Open-Label Lesinurad Monotherapy Extension Study in Gout

• Sponsor: Ardea Biosciences, Inc. (Industry)
• Overall Status: Completed
• CT.gov ID: NCT01650246
• Collaborator: (none)
• Enrollment: 143
• Locations: 75
• Arm: 1
• Duration (Months): 24
• Patients Per Site: 1.9
• Patients Per Site Per Month: 0.1

Study Details

Study Description

Brief Summary

This study will assess the serum uric acid lowering effects and safety of lesinurad over a long-term timeframe.

Condition or Disease	Intervention/Treatment	Phase
Gout	Drug: lesinurad	Phase 3

Detailed Description

This is a Phase 3, open-label, uncontrolled, extension study to assess the long-term efficacy and safety of lesinurad monotherapy in subjects who completed the double-blind treatment period in Study RDEA594-303.

Study Design

• Study Type: Interventional
• Actual Enrollment: 143 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: A Long-Term Open-Label Extension Study for Subjects Completing a Phase 3 Efficacy and Safety Study of Lesinurad Monotherapy in Subjects With Gout
• Study Start Date: Aug 1, 2012
• Actual Primary Completion Date: Apr 1, 2014
• Actual Study Completion Date: Aug 1, 2014

Arms and Interventions

Arm	Intervention/Treatment
Experimental: lesinurad 400 mg	Drug: lesinurad; Tablets, 400 mg QD

Outcome Measures

Primary Outcome Measures

1. Proportion of Subjects With a Serum Urate (sUA) Level That is < 6.0 mg/dL [Month 1]

2. Incidence of Treatment-emergent Adverse Events (TEAEs) [Up to approximately 2 years]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 85 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• Subject is able to understand the study procedures and the risks involved and is willing to provide written informed consent before the first study related activity.

• Subject completed the double-blind treatment period in Study RDEA594-303 and was actively receiving and tolerating study medication (lesinurad or placebo) at Month 6 visit.

• Subject is willing to adhere to the visit/protocol schedules.

• Subject is male or female; female subjects of childbearing potential must agree to use an effective non-hormonal method of birth control during the study and for at least 14 days after the last dose of study medication.

Exclusion Criteria:

• Subject has any other medical or psychological condition, which in the opinion of the Investigator and/or the Medical Monitor, might create undue risk to the subject or interfere with the subject's ability to comply with the protocol requirements or to complete the study.

• Subject has a past medical history of urolithiasis, nephrolithiasis, or kidney stone diathesis.

• Subject developed kidney stones during Study RDEA594-303

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1		Birmingham	Alabama	United States	35209
2		Birmingham	Alabama	United States	35211
3		Birmingham	Alabama	United States	35294
4		Glendale	Arizona	United States	85308
5		Peoria	Arizona	United States	85381
6		Tempe	Arizona	United States	85282
7		Carmichael	California	United States	95608
8		Covina	California	United States	91723
9		Huntington Park	California	United States	90255
10		Irvine	California	United States	92618
11		Colorado Springs	Colorado	United States	80922
12		Denver	Colorado	United States	80220
13		Denver	Colorado	United States	80230
14		Englewood	Colorado	United States	80113
15		Trumbill	Connecticut	United States	06611
16		Boynton Beach	Florida	United States	33472
17		Miami	Florida	United States	33143
18		Plant City	Florida	United States	33563
19		Tampa	Florida	United States	33607
20		Winter Haven	Florida	United States	33880
21		Newnan	Georgia	United States	30265
22		Honolulu	Hawaii	United States	96814
23		Meridian	Indiana	United States	83646
24		Elizabethtown	Kentucky	United States	42701
25		Lexington	Kentucky	United States	40504
26		Metairie	Louisiana	United States	70006
27		Traverse City	Michigan	United States	49684
28		Jackson	Mississippi	United States	39202
29		Olive Branch	Mississippi	United States	38654
30		Albuquerque	New Mexico	United States	87106
31		Brooklyn	New York	United States	11201
32		New Windsor	New York	United States	12553
33		New York	New York	United States	10016
34		Hickory	North Carolina	United States	28602
35		Raleigh	North Carolina	United States	27612
36		Winston Salem	North Carolina	United States	27103
37		Fargo	North Dakota	United States	58103
38		Cincinnati	Ohio	United States	45242
39		Middleburg Heights	Ohio	United States	44130
40		Perrysburg	Ohio	United States	43551
41		Jenkintown	Pennsylvania	United States	19046
42		Landsdale	Pennsylvania	United States	19446
43		Sellersville	Pennsylvania	United States	18960
44		Myrtle Beach	South Carolina	United States	29588
45		Spartanburg	South Carolina	United States	29303
46		Brentwood	Tennessee	United States	37027
47		Spring Hill	Tennessee	United States	37174
48		Dallas	Texas	United States	75235
49		Houston	Texas	United States	77098
50		Bountiful	Utah	United States	84010
51		West Layton	Utah	United States	84041
52		Chesapeake	Virginia	United States	23320
53		Richmond	Virginia	United States	23235
54		Suffold	Virginia	United States	23435
55		Seattle	Washington	United States	98104
56		Spokane	Washington	United States	99208
57		Morgantown	West Virginia	United States	26505
58		Herston	Queensland	Australia	4029
59		Hobart	Tasmania	Australia	7000
60		Genk		Belgium	3600
61		Gozée		Belgium	6534
62		Kortrijk		Belgium	8500
63		Yvoir		Belgium	5530
64		Toronto	Ontario	Canada	M9W 4L6
65		Rimouski	Quebec	Canada	G5L 8W1
66		Quebec		Canada	G1V 3M7
67		Dresden		Germany	01069
68		Leipzig		Germany	04109
69		Grafton	Auckland	New Zealand	1023
70		Tauranga		New Zealand	3143
71		Silverglen	Durban	South Africa	4092
72		Muckleneuk	Pretoria	South Africa	0002
73		Rondebosch		South Africa	7700
74		Stellenbosch		South Africa	7600
75		Thabazimbi		South Africa	0380

Sponsors and Collaborators

• Ardea Biosciences, Inc.

Investigators

• Study Director: Chris Storgard, MD, Ardea Biosciences, Inc.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Ardea Biosciences, Inc.
• ClinicalTrials.gov Identifier: NCT01650246
• Other Study ID Numbers: RDEA594-305
• First Posted: Jul 26, 2012
• Last Update Posted: May 26, 2016
• Last Verified: Apr 1, 2016

• Additional relevant MeSH terms: Gout; Lesinurad

Study Results

Participant Flow

Arm/Group Title	Lesinurad 400 mg
Arm/Group Description	lesinurad 400 mg once daily (qd)
Period Title: Overall Study
STARTED	143
COMPLETED	0
NOT COMPLETED	143

Baseline Characteristics

Arm/Group Title	Lesinurad 400 mg
Arm/Group Description	lesinurad 400 mg once daily (qd)
Overall Participants	143
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	55.1 (12.0)
Age, Customized (Number) [Number]
<65 Years	111 77.6%
>=65 Years	32 22.4%
Sex: Female, Male (Count of Participants)
Female	11 7.7%
Male	132 92.3%
Region of Enrollment (Number) [Number]
Australia	2 1.4%
Belgium	9 6.3%
Canada	6 4.2%
Germany	6 4.2%
New Zealand	3 2.1%
South Africa	16 11.2%
United States	101 70.6%

Outcome Measures

1. Primary Outcome

Title	Proportion of Subjects With a Serum Urate (sUA) Level That is < 6.0 mg/dL
Time Frame	Month 1

Outcome Measure Data

Analysis Population Description

Safety Population

Arm/Group Title	Lesinurad 400 mg
Arm/Group Description	lesinurad 400 mg once daily (qd)
Measure Participants	143
Number [Subjects]	68

2. Primary Outcome

Title	Incidence of Treatment-emergent Adverse Events (TEAEs)
Time Frame	Up to approximately 2 years

Outcome Measure Data

Analysis Population Description

Safety Population

Arm/Group Title	Lesinurad 400 mg
Arm/Group Description	lesinurad 400 mg once daily (qd)
Measure Participants	143
Number [TEAEs]	105

Adverse Events

Arm/Group Title	Lesinurad 400 mg
Arm/Group Description	lesinurad 400 mg once daily (qd)
All Cause Mortality
	Lesinurad 400 mg
	Affected / at Risk (%)	# Events
Total	/ (NaN)
Serious Adverse Events
	Lesinurad 400 mg
	Affected / at Risk (%)	# Events
Total	15/143 (10.5%)
Cardiac disorders
Angina pectoris	1/143 (0.7%)	1
Atrioventricular clock complete	1/143 (0.7%)	1
Coronary Artery disease	1/143 (0.7%)	1
Myocardial infarction	1/143 (0.7%)	1
Gastrointestinal disorders
Pancreatitis	1/143 (0.7%)	1
General disorders
Death	1/143 (0.7%)	1
Infections and infestations
Bursitis infective	1/143 (0.7%)	1
Gastroenteritis salmonella	1/143 (0.7%)	1
Metabolism and nutrition disorders
Gout	1/143 (0.7%)	1
Musculoskeletal and connective tissue disorders
Facet joint syndrome	1/143 (0.7%)	1
Nervous system disorders
Transient ischaemic attack	1/143 (0.7%)	1
Psychiatric disorders
Depression	1/143 (0.7%)	1
Schizoaffective disorder	1/143 (0.7%)	2
Renal and urinary disorders
Nephrolithiasis	3/143 (2.1%)	3
Renal impairment	1/143 (0.7%)	1
Renal Failure Acute	1/143 (0.7%)	1
Other (Not Including Serious) Adverse Events
	Lesinurad 400 mg
	Affected / at Risk (%)	# Events
Total	73/143 (51%)
Gastrointestinal disorders
Abdominal pain upper	3/143 (2.1%)	3
Gastrooesophageal reflux disease	3/143 (2.1%)	3
Vomiting	4/143 (2.8%)	7
General disorders
Fatigue	4/143 (2.8%)	4
Pyrexia	3/143 (2.1%)	3
Infections and infestations
Bronchitis	5/143 (3.5%)	5
Gastroenteritis	7/143 (4.9%)	8
Influenza	3/143 (2.1%)	3
Sinusitis	4/143 (2.8%)	5
Upper respiratory tract infection	14/143 (9.8%)	15
Urinary tract infection	7/143 (4.9%)	8
Nasopharyngitis	4/143 (2.8%)	5
Investigations
Blood creatine phosphokinase increased	4/143 (2.8%)	4
Blood creatinine increased	16/143 (11.2%)	20
Metabolism and nutrition disorders
Hyperlipidaemia	3/143 (2.1%)	3
Musculoskeletal and connective tissue disorders
Arthralgia	6/143 (4.2%)	6
Back pain	7/143 (4.9%)	8
Flank pain	3/143 (2.1%)	4
Pain in extremity	3/143 (2.1%)	4
Nervous system disorders
Headache	6/143 (4.2%)	8
Renal and urinary disorders
Nephrolithiasis	3/143 (2.1%)	3
Renal impairment	4/143 (2.8%)	4
Respiratory, thoracic and mediastinal disorders
Cough	4/143 (2.8%)	5
Vascular disorders
Hypertension	10/143 (7%)	10

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

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.