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Lesinurad Monotherapy in Gout Subjects Intolerant to Xanthine Oxidase Inhibitors (LIGHT)

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ClinicalTrials.gov Identifier: NCT01508702
Recruitment Status : Completed
First Posted : January 12, 2012
Results First Posted : February 12, 2016
Last Update Posted : February 12, 2016
Sponsor:
Information provided by (Responsible Party):
Ardea Biosciences, Inc.

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Triple (Participant, Care Provider, Investigator);   Primary Purpose: Treatment
Condition Gout
Interventions Drug: lesinurad
Drug: Placebo
Enrollment 214
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Lesinurad 400 mg Placebo
Hide Arm/Group Description lesinurad 400 mg [Not Specified]
Period Title: Overall Study
Started 107 107
Completed 84 94
Not Completed 23 13
Reason Not Completed
Adverse Event             7             3
Gout flare             2             0
Protocol Violation             2             1
Lost to Follow-up             1             2
Withdrawal by Subject             11             7
Arm/Group Title Lesinurad 400 mg Placebo Total
Hide Arm/Group Description lesinurad 400 mg [Not Specified] Total of all reporting groups
Overall Number of Baseline Participants 107 107 214
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 107 participants 107 participants 214 participants
53.6  (12.5) 55.3  (12.0) 54.4  (12.2)
Age, Customized  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 107 participants 107 participants 214 participants
<65 87 80 167
>=65 20 27 47
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 107 participants 107 participants 214 participants
Female
9
   8.4%
10
   9.3%
19
   8.9%
Male
98
  91.6%
97
  90.7%
195
  91.1%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 107 participants 107 participants 214 participants
Australia 1 1 2
Belgium 5 4 9
Canada 5 6 11
Germany 5 2 7
New Zealand 3 2 5
South Africa 12 11 23
United States 76 81 157
1.Primary Outcome
Title Number of Subjects With an sUA Level That is < 6.0 mg/dL
Hide Description [Not Specified]
Time Frame 6 months
Hide Outcome Measure Data
Hide Analysis Population Description
ITT Population
Arm/Group Title Lesinurad 400 mg Placebo
Hide Arm/Group Description:
lesinurad 400 mg
Placebo qd
Overall Number of Participants Analyzed 107 107
Overall Number of Units Analyzed
Type of Units Analyzed: Subjects
107 107
Measure Type: Number
Unit of Measure: Number of Subjects
32 2
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Lesinurad 400 mg, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments [Not Specified]
Method Cochran-Mantel-Haenszel
Comments [Not Specified]
Method of Estimation Estimation Parameter Risk Ratio (RR)
Estimated Value 0.28
Confidence Interval (2-Sided) 95%
0.19 to 0.37
Estimation Comments [Not Specified]
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Lesinurad 400 mg Placebo
Hide Arm/Group Description lesinurad 400 mg [Not Specified]
All-Cause Mortality
Lesinurad 400 mg Placebo
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Lesinurad 400 mg Placebo
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   9/107 (8.41%)      4/107 (3.74%)    
Cardiac disorders     
Coronary artery disease  1  0/107 (0.00%)  0 1/107 (0.93%)  1
Pericardial effusion  1  0/107 (0.00%)  0 1/107 (0.93%)  1
General disorders     
Death  1  1/107 (0.93%)  1 0/107 (0.00%)  0
Infections and infestations     
Diverticulitis  1  0/107 (0.00%)  0 1/107 (0.93%)  1
Gastroenteritis  2  0/107 (0.00%)  0 1/107 (0.93%)  1
Metabolism and nutrition disorders     
Gout  1  1/107 (0.93%)  1 1/107 (0.93%)  1
Neoplasms benign, malignant and unspecified (incl cysts and polyps)     
Ovarian epithelial cancer  2  1/107 (0.93%)  1 0/107 (0.00%)  0
Renal and urinary disorders     
Renal failure  1  2/107 (1.87%)  2 0/107 (0.00%)  0
Renal failure acute  1  2/107 (1.87%)  2 0/107 (0.00%)  0
Renal impairment  1  1/107 (0.93%)  1 0/107 (0.00%)  0
Calculus ureteric  2  1/107 (0.93%)  1 0/107 (0.00%)  0
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 15.1
2
Term from vocabulary, MedDRA 14.0
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0.02%
Lesinurad 400 mg Placebo
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   39/107 (36.45%)      8/107 (7.48%)    
Gastrointestinal disorders     
Constipation  1  6/107 (5.61%)  6 0/107 (0.00%)  0
Diarrhoea  1  10/107 (9.35%)  10 6/107 (5.61%)  6
General disorders     
Oedema peripheral  1  3/107 (2.80%)  4 0/107 (0.00%)  0
Pyrexia  1  3/107 (2.80%)  3 0/107 (0.00%)  0
Infections and infestations     
Bronchitis  1  5/107 (4.67%)  5 2/107 (1.87%)  2
Investigations     
Blood creatinine increased  1  9/107 (8.41%)  10 0/107 (0.00%)  0
Metabolism and nutrition disorders     
Hyperkalaemia  1  3/107 (2.80%)  5 0/107 (0.00%)  0
Musculoskeletal and connective tissue disorders     
Musculoskeletal stiffness  1  3/107 (2.80%)  3 0/107 (0.00%)  0
Renal and urinary disorders     
Renal impairment  1  4/107 (3.74%)  5 0/107 (0.00%)  0
Respiratory, thoracic and mediastinal disorders     
Cough  1  4/107 (3.74%)  4 1/107 (0.93%)  1
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 15.1
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
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.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Nihar Bhakta, MD
Organization: Ardea Biosciences, Inc.
Phone: 1-858-652-6671
EMail: nbhakta@ardeabio.com
Layout table for additonal information
Responsible Party: Ardea Biosciences, Inc.
ClinicalTrials.gov Identifier: NCT01508702     History of Changes
Other Study ID Numbers: RDEA594-303
2011-003756-39 ( EudraCT Number )
First Submitted: January 10, 2012
First Posted: January 12, 2012
Results First Submitted: January 14, 2016
Results First Posted: February 12, 2016
Last Update Posted: February 12, 2016