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| ID | Type | Description | Link |
|---|---|---|---|
| U1111-1113-8008 | Registry Identifier | WHO |
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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.
Gout is caused by high levels of uric acid in the body, and is associated with a broad range of conditions including heart disease, chronic kidney disease and high blood pressure. Hyperuricemia, which is defined as an elevation in serum urate levels, develops into gout when urate crystals form in the body and settle in joints and other organs.
Approximately 40-60% of patients with hyperuricemia and gout have some degree of renal impairment. Hyperuricemia has long been associated with renal disease, and chronic hyperuricemia as seen in gout can lead to deposition of urate crystals resulting in diminished renal function.
This study will evaluate the effect of febuxostat on the renal function of patients with hyperuricemia and gout and moderate to severe renal impairment.
All participants must have an average sitting blood pressure measurement less than 160 mmHg systolic and less than 95 mmHg diastolic. All participants must meet the American Rheumatism Association (ARA) diagnostic criteria for gout (subjects with tophi were excluded). Participants are expected to return to the site for approximately 10 visits.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Placebo | Placebo Comparator | Placebo-matching capsules, orally, twice daily for up to 12 months. |
|
| Febuxostat 30 mg BID | Experimental | Febuxostat 30 mg, capsules, orally, twice daily (BID) for up to 12 months. |
|
| Febuxostat 40/80 mg QD | Experimental | Participants initially received febuxostat 40 mg, capsules, once daily (QD) and one placebo-matching capsule QD and remained on this dose for up to 12 months if their serum urate (sUA) was <6.0 mg/dL at the Day 14 visit. Participants whose sUA was ≥6.0 mg/dL at the Day 14 visit received febuxostat 80 mg, capsule, QD, and one placebo-matching capsule QD at the Month 1 visit, and for the remainder of the study. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Febuxostat | Drug | Febuxostat capsules |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline to Month 12 in Serum Creatinine | Renal function was assessed by measuring the change from Baseline in serum creatinine. Analyses were conducted by the Central Laboratory. | Baseline and Month 12 |
| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline to Month 12 in Estimated Glomerular Filtration Rate (eGFR) | Change from baseline to Month 12 in estimated Glomerular Filtration Rate (eGFR) using the Modification of Diet in Renal Disease (MDRD) formula (as calculated by the central laboratory). | Baseline and Month 12 |
| Percentage of Participants With Serum Urate (sUA) Less Than 6 mg/dL at Month 12 |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
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| Name | Affiliation | Role |
|---|---|---|
| Medical Director | Takeda | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Birmingham | Alabama | United States | ||||
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 26894653 | Derived | Saag KG, Whelton A, Becker MA, MacDonald P, Hunt B, Gunawardhana L. Impact of Febuxostat on Renal Function in Gout Patients With Moderate-to-Severe Renal Impairment. Arthritis Rheumatol. 2016 Aug;68(8):2035-43. doi: 10.1002/art.39654. |
| Label | URL |
|---|---|
| Uloric Package Insert | View source |
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Participants meeting the American Rheumatism Association (ARA) diagnostic criteria for gout (subjects with tophi were excluded). were randomized to 1 of 3 arms in a 1:1:1 ratio to receive either febuxostat 40 mg/80 mg once daily (QD) or febuxostat 30 mg twice daily (BID) or placebo for up to 12 months.
Participants took part in the study at 46 investigative sites in the United States from 09 April 2010 to 31 May 2012.
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Placebo | Placebo-matching capsules, orally, twice daily for up to 12 months. |
| FG001 | Febuxostat 30 mg BID | Febuxostat 30 mg, capsules, orally, twice daily (BID) for up to 12 months. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
Not provided
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| Placebo | Drug | Febuxostat placebo-matching capsules |
|
Serum urate concentrations were determined using the enzymatic method as performed by the Central Laboratory. |
| Month 12 |
| Mean Clearance (CL/F) of Febuxostat at Steady State | Mean CL/F at steady state were estimated using a population pharmacokinetic (PK) approach, based on 2 PK samples collected prior to dosing, and 4 PK samples collected postdose. | The 2 pre-dose PK samples collected were collected at any 2 of the following visits: Months 3, 6, 9, and/or 12, at -0.25 to 0 hours. The 4 postdose PK samples were collected at Months 3, 6, and/or 9, at 0.25; 0.75 to 2.0; 2.5 to 4.0; and 5 to 12 hours. |
| Mean Area Under the Concentration-Time Curve During the Dosing Interval (AUC[0-τ]) of Febuxostat at Steady State | Mean AUC during the dosing interval at steady state was estimated using a population pharmacokinetic (PK) approach, based on 2 PK samples collected prior to dosing, and 4 PK samples collected postdose. | The 2 pre-dose PK samples collected were collected at any 2 of the following visits: Months 3, 6, 9, and/or 12, at -0.25 to 0 hours. The 4 postdose PK samples were collected at Months 3, 6, and/or 9, at 0.25; 0.75 to 2.0; 2.5 to 4.0; and 5 to 12 hours. |
| Peoria |
| Arizona |
| United States |
| Sierra Vista | Arizona | United States |
| Tucson | Arizona | United States |
| Little Rock | Arkansas | United States |
| Huntington Park | California | United States |
| Irvine | California | United States |
| Lakewood | California | United States |
| Long Beach | California | United States |
| Sacramento | California | United States |
| San Diego | California | United States |
| San Jose | California | United States |
| Tustin | California | United States |
| Arvada | Colorado | United States |
| Westminster | Colorado | United States |
| Wheat Ridge | Colorado | United States |
| Middlebury | Connecticut | United States |
| Brandon | Florida | United States |
| Daytona Beach | Florida | United States |
| Jacksonville | Florida | United States |
| Miami | Florida | United States |
| Pinellas Park | Florida | United States |
| Port Charlotte | Florida | United States |
| Port Orange | Florida | United States |
| Augusta | Georgia | United States |
| Conyers | Georgia | United States |
| Dunwoody | Georgia | United States |
| Honolulu | Hawaii | United States |
| Boise | Idaho | United States |
| Evergreen Park | Illinois | United States |
| Springfield | Illinois | United States |
| Valparaiso | Indiana | United States |
| Wichita | Kansas | United States |
| Elizabethtown | Kentucky | United States |
| Paducah | Kentucky | United States |
| Baltimore | Maryland | United States |
| Detroit | Michigan | United States |
| Kalamazoo | Michigan | United States |
| Brooklyn Center | Minnesota | United States |
| Neptune City | New Jersey | United States |
| Morganton | North Carolina | United States |
| Wilmington | North Carolina | United States |
| Fargo | North Dakota | United States |
| Oklahoma City | Oklahoma | United States |
| Portland | Oregon | United States |
| Bethlehem | Pennsylvania | United States |
| Anderson | South Carolina | United States |
| Greer | South Carolina | United States |
| Chattanooga | Tennessee | United States |
| Houston | Texas | United States |
| Odessa | Texas | United States |
| San Antonio | Texas | United States |
| Danville | Virginia | United States |
| Fairfax | Virginia | United States |
| Richmond | Virginia | United States |
| Williamsburg | Virginia | United States |
| Clarksburg | West Virginia | United States |
| Wauwatosa | Wisconsin | United States |
| FG002 | Febuxostat 40/80 mg QD | Participants initially received 40 mg febuxostat once daily (QD) and remained on 40 mg QD for up to 12 months if their serum urate (sUA) was <6.0 mg/dL at the Day 14 visit. Participants whose sUA was ≥6.0 mg/dL at the Day 14 visit received febuxostat 80 mg QD at the Month 1 visit, and for the remainder of the study. |
| COMPLETED |
|
| NOT COMPLETED |
|
|
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Placebo | Placebo-matching capsules, orally, twice daily for up to 12 months. |
| BG001 | Febuxostat 30 mg BID | Febuxostat 30 mg, capsules, orally, twice daily (BID) for up to 12 months. |
| BG002 | Febuxostat 40/80 mg QD | Participants initially received 40 mg febuxostat once daily (QD) and remained on 40 mg QD for up to 12 months if their serum urate (sUA) was <6.0 mg/dL at the Day 14 visit. Participants whose sUA was ≥6.0 mg/dL at the Day 14 visit received febuxostat 80 mg QD at the Month 1 visit, and for the remainder of the study. |
| BG003 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age Continuous | Mean | Standard Deviation | years |
| |||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||
| Race/Ethnicity, Customized | Number | participants |
| ||||||||||||||||
| Race/Ethnicity, Customized | Number | participants |
| ||||||||||||||||
| Region of Enrollment | Number | participants |
| ||||||||||||||||
| Height | Mean | Standard Deviation | cm |
| |||||||||||||||
| Weight | Mean | Standard Deviation | kg |
| |||||||||||||||
| Body Mass Index (BMI) | Mean | Standard Deviation | kg/m^2 |
| |||||||||||||||
| Prior Use of ARB or ACEi | ARB = angiotensin receptor blocker ACEi = angiotensin converting enzyme inhibitors | Number | participants |
| |||||||||||||||
| Renal History Based on Creatinine Clearance | Estimated creatinine clearance based on estimated glomerular filtration rate (eGFR) using the Modification of Diet in Renal Disease (MDRD) calculation. Moderately impaired = eGFR ≥ 30-50 mL/min, Severely impaired = eGFR ≥ 15- 29 mL/min. | Number | participants |
| |||||||||||||||
| Serum creatinine level | Number | participants |
| ||||||||||||||||
| Serum Urate | Mean | Standard Deviation | mg/dL |
| |||||||||||||||
| Serum Urate Categories | Number | participants |
| ||||||||||||||||
| Gout flares in the past year | Not all participants had a gout flare within the last year. | Number | participnts |
| |||||||||||||||
| Time since last gout flare | Number | participants |
| ||||||||||||||||
| Previous urate-lowering therapy | Participants may have received more than one urate-lowering therapy. | Number | participants |
| |||||||||||||||
| Number of Lifetime Kidney Stone Episodes | Mean | Standard Deviation | episodes |
| |||||||||||||||
| Kidney Stone Passage | The number of participants with kidney stone episodes was 5, 6 and 11 in each treatment arm respectively. | Number | participants |
| |||||||||||||||
| Composition of most recent passed stone | Number of participants with a kidney stone passage was 2, 1 and 3 in each treatment arm respectively. | Number | participants |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Change From Baseline to Month 12 in Serum Creatinine | Renal function was assessed by measuring the change from Baseline in serum creatinine. Analyses were conducted by the Central Laboratory. | Full analysis set, including all patients who were randomized and received at least 1 dose of double-blind study medication. Only patients with both a baseline value and at least 1 value during the double-blind treatment period are included in the analysis. Missing data were imputed as carrying forward the last observed post-baseline value. | Posted | Least Squares Mean | Standard Error | mg/dL | Baseline and Month 12 |
|
|
|
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Change From Baseline to Month 12 in Estimated Glomerular Filtration Rate (eGFR) | Change from baseline to Month 12 in estimated Glomerular Filtration Rate (eGFR) using the Modification of Diet in Renal Disease (MDRD) formula (as calculated by the central laboratory). | Full analysis set with available data at Baseline. and at least 1 post-baseline value. Missing data was imputed as carrying forward the last post-baseline value. | Posted | Least Squares Mean | Standard Error | mL/min/1.73m² | Baseline and Month 12 |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Percentage of Participants With Serum Urate (sUA) Less Than 6 mg/dL at Month 12 | Serum urate concentrations were determined using the enzymatic method as performed by the Central Laboratory. | Full analysis set, including all patients who were randomized and received at least 1 dose of double-blind study medication. A patient was included in the analysis only when there was at least 1 value during the double-blind treatment period. Missing data were imputed as carrying forward the last observed post-baseline value. | Posted | Number | percentage of participants | Month 12 |
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Mean Clearance (CL/F) of Febuxostat at Steady State | Mean CL/F at steady state were estimated using a population pharmacokinetic (PK) approach, based on 2 PK samples collected prior to dosing, and 4 PK samples collected postdose. | Participants who received febuxostat and had available data for PK analysis. | Posted | Mean | Standard Deviation | liters/hour | The 2 pre-dose PK samples collected were collected at any 2 of the following visits: Months 3, 6, 9, and/or 12, at -0.25 to 0 hours. The 4 postdose PK samples were collected at Months 3, 6, and/or 9, at 0.25; 0.75 to 2.0; 2.5 to 4.0; and 5 to 12 hours. |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Mean Area Under the Concentration-Time Curve During the Dosing Interval (AUC[0-τ]) of Febuxostat at Steady State | Mean AUC during the dosing interval at steady state was estimated using a population pharmacokinetic (PK) approach, based on 2 PK samples collected prior to dosing, and 4 PK samples collected postdose. | Participants who received febuxostat and had available data for PK analysis. | Posted | Mean | Standard Deviation | hr*µg/mL | The 2 pre-dose PK samples collected were collected at any 2 of the following visits: Months 3, 6, 9, and/or 12, at -0.25 to 0 hours. The 4 postdose PK samples were collected at Months 3, 6, and/or 9, at 0.25; 0.75 to 2.0; 2.5 to 4.0; and 5 to 12 hours. |
|
From first double-blind dose date and up to 30 days after the last dose.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Placebo | Placebo-matching capsules, orally, twice daily for up to 12 months. | 7 | 32 | 20 | 32 | ||
| EG001 | Febuxostat 30 mg BID | Febuxostat 30 mg, capsules, orally, twice daily (BID) for up to 12 months. | 5 | 32 | 21 | 32 | ||
| EG002 | Febuxostat 40/80 mg QD | Participants initially received 40 mg febuxostat once daily (QD) and remained on 40 mg QD for up to 12 months if their serum urate (sUA) was <6.0 mg/dL at the Day 14 visit. Participants whose sUA was ≥6.0 mg/dL at the Day 14 visit received febuxostat 80 mg QD at the Month 1 visit, and for the remainder of the study. | 8 | 32 | 23 | 32 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Cardiac Failure Congestive | Cardiac disorders | MedDRA version 15.0 | Systematic Assessment |
| |
| Cardiogenic Shock | Cardiac disorders | MedDRA version 15.0 | Systematic Assessment |
| |
| Acute Myocardial Infarction | Cardiac disorders | MedDRA version 15.0 | Systematic Assessment |
| |
| Atrial Fibrillation | Cardiac disorders | MedDRA version 15.0 | Systematic Assessment |
| |
| Cardiac Arrest | Cardiac disorders | MedDRA version 15.0 | Systematic Assessment |
| |
| Ventricular Fibrillation | Cardiac disorders | MedDRA version 15.0 | Systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA version 15.0 | Systematic Assessment |
| |
| Gastrooesophageal Reflux Disease | Gastrointestinal disorders | MedDRA version 15.0 | Systematic Assessment |
| |
| Adverse Drug Reaction | General disorders | MedDRA version 15.0 | Systematic Assessment |
| |
| Cholecystitis | Hepatobiliary disorders | MedDRA version 15.0 | Systematic Assessment |
| |
| Cholelithiasis | Hepatobiliary disorders | MedDRA version 15.0 | Systematic Assessment |
| |
| Urinary Tract Infection | Infections and infestations | MedDRA version 15.0 | Systematic Assessment |
| |
| Fall | Injury, poisoning and procedural complications | MedDRA version 15.0 | Systematic Assessment |
| |
| Type 2 Diabetes Mellitus | Metabolism and nutrition disorders | MedDRA version 15.0 | Systematic Assessment |
| |
| Hyperkalaemia | Metabolism and nutrition disorders | MedDRA version 15.0 | Systematic Assessment |
| |
| Dehydration | Metabolism and nutrition disorders | MedDRA version 15.0 | Systematic Assessment |
| |
| Fluid Overload | Metabolism and nutrition disorders | MedDRA version 15.0 | Systematic Assessment |
| |
| Flank Pain | Musculoskeletal and connective tissue disorders | MedDRA version 15.0 | Systematic Assessment |
| |
| Musculoskeletal Pain | Musculoskeletal and connective tissue disorders | MedDRA version 15.0 | Systematic Assessment |
| |
| Pain In Extremity | Musculoskeletal and connective tissue disorders | MedDRA version 15.0 | Systematic Assessment |
| |
| Cerebrovascular Accident | Nervous system disorders | MedDRA version 15.0 | Systematic Assessment |
| |
| Renal Failure | Renal and urinary disorders | MedDRA version 15.0 | Systematic Assessment |
| |
| Renal Failure Acute | Renal and urinary disorders | MedDRA version 15.0 | Systematic Assessment |
| |
| Renal Failure Chronic | Renal and urinary disorders | MedDRA version 15.0 | Systematic Assessment |
| |
| Renal Impairment | Renal and urinary disorders | MedDRA version 15.0 | Systematic Assessment |
| |
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA version 15.0 | Systematic Assessment |
| |
| Chronic Obstructive Pulmonary Disease | Respiratory, thoracic and mediastinal disorders | MedDRA version 15.0 | Systematic Assessment |
| |
| Respiratory Failure | Respiratory, thoracic and mediastinal disorders | MedDRA version 15.0 | Systematic Assessment |
| |
| Deep Vein Thrombosis | Vascular disorders | MedDRA version 15.0 | Systematic Assessment |
| |
| Iliac Artery Occlusion | Vascular disorders | MedDRA version 15.0 | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Blood creatinine increased | Investigations | MedDRA version 15.0 | Systematic Assessment |
| |
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA version 15.0 | Systematic Assessment |
| |
| Pain in extremity | Musculoskeletal and connective tissue disorders | MedDRA version 15.0 | Systematic Assessment |
| |
| Renal impairment | Renal and urinary disorders | MedDRA version 15.0 | Systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA version 15.0 | Systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA version 15.0 | Systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA version 15.0 | Systematic Assessment |
| |
| Hyperkalaemia | Metabolism and nutrition disorders | MedDRA version 15.0 | Systematic Assessment |
| |
| Hypokalaemia | Metabolism and nutrition disorders | MedDRA version 15.0 | Systematic Assessment |
| |
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA version 15.0 | Systematic Assessment |
| |
| Hepatic enzyme increased | Investigations | MedDRA version 15.0 | Systematic Assessment |
| |
| Bronchitis | Infections and infestations | MedDRA version 15.0 | Systematic Assessment |
| |
| Oedema peripheral | General disorders | MedDRA version 15.0 | Systematic Assessment |
| |
| Nasopharyngitis | Infections and infestations | MedDRA version 15.0 | Systematic Assessment |
| |
| Hypotension | Vascular disorders | MedDRA version 15.0 | Systematic Assessment |
| |
| Drug hypersensitivity | Immune system disorders | MedDRA version 15.0 | Systematic Assessment |
| |
| Arthritis | Musculoskeletal and connective tissue disorders | MedDRA version 15.0 | Systematic Assessment |
| |
| Depression | Psychiatric disorders | MedDRA version 15.0 | Systematic Assessment |
| |
| Gastritis | Gastrointestinal disorders | MedDRA version 15.0 | Systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA version 15.0 | Systematic Assessment |
| |
| Hypoglycaemia | Metabolism and nutrition disorders | MedDRA version 15.0 | Systematic Assessment |
| |
| Muscle spasms | Musculoskeletal and connective tissue disorders | MedDRA version 15.0 | Systematic Assessment |
| |
| Dizziness | Nervous system disorders | MedDRA version 15.0 | Systematic Assessment |
| |
| Fall | Injury, poisoning and procedural complications | MedDRA version 15.0 | Systematic Assessment |
| |
| Osteoarthritis | Musculoskeletal and connective tissue disorders | MedDRA version 15.0 | Systematic Assessment |
| |
| C-Reactive protein increased | Investigations | MedDRA version 15.0 | Systematic Assessment |
| |
| Rash | Skin and subcutaneous tissue disorders | MedDRA version 15.0 | Systematic Assessment |
| |
| Blood creatine phosphokinase increased | Investigations | MedDRA version 15.0 | Systematic Assessment |
| |
| Tendonitis | Musculoskeletal and connective tissue disorders | MedDRA version 15.0 | Systematic Assessment |
| |
| Urinary tract infection | Infections and infestations | MedDRA version 15.0 | Systematic Assessment |
| |
| Hypertension | Vascular disorders | MedDRA version 15.0 | Systematic Assessment |
|
The first study related publication will be a multi-center publication submitted within 24 months after conclusion or termination of a study at all sites. After such multi site publication, all proposed site publications and presentations will be submitted to sponsor for review 60 days in advance of publication. Site will remove Sponsor confidential information unrelated to study results. Sponsor can delay a proposed publication for another 60 days to preserve intellectual property.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Sr. VP, Clinical Science | Takeda Global Research and Development Center, Inc. | 800-778-2860 | clinicaltrialregistry@tpna.com |
| ID | Term |
|---|---|
| D051437 | Renal Insufficiency |
| D006073 | Gout |
| D033461 | Hyperuricemia |
| ID | Term |
|---|---|
| D007674 | Kidney Diseases |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
| D001168 | Arthritis |
| D007592 | Joint Diseases |
| D009140 | Musculoskeletal Diseases |
| D000070657 | Crystal Arthropathies |
| D012216 | Rheumatic Diseases |
| D011686 | Purine-Pyrimidine Metabolism, Inborn Errors |
| D008661 | Metabolism, Inborn Errors |
| D030342 | Genetic Diseases, Inborn |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
Not provided
Not provided
| ID | Term |
|---|---|
| D000069465 | Febuxostat |
| ID | Term |
|---|---|
| D013844 | Thiazoles |
| D013457 | Sulfur Compounds |
| D009930 | Organic Chemicals |
| D001393 | Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
Not provided
Not provided
| Male |
|
| Not Hispanic or Latino |
|
| Asian |
|
| Native Hawaiian or Other Pacific Islander |
|
| Black or African American |
|
| White |
|
| Other |
|
| Angiotensin converting enzyme inhibitors (ACEi) |
|
| None |
|
| Moderately impaired |
|
| 2.0 to <2.5 mg/dL |
|
| Greater than 2.5 mg/dL |
|
| 9.0 to <10.0 mg/dL |
|
| ≥10 mg/dL |
|
| 4-6 flares |
|
| More than 6 |
|
| 1 to less than 4 months ago |
|
| 4 to less than 6 months ago |
|
| 6 to less than 12 months ago |
|
| more than 1 year ago |
|
| Allopurinol |
|
| Probenecid |
|
| None |
|
| Other |
|
| Uric acid |
|
| Calcium citrate |
|
| Mixed |
|
|
| All statistical tests were two sided and conducted at the 0.05 significance level. | ANCOVA | The model included treatment as a factor, and the baseline value and prior use of an ARB or an ACEi or none as covariates. | 0.789 | No adjustment for multiplicity was made. | LS mean difference | 0.04 | Standard Error of the Mean | 0.133 | 2-Sided | 95 | -0.23 | 0.30 | No | Superiority or Other |
| Units | Counts |
|---|---|
| Participants |
|
|
|
| Units | Counts |
|---|---|
| Participants |
|
|
|
| Units | Counts |
|---|---|
| Participants |
|
|
|
|