Lesinurad and Febuxostat Combination Extension Study in Gout

January 3, 2018 updated by: Ardea Biosciences, Inc.

A Long-Term Extension Study of Lesinurad in Combination With Febuxostat for Subjects With Gout Completing an Efficacy and Safety Study of Lesinurad and Febuxostat

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

This is a Phase 3 extension study to assess the long-term efficacy and safety of lesinurad in combination with febuxostat in subjects who completed the double-blind treatment period in Study RDEA594-304.

Study Type

Interventional

Enrollment (Actual)

196

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
    • New South Wales
      • Camperdown, New South Wales, Australia, 2050
    • South Australia
      • Woodville South, South Australia, Australia, 5011
    • Tasmania
      • Hobart, Tasmania, Australia, 7000
  • Canada
    • Ontario
      • Mississauga, Ontario, Canada, L5M 2V8
      • Toronto, Ontario, Canada, M9W4L6
  • New Zealand
      • Tauranga, New Zealand, 3143
    • Auckland
      • Grafton, Auckland, New Zealand, 1023
  • Poland
    • Iodzkie
      • Kutno, Iodzkie, Poland, 99-300
    • Malopolskie
      • Krakow, Malopolskie, Poland, 30-510
      • Krakow, Malopolskie, Poland, 31-501
    • Podlaskie
      • Bialystok, Podlaskie, Poland, 15-430
    • Slaskie
      • Katowice, Slaskie, Poland, 40-954
    • Swietokrzyskie
      • Konskie, Swietokrzyskie, Poland, 26-200
    • Warminsko-Mazurskie
      • Elblag, Warminsko-Mazurskie, Poland, 82-300
    • Wielkopolskie
      • Poznan, Wielkopolskie, Poland, 60-773
  • Switzerland
      • Fribourg, Switzerland, 1708
      • Fribourg, Switzerland, 1705
  • United States
    • Alabama
      • Birmingham, Alabama, United States, 35211
    • Arizona
      • Tempe, Arizona, United States, 85282
    • California
      • Glendale, California, United States, 91204
      • Huntington Beach, California, United States, 92646
      • Irvine, California, United States, 92618
      • San Diego, California, United States, 92108
    • Colorado
      • Denver, Colorado, United States, 80220
      • Englewood, Colorado, United States, 80113
    • Florida
      • Boynton Beach, Florida, United States, 33472
      • Naples, Florida, United States, 34102
      • Pembroke Pines, Florida, United States, 33027
      • Tampa, Florida, United States, 33606
      • Tampa, Florida, United States, 33614
      • Winter Haven, Florida, United States, 33880
    • Georgia
      • Johns Creek, Georgia, United States, 30097
    • Hawaii
      • Honolulu, Hawaii, United States, 96814
    • Idaho
      • Meridian, Idaho, United States, 83646
    • Illinois
      • Gurnee, Illinois, United States, 60031
      • Springfield, Illinois, United States, 62704
    • Kentucky
      • Elizabethtown, Kentucky, United States, 42701
    • Maryland
      • Frederick, Maryland, United States, 21702
    • Michigan
      • Ann Arbor, Michigan, United States, 48109
      • Southfield, Michigan, United States, 48034
    • Mississippi
      • Jackson, Mississippi, United States, 39202
      • Olive Branch, Mississippi, United States, 38654
    • Missouri
      • Jefferson City, Missouri, United States, 65109
      • Saint Louis, Missouri, United States, 63117
    • New York
      • New York, New York, United States, 10036
    • North Carolina
      • Wilmington, North Carolina, United States, 28401
    • North Dakota
      • Fargo, North Dakota, United States, 58103
    • Ohio
      • Columbus, Ohio, United States, 43203
      • Middleburg Heights, Ohio, United States, 44130
      • Wadsworth, Ohio, United States, 44281
    • Oklahoma
      • Oklahoma City, Oklahoma, United States, 73103
    • Pennsylvania
      • Belle Vernon, Pennsylvania, United States, 15012
      • Lansdale, Pennsylvania, United States, 19446
      • Pittsburgh, Pennsylvania, United States, 15206
      • Sellersville, Pennsylvania, United States, 18960
    • South Carolina
      • Columbia, South Carolina, United States, 29204
      • Mount Pleasant, South Carolina, United States, 29464
      • Spartanburg, South Carolina, United States, 29303
    • Tennessee
      • Memphis, Tennessee, United States, 38119
    • Texas
      • Austin, Texas, United States, 78705
      • Austin, Texas, United States, 78758
      • Dallas, Texas, United States, 75218
      • Houston, Texas, United States, 77074
      • San Antonio, Texas, United States, 78229
      • Sugar Land, Texas, United States, 77479
      • Victoria, Texas, United States, 77901
      • Waco, Texas, United States, 76710
    • Virginia
      • Chesapeake, Virginia, United States, 23320
      • Danville, Virginia, United States, 24541
      • Richmond, Virginia, United States, 23235
    • Washington
      • Seattle, Washington, United States, 98104
    • 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 RDEA594-304 and was actively receiving and tolerating study medication (lesinurad or placebo) and febuxostat 80 mg at the Month 12 visit.
  • 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 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.

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: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: DOUBLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: lesinurad 400 mg + febuxostat 80 mg
Patients on lesinurad 400 mg had their dose changed to lesinurad 200 mg after implementation of protocol amendment 3, dated 07 October 2015.
Drug: lesinurad
Tablets, 400 mg once daily (QD)
Drug: lesinurad
Tablets, 200 mg QD
Drug: febuxostat
Tabletsm 80 mg QD
EXPERIMENTAL: lesinurad 200 mg + febuxostat 80 mg
Drug: lesinurad
Tablets, 400 mg once daily (QD)
Drug: lesinurad
Tablets, 200 mg QD
Drug: febuxostat
Tabletsm 80 mg QD

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Percentage of Participants With an sUA Level That is < 5.0 mg/dL
Time Frame: Up to approximately 2.5 years (at Extension Month 12)
Percentage of participants in Study 307 With sUA < 5.0 mg/dL from the Core Studies 304 and Extension Study 307 - Observed Cases
Up to approximately 2.5 years (at Extension Month 12)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Percentage of Participants (With at Least One Target Tophus at Baseline) Who Experience Complete Resolution of at Least One Target Tophus
Time Frame: Up to approximatley 2.5 years (at Extension Month 12)
Percentage of participants (With at Least One Target Tophus at Baseline) Who Experience Complete Resolution of at Least One Target Tophus During the Core and Extension Studies at Extension Month 12 (Observed Cases)
Up to approximatley 2.5 years (at Extension Month 12)

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 (ACTUAL)

March 1, 2013

Primary Completion (ACTUAL)

August 9, 2016

Study Completion (ACTUAL)

October 6, 2016

Study Registration Dates

First Submitted

March 7, 2013

First Submitted That Met QC Criteria

March 7, 2013

First Posted (ESTIMATE)

March 11, 2013

Study Record Updates

Last Update Posted (ACTUAL)

January 30, 2018

Last Update Submitted That Met QC Criteria

January 3, 2018

Last Verified

January 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • RDEA594-307
  • 2012-004390-54 (EUDRACT_NUMBER)

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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