Trial Outcomes & Findings for A Phase 4 Safety and Efficacy Study to Evaluate Lesinurad 200 mg in Participants With Gout and Renal Impairment (NCT NCT03226899)
NCT ID: NCT03226899
Last Updated: 2021-11-04
Results Overview
Recruitment status
TERMINATED
Study phase
PHASE4
Target enrollment
242 participants
Primary outcome timeframe
Month 6
Results posted on
2021-11-04
Participant Flow
Participant milestones
| Measure |
Placebo + XOI
Placebo oral tablet once daily (QD) plus a stable, medically appropriate dose of an xanthine oxidase inhibitor (XOI)
|
Lesinurad + XOI
lesinurad 200 mg oral tablet QD plus a stable, medically appropriate dose of an XOI
|
|---|---|---|
|
Overall Study
STARTED
|
118
|
124
|
|
Overall Study
COMPLETED
|
0
|
0
|
|
Overall Study
NOT COMPLETED
|
118
|
124
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
A Phase 4 Safety and Efficacy Study to Evaluate Lesinurad 200 mg in Participants With Gout and Renal Impairment
Baseline characteristics by cohort
| Measure |
Placebo + XOI
n=118 Participants
placebo oral tablet QD plus a stable, medically appropriate dose of an XOI
|
Lesinurad + XOI
n=124 Participants
lesinurad 200 mg oral tablet QD plus a stable, medically appropriate dose of an XOI
|
Total
n=242 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
67.3 years
STANDARD_DEVIATION 8.00 • n=5 Participants
|
66.4 years
STANDARD_DEVIATION 10.10 • n=7 Participants
|
66.8 years
STANDARD_DEVIATION 9.12 • n=5 Participants
|
|
Sex: Female, Male
Female
|
22 Participants
n=5 Participants
|
28 Participants
n=7 Participants
|
50 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
96 Participants
n=5 Participants
|
96 Participants
n=7 Participants
|
192 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
26 Participants
n=5 Participants
|
20 Participants
n=7 Participants
|
46 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
92 Participants
n=5 Participants
|
104 Participants
n=7 Participants
|
196 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
1 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
2 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
14 Participants
n=5 Participants
|
24 Participants
n=7 Participants
|
38 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
99 Participants
n=5 Participants
|
95 Participants
n=7 Participants
|
194 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
2 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Month 6Population: Modified Intent-to-Treat (mITT) Population: all randomized participants who received at least 1 dose of study drug. Participants with a value at Month 6.
Outcome measures
| Measure |
Placebo + XOI
n=80 Participants
placebo oral tablet QD plus a stable, medically appropriate dose of an XOI
|
Lesinurad + XOI
n=80 Participants
lesinurad 200 mg oral tablet QD plus a stable, medically appropriate dose of an XOI
|
|---|---|---|
|
Percentage of Participants Who Achieve Serum Urate (sUA) < 6.0 mg/dL at Month 6
|
33.8 percentage of participants
|
58.8 percentage of participants
|
SECONDARY outcome
Timeframe: Baseline, Months 1, 3, 6, 9, 12, 15, 18Population: mITT Population: all randomized participants who received at least 1 dose of study drug. Participants with a value at baseline and given time point.
Outcome measures
| Measure |
Placebo + XOI
n=116 Participants
placebo oral tablet QD plus a stable, medically appropriate dose of an XOI
|
Lesinurad + XOI
n=123 Participants
lesinurad 200 mg oral tablet QD plus a stable, medically appropriate dose of an XOI
|
|---|---|---|
|
Percentage of Participants Who Achieve sUA < 6.0 mg/dL Over Time
Baseline
|
10.3 percentage of participants
|
10.6 percentage of participants
|
|
Percentage of Participants Who Achieve sUA < 6.0 mg/dL Over Time
Month 1
|
35.1 percentage of participants
|
58.8 percentage of participants
|
|
Percentage of Participants Who Achieve sUA < 6.0 mg/dL Over Time
Month 3
|
36.4 percentage of participants
|
52.5 percentage of participants
|
|
Percentage of Participants Who Achieve sUA < 6.0 mg/dL Over Time
Month 6
|
33.8 percentage of participants
|
58.8 percentage of participants
|
|
Percentage of Participants Who Achieve sUA < 6.0 mg/dL Over Time
Month 9
|
34.0 percentage of participants
|
42.9 percentage of participants
|
|
Percentage of Participants Who Achieve sUA < 6.0 mg/dL Over Time
Month 12
|
42.9 percentage of participants
|
56.5 percentage of participants
|
|
Percentage of Participants Who Achieve sUA < 6.0 mg/dL Over Time
Month 15
|
45.5 percentage of participants
|
62.5 percentage of participants
|
|
Percentage of Participants Who Achieve sUA < 6.0 mg/dL Over Time
Month 18
|
0.0 percentage of participants
|
—
|
SECONDARY outcome
Timeframe: Baseline, Months 1, 3, 6, 9, 12, 15, 18Population: Safety Population: all randomized participants who received at least 1 dose of lesinurad or placebo. Participants with a value at baseline and given time point.
Outcome measures
| Measure |
Placebo + XOI
n=116 Participants
placebo oral tablet QD plus a stable, medically appropriate dose of an XOI
|
Lesinurad + XOI
n=123 Participants
lesinurad 200 mg oral tablet QD plus a stable, medically appropriate dose of an XOI
|
|---|---|---|
|
Change From Baseline in sUA Over Time, Including the Last Value On and Off Treatment
Change at Month 1
|
-57.0 µmol/L
Standard Deviation 96.2
|
-120.3 µmol/L
Standard Deviation 105.3
|
|
Change From Baseline in sUA Over Time, Including the Last Value On and Off Treatment
Change at Month 3
|
-59.8 µmol/L
Standard Deviation 98.6
|
-106.8 µmol/L
Standard Deviation 116.2
|
|
Change From Baseline in sUA Over Time, Including the Last Value On and Off Treatment
Change at Month 6
|
-54.6 µmol/L
Standard Deviation 103.1
|
-125.8 µmol/L
Standard Deviation 140.0
|
|
Change From Baseline in sUA Over Time, Including the Last Value On and Off Treatment
Change at Month 9
|
-70.6 µmol/L
Standard Deviation 128.4
|
-95.9 µmol/L
Standard Deviation 106.5
|
|
Change From Baseline in sUA Over Time, Including the Last Value On and Off Treatment
Change at Month 12
|
-78.7 µmol/L
Standard Deviation 122.4
|
-69.6 µmol/L
Standard Deviation 110.4
|
|
Change From Baseline in sUA Over Time, Including the Last Value On and Off Treatment
Change at Month 15
|
-92.6 µmol/L
Standard Deviation 91.4
|
-116.6 µmol/L
Standard Deviation 76.3
|
|
Change From Baseline in sUA Over Time, Including the Last Value On and Off Treatment
Change at Month 18
|
0.00 µmol/L
Standard Deviation NA
1 participant at this time point.
|
—
|
|
Change From Baseline in sUA Over Time, Including the Last Value On and Off Treatment
Change at Last On-Treatment Visit
|
-57.0 µmol/L
Standard Deviation 104.7
|
-125.5 µmol/L
Standard Deviation 121.4
|
|
Change From Baseline in sUA Over Time, Including the Last Value On and Off Treatment
Change at Last Off-Treatment Visit
|
-70.7 µmol/L
Standard Deviation 105.4
|
-156.6 µmol/L
Standard Deviation 149.2
|
SECONDARY outcome
Timeframe: Baseline, Months 1, 3, 6, 9, 12, 15, 18Population: Safety Population: all randomized participants who received at least 1 dose of lesinurad or placebo. Participants with a value at baseline and given time point.
Outcome measures
| Measure |
Placebo + XOI
n=116 Participants
placebo oral tablet QD plus a stable, medically appropriate dose of an XOI
|
Lesinurad + XOI
n=123 Participants
lesinurad 200 mg oral tablet QD plus a stable, medically appropriate dose of an XOI
|
|---|---|---|
|
Percent Change From Baseline in sUA Over Time, Including the Last Value On and Off Treatment
Change at Month 3
|
-11.4 percent change
Standard Deviation 18.8
|
-21.2 percent change
Standard Deviation 21.7
|
|
Percent Change From Baseline in sUA Over Time, Including the Last Value On and Off Treatment
Change at Month 1
|
-11.3 percent change
Standard Deviation 18.8
|
-24.0 percent change
Standard Deviation 19.3
|
|
Percent Change From Baseline in sUA Over Time, Including the Last Value On and Off Treatment
Change at Month 6
|
-10.0 percent change
Standard Deviation 21.7
|
-23.9 percent change
Standard Deviation 24.4
|
|
Percent Change From Baseline in sUA Over Time, Including the Last Value On and Off Treatment
Change at Month 9
|
-12.6 percent change
Standard Deviation 27.3
|
-18.6 percent change
Standard Deviation 20.2
|
|
Percent Change From Baseline in sUA Over Time, Including the Last Value On and Off Treatment
Change at Month 12
|
-15.2 percent change
Standard Deviation 22.8
|
-14.7 percent change
Standard Deviation 26.7
|
|
Percent Change From Baseline in sUA Over Time, Including the Last Value On and Off Treatment
Change at Month 15
|
-18.9 percent change
Standard Deviation 17.5
|
-26.1 percent change
Standard Deviation 16.3
|
|
Percent Change From Baseline in sUA Over Time, Including the Last Value On and Off Treatment
Change at Month 18
|
0.00 percent change
Standard Deviation NA
1 participant at this time point.
|
—
|
|
Percent Change From Baseline in sUA Over Time, Including the Last Value On and Off Treatment
Change at Last On-Treatment Visit
|
-10.6 percent change
Standard Deviation 22.1
|
-24.8 percent change
Standard Deviation 22.8
|
|
Percent Change From Baseline in sUA Over Time, Including the Last Value On and Off Treatment
Change at Last Off-Treatment Visit
|
-16.1 percent change
Standard Deviation 25.8
|
-27.3 percent change
Standard Deviation 22.6
|
SECONDARY outcome
Timeframe: Baseline, 24 monthsPopulation: Due to early study termination, no participant reached Month 24. Therefore these data are not available.
The eCrCl was calculated by the Cockcroft-Gault formula using ideal body weight.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Baseline, 24 monthsPopulation: Due to early study termination, no participant reached Month 24. Therefore these data are not available.
The eCrCl was calculated by the Cockcroft-Gault formula using ideal body weight.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Baseline, Months 1, 3, 6, 9, 12, 15, 18Population: Safety Population: all randomized participants who received at least 1 dose of lesinurad or placebo. Participants with a value at baseline and given time point.
The eCrCl was calculated by the Cockcroft-Gault formula using ideal body weight.
Outcome measures
| Measure |
Placebo + XOI
n=116 Participants
placebo oral tablet QD plus a stable, medically appropriate dose of an XOI
|
Lesinurad + XOI
n=123 Participants
lesinurad 200 mg oral tablet QD plus a stable, medically appropriate dose of an XOI
|
|---|---|---|
|
Change From Baseline in eCrCl Over the Study Period, Including the Last Value On and Off Treatment
Change at Month 1
|
0.13 mL/min
Standard Deviation 9.67
|
-1.29 mL/min
Standard Deviation 6.45
|
|
Change From Baseline in eCrCl Over the Study Period, Including the Last Value On and Off Treatment
Change at Month 3
|
-0.69 mL/min
Standard Deviation 7.41
|
-1.53 mL/min
Standard Deviation 8.65
|
|
Change From Baseline in eCrCl Over the Study Period, Including the Last Value On and Off Treatment
Change at Month 6
|
-1.84 mL/min
Standard Deviation 7.58
|
-1.80 mL/min
Standard Deviation 7.02
|
|
Change From Baseline in eCrCl Over the Study Period, Including the Last Value On and Off Treatment
Change at Month 9
|
-0.78 mL/min
Standard Deviation 6.85
|
-2.10 mL/min
Standard Deviation 7.97
|
|
Change From Baseline in eCrCl Over the Study Period, Including the Last Value On and Off Treatment
Change at Month 12
|
-2.14 mL/min
Standard Deviation 7.03
|
-4.30 mL/min
Standard Deviation 6.34
|
|
Change From Baseline in eCrCl Over the Study Period, Including the Last Value On and Off Treatment
Change at Month 15
|
0.36 mL/min
Standard Deviation 6.07
|
-6.00 mL/min
Standard Deviation 8.49
|
|
Change From Baseline in eCrCl Over the Study Period, Including the Last Value On and Off Treatment
Change at Month 18
|
-19.0 mL/min
Standard Deviation NA
1 participant at this time point.
|
—
|
|
Change From Baseline in eCrCl Over the Study Period, Including the Last Value On and Off Treatment
Change at Last On-Treatment Visit
|
-1.03 mL/min
Standard Deviation 6.97
|
-1.91 mL/min
Standard Deviation 8.19
|
|
Change From Baseline in eCrCl Over the Study Period, Including the Last Value On and Off Treatment
Change at Last Off-Treatment Visit
|
2.33 mL/min
Standard Deviation 5.61
|
-2.45 mL/min
Standard Deviation 5.41
|
SECONDARY outcome
Timeframe: Baseline, Months 1, 3, 6, 9, 12, 15, 18Population: Safety Population: all randomized participants who received at least 1 dose of lesinurad or placebo. Participants with a value at baseline and given time point.
The eCrCl was calculated by the Cockcroft-Gault formula using ideal body weight.
Outcome measures
| Measure |
Placebo + XOI
n=116 Participants
placebo oral tablet QD plus a stable, medically appropriate dose of an XOI
|
Lesinurad + XOI
n=123 Participants
lesinurad 200 mg oral tablet QD plus a stable, medically appropriate dose of an XOI
|
|---|---|---|
|
Percent Change From Baseline in eCrCl Over the Study Period, Including the Last Value On and Off Treatment
Change at Last On-Treatment Visit
|
-1.13 percent change
Standard Deviation 16.86
|
-3.04 percent change
Standard Deviation 18.21
|
|
Percent Change From Baseline in eCrCl Over the Study Period, Including the Last Value On and Off Treatment
Change at Last Off-Treatment Visit
|
4.14 percent change
Standard Deviation 13.67
|
-5.35 percent change
Standard Deviation 13.52
|
|
Percent Change From Baseline in eCrCl Over the Study Period, Including the Last Value On and Off Treatment
Change at Month 18
|
-31.7 percent change
Standard Deviation NA
1 participant at this time point.
|
—
|
|
Percent Change From Baseline in eCrCl Over the Study Period, Including the Last Value On and Off Treatment
Change at Month 1
|
1.16 percent change
Standard Deviation 19.90
|
-2.07 percent change
Standard Deviation 15.30
|
|
Percent Change From Baseline in eCrCl Over the Study Period, Including the Last Value On and Off Treatment
Change at Month 3
|
-0.18 percent change
Standard Deviation 17.70
|
-2.14 percent change
Standard Deviation 20.12
|
|
Percent Change From Baseline in eCrCl Over the Study Period, Including the Last Value On and Off Treatment
Change at Month 6
|
-2.49 percent change
Standard Deviation 17.96
|
-3.01 percent change
Standard Deviation 15.32
|
|
Percent Change From Baseline in eCrCl Over the Study Period, Including the Last Value On and Off Treatment
Change at Month 9
|
-0.26 percent change
Standard Deviation 18.67
|
-3.42 percent change
Standard Deviation 17.05
|
|
Percent Change From Baseline in eCrCl Over the Study Period, Including the Last Value On and Off Treatment
Change at Month 12
|
-3.38 percent change
Standard Deviation 15.71
|
-8.1 percent change
Standard Deviation 12.9
|
|
Percent Change From Baseline in eCrCl Over the Study Period, Including the Last Value On and Off Treatment
Change at Month 15
|
3.67 percent change
Standard Deviation 18.6
|
-11.0 percent change
Standard Deviation 16.5
|
SECONDARY outcome
Timeframe: up to 18 monthsPopulation: Safety Population: all randomized participants who received at least 1 dose of lesinurad or placebo.
Outcome measures
| Measure |
Placebo + XOI
n=116 Participants
placebo oral tablet QD plus a stable, medically appropriate dose of an XOI
|
Lesinurad + XOI
n=123 Participants
lesinurad 200 mg oral tablet QD plus a stable, medically appropriate dose of an XOI
|
|---|---|---|
|
Percentage of Participants With Serum Creatinine (sCr) Elevations (≥1.5 × Baseline) Over the Study Period
|
5.2 percentage of participants
|
7.3 percentage of participants
|
SECONDARY outcome
Timeframe: up to 18 monthsPopulation: Safety Population: all randomized participants who received at least 1 dose of lesinurad or placebo.
Kidney function was monitored throughout the study by measuring sCr and calculating eCrCl by Cockcroft-Gault formula using ideal body weight. Treatment discontinuations were required if a participant experienced an absolute sCr ≥4.0 mg/dL or an eCrCl \<20 mL/min (based on central laboratory results).
Outcome measures
| Measure |
Placebo + XOI
n=116 Participants
placebo oral tablet QD plus a stable, medically appropriate dose of an XOI
|
Lesinurad + XOI
n=123 Participants
lesinurad 200 mg oral tablet QD plus a stable, medically appropriate dose of an XOI
|
|---|---|---|
|
Percentage of Participants Meeting Criteria (eg, Based on sCr or eCrCl Criteria) for Treatment Discontinuations Over the Study Period
|
0.0 percentage of participants
|
0.0 percentage of participants
|
SECONDARY outcome
Timeframe: From first dose of study drug through each participant's study duration, up to approximately 18 months.Population: All Randomized Participants
Renal-related and kidney stone events were based on Medical Dictionary for Regulatory Activities (MedDRA) "Renal and Urinary Disorders" system organ classification. AEs that started on or after the first dose of study drug in this study, or those AEs with onset prior to the first dose of study drug but worsened after the first dose of study drug, were considered treatment emergent.
Outcome measures
| Measure |
Placebo + XOI
n=118 Participants
placebo oral tablet QD plus a stable, medically appropriate dose of an XOI
|
Lesinurad + XOI
n=124 Participants
lesinurad 200 mg oral tablet QD plus a stable, medically appropriate dose of an XOI
|
|---|---|---|
|
Percentage of Participants Renal-Related and Kidney Stone Treatment-Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs)
Treatment-Emergent SAEs
|
0.0 percentage of participants
|
0.8 percentage of participants
|
|
Percentage of Participants Renal-Related and Kidney Stone Treatment-Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs)
Treatment-Emergent AEs
|
4.2 percentage of participants
|
5.6 percentage of participants
|
SECONDARY outcome
Timeframe: From first dose of study drug through each participant's study duration, up to approximately 18 months.Population: This was not analyzed; no events were adjudicated since the study was terminated early.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: From first dose of study drug through each participant's study duration, up to approximately 18 months.Population: This was not analyzed; no events were adjudicated since the study was terminated early.
MACEs are defined as Cardiovascular Death, Nonfatal Myocardial Infarction, and Nonfatal Stroke.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: From first dose of study drug through each participant's study duration, up to approximately 18 months.Population: This was not analyzed; no events were adjudicated since the study was terminated early.
MACEs are defined as Cardiovascular Death, Nonfatal Myocardial Infarction, and Nonfatal Stroke.
Outcome measures
Outcome data not reported
Adverse Events
Placebo + XOI
Serious events: 7 serious events
Other events: 9 other events
Deaths: 0 deaths
Lesinurad + XOI
Serious events: 13 serious events
Other events: 18 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Placebo + XOI
n=118 participants at risk
placebo oral tablet QD plus a stable, medically appropriate dose of an XOI
|
Lesinurad + XOI
n=124 participants at risk
lesinurad 200 mg oral tablet QD plus a stable, medically appropriate dose of an XOI
|
|---|---|---|
|
Cardiac disorders
Arteriosclerosis coronary artery
|
0.00%
0/118 • From first dose of study drug through each participant's study duration, up to approximately 18 months.
|
0.81%
1/124 • From first dose of study drug through each participant's study duration, up to approximately 18 months.
|
|
Cardiac disorders
Atrial fibrillation
|
0.85%
1/118 • From first dose of study drug through each participant's study duration, up to approximately 18 months.
|
0.00%
0/124 • From first dose of study drug through each participant's study duration, up to approximately 18 months.
|
|
Cardiac disorders
Cardiac failure congestive
|
0.00%
0/118 • From first dose of study drug through each participant's study duration, up to approximately 18 months.
|
0.81%
1/124 • From first dose of study drug through each participant's study duration, up to approximately 18 months.
|
|
Cardiac disorders
Coronary artery disease
|
0.00%
0/118 • From first dose of study drug through each participant's study duration, up to approximately 18 months.
|
0.81%
1/124 • From first dose of study drug through each participant's study duration, up to approximately 18 months.
|
|
Cardiac disorders
Coronary artery occlusion
|
0.85%
1/118 • From first dose of study drug through each participant's study duration, up to approximately 18 months.
|
0.00%
0/124 • From first dose of study drug through each participant's study duration, up to approximately 18 months.
|
|
Cardiac disorders
Myocarditis
|
0.00%
0/118 • From first dose of study drug through each participant's study duration, up to approximately 18 months.
|
0.81%
1/124 • From first dose of study drug through each participant's study duration, up to approximately 18 months.
|
|
Cardiac disorders
Tricuspid valve incompetence
|
0.85%
1/118 • From first dose of study drug through each participant's study duration, up to approximately 18 months.
|
0.00%
0/124 • From first dose of study drug through each participant's study duration, up to approximately 18 months.
|
|
General disorders
Non-cardiac chest pain
|
0.00%
0/118 • From first dose of study drug through each participant's study duration, up to approximately 18 months.
|
1.6%
2/124 • From first dose of study drug through each participant's study duration, up to approximately 18 months.
|
|
General disorders
Asthenia
|
0.00%
0/118 • From first dose of study drug through each participant's study duration, up to approximately 18 months.
|
0.81%
1/124 • From first dose of study drug through each participant's study duration, up to approximately 18 months.
|
|
General disorders
Vascular stent occlusion
|
0.85%
1/118 • From first dose of study drug through each participant's study duration, up to approximately 18 months.
|
0.00%
0/124 • From first dose of study drug through each participant's study duration, up to approximately 18 months.
|
|
Respiratory, thoracic and mediastinal disorders
Acute respiratory failure
|
0.85%
1/118 • From first dose of study drug through each participant's study duration, up to approximately 18 months.
|
0.00%
0/124 • From first dose of study drug through each participant's study duration, up to approximately 18 months.
|
|
Respiratory, thoracic and mediastinal disorders
Chronic obstructive pulmonary disease
|
0.85%
1/118 • From first dose of study drug through each participant's study duration, up to approximately 18 months.
|
0.00%
0/124 • From first dose of study drug through each participant's study duration, up to approximately 18 months.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.00%
0/118 • From first dose of study drug through each participant's study duration, up to approximately 18 months.
|
0.81%
1/124 • From first dose of study drug through each participant's study duration, up to approximately 18 months.
|
|
Respiratory, thoracic and mediastinal disorders
Emphysema
|
0.00%
0/118 • From first dose of study drug through each participant's study duration, up to approximately 18 months.
|
0.81%
1/124 • From first dose of study drug through each participant's study duration, up to approximately 18 months.
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
0.00%
0/118 • From first dose of study drug through each participant's study duration, up to approximately 18 months.
|
0.81%
1/124 • From first dose of study drug through each participant's study duration, up to approximately 18 months.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary hypertension
|
0.00%
0/118 • From first dose of study drug through each participant's study duration, up to approximately 18 months.
|
0.81%
1/124 • From first dose of study drug through each participant's study duration, up to approximately 18 months.
|
|
Hepatobiliary disorders
Bile duct stone
|
0.00%
0/118 • From first dose of study drug through each participant's study duration, up to approximately 18 months.
|
0.81%
1/124 • From first dose of study drug through each participant's study duration, up to approximately 18 months.
|
|
Hepatobiliary disorders
Cholecystitis
|
0.85%
1/118 • From first dose of study drug through each participant's study duration, up to approximately 18 months.
|
0.00%
0/124 • From first dose of study drug through each participant's study duration, up to approximately 18 months.
|
|
Hepatobiliary disorders
Cholecystitis acute
|
0.00%
0/118 • From first dose of study drug through each participant's study duration, up to approximately 18 months.
|
0.81%
1/124 • From first dose of study drug through each participant's study duration, up to approximately 18 months.
|
|
Metabolism and nutrition disorders
Dehydration
|
0.85%
1/118 • From first dose of study drug through each participant's study duration, up to approximately 18 months.
|
0.00%
0/124 • From first dose of study drug through each participant's study duration, up to approximately 18 months.
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
0.00%
0/118 • From first dose of study drug through each participant's study duration, up to approximately 18 months.
|
0.81%
1/124 • From first dose of study drug through each participant's study duration, up to approximately 18 months.
|
|
Blood and lymphatic system disorders
Haemorrhagic anaemia
|
0.00%
0/118 • From first dose of study drug through each participant's study duration, up to approximately 18 months.
|
0.81%
1/124 • From first dose of study drug through each participant's study duration, up to approximately 18 months.
|
|
Gastrointestinal disorders
Diverticulum
|
0.85%
1/118 • From first dose of study drug through each participant's study duration, up to approximately 18 months.
|
0.00%
0/124 • From first dose of study drug through each participant's study duration, up to approximately 18 months.
|
|
Investigations
Blood creatine phosphokinase increased
|
0.00%
0/118 • From first dose of study drug through each participant's study duration, up to approximately 18 months.
|
0.81%
1/124 • From first dose of study drug through each participant's study duration, up to approximately 18 months.
|
|
Investigations
Weight decreased
|
0.00%
0/118 • From first dose of study drug through each participant's study duration, up to approximately 18 months.
|
0.81%
1/124 • From first dose of study drug through each participant's study duration, up to approximately 18 months.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Colon cancer recurrent
|
0.00%
0/118 • From first dose of study drug through each participant's study duration, up to approximately 18 months.
|
0.81%
1/124 • From first dose of study drug through each participant's study duration, up to approximately 18 months.
|
|
Nervous system disorders
Syncope
|
0.00%
0/118 • From first dose of study drug through each participant's study duration, up to approximately 18 months.
|
0.81%
1/124 • From first dose of study drug through each participant's study duration, up to approximately 18 months.
|
|
Renal and urinary disorders
Acute kidney injury
|
0.00%
0/118 • From first dose of study drug through each participant's study duration, up to approximately 18 months.
|
0.81%
1/124 • From first dose of study drug through each participant's study duration, up to approximately 18 months.
|
Other adverse events
| Measure |
Placebo + XOI
n=118 participants at risk
placebo oral tablet QD plus a stable, medically appropriate dose of an XOI
|
Lesinurad + XOI
n=124 participants at risk
lesinurad 200 mg oral tablet QD plus a stable, medically appropriate dose of an XOI
|
|---|---|---|
|
Infections and infestations
Viral upper respiratory tract infection
|
3.4%
4/118 • From first dose of study drug through each participant's study duration, up to approximately 18 months.
|
4.0%
5/124 • From first dose of study drug through each participant's study duration, up to approximately 18 months.
|
|
Infections and infestations
Upper respiratory tract infection
|
0.00%
0/118 • From first dose of study drug through each participant's study duration, up to approximately 18 months.
|
3.2%
4/124 • From first dose of study drug through each participant's study duration, up to approximately 18 months.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.85%
1/118 • From first dose of study drug through each participant's study duration, up to approximately 18 months.
|
2.4%
3/124 • From first dose of study drug through each participant's study duration, up to approximately 18 months.
|
|
Vascular disorders
Hypertension
|
3.4%
4/118 • From first dose of study drug through each participant's study duration, up to approximately 18 months.
|
2.4%
3/124 • From first dose of study drug through each participant's study duration, up to approximately 18 months.
|
|
Metabolism and nutrition disorders
Vitamin D deficiency
|
0.00%
0/118 • From first dose of study drug through each participant's study duration, up to approximately 18 months.
|
2.4%
3/124 • From first dose of study drug through each participant's study duration, up to approximately 18 months.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee PI may publish or disclose the results of the study 24 months after final data lock provided that sponsor can review the publication prior to public release, sponsor can request removal of confidential information of sponsor (not including results of trial), and sponsor can request a publication delay in order to protect potentially patentable information. Furthermore, if a publication committee is developing an initial publication, PI is to delay disclosure until that publication is published.
- Publication restrictions are in place
Restriction type: OTHER