Clinical trials: Uric Acid
Renal Impairment
Effect of Febuxostat on Renal Function in Patients With Gout and Moderate to Severe Renal Impairment
The purpose of this study is to determine the effect of febuxostat, once daily (QD) or twice daily (BID), on renal function in gout patients with elevated serum urate levels and who have moderate to severe renal impairment.
- Trial name
- NCT01082640
- Testing
- Febuxostat
- Where
- 58 sites in United States
- Volunteers
- 96 people
- Sponsor
- Takeda
Gout
PREventative Study Against URate-Lowering Drug-Induced Gout Exacerbations (PRE-SURGE 2)
The purpose of this clinical research study was to determine the safety and effectiveness of an experimental drug called rilonacept in participants with gout who are beginning allopurinol treatment for gout.
- Trial name
- NCT00958438
- Testing
- Rilonacept
- Where
- 61 sites in Germany, India and 3 more
- Volunteers
- 248 people
- Sponsor
- Regeneron Pharmaceuticals
Tophaceous Gout
Combination Treatment Study in Subjects With Tophaceous Gout With Lesinurad and Febuxostat
This study will compare the serum uric acid lowering effects, clinical benefits, and safety of lesinurad in combination with febuxostat to febuxostat alone in patients with tophaceaous gout.
- Trial name
- CRYSTAL (NCT01510769)
- Testing
- Lesinurad, Febuxostat
- Where
- 124 sites in United States, Australia and 4 more
- Volunteers
- 330 people
- Sponsor
- Ardea Biosciences, Inc.
Cardiovascular Disease
Cardiovascular Safety of Febuxostat and Allopurinol in Participants With Gout and Cardiovascular Comorbidities (CARES)
The purpose of this study is to see whether subjects with gout who receive febuxostat or allopurinol for up to 9 years have a higher rate of serious heart and blood vessel complications (major cardiovascular events).
- Trial name
- CARES (NCT01101035)
- Testing
- Febuxostat, Allopurinol
- Where
- 203 sites in United States, Mexico
- Volunteers
- 6,198 people
- Sponsor
- Takeda
Gout
Intensive Urate Lowering Therapy of Febuxostat Compared to Allopurinol on Cardiovascular Risk in Patients With Gout
There is a mounting and clear association between hyperuricaemia, gout and the presence of traditional cardiovascular (CV) risk factors and CV event-equivalent conditions such as chronic kidney disease, metabolic syndrome, and…
- Trial name
- FORWARD (NCT02500641)
- Testing
- Febuxostat 80/120mg/day, Allopurinol 100 up to 600mg/day, Colchicine
- Where
- 26 sites in Germany, Italy and 4 more
- Volunteers
- 196 people
- Sponsor
- Menarini International Operations Luxembourg SA
Hyperuricosuria, Kidney Stones
Febuxostat Versus Allopurinol or Placebo in Patients With Hyperuricosuria and Calcium Oxalate Stones
The purpose of this study is to determine the efficacy of febuxostat, once daily (QD), compared to allopurinol or placebo in patients with excessive amounts of uric acid in their urine and who have recently had kidney stones.
- Trial name
- NCT01077284
- Testing
- Febuxostat, Allopurinol
- Where
- 28 sites in United States
- Volunteers
- 99 people
- Sponsor
- Takeda
Gout
Long-Term Safety of Febuxostat in Subjects With Gout.
The purpose of this study is to evaluate the long-term safety of febuxostat, once daily (QD), in maintaining serum urate levels within clinically acceptable levels in subjects with gout.
- Trial name
- FOCUS (NCT00174941)
- Testing
- Febuxostat
- Volunteers
- 116 people
- Sponsor
- Takeda
Gout
Efficacy and Safety of Oral Febuxostat in Participants With Gout
The purpose of this study is to compare the efficacy and safety of febuxostat, once Daily (QD), to allopurinol in subjects with hyperuricemia and gout.
- Trial name
- CONFIRMS (NCT00430248)
- Testing
- Febuxostat, Allopurinol
- Where
- 258 sites in United States
- Volunteers
- 2,269 people
- Sponsor
- Takeda
Tumor Lysis Syndrome, Cancer
Rasburicase Versus Allopurinol in Tumor Patients at Risk for Hyperuricemia and Tumor Lysis Syndrome
This is a randomized, multi-center, open-label, parallel group study with three arms: Rasburicase alone Rasburicase followed by Allopurinol Allopurinol alone The primary objective is to compare the adequacy of control of plasma…
- Conditions
- Tumor Lysis Syndrome, Cancer, Hyperuricemia
- Trial name
- NCT00230178
- Testing
- Rasburicase (SR29142), Allopurinol
- Where
- 15 sites in United States
- Volunteers
- 280 people
- Sponsor
- Sanofi
Gout
Phase 3, Febuxostat, Allopurinol and Placebo-Controlled Study in Gout Subjects.
The purpose of this study is to compare febuxostat, allopurinol and placebo, once daily (QD), in subjects with gout.
- Trial name
- APEX (NCT00174915)
- Testing
- Febuxostat, Allopurinol
- Volunteers
- 1,072 people
- Sponsor
- Takeda
Uncontrolled Gout
Pegloticase and Methotrexate Co-administered in Participants With Uncontrolled Gout Who Previously Failed Pegloticase Monotherapy
This is a Phase 4, multicenter, open-label trial of pegloticase with methotrexate (MTX) in adult participants with uncontrolled gout who were previously treated with pegloticase without a concomitant immunomodulator and stopped…
- Trial name
- NCT04772313
- Testing
- Pegloticase, Methotrexate (MTX)
- Where
- 15 sites in United States
- Volunteers
- 11 people
- Sponsor
- Amgen
Gout, Chronic Kidney Disease (CKD)
A Phase 4 Safety and Efficacy Study to Evaluate Lesinurad 200 mg in Participants With Gout and Renal Impairment
This study evaluates the safety and efficacy of lesinurad administered with an XOI versus a placebo plus an XOI in gout participants who have moderate renal impairment and who are not at target level of serum urate (sUA).
- Trial name
- NCT03226899
- Testing
- Lesinurad, XOI, colchicine
- Where
- 116 sites in United States, Czechia and 2 more
- Volunteers
- 242 people
- Sponsor
- Ironwood Pharmaceuticals, Inc.
Gout
Dose-Response, Safety and Efficacy of Febuxostat in Subjects With Gout
The purpose of this study is to determine the efficacy of febuxostat, once daily (QD), in reducing serum urate levels in subjects with gout.
- Trial name
- NCT00174967
- Testing
- Febuxostat
- Volunteers
- 153 people
- Sponsor
- Takeda
Acute Gouty Arthritis
Long-Term Safety and Tolerability of Canakinumab Prefilled Syringes in Frequently Flaring Acute Gouty Arthritis Patients
This is a 36 week open-label extension of the canakinumab pre-filled syringe study for safety and tolerability in patients who have frequent flares of acute gouty arthritis.
- Trial name
- NCT01431638
- Testing
- Canakinumab 150mg in prefilled syringe
- Where
- 68 sites in United States, Canada and 2 more
- Volunteers
- 397 people
- Sponsor
- Novartis Pharmaceuticals
Hypertension
Impact of MK-0954A on Uric Acid in the Management of Hypertension (MK-0954A-366)
This was a retrospective, chart review, observational study to assess the effect of MK-0954A (losartan potassium 50 mg + hydrochlorothiazide 12.5 mg [Hyzaar(R)]) treatment for a period of at least three months on serum uric acid…
- Trial name
- NCT01368185
- Volunteers
- 1,705 people
- Sponsor
- Organon and Co
Gout
Febuxostat Versus Allopurinol Control Trial in Subjects With Gout
The purpose of this study is to evaluate the safety and efficacy of febuxostat, once daily (QD), versus allopurinol in subjects with gout.
- Trial name
- FACT (NCT00102440)
- Testing
- Febuxostat, Allopurinol
- Volunteers
- 760 people
- Sponsor
- Takeda
Asymptomatic Hyperuricemia
A Study to Assess the Effect of Intensive Uric Acid (UA) Lowering Therapy With RDEA3170, Febuxostat, Dapagliflozin on Urinary Excretion of UA
This is a randomized, placebo controlled, double-blind, 2-way crossover study conducted on asymptomatic hyperuricemic patients. The core study consists of screening period, 2 treatment periods (verinurad + febuxostat +…
- Trial name
- NCT03316131
- Testing
- Verinurad, Febuxostat, Dapagliflozin
- Where
- 2 sites in United States
- Volunteers
- 36 people
- Sponsor
- AstraZeneca
Gout
Allopurinol Versus Febuxostat in Subjects Completing the Phase 3 Trials C02-009 or C02-010
The purpose of this study is to determine the long-term safety of febuxostat, once daily (QD), compared to allopurinol in reducing serum urate levels in subjects with gout.
- Trial name
- EXCEL (NCT00175019)
- Testing
- Febuxostat, Allopurinol
- Volunteers
- 1,086 people
- Sponsor
- Takeda
Acute Gouty Arthritis
Safety and Efficacy of Canakinumab Prefilled Syringes in Frequently Flaring Acute Gouty Arthritis Patients
This study assessed the safety and efficacy of canakinumab pre-filled syringes in comparison to triamcinolone acetonide 40 mg and canakinumab lyophilizate in patients that have frequent flares of acute gouty arthritis.
- Trial name
- NCT01356602
- Testing
- Canakinumab pre-filled syringe, Canakinumab lyophilized powder, Triamcinolone Acetonide
- Where
- 99 sites in United States, Canada and 3 more
- Volunteers
- 397 people
- Sponsor
- Novartis Pharmaceuticals
Intercritical Gout
PREventative Study Against URate-lowering Drug-induced Gout Exacerbations 1
The purpose of this clinical research study was to determine the safety and effectiveness of an experimental drug called rilonacept in subjects with gout who are beginning allopurinol treatment for gout.
- Trial name
- PRE-SURGE1 (NCT00829829)
- Testing
- Rilonacept 80 mg, Rilonacept 160 mg
- Where
- 91 sites in United States, Canada
- Volunteers
- 241 people
- Sponsor
- Regeneron Pharmaceuticals