Trial · NCT01808144

Lesinurad and Febuxostat Combination Extension Study in Gout

NCT01808144, Phase 3, Completed, Ardea Biosciences, Inc.; results first posted 2018-01-30

3 sourcestrials-2026-11-12-0.4.0

Cite this record

ConductScience Library. Lesinurad and Febuxostat Combination Extension Study in Gout. Trials, record NCT01808144. Release trials-2026-11-12-0.4.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01808144

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Trial

As registered on ClinicalTrials.gov, in the graph's capture of the registry.

Title: Lesinurad and Febuxostat Combination Extension Study in Gout
NCT number: NCT01808144
Status: Completed
Phases: Phase 3
Enrollment: 196 participants, actual
Lead sponsor: Ardea Biosciences, Inc.
Conditions: Gout
Interventions: lesinurad, lesinurad, febuxostat
First posted: 2013-03-11
Last updated: 2018-01-30
Other registries' IDs: eudract:2012-004390-54
Results first posted: 2018-01-30

Source ClinicalTrials.gov

Registered outcomes2

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

List	Outcome	Time frame	Description
Primary	Percentage of Participants With an sUA Level That is < 5.0 mg/dL	Up to approximately 2.5 years (at Extension Month 12)	Percentage of participants in Study 307 With sUA \< 5.0 mg/dL from the Core Studies 304 and Extension Study 307 - Observed Cases
Secondary	Percentage of Participants (With at Least One Target Tophus at Baseline) Who Experience Complete Resolution of at Least One Target Tophus	Up to approximatley 2.5 years (at Extension Month 12)	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)

Source ClinicalTrials.gov

Outcomes2

Each outcome the trial posted results for, in ClinicalTrials.gov's words.

Type	Outcome	Time frame	Population	Units	Measured as
PRIMARY	Percentage of Participants With an sUA Level That is < 5.0 mg/dL	Up to approximately 2.5 years (at Extension Month 12)	Number of Participants Analyzed for this Outcome Measure reflects the number of participants who completed Extension Month 12.	Percentage of participants	NUMBER
SECONDARY	Percentage of Participants (With at Least One Target Tophus at Baseline) Who Experience Complete Resolution of at Least One Target Tophus	Up to approximatley 2.5 years (at Extension Month 12)	ITT Population Number of Participants Analyzed for this Outcome Measure reflects the number of participants who completed through Month 12.	Percentage of participants	NUMBER

Source ClinicalTrials.gov

Results by group4

Each measurement the trial posted, group by group, in the words and numbers it posted.

Outcome	Group	Value	Units
Percentage of Participants With an sUA Level That is < 5.0 mg/dL	Lesinurad 400 mg + Febuxostat 80 mg	82.5	Percentage of participants
Percentage of Participants With an sUA Level That is < 5.0 mg/dL	Lesinurad 200 mg + Febuxostat 80 mg	77.8	Percentage of participants
Percentage of Participants (With at Least One Target Tophus at Baseline) Who Experience Complete Resolution of at Least One Target Tophus	Lesinurad 400 mg + Febuxostat 80 mg	61.0	Percentage of participants
Percentage of Participants (With at Least One Target Tophus at Baseline) Who Experience Complete Resolution of at Least One Target Tophus	Lesinurad 200 mg + Febuxostat 80 mg	54.3	Percentage of participants

Source ClinicalTrials.gov

Participant flow6

How many started, completed or left each group, period by period.

Period	Milestone	Group	Participants
Overall Study	STARTED	Lesinurad 200 mg + Febuxostat 80 mg	97
Overall Study	STARTED	Lesinurad 400 mg + Febuxostat 80 mg	99
Overall Study	COMPLETED	Lesinurad 200 mg + Febuxostat 80 mg	57
Overall Study	COMPLETED	Lesinurad 400 mg + Febuxostat 80 mg	51
Overall Study	NOT COMPLETED	Lesinurad 200 mg + Febuxostat 80 mg	40
Overall Study	NOT COMPLETED	Lesinurad 400 mg + Febuxostat 80 mg	48

Source ClinicalTrials.gov

Adverse events132

Each adverse event the trial posted, group by group: the participants affected out of those at risk.

Type	Event	Organ system	Group	Affected	At risk	Events
other	Blood creatinine increased	Investigations	Lesinurad 200 mg + Febuxostat 80 mg	11	97	14
other	Blood creatinine increased	Investigations	Lesinurad 400 mg + Febuxostat 80 mg	13	99	15
other	Nasopharyngitis	Infections and infestations	Lesinurad 200 mg + Febuxostat 80 mg	6	97	6
other	Nasopharyngitis	Infections and infestations	Lesinurad 400 mg + Febuxostat 80 mg	14	99	20
other	Hypertension	Vascular disorders	Lesinurad 200 mg + Febuxostat 80 mg	6	97	6
other	Hypertension	Vascular disorders	Lesinurad 400 mg + Febuxostat 80 mg	10	99	10
other	Bronchitis	Infections and infestations	Lesinurad 200 mg + Febuxostat 80 mg	11	97	12
other	Bronchitis	Infections and infestations	Lesinurad 400 mg + Febuxostat 80 mg	4	99	5
other	Upper respiratory tract infection	Infections and infestations	Lesinurad 200 mg + Febuxostat 80 mg	8	97	10
other	Upper respiratory tract infection	Infections and infestations	Lesinurad 400 mg + Febuxostat 80 mg	6	99	9

1 to 10 of 132Source ClinicalTrials.gov

See all 132 adverse events

Adverse event totals6

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	Lesinurad 200 mg + Febuxostat 80 mg	1	97
Total, all-cause mortality	Lesinurad 400 mg + Febuxostat 80 mg	0	99
Total, other adverse events	Lesinurad 200 mg + Febuxostat 80 mg	61	97
Total, other adverse events	Lesinurad 400 mg + Febuxostat 80 mg	70	99
Total, serious adverse events	Lesinurad 200 mg + Febuxostat 80 mg	16	97
Total, serious adverse events	Lesinurad 400 mg + Febuxostat 80 mg	19	99

Source ClinicalTrials.gov

Papers0

The papers the trial lists on ClinicalTrials.gov.

None in this release.

Grants0

The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.

None in this release.

Trial comparisons2

Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.

Comparison	Source
Lesinurad 200 mg + Febuxostat 80 mg vs Lesinurad 400 mg + Febuxostat 80 mg: deaths from any cause	Trial comparisons
Lesinurad 200 mg + Febuxostat 80 mg vs Lesinurad 400 mg + Febuxostat 80 mg: serious adverse events	Trial comparisons

Tests0

The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.

None in this release.

Source

Release: trials-2026-11-12-0.4.0
Release manifest SHA-256: 0f4a8d8c48aee2a7573ae0fa94ecbeab70c1adbe449bbc95c424bc7d3e97b9d4
Registry capture: 2026-11-12
Results copy, AACT: 2026-03-23
NIH clinical studies file: 2026-11-13

Source ClinicalTrials.gov

Sources 3

ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
ClinicalTrials.govNone stated
NIH RePORTER's clinical studies and project filesPublic domain

Each source's terms

ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
ClinicalTrials.govnone stated
NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)

ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.

For software

Read this trial from software.

The record and each of its lists are JSON, twenty rows a page. No key.

GET https://conductscience.org/api/trials/v1/NCT01808144

GET https://conductscience.org/api/trials/v1/NCT01808144/events?page=2

API reference For AI assistants