Trial Outcomes & Findings for Lesinurad Monotherapy in Gout Subjects Intolerant to Xanthine Oxidase Inhibitors (NCT NCT01508702)
NCT ID: NCT01508702
Last Updated: 2016-02-12
Results Overview
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
214 participants
Primary outcome timeframe
6 months
Results posted on
2016-02-12
Participant Flow
Participant milestones
| Measure |
Lesinurad 400 mg
lesinurad 400 mg
|
Placebo
|
|---|---|---|
|
Overall Study
STARTED
|
107
|
107
|
|
Overall Study
COMPLETED
|
84
|
94
|
|
Overall Study
NOT COMPLETED
|
23
|
13
|
Reasons for withdrawal
| Measure |
Lesinurad 400 mg
lesinurad 400 mg
|
Placebo
|
|---|---|---|
|
Overall Study
Adverse Event
|
7
|
3
|
|
Overall Study
Gout flare
|
2
|
0
|
|
Overall Study
Protocol Violation
|
2
|
1
|
|
Overall Study
Lost to Follow-up
|
1
|
2
|
|
Overall Study
Withdrawal by Subject
|
11
|
7
|
Baseline Characteristics
Lesinurad Monotherapy in Gout Subjects Intolerant to Xanthine Oxidase Inhibitors
Baseline characteristics by cohort
| Measure |
Lesinurad 400 mg
n=107 Participants
lesinurad 400 mg
|
Placebo
n=107 Participants
|
Total
n=214 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
53.6 Years
STANDARD_DEVIATION 12.5 • n=99 Participants
|
55.3 Years
STANDARD_DEVIATION 12.0 • n=107 Participants
|
54.4 Years
STANDARD_DEVIATION 12.2 • n=206 Participants
|
|
Age, Customized
<65
|
87 Participants
n=99 Participants
|
80 Participants
n=107 Participants
|
167 Participants
n=206 Participants
|
|
Age, Customized
>=65
|
20 Participants
n=99 Participants
|
27 Participants
n=107 Participants
|
47 Participants
n=206 Participants
|
|
Sex: Female, Male
Female
|
9 Participants
n=99 Participants
|
10 Participants
n=107 Participants
|
19 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
98 Participants
n=99 Participants
|
97 Participants
n=107 Participants
|
195 Participants
n=206 Participants
|
|
Region of Enrollment
Australia
|
1 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
2 Participants
n=206 Participants
|
|
Region of Enrollment
Belgium
|
5 Participants
n=99 Participants
|
4 Participants
n=107 Participants
|
9 Participants
n=206 Participants
|
|
Region of Enrollment
Canada
|
5 Participants
n=99 Participants
|
6 Participants
n=107 Participants
|
11 Participants
n=206 Participants
|
|
Region of Enrollment
Germany
|
5 Participants
n=99 Participants
|
2 Participants
n=107 Participants
|
7 Participants
n=206 Participants
|
|
Region of Enrollment
New Zealand
|
3 Participants
n=99 Participants
|
2 Participants
n=107 Participants
|
5 Participants
n=206 Participants
|
|
Region of Enrollment
South Africa
|
12 Participants
n=99 Participants
|
11 Participants
n=107 Participants
|
23 Participants
n=206 Participants
|
|
Region of Enrollment
United States
|
76 Participants
n=99 Participants
|
81 Participants
n=107 Participants
|
157 Participants
n=206 Participants
|
PRIMARY outcome
Timeframe: 6 monthsPopulation: ITT Population
Outcome measures
| Measure |
Lesinurad 400 mg
n=107 Subjects
lesinurad 400 mg
|
Placebo
n=107 Subjects
Placebo qd
|
|---|---|---|
|
Number of Subjects With an sUA Level That is < 6.0 mg/dL
|
32 Number of Subjects
|
2 Number of Subjects
|
Adverse Events
Lesinurad 400 mg
Serious events: 9 serious events
Other events: 39 other events
Deaths: 0 deaths
Placebo
Serious events: 4 serious events
Other events: 8 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Lesinurad 400 mg
n=107 participants at risk
lesinurad 400 mg
|
Placebo
n=107 participants at risk
|
|---|---|---|
|
Cardiac disorders
Coronary artery disease
|
0.00%
0/107
|
0.93%
1/107 • Number of events 1
|
|
Cardiac disorders
Pericardial effusion
|
0.00%
0/107
|
0.93%
1/107 • Number of events 1
|
|
General disorders
Death
|
0.93%
1/107 • Number of events 1
|
0.00%
0/107
|
|
Infections and infestations
Diverticulitis
|
0.00%
0/107
|
0.93%
1/107 • Number of events 1
|
|
Metabolism and nutrition disorders
Gout
|
0.93%
1/107 • Number of events 1
|
0.93%
1/107 • Number of events 1
|
|
Renal and urinary disorders
Renal failure
|
1.9%
2/107 • Number of events 2
|
0.00%
0/107
|
|
Renal and urinary disorders
Renal failure acute
|
1.9%
2/107 • Number of events 2
|
0.00%
0/107
|
|
Renal and urinary disorders
Renal impairment
|
0.93%
1/107 • Number of events 1
|
0.00%
0/107
|
|
Infections and infestations
Gastroenteritis
|
0.00%
0/107
|
0.93%
1/107 • Number of events 1
|
|
Renal and urinary disorders
Calculus ureteric
|
0.93%
1/107 • Number of events 1
|
0.00%
0/107
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Ovarian epithelial cancer
|
0.93%
1/107 • Number of events 1
|
0.00%
0/107
|
Other adverse events
| Measure |
Lesinurad 400 mg
n=107 participants at risk
lesinurad 400 mg
|
Placebo
n=107 participants at risk
|
|---|---|---|
|
Gastrointestinal disorders
Constipation
|
5.6%
6/107 • Number of events 6
|
0.00%
0/107
|
|
Gastrointestinal disorders
Diarrhoea
|
9.3%
10/107 • Number of events 10
|
5.6%
6/107 • Number of events 6
|
|
General disorders
Oedema peripheral
|
2.8%
3/107 • Number of events 4
|
0.00%
0/107
|
|
General disorders
Pyrexia
|
2.8%
3/107 • Number of events 3
|
0.00%
0/107
|
|
Infections and infestations
Bronchitis
|
4.7%
5/107 • Number of events 5
|
1.9%
2/107 • Number of events 2
|
|
Investigations
Blood creatinine increased
|
8.4%
9/107 • Number of events 10
|
0.00%
0/107
|
|
Metabolism and nutrition disorders
Hyperkalaemia
|
2.8%
3/107 • Number of events 5
|
0.00%
0/107
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal stiffness
|
2.8%
3/107 • Number of events 3
|
0.00%
0/107
|
|
Renal and urinary disorders
Renal impairment
|
3.7%
4/107 • Number of events 5
|
0.00%
0/107
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
3.7%
4/107 • Number of events 4
|
0.93%
1/107 • Number of events 1
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee PI shall submit a copy of the Publication to Sponsor for review at least 45 days prior to its proposed submission. Sponsor reserves the right to delay any such publication for an additional period of 60 days. Upon Sponsor's request, PI agrees to delete from the proposed publication any Confidential Information. PI agrees not to release any publication without the prior written permission of Sponsor.
- Publication restrictions are in place
Restriction type: OTHER