A Phase 3 interventional study of lesinurad and lesinurad in Gout, sponsored by Ardea Biosciences, Inc.. Completed at 72 sites in 6 countries. Open to participants aged 18 Years to 85 Years. Per ClinicalTrials.gov, last updated 2018-01-30.
Sponsored by Ardea Biosciences, Inc. (part of AstraZeneca) · Phase 3, Interventional, and Treatment
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Among 12 studies testing lesinurad in Gout — none open to participants now, none under way, none of them phase 3. lesinurad · Gout.
Among the 12 studies testing lesinurad in Gout, this one is the 8th largest by enrollment, is one of 3 that started in 2013, is one of 7 in phase 3, and was the 8th registered.
345 studies on the registry are indexed under Gout; 49 are open to participants now.
Browse Gout studies →None of the 12 studies testing lesinurad in Gout is open now. The open studies under Gout, anywhere →
lesinurad: first FDA approval 2015 (ZURAMPIC), first EMA approval 2016. What it is approved for, and how studies give it, is on its page →
Of the 30 Gout studies recruiting now, 14 (47%) set no upper age limit and 10 (33%) stop at 75 or younger; none take children under 18; none take healthy volunteers.
This study: 18 Years to 85 Years · all sexes · no healthy volunteers.
The full table on the hub →This tab as a report to print or save as PDF → With an account.
12 studies; the count open now beside each. This study's row is marked.
First in 2009; this study’s year is marked. 3 started in 2013.
By drug class, each counting the studies that test any of its medicines:
This study's enrollment of 196 is above the median of 83 across 286 interventional studies indexed under Gout.
Median enrollment 221 across the 12 interventional studies. Of the 12 that completed or were terminated, 7 (58%) have results posted.
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12 of 12 have an industry lead sponsor. The 2 most frequent:
This study is registered under Ardea Biosciences, Inc., one of the names counted as AstraZeneca. Under that name alone:
Ardea Biosciences, Inc. is the lead sponsor of 36 studies on the registry; none are open to participants now.
27 studies in Gout by AstraZeneca: none open now, none under way, none of them phase 3. Of 26 finished, 14 (54%) have results posted.
Among the 27 studies in Gout by AstraZeneca, this one is the 9th largest by enrollment of the 24 interventional ones that give a count, is one of 5 that started in 2013, is one of 7 in phase 3, and was the 11th registered.
AstraZeneca’s Gout studies by the year they started, since 2008.
None of the studies under way reaches primary completion within a year.
Among the 12 studies testing lesinurad in Gout, from their registry updates:
Nothing recorded among them since 2026-09-25.
Among AstraZeneca’s 27 in Gout:
Nothing recorded among them since 2026-09-25.
This tab as a report to print or save as PDF → With an account.
This study will assess the serum uric acid lowering effects and safety of lesinurad in combination with febuxostat over a long-term timeframe.
This is a Phase 3 extension study to assess the long-term efficacy and safety of lesinurad in combination with febuxostat in subjects who completed the double-blind treatment period in Study RDEA594-304.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Childbearing potential
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Patients on lesinurad 400 mg had their dose changed to lesinurad 200 mg after implementation of protocol amendment 3, dated 07 October 2015.
Drug: lesinurad · Drug: febuxostat
Drug: lesinurad · Drug: febuxostat
Tablets, 400 mg once daily (QD)
Tablets, 200 mg QD
Tabletsm 80 mg QD
Percentage of Participants With an sUA Level That is < 5.0 mg/dL
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)
Percentage of Participants (With at Least One Target Tophus at Baseline) Who Experience Complete Resolution of at Least One Target Tophus
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)
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.
| Milestone | Lesinurad 200 mg + Febuxostat 80 mg | Lesinurad 400 mg + Febuxostat 80 mg |
|---|---|---|
| Started | 97 | 99 |
| Completed | 57 | 51 |
| Not completed | 40 | 48 |
| Withdrew: Death | 1 | 0 |
| Withdrew: Withdrawal by subject | 16 | 23 |
| Withdrew: Lost to follow-up | 6 | 3 |
| Withdrew: Protocol violation | 6 | 6 |
| Withdrew: Gout flare | 0 | 1 |
| Withdrew: Adverse event | 11 | 15 |
Percentage of participants in Study 307 With sUA \< 5.0 mg/dL from the Core Studies 304 and Extension Study 307 - Observed Cases
| Percentage of participants | Lesinurad 400 mg + Febuxostat 80 mg | Lesinurad 200 mg + Febuxostat 80 mg |
|---|---|---|
| Percentage of Participants With an sUA Level That is < 5.0 mg/dL | 82.5 | 77.8 |
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)
| Percentage of participants | Lesinurad 400 mg + Febuxostat 80 mg | Lesinurad 200 mg + Febuxostat 80 mg |
|---|---|---|
| Percentage of Participants (With at Least One Target Tophus at Baseline) Who Experience Complete Resolution of at Least One Target Tophus | 61.0 | 54.3 |
Collected over Up to approximately 2.5 years (at Extension Month 12). Non-serious events are listed at a .05% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Lesinurad 200 mg + Febuxostat 80 mg | 1/97 (1%) | 16/97 (16.5%) | 61/97 (62.9%) |
| Lesinurad 400 mg + Febuxostat 80 mg | 0/99 (0%) | 19/99 (19.2%) | 70/99 (70.7%) |
| Event | Lesinurad 200 mg + Febuxostat 80 mg | Lesinurad 400 mg + Febuxostat 80 mg |
|---|---|---|
| PneumoniaInfections and infestations | 2/97 | 1/99 |
| Atrial fibrillationCardiac disorders | 2/97 | 0/99 |
| NephrolithiasisRenal and urinary disorders | 0/97 | 2/99 |
| Renal failure acuteRenal and urinary disorders | 0/97 | 2/99 |
| CellulitisInfections and infestations | 1/97 | 0/99 |
| Device related infectionInfections and infestations | 1/97 | 0/99 |
| DiverticulitisInfections and infestations | 1/97 | 0/99 |
| AnaemiaBlood and lymphatic system disorders | 1/97 | 0/99 |
| GoutMetabolism and nutrition disorders | 1/97 | 0/99 |
| Cerebrovascular accidentNervous system disorders | 1/97 | 0/99 |
| Event | Lesinurad 200 mg + Febuxostat 80 mg | Lesinurad 400 mg + Febuxostat 80 mg |
|---|---|---|
| NasopharyngitisInfections and infestations | 6/97 | 14/99 |
| Blood creatinine increasedInvestigations | 11/97 | 13/99 |
| BronchitisInfections and infestations | 11/97 | 4/99 |
| HypertensionVascular disorders | 6/97 | 10/99 |
| Upper respiratory tract infectionInfections and infestations | 8/97 | 6/99 |
| SinusitisInfections and infestations | 8/97 | 5/99 |
| HeadacheNervous system disorders | 5/97 | 7/99 |
| Back painMusculoskeletal and connective tissue disorders | 6/97 | 5/99 |
| Urinary tract infectionInfections and infestations | 6/97 | 5/99 |
| Muscle strainInjury, poisoning and procedural complications | 6/97 | 0/99 |
| Age, Continuous(Years) | Lesinurad 400 mg + Febuxostat 80 mg | Lesinurad 200 mg + Febuxostat 80 mg | Total |
|---|---|---|---|
| Mean | 52.1 ± 10.58 | 52.9 ± 10.24 | 52.5 ± 10.41 |
| Age, Customized(Participants) | Lesinurad 400 mg + Febuxostat 80 mg | Lesinurad 200 mg + Febuxostat 80 mg | Total |
|---|---|---|---|
| < 65 years | 88 | 87 | 175 |
| >=65 years | 11 | 10 | 21 |
| Sex/Gender, Customized(Participant) | Lesinurad 400 mg + Febuxostat 80 mg | Lesinurad 200 mg + Febuxostat 80 mg | Total |
|---|---|---|---|
| Male | 7 | 1 | 8 |
| Female | 92 | 96 | 188 |
| Region of Enrollment(Participants) | Lesinurad 400 mg + Febuxostat 80 mg | Lesinurad 200 mg + Febuxostat 80 mg | Total |
|---|---|---|---|
| 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 |
Ran from Mar 2013 to primary completion in Aug 2016, 41 months.
Results were first posted in Jan 2018, 1 year 5 months after primary completion.
Of 21 phase 3 interventional studies under Gout, half reached primary completion within 20 months of starting (the median), counting those still running; a quarter within 17 and three quarters within 25. This study's 41 months is above that.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Jan 2018. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Lesinurad