Lesinurad and Allopurinol Combination Extension Study in Gout

January 23, 2017 updated by: Ardea Biosciences, Inc.

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

This study will assess the serum uric acid lowering effects and safety of lesinurad in combination with allopurinol 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 allopurinol in subjects who completed the double-blind treatment period in Studies RDEA594-301 and RDEA594-302.

Study Type

Interventional

Enrollment (Actual)

717

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
      • Brisbane, Australia, QLD 4152
      • Woodville South, Australia, 5011
    • Queensland
      • Herston, Queensland, Australia, 4029
    • Victoria
      • Clayton, Victoria, Australia, 3168
      • Heidelberg West, Victoria, Australia, 3081
  • Belgium
      • Genk, Belgium, 3600
      • Kortrijk, Belgium, 8500
      • Lommel, Belgium, 3920
      • Yvoir, Belgium, 5530
  • Canada
    • British Columbia
      • Coquitlam, British Columbia, Canada, V3K 3P4
      • Penticton, British Columbia, Canada, V2A 5C8
    • Ontario
      • Kitchener, Ontario, Canada, N2M 5N6
      • London, Ontario, Canada, N6A 5R8
      • Toronto, Ontario, Canada, M9W4L6
    • Quebec
      • Québec City, Quebec, Canada, G1V 3M7
  • Germany
    • Bayern
      • Eichstätt, Bayern, Germany, 85072
    • Nordrhein-Westfalen
      • Goch, Nordrhein-Westfalen, Germany, 47574
    • Sachsen
      • Dresden, Sachsen, Germany, 01307
      • Dresden, Sachsen, Germany, 01069
      • Kamenz, Sachsen, Germany, 01917
      • Leipzig, Sachsen, Germany, 04109
  • New Zealand
      • Birkinhead, New Zealand, 0626
      • Hamilton, New Zealand, 3204
      • Rotorua, New Zealand, 3010
      • Tauranga, New Zealand, 3143
    • Auckland
      • Grafton, Auckland, New Zealand, 1023
      • Otahuhu, Auckland, New Zealand, 2025
    • Christchurch
      • Beckenham, Christchurch, New Zealand, 8024
  • Poland
      • Warminsko-mazurskie, Poland, 82-300
      • Warszawa, Poland, 01-192
    • Malopolskie
      • Krakow, Malopolskie, Poland, 30-510
    • Slaskie
      • Katowice, Slaskie, Poland, 40-954
    • Swietokrzyskie
      • Konskie, Swietokrzyskie, Poland, 26-200
    • Wielkopolskie
      • Poznan, Wielkopolskie, Poland, 60-773
  • South Africa
      • Durban, South Africa, 4001
      • Paarl, South Africa, 7646
      • Rondebosch, South Africa, 7700
      • Stellenbosch, South Africa, 7600
      • Witbank, South Africa, 1035
      • Worcester, South Africa, 6850
    • Durban
      • Newlands, Durban, South Africa, 4037
      • Silverglen, Durban, South Africa, 4092
    • Johannesburg
      • Newtown, Johannesburg, South Africa, 2113
      • Parktown, Johannesburg, South Africa, 2193
      • Radiokop, Johannesburg, South Africa, 1724
      • Sowento, Johannesburg, South Africa, 1804
    • Limpopo
      • Thabazimbi, Limpopo, South Africa, 0380
    • Pretoria
      • Muckleneuk, Pretoria, South Africa, 0002
  • Spain
      • La Coruna, Spain, 15006
    • Badajoz
      • Merida, Badajoz, Spain, 06800
  • Switzerland
    • Vaud
      • Lausanne, Vaud, Switzerland, CH-1011
  • Ukraine
      • Kharkiv, Ukraine, 61176
      • Kharkiv, Ukraine, 61157
      • Kyiv, Ukraine, 01680
      • Poltava, Ukraine, 36011
      • Vinnytsia, Ukraine, 21018
  • United States
    • Alabama
      • Birmingham, Alabama, United States, 35294
      • Birmingham, Alabama, United States, 35235
      • Birmingham, Alabama, United States, 35213
      • Gulf Shores, Alabama, United States, 36542
      • Pinson, Alabama, United States, 35126
    • Arizona
      • Glendale, Arizona, United States, 85308
      • Mesa, Arizona, United States, 85203
      • Peoria, Arizona, United States, 85381
    • Arkansas
      • Little Rock, Arkansas, United States, 72211
      • Little Rock, Arkansas, United States, 72223
      • Little Rock, Arkansas, United States, 72206
    • California
      • Anaheim, California, United States, 92805
      • Gold River, California, United States, 95670
      • Irvine, California, United States, 92618
      • Roseville, California, United States, 95661
      • Sacramento, California, United States, 95825
      • San Diego, California, United States, 92108
      • San Leandro, California, United States, 94578
      • San Ramon, California, United States, 94582
    • Colorado
      • Colorado Springs, Colorado, United States, 80922
      • Colorado Springs, Colorado, United States, 80918
      • Denver, Colorado, United States, 80220
      • Englewood, Colorado, United States, 80113
    • Florida
      • Brandon, Florida, United States, 33511
      • Brooksville, Florida, United States, 34601
      • Jacksonville, Florida, United States, 32205
      • Jupiter, Florida, United States, 33458
      • Miami, Florida, United States, 33186
      • Miami, Florida, United States, 33125
      • Miami, Florida, United States, 33169
      • Ocala, Florida, United States, 34474
      • Pembroke Pines, Florida, United States, 33027
      • Plant City, Florida, United States, 33563
      • Port Orange, Florida, United States, 32127
      • Tampa, Florida, United States, 33607
      • Tampa, Florida, United States, 33634
      • Vero Beach, Florida, United States, 32960
    • Georgia
      • Atlanta, Georgia, United States, 30308
      • Atlanta, Georgia, United States, 30328
      • Augusta, Georgia, United States, 30909
      • Conyers, Georgia, United States, 30013
      • Johns Creek, Georgia, United States, 30097
      • Roswell, Georgia, United States, 30075
      • Savannah, Georgia, United States, 31406
    • Hawaii
      • Honolulu, Hawaii, United States, 96814
    • Idaho
      • Idaho Falls, Idaho, United States, 83404
      • Meridian, Idaho, United States, 83642
      • Meridian, Idaho, United States, 83646
    • Illinois
      • Gurnee, Illinois, United States, 60031
    • Iowa
      • Cedar Rapids, Iowa, United States, 52403
    • Kentucky
      • Elizabethtown, Kentucky, United States, 42701
      • Lexington, Kentucky, United States, 40503
      • Paducah, Kentucky, United States, 42003
    • Louisiana
      • Metairie, Louisiana, United States, 70006
      • Metairie, Louisiana, United States, 70002
      • Natchitoches, Louisiana, United States, 71457
    • Maryland
      • Cumberland, Maryland, United States, 21502
    • Massachusetts
      • Worcester, Massachusetts, United States, 01605
    • Michigan
      • Ann Arbor, Michigan, United States, 48109
      • Flint, Michigan, United States, 48504
      • Kalamazoo, Michigan, United States, 49009
      • Southfield, Michigan, United States, 48034
      • Traverse City, Michigan, United States, 49684
    • Missouri
      • Hazelwood, Missouri, United States, 63042
      • Jefferson City, Missouri, United States, 65109
      • Kansas City, Missouri, United States, 64114
      • Saint Louis, Missouri, United States, 63117
      • St. Louis, Missouri, United States, 63117
      • Washington, Missouri, United States, 63090
    • Nebraska
      • Omaha, Nebraska, United States, 68114
    • Nevada
      • Reno, Nevada, United States, 89502
    • New Mexico
      • Albuquerque, New Mexico, United States, 87106
    • New York
      • Brooklyn, New York, United States, 11201
      • Hartsdale, New York, United States, 10530
      • New York, New York, United States, 10036
    • North Carolina
      • Calabash, North Carolina, United States, 28467
      • Charlotte, North Carolina, United States, 28210
      • Greensboro, North Carolina, United States, 27405
      • Hickory, North Carolina, United States, 28602
      • Raleigh, North Carolina, United States, 27609
      • Shelby, North Carolina, United States, 28150
      • Shelby, North Carolina, United States, 28152
      • Wilmington, North Carolina, United States, 28401
      • Winston-Salem, North Carolina, United States, 27103
    • North Dakota
      • Fargo, North Dakota, United States, 58103
    • Ohio
      • Cincinnati, Ohio, United States, 45242
      • Cincinnati, Ohio, United States, 45224
      • Cleveland, Ohio, United States, 44122
      • Colombus, Ohio, United States, 43235
      • Dayton, Ohio, United States, 45417
      • Dayton, Ohio, United States, 45424
      • Franklin, Ohio, United States, 45005
      • Middleburg Heights, Ohio, United States, 44130
      • Perrysburg, Ohio, United States, 43551
      • Willoughby Hills, Ohio, United States, 44094
    • Oklahoma
      • Oklahoma City, Oklahoma, United States, 73103
      • Tulsa, Oklahoma, United States, 74104
    • Oregon
      • Portland, Oregon, United States, 97220
    • Pennsylvania
      • Altoona, Pennsylvania, United States, 16602
      • Clairton, Pennsylvania, United States, 15025
      • Duncansville, Pennsylvania, United States, 16635
      • Indiana, Pennsylvania, United States, 15701
      • Jenkintown, Pennsylvania, United States, 19046
      • McMurray, Pennsylvania, United States, 15317
      • Pittsburgh, Pennsylvania, United States, 15206
      • Scottdale, Pennsylvania, United States, 15683
    • South Carolina
      • Columbia, South Carolina, United States, 29204
      • Mount Pleasant, South Carolina, United States, 29464
      • Myrtle Beach, South Carolina, United States, 29588
      • Rock Hill, South Carolina, United States, 29732
      • Spartanburg, South Carolina, United States, 29303
      • Union, South Carolina, United States, 29379
    • Tennessee
      • Knoxville, Tennessee, United States, 37923
      • Knoxville, Tennessee, United States, 37919
      • Memphis, Tennessee, United States, 38119
      • Spring Hill, Tennessee, United States, 37174
    • Texas
      • Austin, Texas, United States, 78758
      • Dallas, Texas, United States, 75218
      • Fort Worth, Texas, United States, 76135
      • Houston, Texas, United States, 77074
      • Houston, Texas, United States, 77099
      • Houston, Texas, United States, 77062
      • Houston, Texas, United States, 77043
      • Irving, Texas, United States, 75061
      • Kingwood, Texas, United States, 77339
      • Nassau Bay, Texas, United States, 77058
      • Plano, Texas, United States, 75024
      • Plano, Texas, United States, 75075
      • San Angelo, Texas, United States, 76904
      • San Antonio, Texas, United States, 78229
      • San Antonio, Texas, United States, 78215
      • San Antonio, Texas, United States, 78209
      • Sealy, Texas, United States, 77474
      • Sugar Land, Texas, United States, 77479
      • Waco, Texas, United States, 76710
    • Utah
      • Bountiful, Utah, United States, 84010
      • Layton, Utah, United States, 84041
      • Salt Lake City, Utah, United States, 84102
      • West Jordan, Utah, United States, 84088
    • Virginia
      • Danville, Virginia, United States, 24541
      • Manassas, Virginia, United States, 20110
      • Midlothian, Virginia, United States, 23114
      • Richmond, Virginia, United States, 23235
      • Richmond, Virginia, United States, 23219
      • Richmond, Virginia, United States, 23233
      • Virginia Beach, Virginia, United States, 23462
    • Washington
      • Olympia, Washington, United States, 98502
      • Seattle, Washington, United States, 98104
      • Spokane, Washington, United States, 99208
      • Tacoma, Washington, United States, 98405
    • West Virginia
      • Morgantown, West Virginia, United States, 26505
    • Wisconsin
      • Milwaukee, Wisconsin, United States, 53226

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 either Study RDEA594-301 or RDEA594-302 and was actively receiving and tolerating study medication (lesinurad or placebo) and allopurinol 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

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 Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: lesinurad 200 mg + allopurinol
Drug: Lesinurad
Tablets, 200 mg QD
Drug: Lesinurad
Tablets, 400 mg QD
Experimental: lesinurad 400 mg + allopurinol
Patients on lesinurad 400 mg had their dose changed to lesinurad 200 mg after implementation of protocol amendment 4, dated 07 October 2015.
Drug: Lesinurad
Tablets, 200 mg QD
Drug: Lesinurad
Tablets, 400 mg QD

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Proportion of subjects with an sUA level that is < 6.0 mg/dL
Time Frame: up to a total of 5 years
up to a total of 5 years

Secondary Outcome Measures

Outcome Measure
Time Frame
Resolution of at least 1 target tophi
Time Frame: Up to Month 12
Up to 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

February 1, 2013

Primary Completion (Actual)

August 1, 2016

Study Completion (Actual)

November 1, 2016

Study Registration Dates

First Submitted

March 7, 2013

First Submitted That Met QC Criteria

March 8, 2013

First Posted (Estimate)

March 11, 2013

Study Record Updates

Last Update Posted (Estimate)

January 24, 2017

Last Update Submitted That Met QC Criteria

January 23, 2017

Last Verified

January 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • RDEA594-306
  • 2012-004389-16 (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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