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EVOLVE: Effects of Intravenous Bendavia™ on Reperfusion Injury in Patients Undergoing Angioplasty of the Renal Artery

Sponsor
Stealth BioTherapeutics Inc. (Industry)
Overall Status
Terminated
CT.gov ID
NCT01755858
Collaborator
(none)
16
Enrollment
1
Location
2
Arms
41
Duration (Months)
0.4
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

This was a Phase 2a prospective, single center, randomized, double-blind, placebo-controlled study designed to assess the efficacy, pharmacokinetics, safety and tolerability of IV elamipretide for reduction of reperfusion injury in subjects with Atherosclerotic Renal Artery Stenosis (ARAS), who are undergoing percutaneous transluminal angioplasty of the renal artery (PTRA).

Condition or Disease Intervention/Treatment Phase
Phase 1/Phase 2

Detailed Description

This was a Phase 2a prospective, single center, randomized, double-blind, placebo-controlled study designed to assess the efficacy, pharmacokinetics, safety and tolerability of IV elamipretide for reduction of reperfusion injury in subjects with ARAS, who are undergoing percutaneous transluminal angioplasty of the renal artery (PTRA).

The randomization (1:1 active:placebo) was stratified by a diagnosis of diabetes mellitus. Participants received either 0.05 mg/kg/h elamipretide or matching placebo, administered as an IV infusion at 60 mL/h infused 30 minutes before and continued 3 hours after PTRA of the renal artery. After completion of the PTRA and stenting, subjects were to receive standard treatment.

Study Design

Study Type:
Interventional
Actual Enrollment :
16 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Triple (Participant, Care Provider, Investigator)
Primary Purpose:
Basic Science
Official Title:
A Phase 2a, Placebo-controlled Trial to Evaluate the Impact of Intravenous Bendavia™ on Ischemia Reperfusion Injury in Atherosclerotic Renal Artery Stenosis in Patients Undergoing Percutaneous Transluminal Angioplasty of the Renal Artery
Study Start Date :
Dec 1, 2012
Actual Primary Completion Date :
Dec 1, 2015
Actual Study Completion Date :
May 1, 2016

Arms and Interventions

Arm Intervention/Treatment
Experimental: Bendavia

Bendavia, intravenous infusion, 0.05 mg/kg/hr for a maximum duration of 4 hours.

Drug: Bendavia
Other Names:
  • MTP-131
  • Elamipretide

    		•
    Placebo Comparator: Placebo

    Placebo (no active drug), intravenous infusion, for a maximum duration of 4 hours.

    Drug: Placebo

    Outcome Measures

    Primary Outcome Measures

    1. Change in Mean Glomerular Filtration Rate (GFR), as Measured by Iothalamate Clearance, at Baseline (Pre-percutaneous Renal Artery Angioplasty and 8 Weeks Post-PTRA. [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..

    Secondary Outcome Measures

    1. Change in Mean Glomerular Flow Rate as Measured Using Multi-Detector Computed Tomography (MDCT) at Baseline (Pre-PTRA) and 8 Weeks Post-PTRA. [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.

    2. Change in Mean Regional Perfusion as Measured by MDCT at Baseline (Pre-PTRA) and 8 Weeks Post-PTRA [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.

    3. Change in Mean Renal Blood Flow as Measured Using Multi-Detector Computed Tomography (MDCT) at Baseline (Pre-PTRA) and 8 Weeks Post-PTRA [Baseline (pre-PTRA) 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

    4. Change in Mean Renal Volume as Measured by Multi-Detector Computed Tomography (MDCT) at Baseline (Pre-PTRA) and 8 Weeks Post-PTRA. [Baseline (Pre-PTRA) and 8 (+4) weeks post-PTRA]

      Change in mean renal volume as measured by Multi-Detector Computed Tomography (MDCT) at Baseline (pre-PTRA) and 8 weeks post-PTRA.

    5. Mean Change in Renal Oxygenation, Axial Aspect, in Stented Kidneys From Baseline (Pre-PTRA), and 27 Hours Post-PTRA and 8 Weeks Post-PTRA [Baseline (Pre-PTRA) , 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.

    6. Mean Change in Renal Oxygenation, Coronal Aspect, in Stented Kidneys Between Baseline Pre-PTRA, 27 Hours Post-PTRA and 8 Weeks Post-PTRA [27H 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

    7. Mean Change in Systolic Blood Pressure Values (mmHg) From Pre-PTRA, Immediately Post-PTRA, 27 Hours and 8 (+4) Weeks Post-PTRA [Pre-PTRA and 27 hours post-PTRA and 8 weeks post-PTRA]

    8. Mean Change in Diastolic Blood Pressure [Pre-PTRA, immediately post-PTRA, 27 hours post-PTRA and 8 weeks post-PTRA]

      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.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    40 Years to 80 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:

    • ≥40 and ≤80 years old.

    • Patients with hypertension (systolic blood pressure [BP] >155 mm Hg) and/or requiring 2 or more antihypertensive medications: no restrictions will be placed on antihypertensive agents, although loop diuretics will be temporarily changed to diluting site agents (eg, hydrochlorothiazide, indapamide, metolazone) prior to each blood oxygen level-dependent magnetic resonance imaging (BOLD-MRI) study performed during the trial, unless, in the judgment of the Investigator, the change represents a hazard to the patient. ARAS patients will be identified based upon radiologic and clinical criteria suggestive of renovascular hypertension and/or hemodynamically significant renovascular disease >60% lumen occlusion (determined by quantitative computed tomography angiography or Doppler ultrasound velocity >200 cm/sec).

    • Have an estimated glomerular filtration rate of ≥15 ml/min/1.73 m2 calculated using the Modification of Diet in Renal Disease (MDRD) formula.

    • Have no contraindications to angiography such as severe contrast allergy.

    • Have no contraindications to non-contrast magnetic resonance evaluations such as a pacemaker or magnetically active metal fragments.

    • Able to comply with protocol.

    • Women of childbearing age must:

    • Have a negative pregnancy serum human chorionic gonadotropin test prior to receiving study drug.

    • Agree to use two forms of contraception for 3 months following receipt of the study drug.

    • Men who are sexually active and able to father a child, must agree to use one of the birth control methods listed below for the entire study and for at least 2 months after receiving the study drug:

    • Barrier methods (such as a condom or diaphragm) used with a spermicide.

    • Hormonal methods used by his partner, such as birth control pills, patches, injections, vaginal ring, or implants.

    • Intrauterine device (IUD) used by his partner.

    • Abstinence (no sex).

    • Competent and able to provide written informed consent

    Exclusion Criteria:

    • Advanced chronic kidney disease defined as either Stage 5 or end-stage renal disease requiring dialysis.

    • Have other clinically significant abnormalities or laboratory results that would, in the opinion of the investigators, compromise the safety of the patient including evidence of diabetic ketoacidosis, paraproteinemia, or triglycerides above 600 mg/dL.

    • Clinically significant medical conditions within the six months before administration of Bendavia (e.g., cancer, stroke, myocardial infarction, active angina, congestive heart failure) that would, in the opinion of the investigators, compromise the safety of the patient.

    • Have received an investigational drug within thirty (30) days of baseline.

    • Have a serum sodium <135 mmol/L on the day of, and prior to, the PTRA.

    • Are pregnant or breast feeding.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Mayo Clinic Rochester Minnesota United States 55905

    Sponsors and Collaborators

    • Stealth BioTherapeutics Inc.

    Investigators

    • Principal Investigator: Stephen C Textor, MD, Mayo Clinic
    • Study Director: Richard Straube, MD, Stealth BioTherapeutics Inc.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Stealth BioTherapeutics Inc.
    ClinicalTrials.gov Identifier:
    NCT01755858
    Other Study ID Numbers:
    • SPIRI-225
    First Posted:
    Dec 24, 2012
    Last Update Posted:
    Aug 11, 2020
    Last Verified:
    Aug 1, 2020
    Keywords provided by Stealth BioTherapeutics Inc.
    elamipretide
    Additional relevant MeSH terms:
    Renal Artery Obstruction
    Hypertension, Renovascular
    Reperfusion Injury
    Ischemia
    Wounds and Injuries

    Study Results

    Participant Flow

    Recruitment Details
    Pre-assignment Detail
    Arm/Group Title Bendavia Placebo
    Arm/Group Description Bendavia, intravenous infusion, 0.05 mg/kg/hr for a maximum duration of 4 hours. Placebo (no active drug), intravenous infusion, for a maximum duration of 4 hours.
    Period Title: Overall Study
    STARTED 7 9
    COMPLETED 6 8
    NOT COMPLETED 1 1

    Baseline Characteristics

    Arm/Group Title Bendavia Placebo Total
    Arm/Group Description Bendavia, intravenous infusion, 0.05 mg/kg/hr for a maximum duration of 4 hours. Placebo (no active drug), intravenous infusion, for a maximum duration of 4 hours. Total of all reporting groups
    Overall Participants 7 9 16
    Age (years) [Mean (Standard Deviation) ]
    Mean (Standard Deviation) [years]
    66.1
    (6.41)
    72.6
    (7.78)
    69.8
    (7.72)
    Sex: Female, Male (Count of Participants)
    Female
    4
    57.1%
    3
    33.3%
    7
    43.8%
    Male
    3
    42.9%
    6
    66.7%
    9
    56.3%
    Diabetes Mellitus Status (Count of Participants)
    Positive
    0
    0%
    3
    33.3%
    3
    18.8%
    Negative
    7
    100%
    6
    66.7%
    13
    81.3%

    Outcome Measures

    1. Primary Outcome
    Title Change in Mean Glomerular Filtration Rate (GFR), as Measured by Iothalamate Clearance, at Baseline (Pre-percutaneous Renal Artery Angioplasty and 8 Weeks Post-PTRA.
    Description 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..
    Time Frame Baseline (pre-PTRA) and 8 weeks post-PTRA

    Outcome Measure Data

    Analysis Population Description
    All participants for whom GFR by iothalamate clearance was measured at Baseline (pre-PTRA) and 8 weeks post-PTRA.
    Arm/Group Title Bendavia Placebo
    Arm/Group Description Bendavia, intravenous infusion, 0.05 mg/kg/hr for a maximum duration of 4 hours. Placebo (no active drug), intravenous infusion, for a maximum duration of 4 hours.
    Measure Participants 6 8
    Mean (Standard Deviation) [mL/min]
    6.3
    (12.14)
    12.0
    (23.84)
    2. Secondary Outcome
    Title Change in Mean Glomerular Flow Rate as Measured Using Multi-Detector Computed Tomography (MDCT) at Baseline (Pre-PTRA) and 8 Weeks Post-PTRA.
    Description 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.
    Time Frame Baseline (pre-PTRA) and 8 weeks post-PTRA

    Outcome Measure Data

    Analysis Population Description
    All participants with stented quantifiable kidneys for whom GFR by MDCT was measured at Baseline (pre-PTRA) and 8 weeks post-PTRA.
    Arm/Group Title Bendavia Placebo
    Arm/Group Description Bendavia, intravenous infusion, 0.05 mg/kg/hr for a maximum duration of 4 hours. Placebo (no active drug), intravenous infusion, for a maximum duration of 4 hours.
    Measure Participants 5 5
    Right Single Kidney
    0.238
    (0.2557)
    0.010
    (0.0552)
    Left Single Kidney
    0.012
    (0.1487)
    0.120
    (0.1600)
    3. Secondary Outcome
    Title Change in Mean Regional Perfusion as Measured by MDCT at Baseline (Pre-PTRA) and 8 Weeks Post-PTRA
    Description 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.
    Time Frame Baseline (pre-PTRA) and 8 weeks post-PTRA

    Outcome Measure Data

    Analysis Population Description
    All participants for whom regional perfusion was measured by MDCT with stented quantifiable scanned kidneys at Baseline (pre-PTRA) and 8 weeks post-PTRA.
    Arm/Group Title Bendavia Placebo
    Arm/Group Description Bendavia, intravenous infusion, 0.05 mg/kg/hr for a maximum duration of 4 hours. Placebo (no active drug), intravenous infusion, for a maximum duration of 4 hours.
    Measure Participants 5 5
    Right Cortical
    1.266
    (0.9341)
    -0.816
    (0.6614)
    Right Medullary
    0.242
    (0.4143)
    -0.082
    (0.2541)
    Left Cortical
    0.614
    (1.2390)
    0.220
    (0.9112)
    Left Medullary
    0.150
    (0.3788)
    0.156
    (0.5184)
    4. Secondary Outcome
    Title Change in Mean Renal Blood Flow as Measured Using Multi-Detector Computed Tomography (MDCT) at Baseline (Pre-PTRA) and 8 Weeks Post-PTRA
    Description 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
    Time Frame Baseline (pre-PTRA) and 8 weeks post-PTRA

    Outcome Measure Data

    Analysis Population Description
    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.
    Arm/Group Title Bendavia Placebo
    Arm/Group Description Bendavia, intravenous infusion, 0.05 mg/kg/hr for a maximum duration of 4 hours. Placebo (no active drug), intravenous infusion, for a maximum duration of 4 hours.
    Measure Participants 5 5
    Right Cortical
    85.056
    (63.2943)
    -28.406
    (54.8919)
    Right Medullary
    6.658
    (20.3007)
    -10.204
    (21.2044)
    Right Total
    91.712
    (82.4794)
    -38.608
    (43.4011)
    Left Cortical
    23.928
    (64.4891)
    35.090
    (59.9470)
    Left Medullary
    3.610
    (14.4951)
    5.930
    (19.0256)
    Left Total
    27.538
    (78.0728)
    41.018
    (75.6824)
    5. Secondary Outcome
    Title Change in Mean Renal Volume as Measured by Multi-Detector Computed Tomography (MDCT) at Baseline (Pre-PTRA) and 8 Weeks Post-PTRA.
    Description Change in mean renal volume as measured by Multi-Detector Computed Tomography (MDCT) at Baseline (pre-PTRA) and 8 weeks post-PTRA.
    Time Frame Baseline (Pre-PTRA) and 8 (+4) weeks post-PTRA

    Outcome Measure Data

    Analysis Population Description
    All participants for whom renal volume was measured at baseline (Pre-PTRA) and 8 weeks post-PTRA in stented quantifiable kidneys.
    Arm/Group Title Bendavia Placebo
    Arm/Group Description Bendavia, intravenous infusion, 0.05 mg/kg/hr for a maximum duration of 4 hours. Placebo (no active drug), intravenous infusion, for a maximum duration of 4 hours.
    Measure Participants 5 5
    Right Total Kidney Volume
    1.270
    (12.8218)
    4.708
    (13.7198)
    Left Total Kidney Volume
    5.090
    (17.6951)
    10.220
    (8.9447)
    Right Cortical
    4.372
    (10.5438)
    9.840
    (13.1156)
    Right Medullary
    -3.162
    (4.7616)
    -5.132
    (7.0670)
    Left Cortical
    4.534
    (15.0459)
    10.100
    (10.8462)
    Left Medullary
    0.558
    (3.1016)
    0.120
    (8.6277)
    6. Secondary Outcome
    Title Mean Change in Renal Oxygenation, Axial Aspect, in Stented Kidneys From Baseline (Pre-PTRA), and 27 Hours Post-PTRA and 8 Weeks Post-PTRA
    Description 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.
    Time Frame Baseline (Pre-PTRA) , 27 hours post-PTRA and 8 weeks post-PTRA

    Outcome Measure Data

    Analysis Population Description
    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.
    Arm/Group Title Bendavia Placebo
    Arm/Group Description Bendavia, intravenous infusion, 0.05 mg/kg/hr for a maximum duration of 4 hours. Placebo (no active drug), intravenous infusion, for a maximum duration of 4 hours.
    Measure Participants 5 6
    AxialRightPrefurosemideFractHyp%>20 27H Post PTRA
    13.440
    (34.6825)
    16.708
    (19.4980)
    AxialRightPrefurosemideFractHyp%>20; 8Wk Post PTRA
    -3.380
    (8.5013)
    -10.892
    (15.370)
    AxialRightPrefurosemideFractHyp%>30 27H PostPTRA
    5.206
    (9.4875)
    11.600
    (17.8192)
    AxialRightPrefurosemideFractHyp%>30 8Wk PostPTRA
    -2.120
    (2.7426)
    -1.840
    (2.8693)
    AxialRightPostfurosemideFracHyp%>20 27HPostPTRA
    24.280
    (27.6206)
    13.854
    (26.2292)
    AxialRightPostfurosemideFracHyp%>20 8WkPostPTRA
    28.625
    (8.9537)
    -7.560
    (13.5471)
    AxialRightPostfurosemideFracHyp %30 27H Post PTRA
    6.080
    (7.6904)
    13.490
    (21.1322)
    AxialRightPostfurosemideFracHyp%>30 8WkPost PTRA
    -0.400
    (2.9473)
    -1.370
    (3.4412)
    AxialLeftPrefurosemide Frac Hyp%>20 27H Post PTRA
    1.320
    (21.7694)
    12.767
    (26.0745)
    AxialLeftPrefurosemide Frac Hyp%>20 8Wk Post PTRA
    -0.420
    (17.3066)
    -8.160
    (16.4477)
    AxialLeft Prefurosemide Frac Hyp %>30 27H PostPTRA
    -3.128
    (3.0154)
    16.938
    (25.4089)
    AxialLeft PrefurosemideFrac Hyp %>30 8Wk PostPTRA
    -0.602
    (7.1510)
    -6.360
    (11.3054)
    AxialLeft Post-FurosemideFrac Hyp%>20 27HPostPTRA
    0.148
    (21.0184)
    14.083
    (34.6825)
    AxialLeft Post-FurosemideFrac Hyp%>20 8WkPostPTRA
    -0.012
    (17.3829)
    -14.220
    (13.303)
    AxialLeft Post-FurosemideFrac Hyp%>30 27HPostPTRA
    -1.874
    (2.5111)
    18.757
    (27.1441)
    AxialLeft Post-FurosemideFrac Hyp%>30 8WkPostPTRA
    1.858
    (7.0087)
    -5.704
    (8.3550)
    7. Secondary Outcome
    Title Mean Change in Renal Oxygenation, Coronal Aspect, in Stented Kidneys Between Baseline Pre-PTRA, 27 Hours Post-PTRA and 8 Weeks Post-PTRA
    Description 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
    Time Frame 27H post PTRA and 8 weeks Post PTRA

    Outcome Measure Data

    Analysis Population Description
    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.
    Arm/Group Title Bendavia Placebo
    Arm/Group Description Bendavia, intravenous infusion, 0.05 mg/kg/hr for a maximum duration of 4 hours. Placebo (no active drug), intravenous infusion, for a maximum duration of 4 hours.
    Measure Participants 5 6
    CoronalRtFractHypoxia% >20Prefuros.27HPost-PTRA
    20.314
    (33.3525)
    9.083
    (17.3368)
    CoronalRtFractHypoxia% >20Prefuros.8WkPost-PTRA
    4.140
    (16.4690)
    -2.220
    (7.5549)
    CoronalRtFractHypoxia% >30Prefuros.27HPost-PTRA
    10.800
    (9.6734)
    9.250
    (30.6001)
    CoronalRtFractHypoxia% >30Prefuros8WkPost-PTRA
    3.300
    (10.1403)
    -2.852
    (11.1986)
    CoronalRtFractHypoxia% >20Postfuros27HPost-PTRA
    29.800
    (33.5328)
    3.840
    (22.4825)
    CoronalRtFractHypoxia% >20Postfuros8WKPost-PTRA
    5.233
    (7.5142)
    -5.220
    (4.6018)
    CoronalRtFractHypoxia% >30Postfuros27HPost-PTRA
    12.875
    (13.2666)
    11.458
    (32.8826)
    CoronalRtFractHypoxia% >30Postfuros8WkPost-PTRA
    2.233
    (3.5119)
    -8.158
    (16.5393)
    CoronalLeftFractHypoxia% >20Prefuros.27HPost-PTRA
    5.000
    (23.7674)
    6.033
    (31.1820)
    CoronalLeftFractHypoxia% >20Prefuros.8WkPost-PTRA
    -3.125
    (10.2970)
    -0.525
    (12.5077)
    CoronalLeftFractHypoxia% >30Prefuros.27HPost-PTRA
    -2.000
    (8.9272)
    22.615
    (35.6971)
    CoronalLeftFractHypoxia% >30Prefuros.8WkPost-PTRA
    -2.275
    (4.4650)
    -1.525
    (12.3605)
    CoronalLeftFractHypoxia% >20Postfuros.27HPost-PTRA
    6.240
    (24.5671)
    6.783
    (29.1337)
    CoronalLeftFractHypoxia% >20Postfuros.8WkPost-PTRA
    3.375
    (9.2525)
    -0.700
    (14.7384)
    CoronalLeftFractHypoxia% >30Postfuros.27HPost-PTRA
    0.080
    (7.3145)
    20.345
    (31.5024)
    CoronalLeftFractHypoxia% >30Postfuros.8WkPost-PTRA
    -0.250
    (2.0873)
    -4.225
    (12.7899)
    8. Secondary Outcome
    Title Mean Change in Systolic Blood Pressure Values (mmHg) From Pre-PTRA, Immediately Post-PTRA, 27 Hours and 8 (+4) Weeks Post-PTRA
    Description
    Time Frame Pre-PTRA and 27 hours post-PTRA and 8 weeks post-PTRA

    Outcome Measure Data

    Analysis Population Description
    All participants for whom systolic blood pressure was measured at baseline (pre-PTRA) and 27 hours post-PTRA, or 8(+4) weeks post-PTRA.
    Arm/Group Title Bendavia Placebo
    Arm/Group Description Bendavia, intravenous infusion, 0.05 mg/kg/hr for a maximum duration of 4 hours. Bendavia Placebo (no active drug), intravenous infusion, for a maximum duration of 4 hours. Placebo
    Measure Participants 7 9
    27 Hours Post-PTRA
    -2.9
    (14.78)
    -3.8
    (15.69)
    8 weeks Post PTRA
    13.2
    (19.88)
    -0.8
    (30.83)
    9. Secondary Outcome
    Title Mean Change in Diastolic Blood Pressure
    Description 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.
    Time Frame Pre-PTRA, immediately post-PTRA, 27 hours post-PTRA and 8 weeks post-PTRA

    Outcome Measure Data

    Analysis Population Description
    All participants for whom diastolic blood pressure was measured.
    Arm/Group Title Bendavia Placebo
    Arm/Group Description Bendavia, intravenous infusion, 0.05 mg/kg/hr for a maximum duration of 4 hours. Placebo (no active drug), intravenous infusion, for a maximum duration of 4 hours.
    Measure Participants 7 9
    27 Hours Post-PTRA
    3.6
    (7.76)
    -2.0
    (9.88)
    8 Weeks Post PTRA
    0.0
    (9.70)
    0.1
    (9.80)

    Adverse Events

    Time Frame
    Adverse Event Reporting Description
    Arm/Group Title Bendavia Placebo
    Arm/Group Description Bendavia, intravenous infusion, 0.05 mg/kg/hr for a maximum duration of 4 hours. Placebo (no active drug), intravenous infusion, for a maximum duration of 4 hours.
    All Cause Mortality
    Bendavia Placebo
    Affected / at Risk (%) # Events Affected / at Risk (%) # Events
    Total 0/7 (0%) 0/9 (0%)
    Serious Adverse Events
    Bendavia Placebo
    Affected / at Risk (%) # Events Affected / at Risk (%) # Events
    Total 1/7 (14.3%) 1/9 (11.1%)
    Cardiac disorders
    Cardiac Failure Acute 0/7 (0%) 0 1/9 (11.1%) 2
    Injury, poisoning and procedural complications
    Vascular Pseudoaneurysm 1/7 (14.3%) 1 0/9 (0%) 0
    Other (Not Including Serious) Adverse Events
    Bendavia Placebo
    Affected / at Risk (%) # Events Affected / at Risk (%) # Events
    Total 2/7 (28.6%) 5/9 (55.6%)
    Gastrointestinal disorders
    Constipation 0/7 (0%) 2/9 (22.2%)
    General disorders
    Oedema peripheral 1/7 (14.3%) 0/9 (0%)
    Infections and infestations
    Pneumonia 0/7 (0%) 1/9 (11.1%)
    Injury, poisoning and procedural complications
    Contusion 1/7 (14.3%) 0/9 (0%)
    Procedural Pain 0/7 (0%) 1/9 (11.1%)
    Investigations
    Blood sodium decreased 1/7 (14.3%) 1/9 (11.1%)
    Blood magnesium decreased 0/7 (0%) 1/9 (11.1%)
    Blood potassium decreased 0/7 (0%) 1/9 (11.1%)
    Pedal pulse decreased 0/7 (0%) 1/9 (11.1%)
    Thyroid function test abnormal 0/7 (0%) 1/9 (11.1%)
    Metabolism and nutrition disorders
    Hyperphosphataemia 0/7 (0%) 1/9 (11.1%)
    Nervous system disorders
    Dizziness 1/7 (14.3%) 0/9 (0%)
    Presyncope 0/7 (0%) 1/9 (11.1%)
    Psychiatric disorders
    Anxiety 0/7 (0%) 1/9 (11.1%)
    Insomnia 0/7 (0%) 1/9 (11.1%)
    Respiratory, thoracic and mediastinal disorders
    Cough 0/7 (0%) 1/9 (11.1%)
    Nasal Dryness 0/7 (0%) 1/9 (11.1%)
    Respiratory Distress 0/7 (0%) 2/9 (22.2%)
    Vascular disorders
    Hypertension 1/7 (14.3%) 1/9 (11.1%)
    Hypotension 1/7 (14.3%) 1/9 (11.1%)
    Labile Blood Pressure 0/7 (0%) 1/9 (11.1%)

    Limitations/Caveats

    [Not Specified]

    More Information

    Certain Agreements

    Principal Investigators are NOT employed by the organization sponsoring the study.

    The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.

    Results Point of Contact

    Name/Title Jim Carr, Pharm.D. Chief Clinical Development Officer
    Organization Stealth BioTherapeutics, Inc
    Phone 1-617-600-6888
    Email jim.carr@stealthbt.com
    Responsible Party:
    Stealth BioTherapeutics Inc.
    ClinicalTrials.gov Identifier:
    NCT01755858
    Other Study ID Numbers:
    • SPIRI-225
    First Posted:
    Dec 24, 2012
    Last Update Posted:
    Aug 11, 2020
    Last Verified:
    Aug 1, 2020