Open-Label Lesinurad Monotherapy Extension Study in Gout

NCT01650246 | Completed Phase 3 Results DMC

• 1 other identifier: RDEA594-305
• Study Type: interventional
• Target: 143
• Locations: 7 countries
• Sites: 75

Brief Summary

This study will assess the serum uric acid lowering effects and safety of lesinurad over a long-term timeframe.

Conditions

Gout

Outcome Measures

Primary Outcomes (2)

• 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

Study Arms (1)

lesinurad 400 mg

EXPERIMENTAL

Drug: lesinurad

Interventions

lesinurad DRUG

Tablets, 400 mg QD

lesinurad 400 mg

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Subject is able to understand the study procedures and the risks involved and is willing to provide written informed consent before the first study related activity.
• Subject completed the double-blind treatment period in Study RDEA594-303 and was actively receiving and tolerating study medication (lesinurad or placebo) at Month 6 visit.
• Subject is willing to adhere to the visit/protocol schedules.
• Subject is male or female; female subjects of childbearing potential must agree to use an effective non-hormonal method of birth control during the study and for at least 14 days after the last dose of study medication.

You may not qualify if:

• Subject has any other medical or psychological condition, which in the opinion of the Investigator and/or the Medical Monitor, might create undue risk to the subject or interfere with the subject's ability to comply with the protocol requirements or to complete the study.
• Subject has a past medical history of urolithiasis, nephrolithiasis, or kidney stone diathesis.
• Subject developed kidney stones during Study RDEA594-303

Sponsors & Collaborators

• Ardea Biosciences, Inc.: lead

Study Sites (75)

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Birmingham, Alabama, 35209, United States

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Birmingham, Alabama, 35211, United States

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Birmingham, Alabama, 35294, United States

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Glendale, Arizona, 85308, United States

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Peoria, Arizona, 85381, United States

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Tempe, Arizona, 85282, United States

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Carmichael, California, 95608, United States

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Covina, California, 91723, United States

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Huntington Park, California, 90255, United States

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Irvine, California, 92618, United States

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Colorado Springs, Colorado, 80922, United States

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Denver, Colorado, 80220, United States

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Denver, Colorado, 80230, United States

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Englewood, Colorado, 80113, United States

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Trumbill, Connecticut, 06611, United States

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Boynton Beach, Florida, 33472, United States

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Miami, Florida, 33143, United States

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Plant City, Florida, 33563, United States

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Tampa, Florida, 33607, United States

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Winter Haven, Florida, 33880, United States

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Newnan, Georgia, 30265, United States

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Honolulu, Hawaii, 96814, United States

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Meridian, Indiana, 83646, United States

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Elizabethtown, Kentucky, 42701, United States

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Lexington, Kentucky, 40504, United States

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Metairie, Louisiana, 70006, United States

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Traverse City, Michigan, 49684, United States

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Jackson, Mississippi, 39202, United States

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Olive Branch, Mississippi, 38654, United States

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Albuquerque, New Mexico, 87106, United States

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Brooklyn, New York, 11201, United States

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New Windsor, New York, 12553, United States

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New York, New York, 10016, United States

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Hickory, North Carolina, 28602, United States

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Raleigh, North Carolina, 27612, United States

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Winston-Salem, North Carolina, 27103, United States

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Fargo, North Dakota, 58103, United States

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Cincinnati, Ohio, 45242, United States

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Middleburg Heights, Ohio, 44130, United States

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Perrysburg, Ohio, 43551, United States

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Jenkintown, Pennsylvania, 19046, United States

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Landsdale, Pennsylvania, 19446, United States

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Sellersville, Pennsylvania, 18960, United States

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Myrtle Beach, South Carolina, 29588, United States

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Spartanburg, South Carolina, 29303, United States

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Brentwood, Tennessee, 37027, United States

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Spring Hill, Tennessee, 37174, United States

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Dallas, Texas, 75235, United States

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Houston, Texas, 77098, United States

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Bountiful, Utah, 84010, United States

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West Layton, Utah, 84041, United States

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Chesapeake, Virginia, 23320, United States

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Richmond, Virginia, 23235, United States

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Suffold, Virginia, 23435, United States

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Seattle, Washington, 98104, United States

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Spokane, Washington, 99208, United States

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Morgantown, West Virginia, 26505, United States

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Herston, Queensland, 4029, Australia

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Hobart, Tasmania, 7000, Australia

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Genk, 3600, Belgium

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Gozée, 6534, Belgium

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Kortrijk, 8500, Belgium

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Yvoir, 5530, Belgium

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Toronto, Ontario, M9W 4L6, Canada

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Québec, Quebec, G1V 3M7, Canada

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Rimouski, Quebec, G5L 8W1, Canada

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Dresden, 01069, Germany

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Leipzig, 04109, Germany

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Grafton, Auckland, 1023, New Zealand

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Tauranga, 3143, New Zealand

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Silverglen, Durban, 4092, South Africa

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Muckleneuk, Pretoria, 0002, South Africa

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Rondebosch, 7700, South Africa

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Stellenbosch, 7600, South Africa

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Thabazimbi, 0380, South Africa

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MeSH Terms

Conditions

Gout

Interventions

lesinurad

Condition Hierarchy (Ancestors)

Arthritis; Joint Diseases; Musculoskeletal Diseases; Crystal Arthropathies; Rheumatic Diseases; Purine-Pyrimidine Metabolism, Inborn Errors; Metabolism, Inborn Errors; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Metabolic Diseases; Nutritional and Metabolic Diseases

Results Point of Contact

• Title: Maple Fung, MD
• Organization: Ardea Biosciences, Inc.

mfung@ardeabio.com

1-858-652-6721

Study Officials

• Chris Storgard, MD

  Ardea Biosciences, Inc.

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 24, 2012
• First Posted: July 26, 2012
• Study Start: August 1, 2012
• Primary Completion: April 1, 2014
• Study Completion: August 1, 2014
• Last Updated: May 26, 2016
• Results First Posted: May 26, 2016

Record last verified: 2016-04

Locations

DE (2); US (57); NZ (2); ZA (5); BE (4); AU (2); CA (3)