Trial Outcomes & Findings for Effects of Intravenous Bendavia™ on Reperfusion Injury in Patients Undergoing Angioplasty of the Renal Artery (NCT NCT01755858)
NCT ID: NCT01755858
Last Updated: 2020-08-11
Results Overview
Change in mean glomerular filtration rate (GFR), as measured by iothalamate clearance, from baseline (pre-percutaneous renal artery angioplasty, or pre-PTRA) and 8 weeks post-PTRA..
Recruitment status
TERMINATED
Study phase
PHASE1/PHASE2
Target enrollment
16 participants
Primary outcome timeframe
Baseline (pre-PTRA) and 8 weeks post-PTRA
Results posted on
2020-08-11
Participant Flow
Participant milestones
| Measure |
Bendavia
Bendavia, intravenous infusion, 0.05 mg/kg/hr for a maximum duration of 4 hours.
|
Placebo
Placebo (no active drug), intravenous infusion, for a maximum duration of 4 hours.
|
|---|---|---|
|
Overall Study
STARTED
|
7
|
9
|
|
Overall Study
COMPLETED
|
6
|
8
|
|
Overall Study
NOT COMPLETED
|
1
|
1
|
Reasons for withdrawal
| Measure |
Bendavia
Bendavia, intravenous infusion, 0.05 mg/kg/hr for a maximum duration of 4 hours.
|
Placebo
Placebo (no active drug), intravenous infusion, for a maximum duration of 4 hours.
|
|---|---|---|
|
Overall Study
Adverse Event
|
1
|
1
|
Baseline Characteristics
Effects of Intravenous Bendavia™ on Reperfusion Injury in Patients Undergoing Angioplasty of the Renal Artery
Baseline characteristics by cohort
| Measure |
Bendavia
n=7 Participants
Bendavia, intravenous infusion, 0.05 mg/kg/hr for a maximum duration of 4 hours.
|
Placebo
n=9 Participants
Placebo (no active drug), intravenous infusion, for a maximum duration of 4 hours.
|
Total
n=16 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
66.1 years
STANDARD_DEVIATION 6.41 • n=5 Participants
|
72.6 years
STANDARD_DEVIATION 7.78 • n=7 Participants
|
69.8 years
STANDARD_DEVIATION 7.72 • n=5 Participants
|
|
Sex: Female, Male
Female
|
4 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
3 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
9 Participants
n=5 Participants
|
|
Diabetes Mellitus Status
Positive
|
0 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
Diabetes Mellitus Status
Negative
|
7 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
13 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Baseline (pre-PTRA) and 8 weeks post-PTRAPopulation: All participants for whom GFR by iothalamate clearance was measured at Baseline (pre-PTRA) and 8 weeks post-PTRA.
Change in mean glomerular filtration rate (GFR), as measured by iothalamate clearance, from baseline (pre-percutaneous renal artery angioplasty, or pre-PTRA) and 8 weeks post-PTRA..
Outcome measures
| Measure |
Bendavia
n=6 Participants
Bendavia, intravenous infusion, 0.05 mg/kg/hr for a maximum duration of 4 hours.
|
Placebo
n=8 Participants
Placebo (no active drug), intravenous infusion, for a maximum duration of 4 hours.
|
|---|---|---|
|
Change in Mean Glomerular Filtration Rate (GFR), as Measured by Iothalamate Clearance, at Baseline (Pre-percutaneous Renal Artery Angioplasty and 8 Weeks Post-PTRA.
|
6.3 mL/min
Standard Deviation 12.14
|
12.0 mL/min
Standard Deviation 23.84
|
SECONDARY outcome
Timeframe: Baseline (pre-PTRA) and 8 weeks post-PTRAPopulation: All participants with stented quantifiable kidneys for whom GFR by MDCT was measured at Baseline (pre-PTRA) and 8 weeks post-PTRA.
Change in mean glomerular flow rate as measured using Multi-Detector Computed Tomography (MDCT) at baseline (pre-PTRA) and 8 weeks post-PTRA, stented quantifiable scanned kidneys.
Outcome measures
| Measure |
Bendavia
n=5 Participants
Bendavia, intravenous infusion, 0.05 mg/kg/hr for a maximum duration of 4 hours.
|
Placebo
n=5 Participants
Placebo (no active drug), intravenous infusion, for a maximum duration of 4 hours.
|
|---|---|---|
|
Change in Mean Glomerular Flow Rate as Measured Using Multi-Detector Computed Tomography (MDCT) at Baseline (Pre-PTRA) and 8 Weeks Post-PTRA.
Right Single Kidney
|
0.238 mL/min
Standard Deviation 0.2557
|
0.010 mL/min
Standard Deviation 0.0552
|
|
Change in Mean Glomerular Flow Rate as Measured Using Multi-Detector Computed Tomography (MDCT) at Baseline (Pre-PTRA) and 8 Weeks Post-PTRA.
Left Single Kidney
|
0.012 mL/min
Standard Deviation 0.1487
|
0.120 mL/min
Standard Deviation 0.1600
|
SECONDARY outcome
Timeframe: Baseline (pre-PTRA) and 8 weeks post-PTRAPopulation: All participants for whom regional perfusion was measured by MDCT with stented quantifiable scanned kidneys at Baseline (pre-PTRA) and 8 weeks post-PTRA.
Change in mean regional perfusion as measured by Multi-Detector Computed Tomography (MDCT) Baseline (pre-PTRA) and 8 weeks post-PTRA for stented quantifiable scanned kidneys.
Outcome measures
| Measure |
Bendavia
n=5 Participants
Bendavia, intravenous infusion, 0.05 mg/kg/hr for a maximum duration of 4 hours.
|
Placebo
n=5 Participants
Placebo (no active drug), intravenous infusion, for a maximum duration of 4 hours.
|
|---|---|---|
|
Change in Mean Regional Perfusion as Measured by MDCT at Baseline (Pre-PTRA) and 8 Weeks Post-PTRA
Right Cortical
|
1.266 mL/min
Standard Deviation 0.9341
|
-0.816 mL/min
Standard Deviation 0.6614
|
|
Change in Mean Regional Perfusion as Measured by MDCT at Baseline (Pre-PTRA) and 8 Weeks Post-PTRA
Right Medullary
|
0.242 mL/min
Standard Deviation 0.4143
|
-0.082 mL/min
Standard Deviation 0.2541
|
|
Change in Mean Regional Perfusion as Measured by MDCT at Baseline (Pre-PTRA) and 8 Weeks Post-PTRA
Left Cortical
|
0.614 mL/min
Standard Deviation 1.2390
|
0.220 mL/min
Standard Deviation 0.9112
|
|
Change in Mean Regional Perfusion as Measured by MDCT at Baseline (Pre-PTRA) and 8 Weeks Post-PTRA
Left Medullary
|
0.150 mL/min
Standard Deviation 0.3788
|
0.156 mL/min
Standard Deviation 0.5184
|
SECONDARY outcome
Timeframe: Baseline (pre-PTRA) and 8 weeks post-PTRAPopulation: All participants for whom renal blood flow as measured by MDCT was measured in stented quantifiable scanned kidneys at baseline and 8 weeks post-PTRA.
Change in mean renal blood flow (ml/minute) as measured using Multi-Detector Computed Tomography (MDCT) at Baseline (pre-PTRA) and 8 weeks post-PTRA for stented quantifiable scanned kidneys
Outcome measures
| Measure |
Bendavia
n=5 Participants
Bendavia, intravenous infusion, 0.05 mg/kg/hr for a maximum duration of 4 hours.
|
Placebo
n=5 Participants
Placebo (no active drug), intravenous infusion, for a maximum duration of 4 hours.
|
|---|---|---|
|
Change in Mean Renal Blood Flow as Measured Using Multi-Detector Computed Tomography (MDCT) at Baseline (Pre-PTRA) and 8 Weeks Post-PTRA
Right Cortical
|
85.056 mL/min
Standard Deviation 63.2943
|
-28.406 mL/min
Standard Deviation 54.8919
|
|
Change in Mean Renal Blood Flow as Measured Using Multi-Detector Computed Tomography (MDCT) at Baseline (Pre-PTRA) and 8 Weeks Post-PTRA
Right Medullary
|
6.658 mL/min
Standard Deviation 20.3007
|
-10.204 mL/min
Standard Deviation 21.2044
|
|
Change in Mean Renal Blood Flow as Measured Using Multi-Detector Computed Tomography (MDCT) at Baseline (Pre-PTRA) and 8 Weeks Post-PTRA
Right Total
|
91.712 mL/min
Standard Deviation 82.4794
|
-38.608 mL/min
Standard Deviation 43.4011
|
|
Change in Mean Renal Blood Flow as Measured Using Multi-Detector Computed Tomography (MDCT) at Baseline (Pre-PTRA) and 8 Weeks Post-PTRA
Left Cortical
|
23.928 mL/min
Standard Deviation 64.4891
|
35.090 mL/min
Standard Deviation 59.9470
|
|
Change in Mean Renal Blood Flow as Measured Using Multi-Detector Computed Tomography (MDCT) at Baseline (Pre-PTRA) and 8 Weeks Post-PTRA
Left Medullary
|
3.610 mL/min
Standard Deviation 14.4951
|
5.930 mL/min
Standard Deviation 19.0256
|
|
Change in Mean Renal Blood Flow as Measured Using Multi-Detector Computed Tomography (MDCT) at Baseline (Pre-PTRA) and 8 Weeks Post-PTRA
Left Total
|
27.538 mL/min
Standard Deviation 78.0728
|
41.018 mL/min
Standard Deviation 75.6824
|
SECONDARY outcome
Timeframe: Baseline (Pre-PTRA) and 8 (+4) weeks post-PTRAPopulation: All participants for whom renal volume was measured at baseline (Pre-PTRA) and 8 weeks post-PTRA in stented quantifiable kidneys.
Change in mean renal volume as measured by Multi-Detector Computed Tomography (MDCT) at Baseline (pre-PTRA) and 8 weeks post-PTRA.
Outcome measures
| Measure |
Bendavia
n=5 Participants
Bendavia, intravenous infusion, 0.05 mg/kg/hr for a maximum duration of 4 hours.
|
Placebo
n=5 Participants
Placebo (no active drug), intravenous infusion, for a maximum duration of 4 hours.
|
|---|---|---|
|
Change in Mean Renal Volume as Measured by Multi-Detector Computed Tomography (MDCT) at Baseline (Pre-PTRA) and 8 Weeks Post-PTRA.
Right Total Kidney Volume
|
1.270 mL
Standard Deviation 12.8218
|
4.708 mL
Standard Deviation 13.7198
|
|
Change in Mean Renal Volume as Measured by Multi-Detector Computed Tomography (MDCT) at Baseline (Pre-PTRA) and 8 Weeks Post-PTRA.
Left Total Kidney Volume
|
5.090 mL
Standard Deviation 17.6951
|
10.220 mL
Standard Deviation 8.9447
|
|
Change in Mean Renal Volume as Measured by Multi-Detector Computed Tomography (MDCT) at Baseline (Pre-PTRA) and 8 Weeks Post-PTRA.
Right Cortical
|
4.372 mL
Standard Deviation 10.5438
|
9.840 mL
Standard Deviation 13.1156
|
|
Change in Mean Renal Volume as Measured by Multi-Detector Computed Tomography (MDCT) at Baseline (Pre-PTRA) and 8 Weeks Post-PTRA.
Right Medullary
|
-3.162 mL
Standard Deviation 4.7616
|
-5.132 mL
Standard Deviation 7.0670
|
|
Change in Mean Renal Volume as Measured by Multi-Detector Computed Tomography (MDCT) at Baseline (Pre-PTRA) and 8 Weeks Post-PTRA.
Left Cortical
|
4.534 mL
Standard Deviation 15.0459
|
10.100 mL
Standard Deviation 10.8462
|
|
Change in Mean Renal Volume as Measured by Multi-Detector Computed Tomography (MDCT) at Baseline (Pre-PTRA) and 8 Weeks Post-PTRA.
Left Medullary
|
0.558 mL
Standard Deviation 3.1016
|
0.120 mL
Standard Deviation 8.6277
|
SECONDARY outcome
Timeframe: Baseline (Pre-PTRA) , 27 hours post-PTRA and 8 weeks post-PTRAPopulation: All participants for whom fractional renal oxygenation, axial aspect, in stented kidneys was measured at baseline, 27 hours post-PTRA and 8 weeks post-PTRA.
Mean change in renal oxygenation, axial aspect, in stented kidneys between baseline (pre-PTRA), and 27 hours post-PTRA and 8 weeks post-PTRA as measured by calculation of fractional hypoxia using blood oxygenation level-dependent magnetic resonance (BOLD-MR) imaging.
Outcome measures
| Measure |
Bendavia
n=5 Participants
Bendavia, intravenous infusion, 0.05 mg/kg/hr for a maximum duration of 4 hours.
|
Placebo
n=6 Participants
Placebo (no active drug), intravenous infusion, for a maximum duration of 4 hours.
|
|---|---|---|
|
Mean Change in Renal Oxygenation, Axial Aspect, in Stented Kidneys From Baseline (Pre-PTRA), and 27 Hours Post-PTRA and 8 Weeks Post-PTRA
AxialRightPrefurosemideFractHyp%>20; 8Wk Post PTRA
|
-3.380 s^-1
Standard Deviation 8.5013
|
-10.892 s^-1
Standard Deviation 15.370
|
|
Mean Change in Renal Oxygenation, Axial Aspect, in Stented Kidneys From Baseline (Pre-PTRA), and 27 Hours Post-PTRA and 8 Weeks Post-PTRA
AxialRightPrefurosemideFractHyp%>30 27H PostPTRA
|
5.206 s^-1
Standard Deviation 9.4875
|
11.600 s^-1
Standard Deviation 17.8192
|
|
Mean Change in Renal Oxygenation, Axial Aspect, in Stented Kidneys From Baseline (Pre-PTRA), and 27 Hours Post-PTRA and 8 Weeks Post-PTRA
AxialRightPrefurosemideFractHyp%>30 8Wk PostPTRA
|
-2.120 s^-1
Standard Deviation 2.7426
|
-1.840 s^-1
Standard Deviation 2.8693
|
|
Mean Change in Renal Oxygenation, Axial Aspect, in Stented Kidneys From Baseline (Pre-PTRA), and 27 Hours Post-PTRA and 8 Weeks Post-PTRA
AxialRightPostfurosemideFracHyp%>20 27HPostPTRA
|
24.280 s^-1
Standard Deviation 27.6206
|
13.854 s^-1
Standard Deviation 26.2292
|
|
Mean Change in Renal Oxygenation, Axial Aspect, in Stented Kidneys From Baseline (Pre-PTRA), and 27 Hours Post-PTRA and 8 Weeks Post-PTRA
AxialRightPostfurosemideFracHyp%>20 8WkPostPTRA
|
28.625 s^-1
Standard Deviation 8.9537
|
-7.560 s^-1
Standard Deviation 13.5471
|
|
Mean Change in Renal Oxygenation, Axial Aspect, in Stented Kidneys From Baseline (Pre-PTRA), and 27 Hours Post-PTRA and 8 Weeks Post-PTRA
AxialRightPostfurosemideFracHyp %30 27H Post PTRA
|
6.080 s^-1
Standard Deviation 7.6904
|
13.490 s^-1
Standard Deviation 21.1322
|
|
Mean Change in Renal Oxygenation, Axial Aspect, in Stented Kidneys From Baseline (Pre-PTRA), and 27 Hours Post-PTRA and 8 Weeks Post-PTRA
AxialRightPostfurosemideFracHyp%>30 8WkPost PTRA
|
-0.400 s^-1
Standard Deviation 2.9473
|
-1.370 s^-1
Standard Deviation 3.4412
|
|
Mean Change in Renal Oxygenation, Axial Aspect, in Stented Kidneys From Baseline (Pre-PTRA), and 27 Hours Post-PTRA and 8 Weeks Post-PTRA
AxialLeftPrefurosemide Frac Hyp%>20 27H Post PTRA
|
1.320 s^-1
Standard Deviation 21.7694
|
12.767 s^-1
Standard Deviation 26.0745
|
|
Mean Change in Renal Oxygenation, Axial Aspect, in Stented Kidneys From Baseline (Pre-PTRA), and 27 Hours Post-PTRA and 8 Weeks Post-PTRA
AxialLeftPrefurosemide Frac Hyp%>20 8Wk Post PTRA
|
-0.420 s^-1
Standard Deviation 17.3066
|
-8.160 s^-1
Standard Deviation 16.4477
|
|
Mean Change in Renal Oxygenation, Axial Aspect, in Stented Kidneys From Baseline (Pre-PTRA), and 27 Hours Post-PTRA and 8 Weeks Post-PTRA
AxialLeft Prefurosemide Frac Hyp %>30 27H PostPTRA
|
-3.128 s^-1
Standard Deviation 3.0154
|
16.938 s^-1
Standard Deviation 25.4089
|
|
Mean Change in Renal Oxygenation, Axial Aspect, in Stented Kidneys From Baseline (Pre-PTRA), and 27 Hours Post-PTRA and 8 Weeks Post-PTRA
AxialLeft PrefurosemideFrac Hyp %>30 8Wk PostPTRA
|
-0.602 s^-1
Standard Deviation 7.1510
|
-6.360 s^-1
Standard Deviation 11.3054
|
|
Mean Change in Renal Oxygenation, Axial Aspect, in Stented Kidneys From Baseline (Pre-PTRA), and 27 Hours Post-PTRA and 8 Weeks Post-PTRA
AxialLeft Post-FurosemideFrac Hyp%>20 27HPostPTRA
|
0.148 s^-1
Standard Deviation 21.0184
|
14.083 s^-1
Standard Deviation 34.6825
|
|
Mean Change in Renal Oxygenation, Axial Aspect, in Stented Kidneys From Baseline (Pre-PTRA), and 27 Hours Post-PTRA and 8 Weeks Post-PTRA
AxialLeft Post-FurosemideFrac Hyp%>20 8WkPostPTRA
|
-0.012 s^-1
Standard Deviation 17.3829
|
-14.220 s^-1
Standard Deviation 13.303
|
|
Mean Change in Renal Oxygenation, Axial Aspect, in Stented Kidneys From Baseline (Pre-PTRA), and 27 Hours Post-PTRA and 8 Weeks Post-PTRA
AxialLeft Post-FurosemideFrac Hyp%>30 27HPostPTRA
|
-1.874 s^-1
Standard Deviation 2.5111
|
18.757 s^-1
Standard Deviation 27.1441
|
|
Mean Change in Renal Oxygenation, Axial Aspect, in Stented Kidneys From Baseline (Pre-PTRA), and 27 Hours Post-PTRA and 8 Weeks Post-PTRA
AxialLeft Post-FurosemideFrac Hyp%>30 8WkPostPTRA
|
1.858 s^-1
Standard Deviation 7.0087
|
-5.704 s^-1
Standard Deviation 8.3550
|
|
Mean Change in Renal Oxygenation, Axial Aspect, in Stented Kidneys From Baseline (Pre-PTRA), and 27 Hours Post-PTRA and 8 Weeks Post-PTRA
AxialRightPrefurosemideFractHyp%>20 27H Post PTRA
|
13.440 s^-1
Standard Deviation 34.6825
|
16.708 s^-1
Standard Deviation 19.4980
|
SECONDARY outcome
Timeframe: 27H post PTRA and 8 weeks Post PTRAPopulation: All participants for whom fractional renal oxygenation, coronal aspect, in stented kidneys was measured at baseline, 27 hours post-PTRA and 8 weeks post-PTRA.
Mean change in renal oxygenation, coronal aspect, in stented kidneys between baseline (pre-PTRA) and 27 hours post-PTRA or 8 weeks post-PTRA, as measured by calculation of fractional hypoxia using blood oxygenation level-dependent magnetic resonance (BOLD-MR) imaging, with and without Bendavia
Outcome measures
| Measure |
Bendavia
n=5 Participants
Bendavia, intravenous infusion, 0.05 mg/kg/hr for a maximum duration of 4 hours.
|
Placebo
n=6 Participants
Placebo (no active drug), intravenous infusion, for a maximum duration of 4 hours.
|
|---|---|---|
|
Mean Change in Renal Oxygenation, Coronal Aspect, in Stented Kidneys Between Baseline Pre-PTRA, 27 Hours Post-PTRA and 8 Weeks Post-PTRA
CoronalRtFractHypoxia% >20Prefuros.27HPost-PTRA
|
20.314 s^-1
Standard Deviation 33.3525
|
9.083 s^-1
Standard Deviation 17.3368
|
|
Mean Change in Renal Oxygenation, Coronal Aspect, in Stented Kidneys Between Baseline Pre-PTRA, 27 Hours Post-PTRA and 8 Weeks Post-PTRA
CoronalRtFractHypoxia% >20Prefuros.8WkPost-PTRA
|
4.140 s^-1
Standard Deviation 16.4690
|
-2.220 s^-1
Standard Deviation 7.5549
|
|
Mean Change in Renal Oxygenation, Coronal Aspect, in Stented Kidneys Between Baseline Pre-PTRA, 27 Hours Post-PTRA and 8 Weeks Post-PTRA
CoronalRtFractHypoxia% >30Prefuros.27HPost-PTRA
|
10.800 s^-1
Standard Deviation 9.6734
|
9.250 s^-1
Standard Deviation 30.6001
|
|
Mean Change in Renal Oxygenation, Coronal Aspect, in Stented Kidneys Between Baseline Pre-PTRA, 27 Hours Post-PTRA and 8 Weeks Post-PTRA
CoronalRtFractHypoxia% >30Prefuros8WkPost-PTRA
|
3.300 s^-1
Standard Deviation 10.1403
|
-2.852 s^-1
Standard Deviation 11.1986
|
|
Mean Change in Renal Oxygenation, Coronal Aspect, in Stented Kidneys Between Baseline Pre-PTRA, 27 Hours Post-PTRA and 8 Weeks Post-PTRA
CoronalRtFractHypoxia% >20Postfuros27HPost-PTRA
|
29.800 s^-1
Standard Deviation 33.5328
|
3.840 s^-1
Standard Deviation 22.4825
|
|
Mean Change in Renal Oxygenation, Coronal Aspect, in Stented Kidneys Between Baseline Pre-PTRA, 27 Hours Post-PTRA and 8 Weeks Post-PTRA
CoronalRtFractHypoxia% >20Postfuros8WKPost-PTRA
|
5.233 s^-1
Standard Deviation 7.5142
|
-5.220 s^-1
Standard Deviation 4.6018
|
|
Mean Change in Renal Oxygenation, Coronal Aspect, in Stented Kidneys Between Baseline Pre-PTRA, 27 Hours Post-PTRA and 8 Weeks Post-PTRA
CoronalRtFractHypoxia% >30Postfuros27HPost-PTRA
|
12.875 s^-1
Standard Deviation 13.2666
|
11.458 s^-1
Standard Deviation 32.8826
|
|
Mean Change in Renal Oxygenation, Coronal Aspect, in Stented Kidneys Between Baseline Pre-PTRA, 27 Hours Post-PTRA and 8 Weeks Post-PTRA
CoronalRtFractHypoxia% >30Postfuros8WkPost-PTRA
|
2.233 s^-1
Standard Deviation 3.5119
|
-8.158 s^-1
Standard Deviation 16.5393
|
|
Mean Change in Renal Oxygenation, Coronal Aspect, in Stented Kidneys Between Baseline Pre-PTRA, 27 Hours Post-PTRA and 8 Weeks Post-PTRA
CoronalLeftFractHypoxia% >20Prefuros.27HPost-PTRA
|
5.000 s^-1
Standard Deviation 23.7674
|
6.033 s^-1
Standard Deviation 31.1820
|
|
Mean Change in Renal Oxygenation, Coronal Aspect, in Stented Kidneys Between Baseline Pre-PTRA, 27 Hours Post-PTRA and 8 Weeks Post-PTRA
CoronalLeftFractHypoxia% >20Prefuros.8WkPost-PTRA
|
-3.125 s^-1
Standard Deviation 10.2970
|
-0.525 s^-1
Standard Deviation 12.5077
|
|
Mean Change in Renal Oxygenation, Coronal Aspect, in Stented Kidneys Between Baseline Pre-PTRA, 27 Hours Post-PTRA and 8 Weeks Post-PTRA
CoronalLeftFractHypoxia% >30Prefuros.27HPost-PTRA
|
-2.000 s^-1
Standard Deviation 8.9272
|
22.615 s^-1
Standard Deviation 35.6971
|
|
Mean Change in Renal Oxygenation, Coronal Aspect, in Stented Kidneys Between Baseline Pre-PTRA, 27 Hours Post-PTRA and 8 Weeks Post-PTRA
CoronalLeftFractHypoxia% >30Prefuros.8WkPost-PTRA
|
-2.275 s^-1
Standard Deviation 4.4650
|
-1.525 s^-1
Standard Deviation 12.3605
|
|
Mean Change in Renal Oxygenation, Coronal Aspect, in Stented Kidneys Between Baseline Pre-PTRA, 27 Hours Post-PTRA and 8 Weeks Post-PTRA
CoronalLeftFractHypoxia% >20Postfuros.27HPost-PTRA
|
6.240 s^-1
Standard Deviation 24.5671
|
6.783 s^-1
Standard Deviation 29.1337
|
|
Mean Change in Renal Oxygenation, Coronal Aspect, in Stented Kidneys Between Baseline Pre-PTRA, 27 Hours Post-PTRA and 8 Weeks Post-PTRA
CoronalLeftFractHypoxia% >20Postfuros.8WkPost-PTRA
|
3.375 s^-1
Standard Deviation 9.2525
|
-0.700 s^-1
Standard Deviation 14.7384
|
|
Mean Change in Renal Oxygenation, Coronal Aspect, in Stented Kidneys Between Baseline Pre-PTRA, 27 Hours Post-PTRA and 8 Weeks Post-PTRA
CoronalLeftFractHypoxia% >30Postfuros.27HPost-PTRA
|
0.080 s^-1
Standard Deviation 7.3145
|
20.345 s^-1
Standard Deviation 31.5024
|
|
Mean Change in Renal Oxygenation, Coronal Aspect, in Stented Kidneys Between Baseline Pre-PTRA, 27 Hours Post-PTRA and 8 Weeks Post-PTRA
CoronalLeftFractHypoxia% >30Postfuros.8WkPost-PTRA
|
-0.250 s^-1
Standard Deviation 2.0873
|
-4.225 s^-1
Standard Deviation 12.7899
|
SECONDARY outcome
Timeframe: Pre-PTRA and 27 hours post-PTRA and 8 weeks post-PTRAPopulation: All participants for whom systolic blood pressure was measured at baseline (pre-PTRA) and 27 hours post-PTRA, or 8(+4) weeks post-PTRA.
Outcome measures
| Measure |
Bendavia
n=7 Participants
Bendavia, intravenous infusion, 0.05 mg/kg/hr for a maximum duration of 4 hours.
|
Placebo
n=9 Participants
Placebo (no active drug), intravenous infusion, for a maximum duration of 4 hours.
|
|---|---|---|
|
Mean Change in Systolic Blood Pressure Values (mmHg) From Pre-PTRA, Immediately Post-PTRA, 27 Hours and 8 (+4) Weeks Post-PTRA
8 weeks Post PTRA
|
13.2 mmHg
Standard Deviation 19.88
|
-0.8 mmHg
Standard Deviation 30.83
|
|
Mean Change in Systolic Blood Pressure Values (mmHg) From Pre-PTRA, Immediately Post-PTRA, 27 Hours and 8 (+4) Weeks Post-PTRA
27 Hours Post-PTRA
|
-2.9 mmHg
Standard Deviation 14.78
|
-3.8 mmHg
Standard Deviation 15.69
|
SECONDARY outcome
Timeframe: Pre-PTRA, immediately post-PTRA, 27 hours post-PTRA and 8 weeks post-PTRAPopulation: All participants for whom diastolic blood pressure was measured.
Mean Change in Diastolic Blood Pressure (DBP) values (mmHg) from baseline (pre-PTRA), immediately post-PTRA, 27 hours and 8 weeks post-PTRA, with and without Bendavia.
Outcome measures
| Measure |
Bendavia
n=7 Participants
Bendavia, intravenous infusion, 0.05 mg/kg/hr for a maximum duration of 4 hours.
|
Placebo
n=9 Participants
Placebo (no active drug), intravenous infusion, for a maximum duration of 4 hours.
|
|---|---|---|
|
Mean Change in Diastolic Blood Pressure
27 Hours Post-PTRA
|
3.6 mmHg
Standard Deviation 7.76
|
-2.0 mmHg
Standard Deviation 9.88
|
|
Mean Change in Diastolic Blood Pressure
8 Weeks Post PTRA
|
0.0 mmHg
Standard Deviation 9.70
|
0.1 mmHg
Standard Deviation 9.80
|
Adverse Events
Bendavia
Serious events: 1 serious events
Other events: 2 other events
Deaths: 0 deaths
Placebo
Serious events: 1 serious events
Other events: 5 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Bendavia
n=7 participants at risk
Bendavia, intravenous infusion, 0.05 mg/kg/hr for a maximum duration of 4 hours.
|
Placebo
n=9 participants at risk
Placebo (no active drug), intravenous infusion, for a maximum duration of 4 hours.
|
|---|---|---|
|
Injury, poisoning and procedural complications
Vascular Pseudoaneurysm
|
14.3%
1/7 • Number of events 1
|
0.00%
0/9
|
|
Cardiac disorders
Cardiac Failure Acute
|
0.00%
0/7
|
11.1%
1/9 • Number of events 2
|
Other adverse events
| Measure |
Bendavia
n=7 participants at risk
Bendavia, intravenous infusion, 0.05 mg/kg/hr for a maximum duration of 4 hours.
|
Placebo
n=9 participants at risk
Placebo (no active drug), intravenous infusion, for a maximum duration of 4 hours.
|
|---|---|---|
|
Vascular disorders
Hypertension
|
14.3%
1/7
|
11.1%
1/9
|
|
Vascular disorders
Hypotension
|
14.3%
1/7
|
11.1%
1/9
|
|
Vascular disorders
Labile Blood Pressure
|
0.00%
0/7
|
11.1%
1/9
|
|
Investigations
Blood sodium decreased
|
14.3%
1/7
|
11.1%
1/9
|
|
Investigations
Blood magnesium decreased
|
0.00%
0/7
|
11.1%
1/9
|
|
Investigations
Blood potassium decreased
|
0.00%
0/7
|
11.1%
1/9
|
|
Investigations
Pedal pulse decreased
|
0.00%
0/7
|
11.1%
1/9
|
|
Investigations
Thyroid function test abnormal
|
0.00%
0/7
|
11.1%
1/9
|
|
Injury, poisoning and procedural complications
Contusion
|
14.3%
1/7
|
0.00%
0/9
|
|
Injury, poisoning and procedural complications
Procedural Pain
|
0.00%
0/7
|
11.1%
1/9
|
|
Gastrointestinal disorders
Constipation
|
0.00%
0/7
|
22.2%
2/9
|
|
Nervous system disorders
Dizziness
|
14.3%
1/7
|
0.00%
0/9
|
|
Nervous system disorders
Presyncope
|
0.00%
0/7
|
11.1%
1/9
|
|
General disorders
Oedema peripheral
|
14.3%
1/7
|
0.00%
0/9
|
|
Infections and infestations
Pneumonia
|
0.00%
0/7
|
11.1%
1/9
|
|
Metabolism and nutrition disorders
Hyperphosphataemia
|
0.00%
0/7
|
11.1%
1/9
|
|
Psychiatric disorders
Anxiety
|
0.00%
0/7
|
11.1%
1/9
|
|
Psychiatric disorders
Insomnia
|
0.00%
0/7
|
11.1%
1/9
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.00%
0/7
|
11.1%
1/9
|
|
Respiratory, thoracic and mediastinal disorders
Nasal Dryness
|
0.00%
0/7
|
11.1%
1/9
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory Distress
|
0.00%
0/7
|
22.2%
2/9
|
Additional Information
Jim Carr, Pharm.D. Chief Clinical Development Officer
Stealth BioTherapeutics, Inc
Phone: 1-617-600-6888
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: LTE60