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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
196

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
March 1, 2013

Primary Completion (ACTUAL)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
August 9, 2016

Study Completion (ACTUAL)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
October 6, 2016

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
March 7, 2013

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 7, 2013

First Posted (ESTIMATE)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
March 11, 2013

Study Record Updates

Last Update Posted (ACTUAL)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
January 30, 2018

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 3, 2018

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
January 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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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