Phase 2
N=60
Intensive Uric Acid Lowering With Verinurad and Febuxostat in Patients With Albuminuria
Hyperuricemia · Albuminuria · Type 2 Diabetes
Bottom Line
View on ClinicalTrials.gov: NCT03118739 ↗Enrolled (actual)
60
Serious AEs
13.3%
Results posted
Jan 2020
Primary outcome: Primary: Urinary Albumin to Creatinine Ratio (UACR) — -48.65; -15.31 Precent change
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- Verinurad 9 mg+Febuxostat 80 mg (Drug); Placebo (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- AstraZeneca
- Primary completion
- Aug 2018
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Urinary Albumin to Creatinine Ratio (UACR) |
-38.40; 21.40 | — |
| PRIMARY Urinary Albumin to Creatinine Ratio (UACR) Compared to Placebo |
-49.26; NA | — |
| PRIMARY Urinary Albumin to Creatinine Ratio (UACR) |
-38.40; 21.40 | — |
| SECONDARY sUA |
-56.81; 6.86; -61.93; 4.73 | — |
| SECONDARY eGFR |
1.25; -4.40; -1.73; 0.55 | — |
| SECONDARY Serum Creatinine |
-0.60; 3.44; 1.93; 0.02 | — |
| SECONDARY Serum Cystatin C |
3.252; 0.114; 5.412; 3.951 | — |
| SECONDARY Serum High Sensitivity C-reactive Protein |
35.863; 11.665; -8.002; 9.793 | — |
| SECONDARY Clinical Assessments |
74.7; 77.8; 1.6; -0.2; 2.0; 1.7 | — |
| SECONDARY MRI Variables - LV Mass/End-diastolic Volume |
0.049; 0.053 | — |
| SECONDARY MRI Variables - Kidney Cortex T2 Star - BOLD MRI |
-1.46; -1.67 | — |
| SECONDARY MRI Variables - LV End-diastolic Volume, LV End-systolic Volume, LV Stroke Volume |
-5.39; -4.93; 1.33; -2.48; -6.73; -2.44 | — |
| SECONDARY MRI Variables - LV Ejection Fraction, Circumferential Strain, Longitudinal Strain, Radial Strain |
-2.08; 0.59; -0.25; -0.07; 0.29; 0.53 | — |
| SECONDARY MRI Variables - Diastolic Circumferential Strain Rate, Longitudinal Strain Rate, Radial Strain Rate and Systolic Circumferential Strain Rate, Longitudinal Strain Rate, Radial Strain Rate |
-0.0496; -0.0384; -0.0043; -0.0300; 0.2348; 0.0201 | — |
| SECONDARY MRI Variables - LV Mass |
1.80; 2.63 | — |
Summary
The purpose of this clinical research study is to evaluate signals of potential clinical benefit of the combination of Verinurad and Febuxostat in lowering concentrations of circulating uric acid and thus improving kidney or cardiovascular status of patients with hyperuricemia, albuminuria, and Type 2 diabetes (T2DM).
Eligibility Criteria
Inclusion Criteria
- Serum Uric Acid ≥6.0 mg/dL
- eGFR ≥30 mL/min/1.73 m2
- UACR between 30 mg/g and 3500 mg/g inclusive
- Diagnosed with T2DM
Exclusion Criteria
- Treated with any drug for hyperuricemia in the 6 months preceding randomization.Drugs for hyperuricemia include all XO inhibitors (allopurinol, febuxostat and topiroxostat) and URAT1 inhibitors (lesinurad, verinurad, probenecid, and benzbromarone)
- Prior history of gout, unless prophylaxis therapy isn't required
- Patients who are pregnant, lactating, or planning to become pregnant
- Patients unsuitable or unable to undergo MRI assessment
Data sourced from ClinicalTrials.gov (NCT03118739). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.