Open-Label Lesinurad Monotherapy Extension Study in Gout

April 20, 2016 updated by: Ardea Biosciences, Inc.

A Long-Term Open-Label Extension Study for Subjects Completing a Phase 3 Efficacy and Safety Study of Lesinurad Monotherapy in Subjects With Gout

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

143

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Australia
    • Queensland
      • Herston, Queensland, Australia, 4029
    • Tasmania
      • Hobart, Tasmania, Australia, 7000
  • Belgium
      • Genk, Belgium, 3600
      • Gozée, Belgium, 6534
      • Kortrijk, Belgium, 8500
      • Yvoir, Belgium, 5530
  • Canada
      • Quebec, Canada, G1V 3M7
    • Ontario
      • Toronto, Ontario, Canada, M9W 4L6
    • Quebec
      • Rimouski, Quebec, Canada, G5L 8W1
  • Germany
      • Dresden, Germany, 01069
      • Leipzig, Germany, 04109
  • New Zealand
      • Tauranga, New Zealand, 3143
    • Auckland
      • Grafton, Auckland, New Zealand, 1023
  • South Africa
      • Rondebosch, South Africa, 7700
      • Stellenbosch, South Africa, 7600
      • Thabazimbi, South Africa, 0380
    • Durban
      • Silverglen, Durban, South Africa, 4092
    • Pretoria
      • Muckleneuk, Pretoria, South Africa, 0002
  • United States
    • Alabama
      • Birmingham, Alabama, United States, 35294
      • Birmingham, Alabama, United States, 35209
      • Birmingham, Alabama, United States, 35211
    • Arizona
      • Glendale, Arizona, United States, 85308
      • Peoria, Arizona, United States, 85381
      • Tempe, Arizona, United States, 85282
    • California
      • Carmichael, California, United States, 95608
      • Covina, California, United States, 91723
      • Huntington Park, California, United States, 90255
      • Irvine, California, United States, 92618
    • Colorado
      • Colorado Springs, Colorado, United States, 80922
      • Denver, Colorado, United States, 80220
      • Denver, Colorado, United States, 80230
      • Englewood, Colorado, United States, 80113
    • Connecticut
      • Trumbill, Connecticut, United States, 06611
    • Florida
      • Boynton Beach, Florida, United States, 33472
      • Miami, Florida, United States, 33143
      • Plant City, Florida, United States, 33563
      • Tampa, Florida, United States, 33607
      • Winter Haven, Florida, United States, 33880
    • Georgia
      • Newnan, Georgia, United States, 30265
    • Hawaii
      • Honolulu, Hawaii, United States, 96814
    • Indiana
      • Meridian, Indiana, United States, 83646
    • Kentucky
      • Elizabethtown, Kentucky, United States, 42701
      • Lexington, Kentucky, United States, 40504
    • Louisiana
      • Metairie, Louisiana, United States, 70006
    • Michigan
      • Traverse City, Michigan, United States, 49684
    • Mississippi
      • Jackson, Mississippi, United States, 39202
      • Olive Branch, Mississippi, United States, 38654
    • New Mexico
      • Albuquerque, New Mexico, United States, 87106
    • New York
      • Brooklyn, New York, United States, 11201
      • New Windsor, New York, United States, 12553
      • New York, New York, United States, 10016
    • North Carolina
      • Hickory, North Carolina, United States, 28602
      • Raleigh, North Carolina, United States, 27612
      • Winston Salem, North Carolina, United States, 27103
    • North Dakota
      • Fargo, North Dakota, United States, 58103
    • Ohio
      • Cincinnati, Ohio, United States, 45242
      • Middleburg Heights, Ohio, United States, 44130
      • Perrysburg, Ohio, United States, 43551
    • Pennsylvania
      • Jenkintown, Pennsylvania, United States, 19046
      • Landsdale, Pennsylvania, United States, 19446
      • Sellersville, Pennsylvania, United States, 18960
    • South Carolina
      • Myrtle Beach, South Carolina, United States, 29588
      • Spartanburg, South Carolina, United States, 29303
    • Tennessee
      • Brentwood, Tennessee, United States, 37027
      • Spring Hill, Tennessee, United States, 37174
    • Texas
      • Dallas, Texas, United States, 75235
      • Houston, Texas, United States, 77098
    • Utah
      • Bountiful, Utah, United States, 84010
      • West Layton, Utah, United States, 84041
    • Virginia
      • Chesapeake, Virginia, United States, 23320
      • Richmond, Virginia, United States, 23235
      • Suffold, Virginia, United States, 23435
    • Washington
      • Seattle, Washington, United States, 98104
      • Spokane, Washington, United States, 99208
    • West Virginia
      • Morgantown, West Virginia, United States, 26505

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 85 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: lesinurad 400 mg
Drug: lesinurad
Tablets, 400 mg QD

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Proportion of Subjects With a Serum Urate (sUA) Level That is < 6.0 mg/dL
Time Frame: Month 1
Month 1
Incidence of Treatment-emergent Adverse Events (TEAEs)
Time Frame: Up to approximately 2 years
Up to approximately 2 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Ardea Biosciences, Inc.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2012

Primary Completion (Actual)

April 1, 2014

Study Completion (Actual)

August 1, 2014

Study Registration Dates

First Submitted

July 24, 2012

First Submitted That Met QC Criteria

July 25, 2012

First Posted (Estimate)

July 26, 2012

Study Record Updates

Last Update Posted (Estimate)

May 26, 2016

Last Update Submitted That Met QC Criteria

April 20, 2016

Last Verified

April 1, 2016

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • RDEA594-305

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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