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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/NCT01650246




Registration number
NCT01650246
Ethics application status
Date submitted
24/07/2012
Date registered
26/07/2012
Date last updated
26/05/2016

Titles & IDs
Public title
Open-Label Lesinurad Monotherapy Extension Study in Gout
Scientific 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
Secondary ID [1] 0 0
RDEA594-305
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Gout 0 0
Condition category
Condition code
Musculoskeletal 0 0 0 0
Other muscular and skeletal disorders
Inflammatory and Immune System 0 0 0 0
Other inflammatory or immune system disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - lesinurad

Experimental: lesinurad 400 mg -


Treatment: Drugs: lesinurad
Tablets, 400 mg QD
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Proportion of Subjects With a Serum Urate (sUA) Level That is < 6.0 mg/dL
Timepoint [1] 0 0
Month 1
Primary outcome [2] 0 0
Incidence of Treatment-emergent Adverse Events (TEAEs)
Timepoint [2] 0 0
Up to approximately 2 years

Eligibility
Key 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.
Minimum age
18 Years
Maximum age
85 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key 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

Study design
Purpose of the study
Treatment
Allocation to intervention
N/A
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Phase 3
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/08/2012
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/08/2014
Sample size
Target
Accrual to date
Final
143
Recruitment in Australia
Recruitment state(s)
QLD,TAS
Recruitment hospital [1] 0 0
- Herston
Recruitment hospital [2] 0 0
- Hobart
Recruitment postcode(s) [1] 0 0
4029 - Herston
Recruitment postcode(s) [2] 0 0
7000 - Hobart
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Alabama
Country [2] 0 0
United States of America
State/province [2] 0 0
Arizona
Country [3] 0 0
United States of America
State/province [3] 0 0
California
Country [4] 0 0
United States of America
State/province [4] 0 0
Colorado
Country [5] 0 0
United States of America
State/province [5] 0 0
Connecticut
Country [6] 0 0
United States of America
State/province [6] 0 0
Florida
Country [7] 0 0
United States of America
State/province [7] 0 0
Georgia
Country [8] 0 0
United States of America
State/province [8] 0 0
Hawaii
Country [9] 0 0
United States of America
State/province [9] 0 0
Indiana
Country [10] 0 0
United States of America
State/province [10] 0 0
Kentucky
Country [11] 0 0
United States of America
State/province [11] 0 0
Louisiana
Country [12] 0 0
United States of America
State/province [12] 0 0
Michigan
Country [13] 0 0
United States of America
State/province [13] 0 0
Mississippi
Country [14] 0 0
United States of America
State/province [14] 0 0
New Mexico
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United States of America
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New York
Country [16] 0 0
United States of America
State/province [16] 0 0
North Carolina
Country [17] 0 0
United States of America
State/province [17] 0 0
North Dakota
Country [18] 0 0
United States of America
State/province [18] 0 0
Ohio
Country [19] 0 0
United States of America
State/province [19] 0 0
Pennsylvania
Country [20] 0 0
United States of America
State/province [20] 0 0
South Carolina
Country [21] 0 0
United States of America
State/province [21] 0 0
Tennessee
Country [22] 0 0
United States of America
State/province [22] 0 0
Texas
Country [23] 0 0
United States of America
State/province [23] 0 0
Utah
Country [24] 0 0
United States of America
State/province [24] 0 0
Virginia
Country [25] 0 0
United States of America
State/province [25] 0 0
Washington
Country [26] 0 0
United States of America
State/province [26] 0 0
West Virginia
Country [27] 0 0
Belgium
State/province [27] 0 0
Genk
Country [28] 0 0
Belgium
State/province [28] 0 0
Gozée
Country [29] 0 0
Belgium
State/province [29] 0 0
Kortrijk
Country [30] 0 0
Belgium
State/province [30] 0 0
Yvoir
Country [31] 0 0
Canada
State/province [31] 0 0
Ontario
Country [32] 0 0
Canada
State/province [32] 0 0
Quebec
Country [33] 0 0
Germany
State/province [33] 0 0
Dresden
Country [34] 0 0
Germany
State/province [34] 0 0
Leipzig
Country [35] 0 0
New Zealand
State/province [35] 0 0
Auckland
Country [36] 0 0
New Zealand
State/province [36] 0 0
Tauranga
Country [37] 0 0
South Africa
State/province [37] 0 0
Durban
Country [38] 0 0
South Africa
State/province [38] 0 0
Pretoria
Country [39] 0 0
South Africa
State/province [39] 0 0
Rondebosch
Country [40] 0 0
South Africa
State/province [40] 0 0
Stellenbosch
Country [41] 0 0
South Africa
State/province [41] 0 0
Thabazimbi

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
Ardea Biosciences, Inc.
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
This study will assess the serum uric acid lowering effects and safety of lesinurad over a
long-term timeframe.
Trial website
https://clinicaltrials.gov/ct2/show/NCT01650246
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Chris Storgard, MD
Address 0 0
Ardea Biosciences, Inc.
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/ct2/show/NCT01650246