Clinical trial NCT01650246: Open-Label Lesinurad Monotherapy Extension Study in Gout
Official title: A Long-Term Open-Label Extension Study for Subjects Completing a Phase 3 Efficacy and Safety Study of Lesinurad Monotherapy in Subjects With Gout
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Gout
Lead sponsor: Ardea Biosciences, Inc.
Sponsor class: INDUSTRY
First posted: 2012-07-26
Enrollment: 143
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

* 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.

Exclusion Criteria:

* 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

Primary outcomes:
measure: Proportion of Subjects With a Serum Urate (sUA) Level That is < 6.0 mg/dL
timeFrame: Month 1
measure: Incidence of Treatment-emergent Adverse Events (TEAEs)
timeFrame: Up to approximately 2 years
Secondary outcomes:
Other outcomes:
Locations:
city: Birmingham
country: United States
state: Alabama
city: Birmingham
country: United States
state: Alabama
city: Birmingham
country: United States
state: Alabama
city: Glendale
country: United States
state: Arizona
city: Peoria
country: United States
state: Arizona
city: Tempe
country: United States
state: Arizona
city: Carmichael
country: United States
state: California
city: Covina
country: United States
state: California
city: Huntington Park
country: United States
state: California
city: Irvine
country: United States
state: California
city: Colorado Springs
country: United States
state: Colorado
city: Denver
country: United States
state: Colorado
city: Denver
country: United States
state: Colorado
city: Englewood
country: United States
state: Colorado
city: Trumbill
country: United States
state: Connecticut
city: Boynton Beach
country: United States
state: Florida
city: Miami
country: United States
state: Florida
city: Plant City
country: United States
state: Florida
city: Tampa
country: United States
state: Florida
city: Winter Haven
country: United States
state: Florida
city: Newnan
country: United States
state: Georgia
city: Honolulu
country: United States
state: Hawaii
city: Meridian
country: United States
state: Indiana
city: Elizabethtown
country: United States
state: Kentucky
city: Lexington
country: United States
state: Kentucky
city: Metairie
country: United States
state: Louisiana
city: Traverse City
country: United States
state: Michigan
city: Jackson
country: United States
state: Mississippi
city: Olive Branch
country: United States
state: Mississippi
city: Albuquerque
country: United States
state: New Mexico
city: Brooklyn
country: United States
state: New York
city: New Windsor
country: United States
state: New York
city: New York
country: United States
state: New York
city: Hickory
country: United States
state: North Carolina
city: Raleigh
country: United States
state: North Carolina
city: Winston Salem
country: United States
state: North Carolina
city: Fargo
country: United States
state: North Dakota
city: Cincinnati
country: United States
state: Ohio
city: Middleburg Heights
country: United States
state: Ohio
city: Perrysburg
country: United States
state: Ohio
city: Jenkintown
country: United States
state: Pennsylvania
city: Landsdale
country: United States
state: Pennsylvania
city: Sellersville
country: United States
state: Pennsylvania
city: Myrtle Beach
country: United States
state: South Carolina
city: Spartanburg
country: United States
state: South Carolina
city: Brentwood
country: United States
state: Tennessee
city: Spring Hill
country: United States
state: Tennessee
city: Dallas
country: United States
state: Texas
city: Houston
country: United States
state: Texas
city: Bountiful
country: United States
state: Utah
city: West Layton
country: United States
state: Utah
city: Chesapeake
country: United States
state: Virginia
city: Richmond
country: United States
state: Virginia
city: Suffold
country: United States
state: Virginia
city: Seattle
country: United States
state: Washington
city: Spokane
country: United States
state: Washington
city: Morgantown
country: United States
state: West Virginia
city: Herston
country: Australia
state: Queensland
city: Hobart
country: Australia
state: Tasmania
city: Genk
country: Belgium
city: Gozée
country: Belgium
city: Kortrijk
country: Belgium
city: Yvoir
country: Belgium
city: Toronto
country: Canada
state: Ontario
city: Rimouski
country: Canada
state: Quebec
city: Quebec
country: Canada
city: Dresden
country: Germany
city: Leipzig
country: Germany
city: Grafton
country: New Zealand
state: Auckland
city: Tauranga
country: New Zealand
city: Silverglen
country: South Africa
state: Durban
city: Muckleneuk
country: South Africa
state: Pretoria
city: Rondebosch
country: South Africa
city: Stellenbosch
country: South Africa
city: Thabazimbi
country: South Africa
Study officials:
affiliation: Ardea Biosciences, Inc.
name: Chris Storgard, MD
role: STUDY_DIRECTOR
References: