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Open-Label Lesinurad Monotherapy Extension Study in Gout

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01650246
Recruitment Status : Completed
First Posted : July 26, 2012
Results First Posted : May 26, 2016
Last Update Posted : May 26, 2016
Sponsor:
Information provided by (Responsible Party):
Ardea Biosciences, Inc.

Study Type Interventional
Study Design Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Gout
Intervention Drug: lesinurad
Enrollment 143
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Lesinurad 400 mg
Hide Arm/Group Description lesinurad 400 mg once daily (qd)
Period Title: Overall Study
Started 143
Completed 0
Not Completed 143
Reason Not Completed
Adverse Event             23
Protocol Violation             5
Sponsor terminated study             53
Lost to Follow-up             5
Withdrawal by Subject             26
Death             1
Lack of Efficacy             30
Arm/Group Title Lesinurad 400 mg
Hide Arm/Group Description lesinurad 400 mg once daily (qd)
Overall Number of Baseline Participants 143
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 143 participants
55.1  (12.0)
Age, Customized   [1] 
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 143 participants
<65 Years 111
>=65 Years 32
[1]
Measure Description: <65 Years, >=65 Years
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 143 participants
Female
11
   7.7%
Male
132
  92.3%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 143 participants
Australia 2
Belgium 9
Canada 6
Germany 6
New Zealand 3
South Africa 16
United States 101
1.Primary Outcome
Title Proportion of Subjects With a Serum Urate (sUA) Level That is < 6.0 mg/dL
Hide Description [Not Specified]
Time Frame Month 1
Hide Outcome Measure Data
Hide Analysis Population Description
Safety Population
Arm/Group Title Lesinurad 400 mg
Hide Arm/Group Description:
lesinurad 400 mg once daily (qd)
Overall Number of Participants Analyzed 143
Measure Type: Number
Unit of Measure: Subjects
68
2.Primary Outcome
Title Incidence of Treatment-emergent Adverse Events (TEAEs)
Hide Description [Not Specified]
Time Frame Up to approximately 2 years
Hide Outcome Measure Data
Hide Analysis Population Description
Safety Population
Arm/Group Title Lesinurad 400 mg
Hide Arm/Group Description:
lesinurad 400 mg once daily (qd)
Overall Number of Participants Analyzed 143
Measure Type: Number
Unit of Measure: TEAEs
105
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Lesinurad 400 mg
Hide Arm/Group Description lesinurad 400 mg once daily (qd)
All-Cause Mortality
Lesinurad 400 mg
Affected / at Risk (%)
Total   --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Lesinurad 400 mg
Affected / at Risk (%) # Events
Total   15/143 (10.49%)    
Cardiac disorders   
Angina pectoris  1  1/143 (0.70%)  1
Atrioventricular clock complete  1  1/143 (0.70%)  1
Coronary Artery disease  1  1/143 (0.70%)  1
Myocardial infarction  1  1/143 (0.70%)  1
Gastrointestinal disorders   
Pancreatitis  1  1/143 (0.70%)  1
General disorders   
Death  1  1/143 (0.70%)  1
Infections and infestations   
Bursitis infective  1  1/143 (0.70%)  1
Gastroenteritis salmonella  1  1/143 (0.70%)  1
Metabolism and nutrition disorders   
Gout  1  1/143 (0.70%)  1
Musculoskeletal and connective tissue disorders   
Facet joint syndrome  1  1/143 (0.70%)  1
Nervous system disorders   
Transient ischaemic attack  1  1/143 (0.70%)  1
Psychiatric disorders   
Depression  1  1/143 (0.70%)  1
Schizoaffective disorder  1  1/143 (0.70%)  2
Renal and urinary disorders   
Nephrolithiasis  1  3/143 (2.10%)  3
Renal impairment  1  1/143 (0.70%)  1
Renal Failure Acute  1  1/143 (0.70%)  1
Indicates events were collected by systematic assessment
1
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
Affected / at Risk (%) # Events
Total   73/143 (51.05%)    
Gastrointestinal disorders   
Abdominal pain upper  1  3/143 (2.10%)  3
Gastrooesophageal reflux disease  1  3/143 (2.10%)  3
Vomiting  1  4/143 (2.80%)  7
General disorders   
Fatigue  1  4/143 (2.80%)  4
Pyrexia  1  3/143 (2.10%)  3
Infections and infestations   
Bronchitis  1  5/143 (3.50%)  5
Gastroenteritis  1  7/143 (4.90%)  8
Influenza  1  3/143 (2.10%)  3
Sinusitis  1  4/143 (2.80%)  5
Upper respiratory tract infection  1  14/143 (9.79%)  15
Urinary tract infection  2  7/143 (4.90%)  8
Nasopharyngitis  1  4/143 (2.80%)  5
Investigations   
Blood creatine phosphokinase increased  1  4/143 (2.80%)  4
Blood creatinine increased  1  16/143 (11.19%)  20
Metabolism and nutrition disorders   
Hyperlipidaemia  1  3/143 (2.10%)  3
Musculoskeletal and connective tissue disorders   
Arthralgia  1  6/143 (4.20%)  6
Back pain  1  7/143 (4.90%)  8
Flank pain  1  3/143 (2.10%)  4
Pain in extremity  1  3/143 (2.10%)  4
Nervous system disorders   
Headache  1  6/143 (4.20%)  8
Renal and urinary disorders   
Nephrolithiasis  1  3/143 (2.10%)  3
Renal impairment  1  4/143 (2.80%)  4
Respiratory, thoracic and mediastinal disorders   
Cough  1  4/143 (2.80%)  5
Vascular disorders   
Hypertension  1  10/143 (6.99%)  10
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 14.0
2
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.
Principal Investigator (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: Maple Fung, MD
Organization: Ardea Biosciences, Inc.
Phone: 1-858-652-6721
EMail: mfung@ardeabio.com
Layout table for additonal information
Responsible Party: Ardea Biosciences, Inc.
ClinicalTrials.gov Identifier: NCT01650246     History of Changes
Other Study ID Numbers: RDEA594-305
First Submitted: July 24, 2012
First Posted: July 26, 2012
Results First Submitted: January 14, 2016
Results First Posted: May 26, 2016
Last Update Posted: May 26, 2016