Open-Label Lesinurad Monotherapy Extension Study in Gout

Phase 3

Completed

• Conditions: Gout
• Interventions: Drug: lesinurad

• Registration Number: NCT01650246
• Lead Sponsor: Ardea Biosciences, Inc.

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.

Study Timeline

• Study First Submitted: 2012-07-24
• Study First Submitted QC: 2012-07-25
• Study First Posted: 2012-07-26
• Study Start: 2012-08
• Primary Completion: 2014-04
• Study Completion: 2014-08
• Disposition First Submitted: 2015-03-23
• Disposition First Submitted QC: 2015-03-23
• Disposition First Posted: 2015-04-10
• Results First Submitted: 2016-01-14
• Status Verified: 2016-04
• Results First Submitted QC: 2016-04-20
• Last Update Submitted: 2016-04-20
• Results First Posted: 2016-05-26
• Last Update Posted: 2016-05-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 143

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
lesinurad 400 mg	lesinurad	-

Primary Outcome Measures

Name	Time	Method
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