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Completed

NCT Number: NCT01650246

Open-Label Lesinurad Monotherapy Extension Study in Gout

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

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Key information

Conditions

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

Age range

18 year–85 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Herston, Queensland, Australia

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

lesinurad

Drug

Tablets, 400 mg QD

Primary outcomes

  1. Proportion of Subjects With a Serum Urate (sUA) Level That is < 6.0 mg/dL

    Time frame: Month 1

  2. Incidence of Treatment-emergent Adverse Events (TEAEs)

    Time frame: Up to approximately 2 years

Sponsors and collaborators

Lead sponsor

Ardea Biosciences, Inc.

Industry

Registry information

Official study 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

Important dates

Study start
2012
Primary completion
2014
Study completion
2014
First posted
Jul 26, 2012
Registry last updated
May 26, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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