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To evaluate the overall safety and tolerability of ulodesine when combined with allopurinol in subjects with moderate renal insufficiency.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Placebo | Experimental | Placebo + Allopurinol 200mg |
|
| Ulodesine (BCX4208) 5mg | Experimental | BCX4208 5mg + Allopurinol 200 mg |
|
| Ulodesine (BCX4208) 10mg | Experimental | BCX4208 10mg + Allopurinol 200mg |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Placebo | Drug | Oral dose administered daily for 84 days. |
| |
| Ulodesine (BCX4208) 5 mg |
| Measure | Description | Time Frame |
|---|---|---|
| To evaluate the overall safety and tolerability of ulodesine when combined with allopurinol in subjects with moderate renal insufficiency by assessment of percent change from baseline in CD4+ lymphocytes at Day 85. | Level of CD4+ lymphocytes to be measured at Day 85 compared to baseline. | 85 days |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Alan Hollister, MD, PhD | BioCryst Pharmaceuticals | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Mobile | Alabama | 36608 | United States | |||
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| Drug |
Oral dose administered daily for 84 days. |
|
| Ulodesine (BCX4208) 10 mg | Drug | Oral dose administered daily for 84 days. |
|
| Peoria |
| Arizona |
| 85381 |
| United States |
| Irvine | California | 92618 | United States |
| Oldsmar | Florida | 34677 | United States |
| Honolulu | Hawaii | 96814 | United States |
| Newton | Kansas | 67114 | United States |
| Knoxville | Tennessee | 37923 | United States |
| Dallas | Texas | 75235 | United States |
| San Antonio | Texas | 78215 | United States |
| Alexandria | Virginia | 22304 | United States |
| ID | Term |
|---|---|
| D006073 | Gout |
| D033461 | Hyperuricemia |
| D001168 | Arthritis |
| D007592 | Joint Diseases |
| D051437 | Renal Insufficiency |
| ID | Term |
|---|---|
| D009140 | Musculoskeletal Diseases |
| D000070657 | Crystal Arthropathies |
| D012216 | Rheumatic Diseases |
| D011686 | Purine-Pyrimidine Metabolism, Inborn Errors |
| D008661 | Metabolism, Inborn Errors |
| D030342 | Genetic Diseases, Inborn |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D007674 | Kidney Diseases |
| 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 |
|---|---|
| C000593472 | ulodesine |
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