GoutPhase 3NCT01808144
Lesinurad and Febuxostat Combination Extension Study in Gout
A Phase 3 study testing lesinurad and febuxostat in people with Gout, run by Ardea Biosciences, Inc. at 72 sites in 6 countries.
Trial summary
This study will assess the serum uric acid lowering effects and safety of lesinurad in combination with febuxostat over a long-term timeframe. Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Gout
- What is being tested?
- lesinurad and febuxostat
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 196 participants
- Where
- 72 sitesin 6 countries
- Study dates
- 1 Mar 2013to 6 Oct 2016
- Phase
- Phase 3
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
72 sites in 6 countries.
72 sites in 6 countries
United States55 sites
Study site
Ann Arbor, Michigan, 48109
Study site
Austin, Texas, 78705
Study site
Austin, Texas, 78758
Study site
Belle Vernon, Pennsylvania, 15012
Study site
Birmingham, Alabama, 35211
Study site
Boynton Beach, Florida, 33472
Study site
Chesapeake, Virginia, 23320
Study site
Columbia, South Carolina, 29204
Study site
Columbus, Ohio, 43203
Study site
Dallas, Texas, 75218
Study site
Danville, Virginia, 24541
Study site
Denver, Colorado, 80220
Study site
Elizabethtown, Kentucky, 42701
Study site
Englewood, Colorado, 80113
Study site
Fargo, North Dakota, 58103
Study site
Frederick, Maryland, 21702
Study site
Glendale, California, 91204
Study site
Gurnee, Illinois, 60031
Study site
Honolulu, Hawaii, 96814
Study site
Houston, Texas, 77074
Study site
Huntington Beach, California, 92646
Study site
Irvine, California, 92618
Study site
Jackson, Mississippi, 39202
Study site
Jefferson City, Missouri, 65109
Study site
Johns Creek, Georgia, 30097
Study site
Lansdale, Pennsylvania, 19446
Study site
Memphis, Tennessee, 38119
Study site
Meridian, Idaho, 83646
Study site
Middleburg Heights, Ohio, 44130
Study site
Morgantown, West Virginia, 26505
Study site
Mt. Pleasant, South Carolina, 29464
Study site
Naples, Florida, 34102
Study site
New York, New York, 10036
Study site
Oklahoma City, Oklahoma, 73103
Study site
Olive Branch, Mississippi, 38654
Study site
Pembroke Pines, Florida, 33027
Study site
Pittsburgh, Pennsylvania, 15206
Study site
Richmond, Virginia, 23235
Study site
San Antonio, Texas, 78229
Study site
San Diego, California, 92108
Study site
Seattle, Washington, 98104
Study site
Sellersville, Pennsylvania, 18960
Study site
Southfield, Michigan, 48034
Study site
Spartanburg, South Carolina, 29303
Study site
Springfield, Illinois, 62704
Study site
St Louis, Missouri, 63117
Study site
Sugar Land, Texas, 77479
Study site
Tampa, Florida, 33606
Study site
Tampa, Florida, 33614
Study site
Tempe, Arizona, 85282
Study site
Victoria, Texas, 77901
Study site
Waco, Texas, 76710
Study site
Wadsworth, Ohio, 44281
Study site
Wilmington, North Carolina, 28401
Study site
Winter Haven, Florida, 33880
Poland8 sites
Study site
Bialystok, Podlaskie Voivodeship, 15-430
Study site
Elblag, Warmian-Masurian Voivodeship, 82-300
Study site
Gmina Końskie, Świętokrzyskie Voivodeship, 26-200
Study site
Katowice, Silesian Voivodeship, 40-954
Study site
Krakow, Lesser Poland Voivodeship, 30-510
Study site
Krakow, Lesser Poland Voivodeship, 31-501
Study site
Kutno, Iodzkie, 99-300
Study site
Poznan, Greater Poland Voivodeship, 60-773
Australia3 sites
Study site
Camperdown, New South Wales, 2050
Study site
Hobart, Tasmania, 7000
Study site
Woodville South, South Australia, 5011
Canada2 sites
Study site
Mississauga, Ontario, L5M 2V8
Study site
Toronto, Ontario, M9W4L6
New Zealand2 sites
Study site
Grafton, Auckland, 1023
Study site
Tauranga, 3143
About this study
Official title: 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.
Read the 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.
- Conditions
- Gout
- Being tested
- lesinurad, febuxostat
- Keywords
- Gout
- Medical subject headings
- Gout
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
lesinuradDrug
Tablets, 400 mg once daily (QD)
lesinuradDrug
Tablets, 200 mg QD
febuxostatDrug
Tabletsm 80 mg QD
| Study group | Role | What they receive |
|---|---|---|
| lesinurad 400 mg + febuxostat 80 mg | Experimental | Patients on lesinurad 400 mg had their dose changed to lesinurad 200 mg after implementation of protocol amendment 3, dated 07 October 2015. Receives: Drug: lesinurad; Drug: febuxostat |
| lesinurad 200 mg + febuxostat 80 mg | Experimental | Not described Receives: Drug: lesinurad; Drug: febuxostat |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of Participants With an sUA Level That is < 5.0 mg/dL
Percentage of participants in Study 307 With sUA < 5.0 mg/dL from the Core Studies 304 and Extension Study 307 - Observed Cases
Measured: Up to approximately 2.5 years (at Extension Month 12)
Secondary outcomes (1)
Percentage of Participants (With at Least One Target Tophus at Baseline) Who Experience Complete Resolution of at Least One Target Tophus
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)
Measured: Up to approximatley 2.5 years (at Extension Month 12)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Mar 2013 (estimated)
- Study start1 Mar 2013
- Primary completion9 Aug 2016
- Study completion6 Oct 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for GoutStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 196 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ardea Biosciences, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Nihar Bhakta, MD, Study director, Ardea Biosciences, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01808144
- Sponsor's protocol ID
- RDEA594-307
- Other IDs
- 2012-004390-54
- Status last verified
- Jan 2018
- First submitted
- 7 Mar 2013
- Last updated
- 30 Jan 2018
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 30 Jan 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT01808144
- Acronym / sponsor ID
- RDEA594-307
- Conditions
- Gout
- Keywords
- Gout
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 196 participants (actual)
- Lead sponsor
- Ardea Biosciences, Inc.Industry (pharma, biotech, devices)
- Study start
- 1 Mar 2013 (actual)
- Primary completion
- 9 Aug 2016 (actual)
- Study completion
- 6 Oct 2016 (actual)
- First posted
- 11 Mar 2013 (estimated)
- Results
- Posted 30 Jan 2018
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study will assess the serum uric acid lowering effects and safety of lesinurad in combination with febuxostat over a long-term timeframe.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| lesinurad 400 mg + febuxostat 80 mg | Experimental | Drug: lesinurad, Drug: febuxostatPatients on lesinurad 400 mg had their dose changed to lesinurad 200 mg after implementation of protocol amendment 3, dated 07 October 2015. |
| lesinurad 200 mg + febuxostat 80 mg | Experimental | Drug: lesinurad, Drug: febuxostat |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (1 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| lesinuradTablets, 400 mg once daily (QD) | Drug | lesinurad 400 mg + febuxostat 80 mg |
| lesinuradTablets, 200 mg QD | Drug | lesinurad 200 mg + febuxostat 80 mg |
| febuxostatTabletsm 80 mg QD | Drug | lesinurad 200 mg + febuxostat 80 mg, lesinurad 400 mg + febuxostat 80 mg |
Primary outcome
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
1 secondary outcome
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)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Jan 2018.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Nihar Bhakta, MD study director
Ardea Biosciences, Inc.
72 sites in 6 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing lesinurad and febuxostat in people with Gout, run by Ardea Biosciences, Inc. at 72 sites in 6 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 30 Jan 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 72 sites in United States, Poland, Australia, Canada, New Zealand and 1 more country. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 30 Jan 2018). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Jan 2018.