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Lesinurad and Febuxostat Combination Extension Study in Gout

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ClinicalTrials.gov Identifier: NCT01808144
Recruitment Status : Completed
First Posted : March 11, 2013
Results First Posted : January 30, 2018
Last Update Posted : January 30, 2018
Sponsor:
Information provided by (Responsible Party):
Ardea Biosciences, Inc.

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Double (Participant, Investigator);   Primary Purpose: Treatment
Condition Gout
Interventions Drug: lesinurad
Drug: febuxostat
Enrollment 196
Recruitment Details Subjects entered this extension Study RDEA594-307 while the core Study RDEA594-304 was ongoing and the database was not yet locked. To maintain the blind of the core study for subjects entering the extension, the lesinurad dose for all subjects in this extension study was blinded to the Sponsor until database lock of Study RDEA594-304.
Pre-assignment Details Subjects randomized to lesinurad (RDEA594) 200 mg or 400 mg + febuxostat (FBX) 80 mg in Study RDEA594-304 continued to receive the same dose in this study. Subjects randomized to placebo + febuxostat 80 mg in Study RDEA594-304 were randomized in a double-blind, 1:1 fashion to either lesinurad 200 mg or 400 mg + febuxostat 80 mg.
Arm/Group Title Lesinurad 200 mg + Febuxostat 80 mg Lesinurad 400 mg + Febuxostat 80 mg
Hide Arm/Group Description [Not Specified] [Not Specified]
Period Title: Overall Study
Started 97 99
Completed 57 51
Not Completed 40 48
Reason Not Completed
Death             1             0
Withdrawal by Subject             16             23
Lost to Follow-up             6             3
Protocol Violation             6             6
Gout flare             0             1
Adverse Event             11             15
Arm/Group Title Lesinurad 400 mg + Febuxostat 80 mg Lesinurad 200 mg + Febuxostat 80 mg Total
Hide Arm/Group Description [Not Specified] [Not Specified] Total of all reporting groups
Overall Number of Baseline Participants 99 97 196
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 99 participants 97 participants 196 participants
52.1  (10.58) 52.9  (10.24) 52.5  (10.41)
Age, Customized  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 99 participants 97 participants 196 participants
< 65 years 88 87 175
>=65 years 11 10 21
Sex/Gender, Customized  
Measure Type: Number
Unit of measure:  Participant
Number Analyzed 99 participants 97 participants 196 participants
Male 7 1 8
Female 92 96 188
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 99 participants 97 participants 196 participants
United States 72 72 144
Canada 2 6 8
Poland 12 13 25
Switzerland 1 0 1
Australia 5 3 8
New Zealand 7 3 10
1.Primary Outcome
Title Percentage of Participants With an sUA Level That is < 5.0 mg/dL
Hide Description Percentage of participants in Study 307 With sUA < 5.0 mg/dL from the Core Studies 304 and Extension Study 307 - Observed Cases
Time Frame Up to approximately 2.5 years (at Extension Month 12)
Hide Outcome Measure Data
Hide Analysis Population Description
Number of Participants Analyzed for this Outcome Measure reflects the number of participants who completed Extension Month 12.
Arm/Group Title Lesinurad 400 mg + Febuxostat 80 mg Lesinurad 200 mg + Febuxostat 80 mg
Hide Arm/Group Description:
[Not Specified]
[Not Specified]
Overall Number of Participants Analyzed 80 72
Measure Type: Number
Unit of Measure: Percentage of participants
82.5 77.8
2.Secondary Outcome
Title Percentage of Participants (With at Least One Target Tophus at Baseline) Who Experience Complete Resolution of at Least One Target Tophus
Hide Description Percentage of participants (With at Least One Target Tophus at Baseline) Who Experience Complete Resolution of at Least One Target Tophus During the Core and Extension Studies at Extension Month 12 (Observed Cases)
Time Frame Up to approximatley 2.5 years (at Extension Month 12)
Hide Outcome Measure Data
Hide Analysis Population Description
ITT Population Number of Participants Analyzed for this Outcome Measure reflects the number of participants who completed through Month 12.
Arm/Group Title Lesinurad 400 mg + Febuxostat 80 mg Lesinurad 200 mg + Febuxostat 80 mg
Hide Arm/Group Description:
[Not Specified]
[Not Specified]
Overall Number of Participants Analyzed 77 70
Measure Type: Number
Unit of Measure: Percentage of participants
61.0 54.3
Time Frame Up to approximately 2.5 years (at Extension Month 12)
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Lesinurad 200 mg + Febuxostat 80 mg Lesinurad 400 mg + Febuxostat 80 mg
Hide Arm/Group Description [Not Specified] [Not Specified]
All-Cause Mortality
Lesinurad 200 mg + Febuxostat 80 mg Lesinurad 400 mg + Febuxostat 80 mg
Affected / at Risk (%) Affected / at Risk (%)
Total   1/97 (1.03%)      0/99 (0.00%)    
Show Serious Adverse Events Hide Serious Adverse Events
Lesinurad 200 mg + Febuxostat 80 mg Lesinurad 400 mg + Febuxostat 80 mg
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   16/97 (16.49%)      19/99 (19.19%)    
Blood and lymphatic system disorders     
Anaemia  1  1/97 (1.03%)  1 0/99 (0.00%)  0
Cardiac disorders     
Atrial fibrillation  1  2/97 (2.06%)  2 0/99 (0.00%)  0
Cardiac failure  1  1/97 (1.03%)  1 0/99 (0.00%)  0
Myocardial infarction  1  0/97 (0.00%)  0 1/99 (1.01%)  1
Gastrointestinal disorders     
Abdominal pain upper  1  0/97 (0.00%)  0 1/99 (1.01%)  1
Gastrointestinal haemorrhage  1  1/97 (1.03%)  1 0/99 (0.00%)  0
Umbilical hernia  1  0/97 (0.00%)  0 1/99 (1.01%)  1
Hepatobiliary disorders     
Cholecystitis  1  1/97 (1.03%)  1 0/99 (0.00%)  0
Infections and infestations     
Pneumonia  1  2/97 (2.06%)  2 1/99 (1.01%)  1
Cellulitis  1  1/97 (1.03%)  1 0/99 (0.00%)  0
Device related infection  1  1/97 (1.03%)  1 0/99 (0.00%)  0
Diverticulitis  1  1/97 (1.03%)  1 0/99 (0.00%)  0
Localised infection  1  0/97 (0.00%)  0 1/99 (1.01%)  1
Urosepsis  1  0/97 (0.00%)  0 1/99 (1.01%)  1
Metabolism and nutrition disorders     
Gout  1  1/97 (1.03%)  1 0/99 (0.00%)  0
Hyperglycaemia  1  0/97 (0.00%)  0 1/99 (1.01%)  1
Musculoskeletal and connective tissue disorders     
Joint destruction  1  0/97 (0.00%)  0 1/99 (1.01%)  1
Lumbar spinal stenosis  1  0/97 (0.00%)  0 1/99 (1.01%)  1
Nervous system disorders     
Cerebrovascular accident  1  1/97 (1.03%)  1 0/99 (0.00%)  0
Subarachnoid haemorrhage  1  1/97 (1.03%)  1 0/99 (0.00%)  0
Syncope  1  0/97 (0.00%)  0 1/99 (1.01%)  1
Psychiatric disorders     
Depression  1  0/97 (0.00%)  0 1/99 (1.01%)  1
Renal and urinary disorders     
Nephrolithiasis  1  0/97 (0.00%)  0 2/99 (2.02%)  2
Renal failure acute  1  0/97 (0.00%)  0 2/99 (2.02%)  2
Renal impairment  1  1/97 (1.03%)  1 0/99 (0.00%)  0
Stag horn calculus  1  0/97 (0.00%)  0 1/99 (1.01%)  1
Respiratory, thoracic and mediastinal disorders     
Dyspnoea  1  1/97 (1.03%)  1 1/99 (1.01%)  1
Epistaxis  1  0/97 (0.00%)  0 1/99 (1.01%)  1
Vascular disorders     
Hypertension  1  0/97 (0.00%)  0 1/99 (1.01%)  1
1
Term from vocabulary, MedDRA version 14.0.
Indicates events were collected by systematic assessment
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events .05%
Lesinurad 200 mg + Febuxostat 80 mg Lesinurad 400 mg + Febuxostat 80 mg
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   61/97 (62.89%)      70/99 (70.71%)    
Gastrointestinal disorders     
Toothache  1  4/97 (4.12%)  4 5/99 (5.05%)  5
Gastrooesophageal reflux disease  1  5/97 (5.15%)  5 1/99 (1.01%)  1
Nausea  1  2/97 (2.06%)  2 2/99 (2.02%)  2
General disorders     
Influenza like illness  1  0/97 (0.00%)  0 4/99 (4.04%)  4
Pyrexia  1  0/97 (0.00%)  0 3/99 (3.03%)  5
Infections and infestations     
Nasopharyngitis  1  6/97 (6.19%)  6 14/99 (14.14%)  20
Bronchitis  1  11/97 (11.34%)  12 4/99 (4.04%)  5
Upper respiratory tract infection  1  8/97 (8.25%)  10 6/99 (6.06%)  9
Sinusitis  1  8/97 (8.25%)  8 5/99 (5.05%)  5
Urinary tract infection  1  6/97 (6.19%)  11 5/99 (5.05%)  5
Influenza  1  0/97 (0.00%)  0 6/99 (6.06%)  7
Cellulitis  1  3/97 (3.09%)  3 2/99 (2.02%)  2
Tooth abscess  1  1/97 (1.03%)  1 2/99 (2.02%)  2
Pharyngitis  1  0/97 (0.00%)  0 2/99 (2.02%)  2
Injury, poisoning and procedural complications     
Laceration  1  0/97 (0.00%)  0 6/99 (6.06%)  6
Muscle strain  1  6/97 (6.19%)  7 0/99 (0.00%)  0
Investigations     
Blood creatinine increased  1  11/97 (11.34%)  14 13/99 (13.13%)  15
Creatinine renal clearance decreased  1  5/97 (5.15%)  6 3/99 (3.03%)  3
Gamma-glutamyltransferase increased  1  2/97 (2.06%)  2 4/99 (4.04%)  6
C-reactive protein increased  1  2/97 (2.06%)  3 2/99 (2.02%)  2
Liver function test abnormal  1  1/97 (1.03%)  1 2/99 (2.02%)  2
Metabolism and nutrition disorders     
Diabetes mellitus  1  0/97 (0.00%)  0 5/99 (5.05%)  6
Hyperlipidaemia  1  0/97 (0.00%)  0 2/99 (2.02%)  2
Vitamin D deficiency  1  0/97 (0.00%)  0 2/99 (2.02%)  2
Musculoskeletal and connective tissue disorders     
Back pain  1  6/97 (6.19%)  10 5/99 (5.05%)  5
Arthralgia  1  4/97 (4.12%)  5 6/99 (6.06%)  11
Osteoarthritis  1  5/97 (5.15%)  5 4/99 (4.04%)  4
Musculoskeletal pain  1  5/97 (5.15%)  5 2/99 (2.02%)  2
Bursitis  1  3/97 (3.09%)  3 2/99 (2.02%)  2
Myalgia  1  2/97 (2.06%)  2 3/99 (3.03%)  3
Joint swelling  1  0/97 (0.00%)  0 4/99 (4.04%)  4
Flank pain  1  0/97 (0.00%)  0 2/99 (2.02%)  3
Neck pain  1  2/97 (2.06%)  2 0/99 (0.00%)  0
Nervous system disorders     
Headache  1  5/97 (5.15%)  6 7/99 (7.07%)  9
Psychiatric disorders     
Insomnia  1  4/97 (4.12%)  4 0/99 (0.00%)  0
Reproductive system and breast disorders     
Benign prostatic hyperplasia  1  1/97 (1.03%)  1 6/99 (6.06%)  7
Vascular disorders     
Hypertension  1  6/97 (6.19%)  6 10/99 (10.10%)  10
1
Term from vocabulary, MedDRA version 14.0.
Indicates events were collected by systematic assessment
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: NCT01808144     History of Changes
Other Study ID Numbers: RDEA594-307
2012-004390-54 ( EudraCT Number )
First Submitted: March 7, 2013
First Posted: March 11, 2013
Results First Submitted: August 21, 2017
Results First Posted: January 30, 2018
Last Update Posted: January 30, 2018