GoutPhase 3NCT01650246
Open-Label Lesinurad Monotherapy Extension Study in Gout
A Phase 3 study testing lesinurad in people with Gout, run by Ardea Biosciences, Inc. at 75 sites in 7 countries.
Trial summary
This study will assess the serum uric acid lowering effects and safety of lesinurad 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
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 143 participants
- Where
- 75 sitesin 7 countries
- Study dates
- Aug 2012to Aug 2014
- 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 RDEA594-303 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.
Who cannot join
- 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
Trial locations and contacts
75 sites in 7 countries.
75 sites in 7 countries
United States57 sites
Study site
Albuquerque, New Mexico, 87106
Study site
Birmingham, Alabama, 35209
Study site
Birmingham, Alabama, 35211
Study site
Birmingham, Alabama, 35294
Study site
Bountiful, Utah, 84010
Study site
Boynton Beach, Florida, 33472
Study site
Brentwood, Tennessee, 37027
Study site
Brooklyn, New York, 11201
Study site
Carmichael, California, 95608
Study site
Chesapeake, Virginia, 23320
Study site
Cincinnati, Ohio, 45242
Study site
Colorado Springs, Colorado, 80922
Study site
Covina, California, 91723
Study site
Dallas, Texas, 75235
Study site
Denver, Colorado, 80220
Study site
Denver, Colorado, 80230
Study site
Elizabethtown, Kentucky, 42701
Study site
Englewood, Colorado, 80113
Study site
Fargo, North Dakota, 58103
Study site
Glendale, Arizona, 85308
Study site
Hickory, North Carolina, 28602
Study site
Honolulu, Hawaii, 96814
Study site
Houston, Texas, 77098
Study site
Huntington Park, California, 90255
Study site
Irvine, California, 92618
Study site
Jackson, Mississippi, 39202
Study site
Jenkintown, Pennsylvania, 19046
Study site
Landsdale, Pennsylvania, 19446
Study site
Lexington, Kentucky, 40504
Study site
Meridian, Indiana, 83646
Study site
Metairie, Louisiana, 70006
Study site
Miami, Florida, 33143
Study site
Middleburg Heights, Ohio, 44130
Study site
Morgantown, West Virginia, 26505
Study site
Myrtle Beach, South Carolina, 29588
Study site
New Windsor, New York, 12553
Study site
New York, New York, 10016
Study site
Newnan, Georgia, 30265
Study site
Olive Branch, Mississippi, 38654
Study site
Peoria, Arizona, 85381
Study site
Perrysburg, Ohio, 43551
Study site
Plant City, Florida, 33563
Study site
Raleigh, North Carolina, 27612
Study site
Richmond, Virginia, 23235
Study site
Seattle, Washington, 98104
Study site
Sellersville, Pennsylvania, 18960
Study site
Spartanburg, South Carolina, 29303
Study site
Spokane, Washington, 99208
Study site
Spring Hill, Tennessee, 37174
Study site
Suffold, Virginia, 23435
Study site
Tampa, Florida, 33607
Study site
Tempe, Arizona, 85282
Study site
Traverse City, Michigan, 49684
Study site
Trumbill, Connecticut, 06611
Study site
West Layton, Utah, 84041
Study site
Winston-Salem, North Carolina, 27103
Study site
Winter Haven, Florida, 33880
South Africa5 sites
Study site
Muckleneuk, Pretoria, 0002
Study site
Rondebosch, 7700
Study site
Silverglen, Durban, 4092
Study site
Stellenbosch, 7600
Study site
Thabazimbi, 0380
Belgium4 sites
Study site
Genk, 3600
Study site
Gozée, 6534
Study site
Kortrijk, 8500
Study site
Yvoir, 5530
Canada3 sites
Study site
Québec, Quebec, G1V 3M7
Study site
Rimouski, Quebec, G5L 8W1
Study site
Toronto, Ontario, M9W 4L6
Australia2 sites
Study site
Herston, Queensland, 4029
Study site
Hobart, Tasmania, 7000
New Zealand2 sites
Study site
Grafton, Auckland, 1023
Study site
Tauranga, 3143
About this study
Official title: 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.
Read the 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.
- Conditions
- Gout
- Being tested
- lesinurad
- 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 QD
| Study group | Role | What they receive |
|---|---|---|
| lesinurad 400 mg | Experimental | Not described Receives: Drug: lesinurad |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of Subjects With a Serum Urate (sUA) Level That is < 6.0 mg/dL
Measured: Month 1
Incidence of Treatment-emergent Adverse Events (TEAEs)
Measured: Up to approximately 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jul 2012 (estimated)
- Study startAug 2012
- Primary completionApr 2014
- Study completionAug 2014
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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 143 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ardea Biosciences, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Chris Storgard, MD, Study director, Ardea Biosciences, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01650246
- Sponsor's protocol ID
- RDEA594-305
- Status last verified
- Apr 2016
- First submitted
- 24 Jul 2012
- Last updated
- 26 May 2016
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 26 May 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Long-Term Open-Label Extension Study for Subjects Completing a Phase 3 Efficacy and Safety Study of Lesinurad Monotherapy in Subjects With Gout
- ClinicalTrials.gov ID
- NCT01650246
- Acronym / sponsor ID
- RDEA594-305
- Conditions
- Gout
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 143 participants (actual)
- Lead sponsor
- Ardea Biosciences, Inc.Industry (pharma, biotech, devices)
- Study start
- Aug 2012
- Primary completion
- Apr 2014 (actual)
- Study completion
- Aug 2014 (actual)
- First posted
- 26 Jul 2012 (estimated)
- Results
- Posted 26 May 2016
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 over a long-term timeframe.
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| lesinurad 400 mg | Experimental | Drug: lesinurad |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 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 RDEA594-303 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.
Key exclusion criteria (3 listed)
- 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
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 QD | Drug | lesinurad 400 mg |
Primary outcome
Proportion of Subjects With a Serum Urate (sUA) Level That is < 6.0 mg/dL
Time frame: Month 1
Incidence of Treatment-emergent Adverse Events (TEAEs)
Time frame: Up to approximately 2 years
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 May 2016.
- 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.
Chris Storgard, MD study director
Ardea Biosciences, Inc.
75 sites in 7 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing lesinurad in people with Gout, run by Ardea Biosciences, Inc. at 75 sites in 7 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 4 inclusion and 3 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 26 May 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 75 sites in United States, South Africa, Belgium, Canada, Australia and 2 more countries. 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 26 May 2016). 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?
Proportion of Subjects With a Serum Urate (sUA) Level That is < 6.0 mg/dL (time frame: Month 1). The study lists 2 primary outcomes in all. 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 26 May 2016.