| Trial ID: | L3002 |
| Source ID: | NCT03118739
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| Associated Drug: |
Verinurad 9 Mg+Febuxostat 80 Mg
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| Title: |
Intensive Uric Acid Lowering With Verinurad and Febuxostat in Patients With Albuminuria
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| Acronym: |
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| Status: |
COMPLETED
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| Study Results: |
YES
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| Results: |
https://ClinicalTrials.gov/show/NCT03118739/results
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| Conditions: |
Hyperuricemia|Albuminuria|Type 2 Diabetes
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| Interventions: |
DRUG: Verinurad 9 mg+Febuxostat 80 mg|DRUG: Placebo
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| Outcome Measures: |
Primary: Urinary Albumin to Creatinine Ratio (UACR), LS Mean Percentage Change (95% CI) from Baseline in UACR, From Baseline to 12 Weeks of Treatment|Urinary Albumin to Creatinine Ratio (UACR) Compared to Placebo, LS Mean Percentage Change (90% CI) from Baseline in UACR Compared to Placebo, From Baseline to 24 Weeks of Treatment|Urinary Albumin to Creatinine Ratio (UACR), LS Mean Percentage Change (95% CI) from Baseline in UACR, From Baseline to 24 Weeks of Treatment | Secondary: sUA, LS Mean Percentage Change (95% CI) from Baseline in sUA, From Baseline to 12 Weeks and 24 Weeks of Treatment|eGFR, LS Mean Percentage Change (95% CI) from Baseline in eGFR, From Baseline to 12 Weeks and 24 Weeks of Treatment|Serum Creatinine, LS Mean Percentage Change (95% CI) from Baseline in Serum Creatinine, From Baseline to 12 Weeks and 24 Weeks of Treatment|Serum Cystatin C, LS Mean Percentage Change (95% CI) from Baseline in Serum Cystatin C, From Baseline to 12 Weeks and 24 Weeks of Treatment|Serum High Sensitivity C-reactive Protein, LS Mean Percentage Change (95% CI) from Baseline in Serum High Sensitivity C-reactive Protein, From Baseline to 12 Weeks and 24 Weeks of Treatment|Clinical Assessments, Change from Baseline in Diastolic and Systolic Blood Pressure, From Baseline to 12 Weeks and 24 Weeks of Treatment|MRI Variables - LV Mass/End-diastolic Volume, Change from Baseline in MRI Variables at Week 24 (CFB = Change from Baseline), From Baseline to 24 Weeks of Treatment|MRI Variables - Kidney Cortex T2 Star - BOLD MRI, Change from Baseline in MRI Variables at Week 24 (CFB = Change from Baseline), From Baseline to 24 Weeks of Treatment|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), From Baseline to 24 Weeks of Treatment|MRI Variables - LV Ejection Fraction, Circumferential Strain, Longitudinal Strain, Radial Strain, Change from baseline in MRI Variables at Week 24 (CFB = Change from Baseline), From Baseline to 24 Weeks of Treatment|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), From Baseline to 24 Weeks of Treatment|MRI Variables - LV Mass, Change from Baseline in MRI Variables at Week 24 (CFB = Change from Baseline), From Baseline to 24 Weeks of Treatment | Other: 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., From Baseline to 12 Weeks and 24 Weeks of Treatment|Urinalysis, Changes in Urinalysis (CFB = Change from Baseline), From Baseline to 12 Weeks and 24 Weeks of Treatment|Clinical Chemistry Values, Changes in Clinical Chemistry Values (CFB = Change for Baseline), From Baseline to 12 Weeks and 24 Weeks of Treatment|Baseline eGFR, Baseline|Baseline UACR, Baseline|Baseline Serum Uric Acid (sUA), Baseline|Baseline Serum Creatinine, Baseline|Baseline Serum Cystatin-C, Baseline|Baseline Serum High-sensitivity C-reactive Protein, Baseline|Baseline MRI Variables - Kidney Cortex T2 Star, Baseline|Baseline MRI Variables - LV End-diastolic Volume, Baseline|Baseline MRI Variables - LV Ejection Fraction, Baseline|Baseline MRI Variables - LV End-systolic Volume, Baseline|Baseline MRI Variables - Circumferential Strain, Baseline|Baseline MRI Variables - Diastolic Circumferential Strain Rate, Baseline|Baseline MRI Variables - Diastolic Longitudinal Strain Rate, Baseline|Baseline MRI Variables - Diastolic Radial Strain Rate, Baseline|Baseline MRI Variables - Longitudinal Strain, Baseline|Baseline MRI Variables - Radial Strain, Baseline|Baseline MRI Variables - Systolic Circumferential Strain Rate, Baseline|Baseline MRI Variables - Systolic Longitudinal Strain Rate, Baseline|Baseline MRI Variables - Systolic Radial Strain Rate, Baseline|Baseline MRI Variables - LV Mass, Baseline|Baseline MRI Variables - LV Mass/End-diastolic Volume, Baseline|Baseline MRI Variables - LV Stroke Volume, Baseline|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., Baseline
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| Sponsor/Collaborators: |
Sponsor: AstraZeneca
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| Gender: |
ALL
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| Age: |
ADULT, OLDER_ADULT
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| Phases: |
PHASE2
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| Enrollment: |
60
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| Study Type: |
INTERVENTIONAL
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| Study Designs: |
Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: QUADRUPLE (PARTICIPANT, CARE_PROVIDER, INVESTIGATOR, OUTCOMES_ASSESSOR)|Primary Purpose: TREATMENT
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| Start Date: |
2017-05-18
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| Completion Date: |
2018-08-13
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| Results First Posted: |
2020-01-10
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| Last Update Posted: |
2020-01-10
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| Locations: |
Research Site, Canyon Country, California, 91351, United States|Research Site, Chula Vista, California, 91911, United States|Research Site, Corona, California, 92882, United States|Research Site, Escondido, California, 92025, United States|Research Site, Lakewood, California, 90805, United States|Research Site, Lincoln, California, 95648, United States|Research Site, Los Angeles, California, 90017, United States|Research Site, Los Angeles, California, 90022, United States|Research Site, Los Angeles, California, 90036, United States|Research Site, North Hollywood, California, 91606, United States|Research Site, Oceanside, California, 92056-4510, United States|Research Site, Orange, California, 92868, United States|Research Site, Sacramento, California, 95821, United States|Research Site, Houston, Texas, 77058, United States|Research Site, Houston, Texas, 77070, United States|Research Site, Pearland, Texas, 77584, United States|Research Site, Sugar Land, Texas, 77478, United States|Research Site, Webster, Texas, 77598, United States
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| URL: |
https://clinicaltrials.gov/show/NCT03118739
|
