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This study will assess the serum uric acid lowering effects and safety of lesinurad over a long-term timeframe.
This is a Phase 3, open-label, uncontrolled, extension study to assess the long-term efficacy and safety of lesinurad monotherapy in subjects who completed the double-blind treatment period in Study RDEA594-303.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| lesinurad 400 mg | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| lesinurad | Drug | Tablets, 400 mg QD |
|
| Measure | Description | Time Frame |
|---|---|---|
| Proportion of Subjects With a Serum Urate (sUA) Level That is < 6.0 mg/dL | Month 1 | |
| Incidence of Treatment-emergent Adverse Events (TEAEs) | Up to approximately 2 years |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Chris Storgard, MD | Ardea Biosciences, Inc. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Birmingham | Alabama | 35209 | United States | |||
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| ID | Title | Description |
|---|---|---|
| FG000 | Lesinurad 400 mg | lesinurad 400 mg once daily (qd) |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Birmingham |
| Alabama |
| 35211 |
| United States |
| Birmingham | Alabama | 35294 | United States |
| Glendale | Arizona | 85308 | United States |
| Peoria | Arizona | 85381 | United States |
| Tempe | Arizona | 85282 | United States |
| Carmichael | California | 95608 | United States |
| Covina | California | 91723 | United States |
| Huntington Park | California | 90255 | United States |
| Irvine | California | 92618 | United States |
| Colorado Springs | Colorado | 80922 | United States |
| Denver | Colorado | 80220 | United States |
| Denver | Colorado | 80230 | United States |
| Englewood | Colorado | 80113 | United States |
| Trumbill | Connecticut | 06611 | United States |
| Boynton Beach | Florida | 33472 | United States |
| Miami | Florida | 33143 | United States |
| Plant City | Florida | 33563 | United States |
| Tampa | Florida | 33607 | United States |
| Winter Haven | Florida | 33880 | United States |
| Newnan | Georgia | 30265 | United States |
| Honolulu | Hawaii | 96814 | United States |
| Meridian | Indiana | 83646 | United States |
| Elizabethtown | Kentucky | 42701 | United States |
| Lexington | Kentucky | 40504 | United States |
| Metairie | Louisiana | 70006 | United States |
| Traverse City | Michigan | 49684 | United States |
| Jackson | Mississippi | 39202 | United States |
| Olive Branch | Mississippi | 38654 | United States |
| Albuquerque | New Mexico | 87106 | United States |
| Brooklyn | New York | 11201 | United States |
| New Windsor | New York | 12553 | United States |
| New York | New York | 10016 | United States |
| Hickory | North Carolina | 28602 | United States |
| Raleigh | North Carolina | 27612 | United States |
| Winston-Salem | North Carolina | 27103 | United States |
| Fargo | North Dakota | 58103 | United States |
| Cincinnati | Ohio | 45242 | United States |
| Middleburg Heights | Ohio | 44130 | United States |
| Perrysburg | Ohio | 43551 | United States |
| Jenkintown | Pennsylvania | 19046 | United States |
| Landsdale | Pennsylvania | 19446 | United States |
| Sellersville | Pennsylvania | 18960 | United States |
| Myrtle Beach | South Carolina | 29588 | United States |
| Spartanburg | South Carolina | 29303 | United States |
| Brentwood | Tennessee | 37027 | United States |
| Spring Hill | Tennessee | 37174 | United States |
| Dallas | Texas | 75235 | United States |
| Houston | Texas | 77098 | United States |
| Bountiful | Utah | 84010 | United States |
| West Layton | Utah | 84041 | United States |
| Chesapeake | Virginia | 23320 | United States |
| Richmond | Virginia | 23235 | United States |
| Suffold | Virginia | 23435 | United States |
| Seattle | Washington | 98104 | United States |
| Spokane | Washington | 99208 | United States |
| Morgantown | West Virginia | 26505 | United States |
| Herston | Queensland | 4029 | Australia |
| Hobart | Tasmania | 7000 | Australia |
| Genk | 3600 | Belgium |
| Gozée | 6534 | Belgium |
| Kortrijk | 8500 | Belgium |
| Yvoir | 5530 | Belgium |
| Toronto | Ontario | M9W 4L6 | Canada |
| Québec | Quebec | G1V 3M7 | Canada |
| Rimouski | Quebec | G5L 8W1 | Canada |
| Dresden | 01069 | Germany |
| Leipzig | 04109 | Germany |
| Grafton | Auckland | 1023 | New Zealand |
| Tauranga | 3143 | New Zealand |
| Silverglen | Durban | 4092 | South Africa |
| Muckleneuk | Pretoria | 0002 | South Africa |
| Rondebosch | 7700 | South Africa |
| Stellenbosch | 7600 | South Africa |
| Thabazimbi | 0380 | South Africa |
| COMPLETED |
|
| NOT COMPLETED |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Lesinurad 400 mg | lesinurad 400 mg once daily (qd) |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | |||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
| ||||||||||||||||||||||
| Age, Customized | <65 Years, >=65 Years | Number | Participants |
| ||||||||||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| |||||||||||||||||||||||
| Region of Enrollment | Number | Participants |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Proportion of Subjects With a Serum Urate (sUA) Level That is < 6.0 mg/dL | Safety Population | Posted | Number | Subjects | Month 1 |
|
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| |||||||||||||||||||||||||||
| Primary | Incidence of Treatment-emergent Adverse Events (TEAEs) | Safety Population | Posted | Number | TEAEs | Up to approximately 2 years |
|
|
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Lesinurad 400 mg | lesinurad 400 mg once daily (qd) | 15 | 143 | 73 | 143 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Pancreatitis | Gastrointestinal disorders | MedDRA 14.0 | Systematic Assessment |
| |
| Death | General disorders | MedDRA 14.0 | Systematic Assessment |
| |
| Bursitis infective | Infections and infestations | MedDRA 14.0 | Systematic Assessment |
| |
| Gastroenteritis salmonella | Infections and infestations | MedDRA 14.0 | Systematic Assessment |
| |
| Gout | Metabolism and nutrition disorders | MedDRA 14.0 | Systematic Assessment |
| |
| Facet joint syndrome | Musculoskeletal and connective tissue disorders | MedDRA 14.0 | Systematic Assessment |
| |
| Transient ischaemic attack | Nervous system disorders | MedDRA 14.0 | Systematic Assessment |
| |
| Nephrolithiasis | Renal and urinary disorders | MedDRA 14.0 | Systematic Assessment |
| |
| Renal impairment | Renal and urinary disorders | MedDRA 14.0 | Systematic Assessment |
| |
| Renal Failure Acute | Renal and urinary disorders | MedDRA 14.0 | Systematic Assessment |
| |
| Depression | Psychiatric disorders | MedDRA 14.0 | Systematic Assessment |
| |
| Schizoaffective disorder | Psychiatric disorders | MedDRA 14.0 | Systematic Assessment |
| |
| Angina pectoris | Cardiac disorders | MedDRA 14.0 | Systematic Assessment |
| |
| Atrioventricular clock complete | Cardiac disorders | MedDRA 14.0 | Systematic Assessment |
| |
| Coronary Artery disease | Cardiac disorders | MedDRA 14.0 | Systematic Assessment |
| |
| Myocardial infarction | Cardiac disorders | MedDRA 14.0 | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Abdominal pain upper | Gastrointestinal disorders | MedDRA 14.0 | Systematic Assessment |
| |
| Gastrooesophageal reflux disease | Gastrointestinal disorders | MedDRA 14.0 | Systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA 14.0 | Systematic Assessment |
| |
| Fatigue | General disorders | MedDRA 14.0 | Systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA 14.0 | Systematic Assessment |
| |
| Bronchitis | Infections and infestations | MedDRA 14.0 | Systematic Assessment |
| |
| Gastroenteritis | Infections and infestations | MedDRA 14.0 | Systematic Assessment |
| |
| Influenza | Infections and infestations | MedDRA 14.0 | Systematic Assessment |
| |
| Sinusitis | Infections and infestations | MedDRA 14.0 | Systematic Assessment |
| |
| Upper respiratory tract infection | Infections and infestations | MedDRA 14.0 | Systematic Assessment |
| |
| Urinary tract infection | Infections and infestations | MedDRA 15.1 | Systematic Assessment |
| |
| Blood creatine phosphokinase increased | Investigations | MedDRA 14.0 | Systematic Assessment |
| |
| Blood creatinine increased | Investigations | MedDRA 14.0 | Systematic Assessment |
| |
| Hyperlipidaemia | Metabolism and nutrition disorders | MedDRA 14.0 | Systematic Assessment |
| |
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA 14.0 | Systematic Assessment |
| |
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA 14.0 | Systematic Assessment |
| |
| Flank pain | Musculoskeletal and connective tissue disorders | MedDRA 14.0 | Systematic Assessment |
| |
| Pain in extremity | Musculoskeletal and connective tissue disorders | MedDRA 14.0 | Systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA 14.0 | Systematic Assessment |
| |
| Nephrolithiasis | Renal and urinary disorders | MedDRA 14.0 | Systematic Assessment |
| |
| Renal impairment | Renal and urinary disorders | MedDRA 14.0 | Systematic Assessment |
| |
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA 14.0 | Systematic Assessment |
| |
| Hypertension | Vascular disorders | MedDRA 14.0 | Systematic Assessment |
| |
| Nasopharyngitis | Infections and infestations | MedDRA 14.0 | Systematic Assessment |
|
Principal Investigator (PI) shall submit a copy of the Publication to Sponsor for review at least 45 days prior to its proposed submission. Sponsor reserves the right to delay any such publication for an additional period of 60 days. Upon Sponsor's request, PI agrees to delete from the proposed publication any Confidential Information. PI agrees not to release any publication without the prior written permission of Sponsor.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Maple Fung, MD | Ardea Biosciences, Inc. | 1-858-652-6721 | mfung@ardeabio.com |
| ID | Term |
|---|---|
| D006073 | Gout |
| ID | Term |
|---|---|
| D001168 | Arthritis |
| D007592 | Joint Diseases |
| 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 |
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| ID | Term |
|---|---|
| C000593471 | lesinurad |
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| Canada |
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| Germany |
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| New Zealand |
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| South Africa |
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| United States |
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