| Primary | Urinary Albumin to Creatinine Ratio (UACR) | LS Mean Percentage Change (95% CI) from Baseline in UACR | Number analyzed at 12 weeks was less than the overall number analyzed due to missing observations | Posted | | Least Squares Mean | 95% Confidence Interval | Precent change | | From Baseline to 12 Weeks of Treatment | | | | ID | Title | Description |
|---|
| OG000 | Verinurad 9 mg+Febuxostat 80 mg | Capsule administered orally, once daily for 24 weeks | | OG001 | Placebo | Capsule administered orally, once daily for 24 weeks |
| | | Title | Denominators | Categories |
|---|
| | | Title | Measurements |
|---|
| - OG000-48.65(-64.807 to -25.089)
- OG001-15.31(-43.244 to 26.370)
|
|
| | Group IDs | Group Description | Statistical Method | Statistical Comment | P-Value | P-Value Comment | Parameter Type | Parameter Value | Dispersion Type | Dispersion Value | Confidence Interval Sides | Confidence Interval % | CI Lower Limit | CI Upper Limit | CI Lower Limit Comment | CI Upper Limit Comment | Estimate Comment | Tested Non-Inferiority | Non-Inferiority Type | Non-Inferiority Comment | Other Analysis Description |
|---|
| | | | | | Mean % Change from Baseline | -39.37 | | | 2-Sided | 90 | -61.785 | -3.814 | | | | | Superiority | | |
|
| Secondary | sUA | LS Mean Percentage Change (95% CI) from Baseline in sUA | Number analyzed at 12 and 24 weeks was less than the overall number analyzed due to missing observations | Posted | | Least Squares Mean | 95% Confidence Interval | Percent change | | From Baseline to 12 Weeks and 24 Weeks of Treatment | | | | ID | Title | Description |
|---|
| OG000 | Verinurad 9 mg+Febuxostat 80 mg | Capsule administered orally, once daily for 24 weeks | | OG001 | Placebo | Capsule administered orally, once daily for 24 weeks |
| |
| Secondary | eGFR | LS Mean Percentage Change (95% CI) from Baseline in eGFR | Number analyzed at 12 and 24 weeks was less than the overall number analyzed due to missing observations | Posted | | Least Squares Mean | 95% Confidence Interval | Percent change | | From Baseline to 12 Weeks and 24 Weeks of Treatment | | | | ID | Title | Description |
|---|
| OG000 | Verinurad 9 mg+Febuxostat 80 mg | Capsule administered orally, once daily for 24 weeks | | OG001 | Placebo | Capsule administered orally, once daily for 24 weeks |
| |
| Secondary | Serum Creatinine | LS Mean Percentage Change (95% CI) from Baseline in Serum Creatinine | Number analyzed at 12 and 24 weeks was less than the overall number analyzed due to missing observations | Posted | | Least Squares Mean | 95% Confidence Interval | Percent change | | From Baseline to 12 Weeks and 24 Weeks of Treatment | | | | ID | Title | Description |
|---|
| OG000 | Verinurad 9 mg+Febuxostat 80 mg | Capsule administered orally, once daily for 24 weeks | | OG001 | Placebo | Capsule administered orally, once daily for 24 weeks |
| |
| Secondary | Serum Cystatin C | LS Mean Percentage Change (95% CI) from Baseline in Serum Cystatin C | Number analyzed at 12 and 24 weeks was less than the overall number analyzed due to missing observations | Posted | | Least Squares Mean | 95% Confidence Interval | Percent change | | From Baseline to 12 Weeks and 24 Weeks of Treatment | | | | ID | Title | Description |
|---|
| OG000 | Verinurad 9 mg+Febuxostat 80 mg | Capsule administered orally, once daily for 24 weeks | | OG001 | Placebo | Capsule administered orally, once daily for 24 weeks |
| |
| Secondary | Serum High Sensitivity C-reactive Protein | LS Mean Percentage Change (95% CI) from Baseline in Serum High Sensitivity C-reactive Protein | Number analyzed at 12 and 24 weeks was less than the overall number analyzed due to missing observations | Posted | | Least Squares Mean | 95% Confidence Interval | Percent change | | From Baseline to 12 Weeks and 24 Weeks of Treatment | | | | ID | Title | Description |
|---|
| OG000 | Verinurad 9 mg+Febuxostat 80 mg | Capsule administered orally, once daily for 24 weeks | | OG001 | Placebo | Capsule administered orally, once daily for 24 weeks |
| |
| Secondary | Clinical Assessments | Change from Baseline in Diastolic and Systolic Blood Pressure | Number analyzed at 12 and 24 weeks was less than the overall number analyzed due to missing observations | Posted | | Mean | Standard Deviation | mm/Hg | | From Baseline to 12 Weeks and 24 Weeks of Treatment | | | | ID | Title | Description |
|---|
| OG000 | Verinurad 9 mg+Febuxostat 80 mg | Capsule administered orally, once daily for 24 weeks | | OG001 | Placebo | Capsule administered orally, once daily for 24 weeks |
| |
| Secondary | MRI Variables - LV Mass/End-diastolic Volume | Change from Baseline in MRI Variables at Week 24 (CFB = Change from Baseline) | Number analyzed at 24 weeks was less than the overall number analyzed due to missing observations | Posted | | Mean | Standard Deviation | g/mL | | From Baseline to 24 Weeks of Treatment | | | | ID | Title | Description |
|---|
| OG000 | Verinurad 9 mg+Febuxostat 80 mg | Capsule administered orally, once daily for 24 weeks | | OG001 | Placebo | Capsule administered orally, once daily for 24 weeks |
| |
| Other Pre-specified | Flow Mediated Dilatation (Reactive Hyperemia) | LS Mean Change (95% CI) from Baseline in Flow Mediated Dilatation. The flow mediated dilatation metric is obtained using a device from Cordex, and a proprietary algorithm. This metric represents the volume difference between a baseline arterial compliance curve and hyperemia arterial compliance curve in the positive transmural pressure region. This metric has a direct relationship to a subject's cardiovascular condition. Output range is 0-150. A higher score is indicative of a better flow mediated dilatation. | Number analyzed at 12 and 24 weeks was less than the overall number analyzed due to missing observations | Posted | | Least Squares Mean | 95% Confidence Interval | Units on a scale | | From Baseline to 12 Weeks and 24 Weeks of Treatment | | | | ID | Title | Description |
|---|
| OG000 | Verinurad 9 mg+Febuxostat 80 mg | Capsule administered orally, once daily for 24 weeks | | OG001 | Placebo | Capsule administered orally, once daily for 24 weeks |
| |
| Other Pre-specified | Urinalysis | Changes in Urinalysis (CFB = Change from Baseline) | Number analyzed at 12 and 24 weeks was less than the overall number analyzed due to missing observations | Posted | | Mean | Standard Deviation | mg/dL | | From Baseline to 12 Weeks and 24 Weeks of Treatment | | | | ID | Title | Description |
|---|
| OG000 | Verinurad 9 mg+Febuxostat 80 mg | Capsule administered orally, once daily for 24 weeks | | OG001 | Placebo | Capsule administered orally, once daily for 24 weeks |
| |
| Other Pre-specified | Clinical Chemistry Values | Changes in Clinical Chemistry Values (CFB = Change for Baseline) | Number analyzed at 12 and 24 weeks was less than the overall number analyzed due to missing observations | Posted | | Mean | Standard Deviation | pmol/L | | From Baseline to 12 Weeks and 24 Weeks of Treatment | | | | ID | Title | Description |
|---|
| OG000 | Verinurad 9 mg+Febuxostat 80 mg | Capsule administered orally, once daily for 24 weeks | | OG001 | Placebo | Capsule administered orally, once daily for 24 weeks |
| |
| Primary | Urinary Albumin to Creatinine Ratio (UACR) Compared to Placebo | LS Mean Percentage Change (90% CI) from Baseline in UACR Compared to Placebo | Number analyzed at 24 weeks was less than the overall number analyzed due to missing observations | Posted | | Least Squares Mean | 90% Confidence Interval | Precent change | | From Baseline to 24 Weeks of Treatment | | | | ID | Title | Description |
|---|
| OG000 | Verinurad 9 mg+Febuxostat 80 mg | Capsule administered orally, once daily for 24 weeks | | OG001 | Placebo | Capsule administered orally, once daily for 24 weeks |
| |
| Secondary | MRI Variables - Kidney Cortex T2 Star - BOLD MRI | Change from Baseline in MRI Variables at Week 24 (CFB = Change from Baseline) | Number analyzed at 24 weeks was less than the overall number analyzed due to missing observations | Posted | | Mean | Standard Deviation | ms | | From Baseline to 24 Weeks of Treatment | | | | ID | Title | Description |
|---|
| OG000 | Verinurad 9 mg+Febuxostat 80 mg | Capsule administered orally, once daily for 24 weeks | | OG001 | Placebo | Capsule administered orally, once daily for 24 weeks |
| |
| Secondary | MRI Variables - LV End-diastolic Volume, LV End-systolic Volume, LV Stroke Volume | Change from Baseline in MRI Variables at Week 24 (CFB = Change from Baseline) | Number analyzed at 24 weeks was less than the overall number analyzed due to missing observations | Posted | | Mean | Standard Deviation | mL | | From Baseline to 24 Weeks of Treatment | | | | ID | Title | Description |
|---|
| OG000 | Verinurad 9 mg+Febuxostat 80 mg | Capsule administered orally, once daily for 24 weeks | | OG001 | Placebo | Capsule administered orally, once daily for 24 weeks |
| |
| Secondary | MRI Variables - LV Ejection Fraction, Circumferential Strain, Longitudinal Strain, Radial Strain | Change from baseline in MRI Variables at Week 24 (CFB = Change from Baseline) | Number analyzed at 24 weeks was less than the overall number analyzed due to missing observations | Posted | | Mean | Standard Deviation | % (change in percentage from baseline) | | From Baseline to 24 Weeks of Treatment | | | | ID | Title | Description |
|---|
| OG000 | Verinurad 9 mg+Febuxostat 80 mg | Capsule administered orally, once daily for 24 weeks | | OG001 | Placebo | Capsule administered orally, once daily for 24 weeks |
| |
| Secondary | MRI Variables - Diastolic Circumferential Strain Rate, Longitudinal Strain Rate, Radial Strain Rate and Systolic Circumferential Strain Rate, Longitudinal Strain Rate, Radial Strain Rate | Change from Baseline in MRI Variables at Week 24 (CFB = Change from Baseline) | Number analyzed at 24 weeks was less than the overall number analyzed due to missing observations | Posted | | Mean | Standard Deviation | s^-1 | | From Baseline to 24 Weeks of Treatment | | | | ID | Title | Description |
|---|
| OG000 | Verinurad 9 mg+Febuxostat 80 mg | Capsule administered orally, once daily for 24 weeks | | OG001 | Placebo | Capsule administered orally, once daily for 24 weeks |
| |
| Secondary | MRI Variables - LV Mass | Change from Baseline in MRI Variables at Week 24 (CFB = Change from Baseline) | Number analyzed at 24 weeks was less than the overall number analyzed due to missing observations | Posted | | Mean | Standard Deviation | g | | From Baseline to 24 Weeks of Treatment | | | | ID | Title | Description |
|---|
| OG000 | Verinurad 9 mg+Febuxostat 80 mg | Capsule administered orally, once daily for 24 weeks | | OG001 | Placebo | Capsule administered orally, once daily for 24 weeks |
| |
| Other Pre-specified | Urinalysis | Changes in Urinalysis (CFB = Change from Baseline) | Number analyzed at 12 and 24 weeks was less than the overall number analyzed due to missing observations | Posted | | Mean | Standard Deviation | mg/g | | From Baseline to 12 Weeks and 24 Weeks of Treatment | | | | ID | Title | Description |
|---|
| OG000 | Verinurad 9 mg+Febuxostat 80 mg | Capsule administered orally, once daily for 24 weeks | | OG001 | Placebo | Capsule administered orally, once daily for 24 weeks |
| |
| Other Pre-specified | Clinical Chemistry Values | Changes in Clinical Chemistry Values (CFB = Change for Baseline) | Number analyzed at 12 and 24 weeks was less than the overall number analyzed due to missing observations | Posted | | Mean | Standard Deviation | % hemoglobin bound to glucose | | From Baseline to 12 Weeks and 24 Weeks of Treatment | | | | ID | Title | Description |
|---|
| OG000 | Verinurad 9 mg+Febuxostat 80 mg | Capsule administered orally, once daily for 24 weeks | | OG001 | Placebo | Capsule administered orally, once daily for 24 weeks |
| |
| Other Pre-specified | Baseline eGFR | | | Posted | | Mean | Standard Deviation | mL/min/1.73m2 | | Baseline | | | | ID | Title | Description |
|---|
| OG000 | Verinurad 9 mg+Febuxostat 80 mg | Capsule administered orally, once daily for 24 weeks | | OG001 | Placebo | Capsule administered orally, once daily for 24 weeks |
| |
| Other Pre-specified | Baseline UACR | | | Posted | | Mean | Standard Deviation | mg/g | | Baseline | | | | ID | Title | Description |
|---|
| OG000 | Verinurad 9 mg+Febuxostat 80 mg | Capsule administered orally, once daily for 24 weeks | | OG001 | Placebo | Capsule administered orally, once daily for 24 weeks |
| |
| Other Pre-specified | Baseline Serum Uric Acid (sUA) | | | Posted | | Mean | Standard Deviation | mg/dL | | Baseline | | | | ID | Title | Description |
|---|
| OG000 | Verinurad 9 mg+Febuxostat 80 mg | Capsule administered orally, once daily for 24 weeks | | OG001 | Placebo | Capsule administered orally, once daily for 24 weeks |
| |
| Other Pre-specified | Baseline Serum Creatinine | | | Posted | | Mean | Standard Deviation | mg/dL | | Baseline | | | | ID | Title | Description |
|---|
| OG000 | Verinurad 9 mg+Febuxostat 80 mg | Capsule administered orally, once daily for 24 weeks | | OG001 | Placebo | Capsule administered orally, once daily for 24 weeks |
| |
| Other Pre-specified | Baseline Serum Cystatin-C | | | Posted | | Mean | Standard Deviation | mg/L | | Baseline | | | | ID | Title | Description |
|---|
| OG000 | Verinurad 9 mg+Febuxostat 80 mg | Capsule administered orally, once daily for 24 weeks | | OG001 | Placebo | Capsule administered orally, once daily for 24 weeks |
| |
| Other Pre-specified | Baseline Serum High-sensitivity C-reactive Protein | | | Posted | | Mean | Standard Deviation | mg/dL | | Baseline | | | | ID | Title | Description |
|---|
| OG000 | Verinurad 9 mg+Febuxostat 80 mg | Capsule administered orally, once daily for 24 weeks | | OG001 | Placebo | Capsule administered orally, once daily for 24 weeks |
| |
| Other Pre-specified | Baseline MRI Variables - Kidney Cortex T2 Star | | Total number differs from Study totals due to subject non compliance with MRI (exam not completed) | Posted | | Mean | Standard Deviation | ms | | Baseline | | | | ID | Title | Description |
|---|
| OG000 | Verinurad 9 mg+Febuxostat 80 mg | Capsule administered orally, once daily for 24 weeks | | OG001 | Placebo | Capsule administered orally, once daily for 24 weeks |
| |
| Other Pre-specified | Baseline MRI Variables - LV End-diastolic Volume | | Total number differs from Study totals due to subject non compliance with MRI (exam not completed) | Posted | | Mean | Standard Deviation | mL | | Baseline | | | | ID | Title | Description |
|---|
| OG000 | Verinurad 9 mg+Febuxostat 80 mg | Capsule administered orally, once daily for 24 weeks | | OG001 | Placebo | Capsule administered orally, once daily for 24 weeks |
| |
| Other Pre-specified | Baseline MRI Variables - LV Ejection Fraction | | Total number differs from Study totals due to subject non compliance with MRI (exam not completed) | Posted | | Mean | Standard Deviation | % (percentage of LV volume) | | Baseline | | | | ID | Title | Description |
|---|
| OG000 | Verinurad 9 mg+Febuxostat 80 mg | Capsule administered orally, once daily for 24 weeks | | OG001 | Placebo | Capsule administered orally, once daily for 24 weeks |
| |
| Other Pre-specified | Baseline MRI Variables - LV End-systolic Volume | | Total number differs from Study totals due to subject non compliance with MRI (exam not completed) | Posted | | Mean | Standard Deviation | mL | | Baseline | | | | ID | Title | Description |
|---|
| OG000 | Verinurad 9 mg+Febuxostat 80 mg | Capsule administered orally, once daily for 24 weeks | | OG001 | Placebo | Capsule administered orally, once daily for 24 weeks |
| |
| Other Pre-specified | Baseline MRI Variables - Circumferential Strain | | Total number differs from Study totals due to subject non compliance with MRI (exam not completed) | Posted | | Mean | Standard Deviation | % (change in percentage in LV dimension) | | Baseline | | | | ID | Title | Description |
|---|
| OG000 | Verinurad 9 mg+Febuxostat 80 mg | Capsule administered orally, once daily for 24 weeks | | OG001 | Placebo | Capsule administered orally, once daily for 24 weeks |
| |
| Other Pre-specified | Baseline MRI Variables - Diastolic Circumferential Strain Rate | | Total number differs from Study totals due to subject non compliance with MRI (exam not completed) | Posted | | Mean | Standard Deviation | s^-1 | | Baseline | | | | ID | Title | Description |
|---|
| OG000 | Verinurad 9 mg+Febuxostat 80 mg | Capsule administered orally, once daily for 24 weeks | | OG001 | Placebo | Capsule administered orally, once daily for 24 weeks |
| |
| Other Pre-specified | Baseline MRI Variables - Diastolic Longitudinal Strain Rate | | Total number differs from Study totals due to subject non compliance with MRI (exam not completed) | Posted | | Mean | Standard Deviation | s^-1 | | Baseline | | | | ID | Title | Description |
|---|
| OG000 | Verinurad 9 mg+Febuxostat 80 mg | Capsule administered orally, once daily for 24 weeks | | OG001 | Placebo | Capsule administered orally, once daily for 24 weeks |
| |
| Other Pre-specified | Baseline MRI Variables - Diastolic Radial Strain Rate | | Total number differs from Study totals due to subject non compliance with MRI (exam not completed) | Posted | | Mean | Standard Deviation | s^-1 | | Baseline | | | | ID | Title | Description |
|---|
| OG000 | Verinurad 9 mg+Febuxostat 80 mg | Capsule administered orally, once daily for 24 weeks | | OG001 | Placebo | Capsule administered orally, once daily for 24 weeks |
| |
| Other Pre-specified | Baseline MRI Variables - Longitudinal Strain | | Total number differs from Study totals due to subject non compliance with MRI (exam not completed) | Posted | | Mean | Standard Deviation | % (change in percentage in LV dimension) | | Baseline | | | | ID | Title | Description |
|---|
| OG000 | Verinurad 9 mg+Febuxostat 80 mg | Capsule administered orally, once daily for 24 weeks | | OG001 | Placebo | Capsule administered orally, once daily for 24 weeks |
| |
| Other Pre-specified | Baseline MRI Variables - Radial Strain | | Total number differs from Study totals due to subject non compliance with MRI (exam not completed) | Posted | | Mean | Standard Deviation | % (change in percentage in LV dimension) | | Baseline | | | | ID | Title | Description |
|---|
| OG000 | Verinurad 9 mg+Febuxostat 80 mg | Capsule administered orally, once daily for 24 weeks | | OG001 | Placebo | Capsule administered orally, once daily for 24 weeks |
| |
| Other Pre-specified | Baseline MRI Variables - Systolic Circumferential Strain Rate | | Total number differs from Study totals due to subject non compliance with MRI (exam not completed) | Posted | | Mean | Standard Deviation | s^-1 | | Baseline | | | | ID | Title | Description |
|---|
| OG000 | Verinurad 9 mg+Febuxostat 80 mg | Capsule administered orally, once daily for 24 weeks | | OG001 | Placebo | Capsule administered orally, once daily for 24 weeks |
| |
| Other Pre-specified | Baseline MRI Variables - Systolic Longitudinal Strain Rate | | Total number differs from Study totals due to subject non compliance with MRI (exam not completed) | Posted | | Mean | Standard Deviation | s^-1 | | Baseline | | | | ID | Title | Description |
|---|
| OG000 | Verinurad 9 mg+Febuxostat 80 mg | Capsule administered orally, once daily for 24 weeks | | OG001 | Placebo | Capsule administered orally, once daily for 24 weeks |
| |
| Other Pre-specified | Baseline MRI Variables - Systolic Radial Strain Rate | | Total number differs from Study totals due to subject non compliance with MRI (exam not completed) | Posted | | Mean | Standard Deviation | s^-1 | | Baseline | | | | ID | Title | Description |
|---|
| OG000 | Verinurad 9 mg+Febuxostat 80 mg | Capsule administered orally, once daily for 24 weeks | | OG001 | Placebo | Capsule administered orally, once daily for 24 weeks |
| |
| Other Pre-specified | Baseline MRI Variables - LV Mass | | Total number differs from Study totals due to subject non compliance with MRI (exam not completed) | Posted | | Mean | Standard Deviation | g | | Baseline | | | | ID | Title | Description |
|---|
| OG000 | Verinurad 9 mg+Febuxostat 80 mg | Capsule administered orally, once daily for 24 weeks | | OG001 | Placebo | Capsule administered orally, once daily for 24 weeks |
| |
| Other Pre-specified | Baseline MRI Variables - LV Mass/End-diastolic Volume | | Total number differs from Study totals due to subject non compliance with MRI (exam not completed) | Posted | | Mean | Standard Deviation | g/mL | | Baseline | | | | ID | Title | Description |
|---|
| OG000 | Verinurad 9 mg+Febuxostat 80 mg | Capsule administered orally, once daily for 24 weeks | | OG001 | Placebo | Capsule administered orally, once daily for 24 weeks |
| |
| Other Pre-specified | Baseline MRI Variables - LV Stroke Volume | | Total number differs from Study totals due to subject non compliance with MRI (exam not completed) | Posted | | Mean | Standard Deviation | mL | | Baseline | | | | ID | Title | Description |
|---|
| OG000 | Verinurad 9 mg+Febuxostat 80 mg | Capsule administered orally, once daily for 24 weeks | | OG001 | Placebo | Capsule administered orally, once daily for 24 weeks |
| |
| Other Pre-specified | Baseline Flow Mediated Dilatation (Reactive Hyperemia) | Baseline in Flow Mediated Dilatation. The flow mediated dilatation metric is obtained using a device from Cordex, and a proprietary algorithm. This metric represents the volume difference between a baseline arterial compliance curve and hyperemia arterial compliance curve in the positive transmural pressure region. This metric has a direct relationship to a subject's cardiovascular condition. Output range is 0-150. A higher score is indicative of a better flow mediated dilatation. | Total number differs from Study totals due to subject non compliance with exam (exam not completed) | Posted | | Mean | Standard Deviation | Units on a scale | | Baseline | | | | ID | Title | Description |
|---|
| OG000 | Verinurad 9 mg+Febuxostat 80 mg | Capsule administered orally, once daily for 24 weeks | | OG001 | Placebo | Capsule administered orally, once daily for 24 weeks |
| |
| Primary | Urinary Albumin to Creatinine Ratio (UACR) | LS Mean Percentage Change (95% CI) from Baseline in UACR | Number analyzed at 24 weeks was less than the overall number analyzed due to missing observations | Posted | | Least Squares Mean | 95% Confidence Interval | Precent change | | From Baseline to 24 Weeks of Treatment | | | | ID | Title | Description |
|---|
| OG000 | Verinurad 9 mg+Febuxostat 80 mg | Capsule administered orally, once daily for 24 weeks | | OG001 | Placebo | Capsule administered orally, once daily for 24 weeks |
| |