | Polycystic Kidney, Autosomal Dominant |
| ID | Term |
|---|---|
| D007690 | Polycystic Kidney Diseases |
| D052177 | Kidney Diseases, Cystic |
| D007674 | Kidney Diseases |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
| D000015 | Abnormalities, Multiple |
| D000013 | Congenital Abnormalities |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D000072661 | Ciliopathies |
| D030342 | Genetic Diseases, Inborn |
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| ID | Term |
|---|---|
| C571826 | XL647 |
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