Gout
Conditions
Brief summary
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.
Interventions
DRUGlesinurad
Tablets, 400 mg QD
Sponsors
Ardea Biosciences, Inc.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 85 Years
Healthy volunteers
No
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 RDEA594-303 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.
Exclusion criteria
* 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Proportion of Subjects With a Serum Urate (sUA) Level That is < 6.0 mg/dL | Month 1 |
| Incidence of Treatment-emergent Adverse Events (TEAEs) | Up to approximately 2 years |
Countries
Australia, Belgium, Canada, Germany, New Zealand, South Africa, United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Lesinurad 400 mg lesinurad 400 mg once daily (qd) | 143 |
| Total | 143 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Adverse Event | 23 |
| Overall Study | Death | 1 |
| Overall Study | Lack of Efficacy | 30 |
| Overall Study | Lost to Follow-up | 5 |
| Overall Study | Protocol Violation | 5 |
| Overall Study | Sponsor terminated study | 53 |
| Overall Study | Withdrawal by Subject | 26 |
Baseline characteristics
| Characteristic | Lesinurad 400 mg |
|---|---|
| Age, Continuous | 55.1 years STANDARD_DEVIATION 12 |
| Age, Customized <65 Years | 111 Participants |
| Age, Customized >=65 Years | 32 Participants |
| Region of Enrollment Australia | 2 Participants |
| Region of Enrollment Belgium | 9 Participants |
| Region of Enrollment Canada | 6 Participants |
| Region of Enrollment Germany | 6 Participants |
| Region of Enrollment New Zealand | 3 Participants |
| Region of Enrollment South Africa | 16 Participants |
| Region of Enrollment United States | 101 Participants |
| Sex: Female, Male Female | 11 Participants |
| Sex: Female, Male Male | 132 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 73 / 143 |
| serious Total, serious adverse events | 15 / 143 |
Outcome results
Primary
Incidence of Treatment-emergent Adverse Events (TEAEs)
Time frame: Up to approximately 2 years
Population: Safety Population
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Lesinurad 400 mg | Incidence of Treatment-emergent Adverse Events (TEAEs) | 105 TEAEs |
Primary
Proportion of Subjects With a Serum Urate (sUA) Level That is < 6.0 mg/dL
Time frame: Month 1
Population: Safety Population
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Lesinurad 400 mg | Proportion of Subjects With a Serum Urate (sUA) Level That is < 6.0 mg/dL | 68 Subjects |