Trial Outcomes & Findings for Intensive Uric Acid Lowering With Verinurad and Febuxostat in Patients With Albuminuria (NCT NCT03118739)
NCT ID: NCT03118739
Last Updated: 2020-01-10
Results Overview
LS Mean Percentage Change (95% CI) from Baseline in UACR
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
60 participants
Primary outcome timeframe
From Baseline to 12 Weeks of Treatment
Results posted on
2020-01-10
Participant Flow
This study was conducted at 19 clinical research centers in the United States of America. First subject enrolled (First subject first visit/first consent signed date): 18 May 2017. Last subject last visit: 13 August 2018.
Patients were screened at Visit 1. Within 1 week, eligible patients collected 3 morning void samples on consecutive days for proteinuria measurements. Patients with acceptable results were scheduled for Visit 2. Prior to randomization and before or on the day of Visit 2, patients underwent MRI. V2 occurred no later than 6 weeks after V1.
Participant milestones
| Measure |
Verinurad 9 mg+Febuxostat 80 mg
Capsule administered orally, once daily for 24 weeks
|
Placebo
Capsule administered orally, once daily for 24 weeks
|
|---|---|---|
|
Overall Study
STARTED
|
32
|
28
|
|
Overall Study
Completed 12 Weeks of Treatment
|
26
|
25
|
|
Overall Study
Completed 24 Weeks of Treatment
|
24
|
25
|
|
Overall Study
COMPLETED
|
25
|
24
|
|
Overall Study
NOT COMPLETED
|
7
|
4
|
Reasons for withdrawal
| Measure |
Verinurad 9 mg+Febuxostat 80 mg
Capsule administered orally, once daily for 24 weeks
|
Placebo
Capsule administered orally, once daily for 24 weeks
|
|---|---|---|
|
Overall Study
Physician Decision
|
0
|
1
|
|
Overall Study
Withdrawal by Subject
|
5
|
3
|
|
Overall Study
Lost to Follow-up
|
2
|
0
|
Baseline Characteristics
Intensive Uric Acid Lowering With Verinurad and Febuxostat in Patients With Albuminuria
Baseline characteristics by cohort
| Measure |
Verinurad 9 mg+Febuxostat 80 mg
n=32 Participants
Capsule administered orally, once daily for 24 weeks
|
Placebo
n=28 Participants
Capsule administered orally, once daily for 24 weeks
|
Total
n=60 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Weight
|
93.72 kg
STANDARD_DEVIATION 20.243 • n=39 Participants
|
96.76 kg
STANDARD_DEVIATION 19.561 • n=41 Participants
|
95.14 kg
STANDARD_DEVIATION 19.818 • n=35 Participants
|
|
Height
|
170.57 cm
STANDARD_DEVIATION 10.662 • n=39 Participants
|
170.75 cm
STANDARD_DEVIATION 9.117 • n=41 Participants
|
170.65 cm
STANDARD_DEVIATION 9.888 • n=35 Participants
|
|
Body Mass Index
|
32.00 kg/m2
STANDARD_DEVIATION 5.082 • n=39 Participants
|
32.95 kg/m2
STANDARD_DEVIATION 4.699 • n=41 Participants
|
32.44 kg/m2
STANDARD_DEVIATION 4.889 • n=35 Participants
|
|
estimated glomerular filtration rate (eGFR)
eGFR<30
|
2 Participants
n=39 Participants
|
1 Participants
n=41 Participants
|
3 Participants
n=35 Participants
|
|
Age, Categorical
<=18 years
|
0 Participants
n=39 Participants
|
0 Participants
n=41 Participants
|
0 Participants
n=35 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
16 Participants
n=39 Participants
|
17 Participants
n=41 Participants
|
33 Participants
n=35 Participants
|
|
Age, Categorical
>=65 years
|
16 Participants
n=39 Participants
|
11 Participants
n=41 Participants
|
27 Participants
n=35 Participants
|
|
Age, Continuous
|
62.0 Years
STANDARD_DEVIATION 9.51 • n=39 Participants
|
60.9 Years
STANDARD_DEVIATION 12.15 • n=41 Participants
|
61.5 Years
STANDARD_DEVIATION 10.74 • n=35 Participants
|
|
Sex: Female, Male
Female
|
10 Participants
n=39 Participants
|
8 Participants
n=41 Participants
|
18 Participants
n=35 Participants
|
|
Sex: Female, Male
Male
|
22 Participants
n=39 Participants
|
20 Participants
n=41 Participants
|
42 Participants
n=35 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
11 Participants
n=39 Participants
|
7 Participants
n=41 Participants
|
18 Participants
n=35 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
21 Participants
n=39 Participants
|
21 Participants
n=41 Participants
|
42 Participants
n=35 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=39 Participants
|
0 Participants
n=41 Participants
|
0 Participants
n=35 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=39 Participants
|
0 Participants
n=41 Participants
|
0 Participants
n=35 Participants
|
|
Race (NIH/OMB)
Asian
|
3 Participants
n=39 Participants
|
4 Participants
n=41 Participants
|
7 Participants
n=35 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
1 Participants
n=39 Participants
|
0 Participants
n=41 Participants
|
1 Participants
n=35 Participants
|
|
Race (NIH/OMB)
Black or African American
|
6 Participants
n=39 Participants
|
5 Participants
n=41 Participants
|
11 Participants
n=35 Participants
|
|
Race (NIH/OMB)
White
|
22 Participants
n=39 Participants
|
15 Participants
n=41 Participants
|
37 Participants
n=35 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=39 Participants
|
0 Participants
n=41 Participants
|
0 Participants
n=35 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=39 Participants
|
4 Participants
n=41 Participants
|
4 Participants
n=35 Participants
|
|
estimated glomerular filtration rate (eGFR)
eGFR >=30 to <60
|
16 Participants
n=39 Participants
|
9 Participants
n=41 Participants
|
25 Participants
n=35 Participants
|
|
estimated glomerular filtration rate (eGFR)
eGFR >=60 to <90
|
9 Participants
n=39 Participants
|
12 Participants
n=41 Participants
|
21 Participants
n=35 Participants
|
|
estimated glomerular filtration rate (eGFR)
eGFR >=90
|
5 Participants
n=39 Participants
|
6 Participants
n=41 Participants
|
11 Participants
n=35 Participants
|
PRIMARY outcome
Timeframe: From Baseline to 12 Weeks of TreatmentPopulation: Number analyzed at 12 weeks was less than the overall number analyzed due to missing observations
LS Mean Percentage Change (95% CI) from Baseline in UACR
Outcome measures
| Measure |
Verinurad 9 mg+Febuxostat 80 mg
n=32 Participants
Capsule administered orally, once daily for 24 weeks
|
Placebo
n=28 Participants
Capsule administered orally, once daily for 24 weeks
|
|---|---|---|
|
Urinary Albumin to Creatinine Ratio (UACR)
|
-48.65 Precent change
Interval -64.807 to -25.089
|
-15.31 Precent change
Interval -43.244 to 26.37
|
PRIMARY outcome
Timeframe: From Baseline to 24 Weeks of TreatmentPopulation: Number analyzed at 24 weeks was less than the overall number analyzed due to missing observations
LS Mean Percentage Change (90% CI) from Baseline in UACR Compared to Placebo
Outcome measures
| Measure |
Verinurad 9 mg+Febuxostat 80 mg
n=32 Participants
Capsule administered orally, once daily for 24 weeks
|
Placebo
n=28 Participants
Capsule administered orally, once daily for 24 weeks
|
|---|---|---|
|
Urinary Albumin to Creatinine Ratio (UACR) Compared to Placebo
|
-49.26 Precent change
Interval -68.206 to -19.009
|
NA Precent change
The primary endpoint is a comparison
|
PRIMARY outcome
Timeframe: From Baseline to 24 Weeks of TreatmentPopulation: Number analyzed at 24 weeks was less than the overall number analyzed due to missing observations
LS Mean Percentage Change (95% CI) from Baseline in UACR
Outcome measures
| Measure |
Verinurad 9 mg+Febuxostat 80 mg
n=32 Participants
Capsule administered orally, once daily for 24 weeks
|
Placebo
n=28 Participants
Capsule administered orally, once daily for 24 weeks
|
|---|---|---|
|
Urinary Albumin to Creatinine Ratio (UACR)
|
-38.40 Precent change
Interval -58.051 to -9.535
|
21.40 Precent change
Interval -18.948 to 81.829
|
SECONDARY outcome
Timeframe: From Baseline to 12 Weeks and 24 Weeks of TreatmentPopulation: Number analyzed at 12 and 24 weeks was less than the overall number analyzed due to missing observations
LS Mean Percentage Change (95% CI) from Baseline in sUA
Outcome measures
| Measure |
Verinurad 9 mg+Febuxostat 80 mg
n=32 Participants
Capsule administered orally, once daily for 24 weeks
|
Placebo
n=28 Participants
Capsule administered orally, once daily for 24 weeks
|
|---|---|---|
|
sUA
12 weeks
|
-56.81 Percent change
Interval -63.879 to -48.35
|
6.86 Percent change
Interval -11.8 to 29.471
|
|
sUA
24 weeks
|
-61.93 Percent change
Interval -68.274 to -54.319
|
4.73 Percent change
Interval -13.795 to 27.239
|
SECONDARY outcome
Timeframe: From Baseline to 12 Weeks and 24 Weeks of TreatmentPopulation: Number analyzed at 12 and 24 weeks was less than the overall number analyzed due to missing observations
LS Mean Percentage Change (95% CI) from Baseline in eGFR
Outcome measures
| Measure |
Verinurad 9 mg+Febuxostat 80 mg
n=32 Participants
Capsule administered orally, once daily for 24 weeks
|
Placebo
n=28 Participants
Capsule administered orally, once daily for 24 weeks
|
|---|---|---|
|
eGFR
12 weeks
|
1.25 Percent change
Interval -6.52 to 9.674
|
-4.40 Percent change
Interval -12.258 to 4.154
|
|
eGFR
24 weeks
|
-1.73 Percent change
Interval -9.446 to 6.648
|
0.55 Percent change
Interval -7.854 to 9.712
|
SECONDARY outcome
Timeframe: From Baseline to 12 Weeks and 24 Weeks of TreatmentPopulation: Number analyzed at 12 and 24 weeks was less than the overall number analyzed due to missing observations
LS Mean Percentage Change (95% CI) from Baseline in Serum Creatinine
Outcome measures
| Measure |
Verinurad 9 mg+Febuxostat 80 mg
n=32 Participants
Capsule administered orally, once daily for 24 weeks
|
Placebo
n=28 Participants
Capsule administered orally, once daily for 24 weeks
|
|---|---|---|
|
Serum Creatinine
12 weeks
|
-0.60 Percent change
Interval -6.946 to 6.188
|
3.44 Percent change
Interval -3.636 to 11.025
|
|
Serum Creatinine
24 weeks
|
1.93 Percent change
Interval -4.743 to 9.078
|
0.02 Percent change
Interval -6.945 to 7.504
|
SECONDARY outcome
Timeframe: From Baseline to 12 Weeks and 24 Weeks of TreatmentPopulation: Number analyzed at 12 and 24 weeks was less than the overall number analyzed due to missing observations
LS Mean Percentage Change (95% CI) from Baseline in Serum Cystatin C
Outcome measures
| Measure |
Verinurad 9 mg+Febuxostat 80 mg
n=32 Participants
Capsule administered orally, once daily for 24 weeks
|
Placebo
n=28 Participants
Capsule administered orally, once daily for 24 weeks
|
|---|---|---|
|
Serum Cystatin C
12 weeks
|
3.252 Percent change
Interval -1.3402 to 8.0581
|
0.114 Percent change
Interval -4.652 to 5.1187
|
|
Serum Cystatin C
24 weeks
|
5.412 Percent change
Interval 0.5212 to 10.5418
|
3.951 Percent change
Interval -1.1612 to 9.3279
|
SECONDARY outcome
Timeframe: From Baseline to 12 Weeks and 24 Weeks of TreatmentPopulation: Number analyzed at 12 and 24 weeks was less than the overall number analyzed due to missing observations
LS Mean Percentage Change (95% CI) from Baseline in Serum High Sensitivity C-reactive Protein
Outcome measures
| Measure |
Verinurad 9 mg+Febuxostat 80 mg
n=32 Participants
Capsule administered orally, once daily for 24 weeks
|
Placebo
n=28 Participants
Capsule administered orally, once daily for 24 weeks
|
|---|---|---|
|
Serum High Sensitivity C-reactive Protein
12 weeks
|
35.863 Percent change
Interval 4.5883 to 76.4884
|
11.665 Percent change
Interval -15.6408 to 47.8091
|
|
Serum High Sensitivity C-reactive Protein
24 weeks
|
-8.002 Percent change
Interval -29.9761 to 20.868
|
9.793 Percent change
Interval -17.8132 to 46.6716
|
SECONDARY outcome
Timeframe: From Baseline to 12 Weeks and 24 Weeks of TreatmentPopulation: Number analyzed at 12 and 24 weeks was less than the overall number analyzed due to missing observations
Change from Baseline in Diastolic and Systolic Blood Pressure
Outcome measures
| Measure |
Verinurad 9 mg+Febuxostat 80 mg
n=32 Participants
Capsule administered orally, once daily for 24 weeks
|
Placebo
n=28 Participants
Capsule administered orally, once daily for 24 weeks
|
|---|---|---|
|
Clinical Assessments
Diastolic BP, mmHg Baseline
|
74.7 mm/Hg
Standard Deviation 9.83
|
77.8 mm/Hg
Standard Deviation 11.91
|
|
Clinical Assessments
Diastolic BP, mmHg 12 weeks (Change from baseline)
|
1.6 mm/Hg
Standard Deviation 11.02
|
-0.2 mm/Hg
Standard Deviation 9.51
|
|
Clinical Assessments
Diastolic BP, mmHg 24 weeks (Change from baseline)
|
2.0 mm/Hg
Standard Deviation 8.53
|
1.7 mm/Hg
Standard Deviation 12.05
|
|
Clinical Assessments
Systolic BP, mmHg Baseline
|
136.4 mm/Hg
Standard Deviation 15.13
|
138.5 mm/Hg
Standard Deviation 16.34
|
|
Clinical Assessments
Systolic BP, mmHg 12 weeks (Change from baseline)
|
-0.8 mm/Hg
Standard Deviation 19.00
|
-3.2 mm/Hg
Standard Deviation 15.48
|
|
Clinical Assessments
Systolic BP, mmHg 24 weeks (Change from baseline)
|
0.4 mm/Hg
Standard Deviation 9.75
|
-0.6 mm/Hg
Standard Deviation 17.78
|
SECONDARY outcome
Timeframe: From Baseline to 24 Weeks of TreatmentPopulation: Number analyzed at 24 weeks was less than the overall number analyzed due to missing observations
Change from Baseline in MRI Variables at Week 24 (CFB = Change from Baseline)
Outcome measures
| Measure |
Verinurad 9 mg+Febuxostat 80 mg
n=32 Participants
Capsule administered orally, once daily for 24 weeks
|
Placebo
n=28 Participants
Capsule administered orally, once daily for 24 weeks
|
|---|---|---|
|
MRI Variables - LV Mass/End-diastolic Volume
|
0.049 g/mL
Standard Deviation 0.1445
|
0.053 g/mL
Standard Deviation 0.1202
|
SECONDARY outcome
Timeframe: From Baseline to 24 Weeks of TreatmentPopulation: Number analyzed at 24 weeks was less than the overall number analyzed due to missing observations
Change from Baseline in MRI Variables at Week 24 (CFB = Change from Baseline)
Outcome measures
| Measure |
Verinurad 9 mg+Febuxostat 80 mg
n=32 Participants
Capsule administered orally, once daily for 24 weeks
|
Placebo
n=28 Participants
Capsule administered orally, once daily for 24 weeks
|
|---|---|---|
|
MRI Variables - Kidney Cortex T2 Star - BOLD MRI
|
-1.46 ms
Standard Deviation 6.511
|
-1.67 ms
Standard Deviation 6.440
|
SECONDARY outcome
Timeframe: From Baseline to 24 Weeks of TreatmentPopulation: Number analyzed at 24 weeks was less than the overall number analyzed due to missing observations
Change from Baseline in MRI Variables at Week 24 (CFB = Change from Baseline)
Outcome measures
| Measure |
Verinurad 9 mg+Febuxostat 80 mg
n=32 Participants
Capsule administered orally, once daily for 24 weeks
|
Placebo
n=28 Participants
Capsule administered orally, once daily for 24 weeks
|
|---|---|---|
|
MRI Variables - LV End-diastolic Volume, LV End-systolic Volume, LV Stroke Volume
LV End-diastolic Volume (mL) (CFB)
|
-5.39 mL
Standard Deviation 27.458
|
-4.93 mL
Standard Deviation 20.665
|
|
MRI Variables - LV End-diastolic Volume, LV End-systolic Volume, LV Stroke Volume
LV End-systolic Volume (mL) (CFB)
|
1.33 mL
Standard Deviation 14.106
|
-2.48 mL
Standard Deviation 10.703
|
|
MRI Variables - LV End-diastolic Volume, LV End-systolic Volume, LV Stroke Volume
LV Stroke Volume (mL) (CFB)
|
-6.73 mL
Standard Deviation 15.923
|
-2.44 mL
Standard Deviation 12.458
|
SECONDARY outcome
Timeframe: From Baseline to 24 Weeks of TreatmentPopulation: Number analyzed at 24 weeks was less than the overall number analyzed due to missing observations
Change from baseline in MRI Variables at Week 24 (CFB = Change from Baseline)
Outcome measures
| Measure |
Verinurad 9 mg+Febuxostat 80 mg
n=32 Participants
Capsule administered orally, once daily for 24 weeks
|
Placebo
n=28 Participants
Capsule administered orally, once daily for 24 weeks
|
|---|---|---|
|
MRI Variables - LV Ejection Fraction, Circumferential Strain, Longitudinal Strain, Radial Strain
LV Ejection Fraction (%) (CFB)
|
-2.08 % (change in percentage from baseline)
Standard Deviation 3.761
|
0.59 % (change in percentage from baseline)
Standard Deviation 3.374
|
|
MRI Variables - LV Ejection Fraction, Circumferential Strain, Longitudinal Strain, Radial Strain
Circumferential Strain (%) (CFB)
|
-0.25 % (change in percentage from baseline)
Standard Deviation 2.321
|
-0.07 % (change in percentage from baseline)
Standard Deviation 2.192
|
|
MRI Variables - LV Ejection Fraction, Circumferential Strain, Longitudinal Strain, Radial Strain
Longitudinal Strain (%) (CFB)
|
0.29 % (change in percentage from baseline)
Standard Deviation 1.949
|
0.53 % (change in percentage from baseline)
Standard Deviation 1.729
|
|
MRI Variables - LV Ejection Fraction, Circumferential Strain, Longitudinal Strain, Radial Strain
Radial Strain (%) (CFB)
|
-2.29 % (change in percentage from baseline)
Standard Deviation 7.136
|
1.44 % (change in percentage from baseline)
Standard Deviation 8.109
|
SECONDARY outcome
Timeframe: From Baseline to 24 Weeks of TreatmentPopulation: Number analyzed at 24 weeks was less than the overall number analyzed due to missing observations
Change from Baseline in MRI Variables at Week 24 (CFB = Change from Baseline)
Outcome measures
| Measure |
Verinurad 9 mg+Febuxostat 80 mg
n=32 Participants
Capsule administered orally, once daily for 24 weeks
|
Placebo
n=28 Participants
Capsule administered orally, once daily for 24 weeks
|
|---|---|---|
|
MRI Variables - Diastolic Circumferential Strain Rate, Longitudinal Strain Rate, Radial Strain Rate and Systolic Circumferential Strain Rate, Longitudinal Strain Rate, Radial Strain Rate
Diastolic Circumferential Strain Rate (s^-1) (CFB)
|
-0.0496 s^-1
Standard Deviation 0.13769
|
-0.0384 s^-1
Standard Deviation 0.13791
|
|
MRI Variables - Diastolic Circumferential Strain Rate, Longitudinal Strain Rate, Radial Strain Rate and Systolic Circumferential Strain Rate, Longitudinal Strain Rate, Radial Strain Rate
Diastolic Longitudinal Strain Rate (s^-1) (CFB)
|
-0.0043 s^-1
Standard Deviation 0.10629
|
-0.0300 s^-1
Standard Deviation 0.16940
|
|
MRI Variables - Diastolic Circumferential Strain Rate, Longitudinal Strain Rate, Radial Strain Rate and Systolic Circumferential Strain Rate, Longitudinal Strain Rate, Radial Strain Rate
Diastolic Radial Strain Rate (s^-1) (CFB)
|
0.2348 s^-1
Standard Deviation 0.43676
|
0.0201 s^-1
Standard Deviation 0.72927
|
|
MRI Variables - Diastolic Circumferential Strain Rate, Longitudinal Strain Rate, Radial Strain Rate and Systolic Circumferential Strain Rate, Longitudinal Strain Rate, Radial Strain Rate
Systolic Circumferential Strain Rate (s^-1) (CFB)
|
0.0115 s^-1
Standard Deviation 0.11314
|
-0.0743 s^-1
Standard Deviation 0.11616
|
|
MRI Variables - Diastolic Circumferential Strain Rate, Longitudinal Strain Rate, Radial Strain Rate and Systolic Circumferential Strain Rate, Longitudinal Strain Rate, Radial Strain Rate
Systolic Longitudinal Strain Rate (s^-1) (CFB)
|
0.0285 s^-1
Standard Deviation 0.08436
|
-0.0021 s^-1
Standard Deviation 0.08052
|
|
MRI Variables - Diastolic Circumferential Strain Rate, Longitudinal Strain Rate, Radial Strain Rate and Systolic Circumferential Strain Rate, Longitudinal Strain Rate, Radial Strain Rate
Systolic Radial Strain Rate (s^-1) (CFB)
|
-0.1917 s^-1
Standard Deviation 0.31833
|
0.2516 s^-1
Standard Deviation 0.38049
|
SECONDARY outcome
Timeframe: From Baseline to 24 Weeks of TreatmentPopulation: Number analyzed at 24 weeks was less than the overall number analyzed due to missing observations
Change from Baseline in MRI Variables at Week 24 (CFB = Change from Baseline)
Outcome measures
| Measure |
Verinurad 9 mg+Febuxostat 80 mg
n=32 Participants
Capsule administered orally, once daily for 24 weeks
|
Placebo
n=28 Participants
Capsule administered orally, once daily for 24 weeks
|
|---|---|---|
|
MRI Variables - LV Mass
|
1.80 g
Standard Deviation 7.532
|
2.63 g
Standard Deviation 9.994
|
OTHER_PRE_SPECIFIED outcome
Timeframe: From Baseline to 12 Weeks and 24 Weeks of TreatmentPopulation: Number analyzed at 12 and 24 weeks was less than the overall number analyzed due to missing observations
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.
Outcome measures
| Measure |
Verinurad 9 mg+Febuxostat 80 mg
n=32 Participants
Capsule administered orally, once daily for 24 weeks
|
Placebo
n=28 Participants
Capsule administered orally, once daily for 24 weeks
|
|---|---|---|
|
Flow Mediated Dilatation (Reactive Hyperemia)
12 weeks Change from Baseline
|
0.8 Units on a scale
Interval -10.59 to 12.24
|
-5.9 Units on a scale
Interval -17.04 to 5.29
|
|
Flow Mediated Dilatation (Reactive Hyperemia)
24 weeks Change from Baseline
|
0.5 Units on a scale
Interval -9.44 to 10.47
|
-5.5 Units on a scale
Interval -15.47 to 4.44
|
OTHER_PRE_SPECIFIED outcome
Timeframe: From Baseline to 12 Weeks and 24 Weeks of TreatmentPopulation: Number analyzed at 12 and 24 weeks was less than the overall number analyzed due to missing observations
Changes in Urinalysis (CFB = Change from Baseline)
Outcome measures
| Measure |
Verinurad 9 mg+Febuxostat 80 mg
n=32 Participants
Capsule administered orally, once daily for 24 weeks
|
Placebo
n=28 Participants
Capsule administered orally, once daily for 24 weeks
|
|---|---|---|
|
Urinalysis
Baseline Protein, mg/dL
|
72.01 mg/dL
Standard Deviation 99.767
|
65.74 mg/dL
Standard Deviation 78.686
|
|
Urinalysis
Protein, mg/dL 12 weeks (CFB)
|
-11.40 mg/dL
Standard Deviation 65.896
|
-4.07 mg/dL
Standard Deviation 71.047
|
|
Urinalysis
Protein, mg/dL 24 weeks (CFB)
|
-16.73 mg/dL
Standard Deviation 101.052
|
11.40 mg/dL
Standard Deviation 76.645
|
|
Urinalysis
Baseline Urine Albumin, mg/dL
|
38.0907 mg/dL
Standard Deviation 55.62178
|
35.8905 mg/dL
Standard Deviation 47.17446
|
|
Urinalysis
Urine Albumin, mg/dL 12 weeks (CFB)
|
-9.4766 mg/dL
Standard Deviation 35.73442
|
-0.3019 mg/dL
Standard Deviation 45.81688
|
|
Urinalysis
Urine Albumin, mg/dL 24 weeks (CFB)
|
-6.9482 mg/dL
Standard Deviation 50.66844
|
11.6049 mg/dL
Standard Deviation 53.13042
|
|
Urinalysis
Baseline Urine Creatinine, mg/dL
|
96.52 mg/dL
Standard Deviation 51.570
|
86.25 mg/dL
Standard Deviation 46.189
|
|
Urinalysis
Urine Creatinine, mg/dL 12 weeks (CFB)
|
5.06 mg/dL
Standard Deviation 53.378
|
12.95 mg/dL
Standard Deviation 34.987
|
|
Urinalysis
Urine Creatinine, mg/dL 24 weeks (CFB)
|
7.58 mg/dL
Standard Deviation 55.930
|
8.53 mg/dL
Standard Deviation 36.430
|
|
Urinalysis
Baseline Urine Urate, mg/dL
|
28.354 mg/dL
Standard Deviation 12.0591
|
23.960 mg/dL
Standard Deviation 10.6862
|
|
Urinalysis
Urine Urate, mg/dL 12 weeks (CFB)
|
-13.394 mg/dL
Standard Deviation 13.2757
|
3.560 mg/dL
Standard Deviation 12.3875
|
|
Urinalysis
Urine Urate, mg/dL 24 weeks (CFB)
|
-10.732 mg/dL
Standard Deviation 16.4720
|
2.294 mg/dL
Standard Deviation 9.3407
|
OTHER_PRE_SPECIFIED outcome
Timeframe: From Baseline to 12 Weeks and 24 Weeks of TreatmentPopulation: Number analyzed at 12 and 24 weeks was less than the overall number analyzed due to missing observations
Changes in Clinical Chemistry Values (CFB = Change for Baseline)
Outcome measures
| Measure |
Verinurad 9 mg+Febuxostat 80 mg
n=32 Participants
Capsule administered orally, once daily for 24 weeks
|
Placebo
n=28 Participants
Capsule administered orally, once daily for 24 weeks
|
|---|---|---|
|
Clinical Chemistry Values
Aldosterone, pmol/L 24 weeks (CFB)
|
9.14 pmol/L
Standard Deviation 102.932
|
38.14 pmol/L
Standard Deviation 90.007
|
|
Clinical Chemistry Values
Baseline Aldosterone, pmol/L
|
134.58 pmol/L
Standard Deviation 126.126
|
95.11 pmol/L
Standard Deviation 72.640
|
|
Clinical Chemistry Values
Aldosterone, pmol/L 12 weeks (CFB)
|
1.12 pmol/L
Standard Deviation 118.622
|
14.72 pmol/L
Standard Deviation 72.485
|
|
Clinical Chemistry Values
Baseline NT-proBNP, pmol/L
|
23.230 pmol/L
Standard Deviation 22.6864
|
15.866 pmol/L
Standard Deviation 28.2147
|
|
Clinical Chemistry Values
NT-proBNP, pmol/L 12 weeks (CFB)
|
4.621 pmol/L
Standard Deviation 31.1027
|
1.556 pmol/L
Standard Deviation 10.0140
|
|
Clinical Chemistry Values
NT-proBNP, pmol/L 24 weeks (CFB)
|
6.267 pmol/L
Standard Deviation 19.0367
|
15.866 pmol/L
Standard Deviation 46.4392
|
OTHER_PRE_SPECIFIED outcome
Timeframe: From Baseline to 12 Weeks and 24 Weeks of TreatmentPopulation: Number analyzed at 12 and 24 weeks was less than the overall number analyzed due to missing observations
Changes in Urinalysis (CFB = Change from Baseline)
Outcome measures
| Measure |
Verinurad 9 mg+Febuxostat 80 mg
n=32 Participants
Capsule administered orally, once daily for 24 weeks
|
Placebo
n=28 Participants
Capsule administered orally, once daily for 24 weeks
|
|---|---|---|
|
Urinalysis
Baseline Protein/Creatinine, mg/g
|
945.56 mg/g
Standard Deviation 1457.714
|
828.52 mg/g
Standard Deviation 987.671
|
|
Urinalysis
Protein/Creatinine, mg/g 12 weeks (CFB)
|
-185.33 mg/g
Standard Deviation 366.340
|
-155.44 mg/g
Standard Deviation 584.772
|
|
Urinalysis
Protein/Creatinine, mg/g 24 weeks (CFB)
|
-98.60 mg/g
Standard Deviation 397.778
|
177.11 mg/g
Standard Deviation 1387.627
|
OTHER_PRE_SPECIFIED outcome
Timeframe: From Baseline to 12 Weeks and 24 Weeks of TreatmentPopulation: Number analyzed at 12 and 24 weeks was less than the overall number analyzed due to missing observations
Changes in Clinical Chemistry Values (CFB = Change for Baseline)
Outcome measures
| Measure |
Verinurad 9 mg+Febuxostat 80 mg
n=32 Participants
Capsule administered orally, once daily for 24 weeks
|
Placebo
n=28 Participants
Capsule administered orally, once daily for 24 weeks
|
|---|---|---|
|
Clinical Chemistry Values
Baseline Hemoglobin A1C/Hemoglobin, %
|
8.14 % hemoglobin bound to glucose
Standard Deviation 1.913
|
8.28 % hemoglobin bound to glucose
Standard Deviation 2.025
|
|
Clinical Chemistry Values
Hemoglobin A1C/Hemoglobin, % 12 weeks (CFB)
|
0.20 % hemoglobin bound to glucose
Standard Deviation 1.399
|
0.13 % hemoglobin bound to glucose
Standard Deviation 1.159
|
|
Clinical Chemistry Values
Hemoglobin A1C/Hemoglobin, % 24 weeks (CFB)
|
-0.14 % hemoglobin bound to glucose
Standard Deviation 0.884
|
0.22 % hemoglobin bound to glucose
Standard Deviation 1.863
|
OTHER_PRE_SPECIFIED outcome
Timeframe: BaselineOutcome measures
| Measure |
Verinurad 9 mg+Febuxostat 80 mg
n=32 Participants
Capsule administered orally, once daily for 24 weeks
|
Placebo
n=28 Participants
Capsule administered orally, once daily for 24 weeks
|
|---|---|---|
|
Baseline eGFR
|
59.2 mL/min/1.73m2
Standard Deviation 25.25
|
68.1 mL/min/1.73m2
Standard Deviation 23.15
|
OTHER_PRE_SPECIFIED outcome
Timeframe: BaselineOutcome measures
| Measure |
Verinurad 9 mg+Febuxostat 80 mg
n=32 Participants
Capsule administered orally, once daily for 24 weeks
|
Placebo
n=28 Participants
Capsule administered orally, once daily for 24 weeks
|
|---|---|---|
|
Baseline UACR
|
459.05 mg/g
Standard Deviation 824.731
|
411.55 mg/g
Standard Deviation 547.816
|
OTHER_PRE_SPECIFIED outcome
Timeframe: BaselineOutcome measures
| Measure |
Verinurad 9 mg+Febuxostat 80 mg
n=32 Participants
Capsule administered orally, once daily for 24 weeks
|
Placebo
n=28 Participants
Capsule administered orally, once daily for 24 weeks
|
|---|---|---|
|
Baseline Serum Uric Acid (sUA)
|
7.51 mg/dL
Standard Deviation 1.558
|
7.02 mg/dL
Standard Deviation 0.813
|
OTHER_PRE_SPECIFIED outcome
Timeframe: BaselineOutcome measures
| Measure |
Verinurad 9 mg+Febuxostat 80 mg
n=32 Participants
Capsule administered orally, once daily for 24 weeks
|
Placebo
n=28 Participants
Capsule administered orally, once daily for 24 weeks
|
|---|---|---|
|
Baseline Serum Creatinine
|
1.40 mg/dL
Standard Deviation 0.595
|
1.19 mg/dL
Standard Deviation 0.362
|
OTHER_PRE_SPECIFIED outcome
Timeframe: BaselineOutcome measures
| Measure |
Verinurad 9 mg+Febuxostat 80 mg
n=32 Participants
Capsule administered orally, once daily for 24 weeks
|
Placebo
n=28 Participants
Capsule administered orally, once daily for 24 weeks
|
|---|---|---|
|
Baseline Serum Cystatin-C
|
1.579 mg/L
Standard Deviation 0.5274
|
1.313 mg/L
Standard Deviation 0.3532
|
OTHER_PRE_SPECIFIED outcome
Timeframe: BaselineOutcome measures
| Measure |
Verinurad 9 mg+Febuxostat 80 mg
n=32 Participants
Capsule administered orally, once daily for 24 weeks
|
Placebo
n=28 Participants
Capsule administered orally, once daily for 24 weeks
|
|---|---|---|
|
Baseline Serum High-sensitivity C-reactive Protein
|
0.410 mg/dL
Standard Deviation 0.3670
|
0.358 mg/dL
Standard Deviation 0.2506
|
OTHER_PRE_SPECIFIED outcome
Timeframe: BaselinePopulation: Total number differs from Study totals due to subject non compliance with MRI (exam not completed)
Outcome measures
| Measure |
Verinurad 9 mg+Febuxostat 80 mg
n=32 Participants
Capsule administered orally, once daily for 24 weeks
|
Placebo
n=27 Participants
Capsule administered orally, once daily for 24 weeks
|
|---|---|---|
|
Baseline MRI Variables - Kidney Cortex T2 Star
|
81.13 ms
Standard Deviation 12.995
|
82.31 ms
Standard Deviation 11.625
|
OTHER_PRE_SPECIFIED outcome
Timeframe: BaselinePopulation: Total number differs from Study totals due to subject non compliance with MRI (exam not completed)
Outcome measures
| Measure |
Verinurad 9 mg+Febuxostat 80 mg
n=32 Participants
Capsule administered orally, once daily for 24 weeks
|
Placebo
n=26 Participants
Capsule administered orally, once daily for 24 weeks
|
|---|---|---|
|
Baseline MRI Variables - LV End-diastolic Volume
|
161.47 mL
Standard Deviation 37.766
|
161.50 mL
Standard Deviation 32.639
|
OTHER_PRE_SPECIFIED outcome
Timeframe: BaselinePopulation: Total number differs from Study totals due to subject non compliance with MRI (exam not completed)
Outcome measures
| Measure |
Verinurad 9 mg+Febuxostat 80 mg
n=32 Participants
Capsule administered orally, once daily for 24 weeks
|
Placebo
n=26 Participants
Capsule administered orally, once daily for 24 weeks
|
|---|---|---|
|
Baseline MRI Variables - LV Ejection Fraction
|
59.77 % (percentage of LV volume)
Standard Deviation 7.869
|
60.19 % (percentage of LV volume)
Standard Deviation 6.134
|
OTHER_PRE_SPECIFIED outcome
Timeframe: BaselinePopulation: Total number differs from Study totals due to subject non compliance with MRI (exam not completed)
Outcome measures
| Measure |
Verinurad 9 mg+Febuxostat 80 mg
n=32 Participants
Capsule administered orally, once daily for 24 weeks
|
Placebo
n=26 Participants
Capsule administered orally, once daily for 24 weeks
|
|---|---|---|
|
Baseline MRI Variables - LV End-systolic Volume
|
66.43 mL
Standard Deviation 26.089
|
64.63 mL
Standard Deviation 17.977
|
OTHER_PRE_SPECIFIED outcome
Timeframe: BaselinePopulation: Total number differs from Study totals due to subject non compliance with MRI (exam not completed)
Outcome measures
| Measure |
Verinurad 9 mg+Febuxostat 80 mg
n=32 Participants
Capsule administered orally, once daily for 24 weeks
|
Placebo
n=26 Participants
Capsule administered orally, once daily for 24 weeks
|
|---|---|---|
|
Baseline MRI Variables - Circumferential Strain
|
-14.10 % (change in percentage in LV dimension)
Standard Deviation 3.925
|
-15.37 % (change in percentage in LV dimension)
Standard Deviation 2.901
|
OTHER_PRE_SPECIFIED outcome
Timeframe: BaselinePopulation: Total number differs from Study totals due to subject non compliance with MRI (exam not completed)
Outcome measures
| Measure |
Verinurad 9 mg+Febuxostat 80 mg
n=32 Participants
Capsule administered orally, once daily for 24 weeks
|
Placebo
n=26 Participants
Capsule administered orally, once daily for 24 weeks
|
|---|---|---|
|
Baseline MRI Variables - Diastolic Circumferential Strain Rate
|
0.6371 s^-1
Standard Deviation 0.24946
|
0.7588 s^-1
Standard Deviation 0.21276
|
OTHER_PRE_SPECIFIED outcome
Timeframe: BaselinePopulation: Total number differs from Study totals due to subject non compliance with MRI (exam not completed)
Outcome measures
| Measure |
Verinurad 9 mg+Febuxostat 80 mg
n=32 Participants
Capsule administered orally, once daily for 24 weeks
|
Placebo
n=26 Participants
Capsule administered orally, once daily for 24 weeks
|
|---|---|---|
|
Baseline MRI Variables - Diastolic Longitudinal Strain Rate
|
0.4833 s^-1
Standard Deviation 0.21090
|
0.5258 s^-1
Standard Deviation 0.16476
|
OTHER_PRE_SPECIFIED outcome
Timeframe: BaselinePopulation: Total number differs from Study totals due to subject non compliance with MRI (exam not completed)
Outcome measures
| Measure |
Verinurad 9 mg+Febuxostat 80 mg
n=32 Participants
Capsule administered orally, once daily for 24 weeks
|
Placebo
n=26 Participants
Capsule administered orally, once daily for 24 weeks
|
|---|---|---|
|
Baseline MRI Variables - Diastolic Radial Strain Rate
|
-2.3143 s^-1
Standard Deviation 1.08926
|
-2.7591 s^-1
Standard Deviation 1.05712
|
OTHER_PRE_SPECIFIED outcome
Timeframe: BaselinePopulation: Total number differs from Study totals due to subject non compliance with MRI (exam not completed)
Outcome measures
| Measure |
Verinurad 9 mg+Febuxostat 80 mg
n=32 Participants
Capsule administered orally, once daily for 24 weeks
|
Placebo
n=26 Participants
Capsule administered orally, once daily for 24 weeks
|
|---|---|---|
|
Baseline MRI Variables - Longitudinal Strain
|
-12.07 % (change in percentage in LV dimension)
Standard Deviation 3.779
|
-12.21 % (change in percentage in LV dimension)
Standard Deviation 3.102
|
OTHER_PRE_SPECIFIED outcome
Timeframe: BaselinePopulation: Total number differs from Study totals due to subject non compliance with MRI (exam not completed)
Outcome measures
| Measure |
Verinurad 9 mg+Febuxostat 80 mg
n=32 Participants
Capsule administered orally, once daily for 24 weeks
|
Placebo
n=26 Participants
Capsule administered orally, once daily for 24 weeks
|
|---|---|---|
|
Baseline MRI Variables - Radial Strain
|
43.47 % (change in percentage in LV dimension)
Standard Deviation 15.943
|
46.45 % (change in percentage in LV dimension)
Standard Deviation 12.743
|
OTHER_PRE_SPECIFIED outcome
Timeframe: BaselinePopulation: Total number differs from Study totals due to subject non compliance with MRI (exam not completed)
Outcome measures
| Measure |
Verinurad 9 mg+Febuxostat 80 mg
n=32 Participants
Capsule administered orally, once daily for 24 weeks
|
Placebo
n=26 Participants
Capsule administered orally, once daily for 24 weeks
|
|---|---|---|
|
Baseline MRI Variables - Systolic Circumferential Strain Rate
|
-0.7673 s^-1
Standard Deviation 0.19408
|
-0.7797 s^-1
Standard Deviation 0.12776
|
OTHER_PRE_SPECIFIED outcome
Timeframe: BaselinePopulation: Total number differs from Study totals due to subject non compliance with MRI (exam not completed)
Outcome measures
| Measure |
Verinurad 9 mg+Febuxostat 80 mg
n=32 Participants
Capsule administered orally, once daily for 24 weeks
|
Placebo
n=26 Participants
Capsule administered orally, once daily for 24 weeks
|
|---|---|---|
|
Baseline MRI Variables - Systolic Longitudinal Strain Rate
|
-0.6278 s^-1
Standard Deviation 0.16784
|
-0.6552 s^-1
Standard Deviation 0.12734
|
OTHER_PRE_SPECIFIED outcome
Timeframe: BaselinePopulation: Total number differs from Study totals due to subject non compliance with MRI (exam not completed)
Outcome measures
| Measure |
Verinurad 9 mg+Febuxostat 80 mg
n=32 Participants
Capsule administered orally, once daily for 24 weeks
|
Placebo
n=26 Participants
Capsule administered orally, once daily for 24 weeks
|
|---|---|---|
|
Baseline MRI Variables - Systolic Radial Strain Rate
|
2.1059 s^-1
Standard Deviation 0.66890
|
2.1220 s^-1
Standard Deviation 0.58484
|
OTHER_PRE_SPECIFIED outcome
Timeframe: BaselinePopulation: Total number differs from Study totals due to subject non compliance with MRI (exam not completed)
Outcome measures
| Measure |
Verinurad 9 mg+Febuxostat 80 mg
n=32 Participants
Capsule administered orally, once daily for 24 weeks
|
Placebo
n=26 Participants
Capsule administered orally, once daily for 24 weeks
|
|---|---|---|
|
Baseline MRI Variables - LV Mass
|
110.27 g
Standard Deviation 26.229
|
110.82 g
Standard Deviation 28.487
|
OTHER_PRE_SPECIFIED outcome
Timeframe: BaselinePopulation: Total number differs from Study totals due to subject non compliance with MRI (exam not completed)
Outcome measures
| Measure |
Verinurad 9 mg+Febuxostat 80 mg
n=32 Participants
Capsule administered orally, once daily for 24 weeks
|
Placebo
n=26 Participants
Capsule administered orally, once daily for 24 weeks
|
|---|---|---|
|
Baseline MRI Variables - LV Mass/End-diastolic Volume
|
0.696 g/mL
Standard Deviation 0.1437
|
0.687 g/mL
Standard Deviation 0.1163
|
OTHER_PRE_SPECIFIED outcome
Timeframe: BaselinePopulation: Total number differs from Study totals due to subject non compliance with MRI (exam not completed)
Outcome measures
| Measure |
Verinurad 9 mg+Febuxostat 80 mg
n=32 Participants
Capsule administered orally, once daily for 24 weeks
|
Placebo
n=26 Participants
Capsule administered orally, once daily for 24 weeks
|
|---|---|---|
|
Baseline MRI Variables - LV Stroke Volume
|
95.05 mL
Standard Deviation 19.327
|
96.86 mL
Standard Deviation 21.286
|
OTHER_PRE_SPECIFIED outcome
Timeframe: BaselinePopulation: Total number differs from Study totals due to subject non compliance with exam (exam not completed)
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.
Outcome measures
| Measure |
Verinurad 9 mg+Febuxostat 80 mg
n=29 Participants
Capsule administered orally, once daily for 24 weeks
|
Placebo
n=26 Participants
Capsule administered orally, once daily for 24 weeks
|
|---|---|---|
|
Baseline Flow Mediated Dilatation (Reactive Hyperemia)
|
60.4 Units on a scale
Standard Deviation 28.76
|
60.6 Units on a scale
Standard Deviation 30.90
|
Adverse Events
Verinurad 9 mg+Febuxostat 80 mg
Serious events: 5 serious events
Other events: 9 other events
Deaths: 0 deaths
Placebo
Serious events: 3 serious events
Other events: 2 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Verinurad 9 mg+Febuxostat 80 mg
n=32 participants at risk
Capsule administered orally, once daily for 24 weeks
|
Placebo
n=28 participants at risk
Capsule administered orally, once daily for 24 weeks
|
|---|---|---|
|
Cardiac disorders
Acute Myocardial Infarction
|
0.00%
0/32 • Adverse Events were collected from time of signature of informed consent (Screening Visit) throughout the treatment period and including the follow-up period (Day 190).
AEs were spontaneously reported by the patient or reported in response to an open question from the study site staff.
|
3.6%
1/28 • Number of events 1 • Adverse Events were collected from time of signature of informed consent (Screening Visit) throughout the treatment period and including the follow-up period (Day 190).
AEs were spontaneously reported by the patient or reported in response to an open question from the study site staff.
|
|
Cardiac disorders
Cardiac Failure Congestive
|
0.00%
0/32 • Adverse Events were collected from time of signature of informed consent (Screening Visit) throughout the treatment period and including the follow-up period (Day 190).
AEs were spontaneously reported by the patient or reported in response to an open question from the study site staff.
|
3.6%
1/28 • Number of events 1 • Adverse Events were collected from time of signature of informed consent (Screening Visit) throughout the treatment period and including the follow-up period (Day 190).
AEs were spontaneously reported by the patient or reported in response to an open question from the study site staff.
|
|
Gastrointestinal disorders
Abdominal Distension
|
3.1%
1/32 • Number of events 1 • Adverse Events were collected from time of signature of informed consent (Screening Visit) throughout the treatment period and including the follow-up period (Day 190).
AEs were spontaneously reported by the patient or reported in response to an open question from the study site staff.
|
0.00%
0/28 • Adverse Events were collected from time of signature of informed consent (Screening Visit) throughout the treatment period and including the follow-up period (Day 190).
AEs were spontaneously reported by the patient or reported in response to an open question from the study site staff.
|
|
Infections and infestations
Bronchitis
|
3.1%
1/32 • Number of events 1 • Adverse Events were collected from time of signature of informed consent (Screening Visit) throughout the treatment period and including the follow-up period (Day 190).
AEs were spontaneously reported by the patient or reported in response to an open question from the study site staff.
|
0.00%
0/28 • Adverse Events were collected from time of signature of informed consent (Screening Visit) throughout the treatment period and including the follow-up period (Day 190).
AEs were spontaneously reported by the patient or reported in response to an open question from the study site staff.
|
|
Injury, poisoning and procedural complications
Rib Fracture
|
3.1%
1/32 • Number of events 1 • Adverse Events were collected from time of signature of informed consent (Screening Visit) throughout the treatment period and including the follow-up period (Day 190).
AEs were spontaneously reported by the patient or reported in response to an open question from the study site staff.
|
0.00%
0/28 • Adverse Events were collected from time of signature of informed consent (Screening Visit) throughout the treatment period and including the follow-up period (Day 190).
AEs were spontaneously reported by the patient or reported in response to an open question from the study site staff.
|
|
Injury, poisoning and procedural complications
Road Traffic Accident
|
3.1%
1/32 • Number of events 1 • Adverse Events were collected from time of signature of informed consent (Screening Visit) throughout the treatment period and including the follow-up period (Day 190).
AEs were spontaneously reported by the patient or reported in response to an open question from the study site staff.
|
0.00%
0/28 • Adverse Events were collected from time of signature of informed consent (Screening Visit) throughout the treatment period and including the follow-up period (Day 190).
AEs were spontaneously reported by the patient or reported in response to an open question from the study site staff.
|
|
Investigations
Troponin I Increased
|
0.00%
0/32 • Adverse Events were collected from time of signature of informed consent (Screening Visit) throughout the treatment period and including the follow-up period (Day 190).
AEs were spontaneously reported by the patient or reported in response to an open question from the study site staff.
|
3.6%
1/28 • Number of events 1 • Adverse Events were collected from time of signature of informed consent (Screening Visit) throughout the treatment period and including the follow-up period (Day 190).
AEs were spontaneously reported by the patient or reported in response to an open question from the study site staff.
|
|
Musculoskeletal and connective tissue disorders
Back Pain
|
3.1%
1/32 • Number of events 1 • Adverse Events were collected from time of signature of informed consent (Screening Visit) throughout the treatment period and including the follow-up period (Day 190).
AEs were spontaneously reported by the patient or reported in response to an open question from the study site staff.
|
0.00%
0/28 • Adverse Events were collected from time of signature of informed consent (Screening Visit) throughout the treatment period and including the follow-up period (Day 190).
AEs were spontaneously reported by the patient or reported in response to an open question from the study site staff.
|
|
Renal and urinary disorders
Acute Kidney Injury
|
3.1%
1/32 • Number of events 1 • Adverse Events were collected from time of signature of informed consent (Screening Visit) throughout the treatment period and including the follow-up period (Day 190).
AEs were spontaneously reported by the patient or reported in response to an open question from the study site staff.
|
0.00%
0/28 • Adverse Events were collected from time of signature of informed consent (Screening Visit) throughout the treatment period and including the follow-up period (Day 190).
AEs were spontaneously reported by the patient or reported in response to an open question from the study site staff.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
3.1%
1/32 • Number of events 2 • Adverse Events were collected from time of signature of informed consent (Screening Visit) throughout the treatment period and including the follow-up period (Day 190).
AEs were spontaneously reported by the patient or reported in response to an open question from the study site staff.
|
0.00%
0/28 • Adverse Events were collected from time of signature of informed consent (Screening Visit) throughout the treatment period and including the follow-up period (Day 190).
AEs were spontaneously reported by the patient or reported in response to an open question from the study site staff.
|
|
Surgical and medical procedures
Wound Drainage
|
0.00%
0/32 • Adverse Events were collected from time of signature of informed consent (Screening Visit) throughout the treatment period and including the follow-up period (Day 190).
AEs were spontaneously reported by the patient or reported in response to an open question from the study site staff.
|
3.6%
1/28 • Number of events 1 • Adverse Events were collected from time of signature of informed consent (Screening Visit) throughout the treatment period and including the follow-up period (Day 190).
AEs were spontaneously reported by the patient or reported in response to an open question from the study site staff.
|
Other adverse events
| Measure |
Verinurad 9 mg+Febuxostat 80 mg
n=32 participants at risk
Capsule administered orally, once daily for 24 weeks
|
Placebo
n=28 participants at risk
Capsule administered orally, once daily for 24 weeks
|
|---|---|---|
|
Gastrointestinal disorders
Diarrhoea
|
12.5%
4/32 • Number of events 4 • Adverse Events were collected from time of signature of informed consent (Screening Visit) throughout the treatment period and including the follow-up period (Day 190).
AEs were spontaneously reported by the patient or reported in response to an open question from the study site staff.
|
3.6%
1/28 • Number of events 1 • Adverse Events were collected from time of signature of informed consent (Screening Visit) throughout the treatment period and including the follow-up period (Day 190).
AEs were spontaneously reported by the patient or reported in response to an open question from the study site staff.
|
|
Infections and infestations
Nasopharyngitis
|
6.2%
2/32 • Number of events 2 • Adverse Events were collected from time of signature of informed consent (Screening Visit) throughout the treatment period and including the follow-up period (Day 190).
AEs were spontaneously reported by the patient or reported in response to an open question from the study site staff.
|
3.6%
1/28 • Number of events 1 • Adverse Events were collected from time of signature of informed consent (Screening Visit) throughout the treatment period and including the follow-up period (Day 190).
AEs were spontaneously reported by the patient or reported in response to an open question from the study site staff.
|
|
Nervous system disorders
Dizziness
|
9.4%
3/32 • Number of events 3 • Adverse Events were collected from time of signature of informed consent (Screening Visit) throughout the treatment period and including the follow-up period (Day 190).
AEs were spontaneously reported by the patient or reported in response to an open question from the study site staff.
|
0.00%
0/28 • Adverse Events were collected from time of signature of informed consent (Screening Visit) throughout the treatment period and including the follow-up period (Day 190).
AEs were spontaneously reported by the patient or reported in response to an open question from the study site staff.
|
Additional Information
Fredrik Erlandsson, Global Clinical Lead
AstraZeneca R&D
Phone: +46317762365
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: GT60