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    Clinical Trial Results:
    A Phase 2, Multicenter, Blinded, Sham Procedure-Controlled Trial of Renal Denervation by the Peregrine System Kit, in Subjects with Hypertension, in the Absence of Antihypertensive Medications

    Summary
    EudraCT number
    		 2018-000036-96
    Trial protocol
    		 BE   GB   DE   IE   NL  
    Global end of trial date
    19 Jan 2024

    Results information
    Results version number
    		 v1(current)
    This version publication date
    03 Feb 2025
    First version publication date
    03 Feb 2025
    Other versions
    Summary report(s)
    		 Primary publication

    Trial information

    		 Close Top of page
    Trial identification
    Sponsor protocol code
    CR0014
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT03503773
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Ablative Solutions, Inc.
    Sponsor organisation address
    301 Edgewater Pl Suite 100, Wakefield, United States, MA 01880
    Public contact
    Clinical & Regulatory Affairs, Ablative Solutions, Inc., +1 4084212496, EU-Regulatory@ablativesolutions.com
    Scientific contact
    Clinical & Regulatory Affairs, Ablative Solutions, Inc., +1 4084212496, EU-Regulatory@ablativesolutions.com
    Paediatric regulatory details
    Is trial part of an agreed paediatric investigation plan (PIP)
    No
    Does article 45 of REGULATION (EC) No 1901/2006 apply to this trial?
    No
    Does article 46 of REGULATION (EC) No 1901/2006 apply to this trial?
    No
    Results analysis stage
    Analysis stage
    Final
    Date of interim/final analysis
    19 Jan 2024
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    19 Jan 2024
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    To evaluate the efficacy of renal denervation by alcohol-mediated neurolysis using the Peregrine Kit in hypertensive subjects, when used in the absence of antihypertensive medications, as evaluated by change in mean 24-hour ambulatory systolic blood pressure (SBP) from baseline to 8 weeks post-treatment.
    Protection of trial subjects
    A Data Safety Monitoring Board (DSMB) regularly reviewed the safety data. The DSMB reviewed all 1 year data from all participants and the study had been unblinded to confirmed that there were no safety concerns, so the crossover phase of the trial was endorsed by the DSMB. All participants received sedation and analgesia, which was applicable to the renal denervation (treatment) group and the sham control group.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    01 May 2018
    Long term follow-up planned
    No
    Independent data monitoring committee (IDMC) involvement?
    Yes
    Population of trial subjects
    Number of subjects enrolled per country
    Country: Number of subjects enrolled
    Netherlands: 26
    Country: Number of subjects enrolled
    United Kingdom: 43
    Country: Number of subjects enrolled
    Belgium: 8
    Country: Number of subjects enrolled
    France: 34
    Country: Number of subjects enrolled
    Germany: 199
    Country: Number of subjects enrolled
    Ireland: 14
    Country: Number of subjects enrolled
    United States: 26
    Worldwide total number of subjects
    350
    EEA total number of subjects
    281
    Number of subjects enrolled per age group
    In utero
    0
    Preterm newborn - gestational age < 37 wk
    0
    Newborns (0-27 days)
    0
    Infants and toddlers (28 days-23 months)
    0
    Children (2-11 years)
    0
    Adolescents (12-17 years)
    0
    Adults (18-64 years)
    212
    From 65 to 84 years
    138
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 A total of 350 participants provided informed consent and were enrolled and 106 of these participants were randomized and treated between 20 March 2019 and 28 December 2020. The trial was conducted in the EEA and the United States

    Pre-assignment
    Screening details
    		 Participants must have met all of the inclusion criteria to be eligible and undergo the procedure and with 3 office BP measurements with a mean office SBP of ≥ 140 mmHg and ≤ 180 mmHg AND mean office DBP ≥ 90 mmHg, and be willing to adhere to the no-medication regimen for at least 12 weeks (4 week run-in period and 8-week post-procedure.

    Period 1
    Period 1 title
    Randomized phase
    Is this the baseline period?
    		 Yes
    Allocation method
    Randomised - controlled
    Blinding used
    		 Double blind
    Roles blinded
    		 Subject, Investigator, Carer
    Blinding implementation details
    Participants received sedation, were blindfolded, and wore headsets (listening to music), so that they were unaware of any commentary from physicians or staff during the procedure.

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Treatment arm (renal denervation)
    Arm description
    		 Double-blind phase where participants were randomized in a 1:1 ratio to one of the following 2 groups via central randomization (stratified by study site): • Treatment Arm: renal denervation (using the Peregrine Kit) performed with alcohol (0.6 mL per treated renal artery) infused through the Peregrine Catheter (minimum treatment: the 2 main renal arteries [1 per side]; physician was also permitted to treat up to 1 additional accessory renal artery on each side. Thus, the planned maximum total dose was 4 × 0.6 mL = 2.4 mL). • Sham Control Arm: only renal angiography performed. No renal denervation and no alcohol infusion has been performed.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Peregine Kit (Alcohol USP/renal denervation)
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for injection in vial
    Routes of administration
    Intravenous use
    Dosage and administration details
    The test product in this study is a co-packaged product, the Peregrine Kit, which includes the Peregrine Catheter and alcohol for injection. The catheter will be used to deliver a dose of 0.6 mL alcohol by direct infusion to the perivascular space of each renal artery in a single treatment session (i.e., a target dose of 1.2 mL). The 2 main renal arteries (1 on each side) will be treated. However, the treating physician is permitted to treat up to 1 additional accessory renal artery on each side (during the same treatment session) as well (depending on individual participant anatomy). Thus, the planned maximum total dose per participant is 4 × 0.6 mL = 2.4 mL.

    Arm title
    		 Sham control
    Arm description
    		 Sham Control Arm: only renal angiography performed. No renal denervation and no alcohol infusion has been performed.
    Arm type
    		 No intervention

    Investigational medicinal product name
    No investigational medicinal product assigned in this arm
    Number of subjects in period 1 [1]
    		Treatment arm (renal denervation) Sham control
    Started
    50
    56
    Completed
    50
    47
    Not completed
    0
    9
         Lost to follow-up
    -
    5
         Crossover prior to Year 2
    -
    3
         Did not attend follow-up visit
    -
    1
    Notes
    [1] - The number of subjects reported to be in the baseline period are not the same as the worldwide number enrolled in the trial. It is expected that these numbers will be the same.
    Justification: 350 participants were enrolled, 244 participants were screen failures, and 106 participants were enrolled
    Period 2
    Period 2 title
    Crossover phase
    Is this the baseline period?
    		 No
    Allocation method
    Non-randomised - controlled
    Blinding used
    		 Not blinded

    Arms
    Arm title
    		 Treatment arm (renal denervation)
    Arm description
    		 Renal denervation (using the Peregrine Kit) performed with alcohol (0.6 mL per treated renal artery) infused through the Peregrine Catheter (minimum treatment: the 2 main renal arteries [1 per side]; physician was also permitted to treat up to 1 additional accessory renal artery on each side. Thus, the planned maximum total dose was 4 × 0.6 mL = 2.4 mL).
    Arm type
    		 Experimental

    Investigational medicinal product name
    Peregine Kit (Alcohol USP/renal denervation)
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for injection in vial
    Routes of administration
    Intravenous use
    Dosage and administration details
    The test product in this study is a co-packaged product, the Peregrine Kit, which includes the Peregrine Catheter and alcohol for injection. The catheter will be used to deliver a dose of 0.6 mL alcohol by direct infusion to the perivascular space of each renal artery in a single treatment session (i.e., a target dose of 1.2 mL). The 2 main renal arteries (1 on each side) will be treated. However, the treating physician is permitted to treat up to 1 additional accessory renal artery on each side (during the same treatment session) as well (depending on individual participant anatomy). Thus, the planned maximum total dose per participant is 4 × 0.6 mL = 2.4 mL.

    Number of subjects in period 2 [2]
    		Treatment arm (renal denervation)
    Started
    21
    Completed
    21
    Notes
    [2] - The number of subjects starting the period is not consistent with the number completing the preceding period. It is expected the number of subjects starting the subsequent period will be the same as the number completing the preceding period.
    Justification: 24 participants from the Sham Control group were re-screened for the Crossover Phase, 3 of whom were screen failures. The remaining 21 participants (from 15 study sites) crossed over and underwent alcohol-mediated renal denervation.

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Randomized phase
    Reporting group description
    		 -

    Reporting group values
    		 Randomized phase Total
    Number of subjects
    		 106 106
    Age categorical
    Units: Subjects
        In utero
    		 0
        Preterm newborn infants (gestational age < 37 wks)
    		 0
        Newborns (0-27 days)
    		 0
        Infants and toddlers (28 days-23 months)
    		 0
        Children (2-11 years)
    		 0
        Adolescents (12-17 years)
    		 0
        Adults (18-64 years)
    		 0
        From 65-84 years
    		 0
        85 years and over
    		 0
    Age continuous
    Units: years
        arithmetic mean (standard deviation)
    		 54.1 ( 11.3 ) -
    Gender categorical
    Units: Subjects
        Female
    		 28 28
        Male
    		 78 78
    Type 2 diabetes
    Units: Subjects
        Yes
    		 7 7
        No
    		 99 99
    eGFR < 60 mL/min/1.73m2
    Units: Subjects
        Yes
    		 5 5
        No
    		 101 101
    Smoking (current)
    Units: Subjects
        Yes
    		 11 11
        No
    		 95 95
    Peripheral vascular occlusive disease
    Units: Subjects
        Yes
    		 2 2
        No
    		 104 104
    Angiographically determined CAD
    Units: Subjects
        Yes
    		 3 3
        No
    		 103 103
    eGFR
    Units: mL/min/1.73m2
        arithmetic mean (standard deviation)
    		 85.8 ( 13.4 ) -

    End points

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    End points reporting groups
    Reporting group title
    Treatment arm (renal denervation)
    Reporting group description
    		 Double-blind phase where participants were randomized in a 1:1 ratio to one of the following 2 groups via central randomization (stratified by study site): • Treatment Arm: renal denervation (using the Peregrine Kit) performed with alcohol (0.6 mL per treated renal artery) infused through the Peregrine Catheter (minimum treatment: the 2 main renal arteries [1 per side]; physician was also permitted to treat up to 1 additional accessory renal artery on each side. Thus, the planned maximum total dose was 4 × 0.6 mL = 2.4 mL). • Sham Control Arm: only renal angiography performed. No renal denervation and no alcohol infusion has been performed.

    Reporting group title
    Sham control
    Reporting group description
    		 Sham Control Arm: only renal angiography performed. No renal denervation and no alcohol infusion has been performed.
    Reporting group title
    Treatment arm (renal denervation)
    Reporting group description
    		 Renal denervation (using the Peregrine Kit) performed with alcohol (0.6 mL per treated renal artery) infused through the Peregrine Catheter (minimum treatment: the 2 main renal arteries [1 per side]; physician was also permitted to treat up to 1 additional accessory renal artery on each side. Thus, the planned maximum total dose was 4 × 0.6 mL = 2.4 mL).

    Primary: Change from baseline to 8 weeks post-procedure in 24 hour ambulatory SBP

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    End point title
    		 Change from baseline to 8 weeks post-procedure in 24 hour ambulatory SBP
    End point description
    End point type
    Primary
    End point timeframe
    8 weeks
    End point values
    		 Treatment arm (renal denervation) Sham control
    Number of subjects analysed
    50
    56
    Units: mmHg
        arithmetic mean (standard deviation)
    144.6 ( 10.1 )
    147.0 ( 11.5 )
    Statistical analysis title
    		 ANCOVA analysis
    Comparison groups
    Treatment arm (renal denervation) v Sham control
    Number of subjects included in analysis
    106
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.2954
    Method
    		 ANCOVA
    Confidence interval

    Secondary: Change from baseline to 8 weeks post-procedure in 24 hour ambulatory DBP

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    End point title
    		 Change from baseline to 8 weeks post-procedure in 24 hour ambulatory DBP
    End point description
    End point type
    Secondary
    End point timeframe
    8 weeks
    End point values
    		 Treatment arm (renal denervation) Sham control
    Number of subjects analysed
    50
    56
    Units: mmHg
        arithmetic mean (standard deviation)
    90.0 ( 7.3 )
    90.1 ( 9.7 )
    No statistical analyses for this end point

    Secondary: Change from baseline in mean 24 hour ambulatory SBP at 6 months post-procedure

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    End point title
    		 Change from baseline in mean 24 hour ambulatory SBP at 6 months post-procedure
    End point description
    End point type
    Secondary
    End point timeframe
    6 months
    End point values
    		 Treatment arm (renal denervation) Sham control
    Number of subjects analysed
    50
    56
    Units: mmHg
        arithmetic mean (standard deviation)
    134.1 ( 11.6 )
    135.1 ( 11.7 )
    No statistical analyses for this end point

    Secondary: Change from baseline in mean 24 hour ambulatory SBP at 12 months post-procedure

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    End point title
    		 Change from baseline in mean 24 hour ambulatory SBP at 12 months post-procedure
    End point description
    End point type
    Secondary
    End point timeframe
    12 months
    End point values
    		 Treatment arm (renal denervation) Sham control
    Number of subjects analysed
    50
    56
    Units: mmHg
        arithmetic mean (standard deviation)
    137.6 ( 11.4 )
    133.7 ( 11.3 )
    No statistical analyses for this end point

    Secondary: Change from baseline in mean 24 hour ambulatory DBP at 6 months post-procedure

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    End point title
    		 Change from baseline in mean 24 hour ambulatory DBP at 6 months post-procedure
    End point description
    End point type
    Secondary
    End point timeframe
    6 months
    End point values
    		 Treatment arm (renal denervation) Sham control
    Number of subjects analysed
    50
    56
    Units: mmHg
        arithmetic mean (standard deviation)
    83.0 ( 8.4 )
    83.4 ( 9.0 )
    No statistical analyses for this end point

    Secondary: Change from baseline in mean 24 hour ambulatory DBP at 12 months post-procedure

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    End point title
    		 Change from baseline in mean 24 hour ambulatory DBP at 12 months post-procedure
    End point description
    End point type
    Secondary
    End point timeframe
    12 months
    End point values
    		 Treatment arm (renal denervation) Sham control
    Number of subjects analysed
    50
    56
    Units: mmHg
        arithmetic mean (standard deviation)
    85.6 ( 8.7 )
    81.0 ( 7.9 )
    No statistical analyses for this end point

    Secondary: Change from baseline in mean daytime ambulatory SBP at 8 weeks

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    End point title
    		 Change from baseline in mean daytime ambulatory SBP at 8 weeks
    End point description
    End point type
    Secondary
    End point timeframe
    8 weeks
    End point values
    		 Treatment arm (renal denervation) Sham control
    Number of subjects analysed
    50
    56
    Units: mmHg
        arithmetic mean (standard deviation)
    150.6 ( 10.5 )
    153.2 ( 12.0 )
    Statistical analysis title
    		 ANCOVA analysis
    Comparison groups
    Treatment arm (renal denervation) v Sham control
    Number of subjects included in analysis
    106
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.323
    Method
    		 ANCOVA
    Confidence interval

    Secondary: Change from baseline in mean daytime ambulatory SBP at 6 months

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    End point title
    		 Change from baseline in mean daytime ambulatory SBP at 6 months
    End point description
    End point type
    Secondary
    End point timeframe
    6 months
    End point values
    		 Treatment arm (renal denervation) Sham control
    Number of subjects analysed
    50
    56
    Units: mmHg
        arithmetic mean (standard deviation)
    139.7 ( 12.8 )
    140.6 ( 12.3 )
    Statistical analysis title
    		 ANCOVA analysis
    Comparison groups
    Treatment arm (renal denervation) v Sham control
    Number of subjects included in analysis
    106
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.887
    Method
    		 ANCOVA
    Confidence interval

    Secondary: Change from baseline in mean daytime ambulatory SBP at 12 months

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    End point title
    		 Change from baseline in mean daytime ambulatory SBP at 12 months
    End point description
    End point type
    Secondary
    End point timeframe
    12 months
    End point values
    		 Treatment arm (renal denervation) Sham control
    Number of subjects analysed
    50
    56
    Units: mmHg
        arithmetic mean (standard deviation)
    143.5 ( 12.6 )
    140.1 ( 12.1 )
    No statistical analyses for this end point

    Secondary: Change from baseline in mean daytime ambulatory DBP at 8 weeks

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    End point title
    		 Change from baseline in mean daytime ambulatory DBP at 8 weeks
    End point description
    End point type
    Secondary
    End point timeframe
    8 weeks
    End point values
    		 Treatment arm (renal denervation) Sham control
    Number of subjects analysed
    50
    56
    Units: mmHg
        arithmetic mean (standard deviation)
    95.2 ( 7.5 )
    94.7 ( 9.7 )
    No statistical analyses for this end point

    Secondary: Change from baseline in mean daytime ambulatory DBP at 6 months

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    End point title
    		 Change from baseline in mean daytime ambulatory DBP at 6 months
    End point description
    End point type
    Secondary
    End point timeframe
    6 months
    End point values
    		 Treatment arm (renal denervation) Sham control
    Number of subjects analysed
    50
    56
    Units: mmHg
        arithmetic mean (standard deviation)
    87.8 ( 9.2 )
    87.6 ( 9.0 )
    Statistical analysis title
    		 ANCOVA analysis
    Comparison groups
    Treatment arm (renal denervation) v Sham control
    Number of subjects included in analysis
    106
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.959
    Method
    		 ANCOVA
    Confidence interval

    Secondary: Change from baseline in mean daytime ambulatory DBP at 12 months

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    End point title
    		 Change from baseline in mean daytime ambulatory DBP at 12 months
    End point description
    End point type
    Secondary
    End point timeframe
    12 months
    End point values
    		 Treatment arm (renal denervation) Sham control
    Number of subjects analysed
    50
    56
    Units: mmHg
        arithmetic mean (standard deviation)
    90.4 ( 9.6 )
    86.0 ( 8.7 )
    No statistical analyses for this end point

    Secondary: Change from baseline in mean nighttime ambulatory SBP at 8 weeks

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    End point title
    		 Change from baseline in mean nighttime ambulatory SBP at 8 weeks
    End point description
    End point type
    Secondary
    End point timeframe
    8 weeks
    End point values
    		 Treatment arm (renal denervation) Sham control
    Number of subjects analysed
    50
    56
    Units: mmHg
        arithmetic mean (standard deviation)
    134.4 ( 11.6 )
    136.9 ( 14.6 )
    No statistical analyses for this end point

    Secondary: Change from baseline in mean nighttime ambulatory SBP at 6 months

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    End point title
    		 Change from baseline in mean nighttime ambulatory SBP at 6 months
    End point description
    End point type
    Secondary
    End point timeframe
    6 months
    End point values
    		 Treatment arm (renal denervation) Sham control
    Number of subjects analysed
    50
    56
    Units: mmHg
        arithmetic mean (standard deviation)
    125.4 ( 12.1 )
    125.6 ( 13.9 )
    No statistical analyses for this end point

    Secondary: Change from baseline in mean nighttime ambulatory SBP at 12 months

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    End point title
    		 Change from baseline in mean nighttime ambulatory SBP at 12 months
    End point description
    End point type
    Secondary
    End point timeframe
    12 months
    End point values
    		 Treatment arm (renal denervation) Sham control
    Number of subjects analysed
    50
    56
    Units: mmHg
        arithmetic mean (standard deviation)
    127.8 ( 10.7 )
    123.1 ( 12.3 )
    No statistical analyses for this end point

    Secondary: Change from baseline in mean nighttime ambulatory DBP at 8 weeks

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    End point title
    		 Change from baseline in mean nighttime ambulatory DBP at 8 weeks
    End point description
    End point type
    Secondary
    End point timeframe
    8 weeks
    End point values
    		 Treatment arm (renal denervation) Sham control
    Number of subjects analysed
    50
    56
    Units: mmHg
        arithmetic mean (standard deviation)
    81.5 ( 8.4 )
    82.5 ( 12.5 )
    No statistical analyses for this end point

    Secondary: Change from baseline in mean nighttime ambulatory DBP at 6 months

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    End point title
    		 Change from baseline in mean nighttime ambulatory DBP at 6 months
    End point description
    End point type
    Secondary
    End point timeframe
    6 months
    End point values
    		 Treatment arm (renal denervation) Sham control
    Number of subjects analysed
    50
    56
    Units: mmHg
        arithmetic mean (standard deviation)
    75.5 ( 9.2 )
    75.8 ( 10.8 )
    No statistical analyses for this end point

    Secondary: Change from baseline in mean nighttime ambulatory DBP at 12 months

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    End point title
    		 Change from baseline in mean nighttime ambulatory DBP at 12 months
    End point description
    End point type
    Secondary
    End point timeframe
    12 months
    End point values
    		 Treatment arm (renal denervation) Sham control
    Number of subjects analysed
    50
    56
    Units: mmHg
        arithmetic mean (standard deviation)
    77.4 ( 7.8 )
    72.8 ( 8.2 )
    No statistical analyses for this end point

    Secondary: Change from baseline in mean office SBP at 8 weeks

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    End point title
    		 Change from baseline in mean office SBP at 8 weeks
    End point description
    End point type
    Secondary
    End point timeframe
    8 weeks
    End point values
    		 Treatment arm (renal denervation) Sham control
    Number of subjects analysed
    50
    56
    Units: mmHg
        arithmetic mean (standard deviation)
    155.4 ( 14.3 )
    160.6 ( 16.3 )
    No statistical analyses for this end point

    Secondary: Change from baseline in mean office SBP at 6 months

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    End point title
    		 Change from baseline in mean office SBP at 6 months
    End point description
    End point type
    Secondary
    End point timeframe
    6 months
    End point values
    		 Treatment arm (renal denervation) Sham control
    Number of subjects analysed
    50
    56
    Units: mmHg
        arithmetic mean (standard deviation)
    146.1 ( 16.4 )
    145.7 ( 14.3 )
    No statistical analyses for this end point

    Secondary: Change from baseline in mean office SBP at 12 months

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    End point title
    		 Change from baseline in mean office SBP at 12 months
    End point description
    End point type
    Secondary
    End point timeframe
    12 months
    End point values
    		 Treatment arm (renal denervation) Sham control
    Number of subjects analysed
    50
    56
    Units: mmHg
        arithmetic mean (standard deviation)
    147.9 ( 18.5 )
    147.8 ( 15.1 )
    Statistical analysis title
    		 ANCOVA analysis
    Comparison groups
    Treatment arm (renal denervation) v Sham control
    Number of subjects included in analysis
    106
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.682
    Method
    		 ANCOVA
    Confidence interval

    Secondary: Change from baseline in mean office SBP at 24 months

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    End point title
    		 Change from baseline in mean office SBP at 24 months
    End point description
    End point type
    Secondary
    End point timeframe
    24 months
    End point values
    		 Treatment arm (renal denervation) Sham control
    Number of subjects analysed
    50
    56
    Units: mmHg
        arithmetic mean (standard deviation)
    147.1 ( 20.0 )
    142.1 ( 14.9 )
    No statistical analyses for this end point

    Secondary: Participants achieving target 24-hour ambulatory BP (SBP ≤ 140 mmHg and DBP ≤ 90 mmHg) at 8 weeks

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    End point title
    		 Participants achieving target 24-hour ambulatory BP (SBP ≤ 140 mmHg and DBP ≤ 90 mmHg) at 8 weeks
    End point description
    End point type
    Secondary
    End point timeframe
    8 weeks
    End point values
    		 Treatment arm (renal denervation) Sham control
    Number of subjects analysed
    50
    56
    Units: participants
    15
    10
    No statistical analyses for this end point

    Secondary: Participants achieving target 24-hour ambulatory BP (SBP ≤ 140 mmHg and DBP ≤ 90 mmHg) at 6 months

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    End point title
    		 Participants achieving target 24-hour ambulatory BP (SBP ≤ 140 mmHg and DBP ≤ 90 mmHg) at 6 months
    End point description
    End point type
    Secondary
    End point timeframe
    6 months
    End point values
    		 Treatment arm (renal denervation) Sham control
    Number of subjects analysed
    50
    56
    Units: participants
    31
    28
    No statistical analyses for this end point

    Secondary: Participants achieving target 24-hour ambulatory BP (SBP ≤ 140 mmHg and DBP ≤ 90 mmHg) at 12 months

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    End point title
    		 Participants achieving target 24-hour ambulatory BP (SBP ≤ 140 mmHg and DBP ≤ 90 mmHg) at 12 months
    End point description
    End point type
    Secondary
    End point timeframe
    12 months
    End point values
    		 Treatment arm (renal denervation) Sham control
    Number of subjects analysed
    50
    56
    Units: participants
    22
    29
    No statistical analyses for this end point

    Secondary: Participants achieving target office BP (SBP ≤ 140 mmHg and DBP ≤ 90 mmHg) at 8 weeks

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    End point title
    		 Participants achieving target office BP (SBP ≤ 140 mmHg and DBP ≤ 90 mmHg) at 8 weeks
    End point description
    End point type
    Secondary
    End point timeframe
    8 weeks
    End point values
    		 Treatment arm (renal denervation) Sham control
    Number of subjects analysed
    50
    56
    Units: participants
    5
    3
    No statistical analyses for this end point

    Secondary: Participants achieving target office BP (SBP ≤ 140 mmHg and DBP ≤ 90 mmHg) at 6 months

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    End point title
    		 Participants achieving target office BP (SBP ≤ 140 mmHg and DBP ≤ 90 mmHg) at 6 months
    End point description
    End point type
    Secondary
    End point timeframe
    6 months
    End point values
    		 Treatment arm (renal denervation) Sham control
    Number of subjects analysed
    50
    56
    Units: participants
    14
    14
    No statistical analyses for this end point

    Secondary: Participants achieving target office BP (SBP ≤ 140 mmHg and DBP ≤ 90 mmHg) at 12 months

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    End point title
    		 Participants achieving target office BP (SBP ≤ 140 mmHg and DBP ≤ 90 mmHg) at 12 months
    End point description
    End point type
    Secondary
    End point timeframe
    12 months
    End point values
    		 Treatment arm (renal denervation) Sham control
    Number of subjects analysed
    50
    56
    Units: participants
    15
    15
    No statistical analyses for this end point

    Secondary: Participants achieving target office BP (SBP ≤ 140 mmHg and DBP ≤ 90 mmHg) at 24 months

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    End point title
    		 Participants achieving target office BP (SBP ≤ 140 mmHg and DBP ≤ 90 mmHg) at 24 months
    End point description
    End point type
    Secondary
    End point timeframe
    24 months
    End point values
    		 Treatment arm (renal denervation) Sham control
    Number of subjects analysed
    50
    56
    Units: participants
    14
    18
    No statistical analyses for this end point

    Secondary: Mean antihypertensive medications prescribed at 8 weeks

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    End point title
    		 Mean antihypertensive medications prescribed at 8 weeks
    End point description
    End point type
    Secondary
    End point timeframe
    8 weeks
    End point values
    		 Treatment arm (renal denervation) Sham control
    Number of subjects analysed
    50
    56
    Units: Number of medications
        arithmetic mean (standard deviation)
    0.060 ( 0.240 )
    0.089 ( 0.288 )
    No statistical analyses for this end point

    Secondary: Major adverse events at 30 days

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    End point title
    		 Major adverse events at 30 days
    End point description
    End point type
    Secondary
    End point timeframe
    30 days
    End point values
    		 Treatment arm (renal denervation) Sham control
    Number of subjects analysed
    50
    56
    Units: number of events
    1
    1
    No statistical analyses for this end point

    Other pre-specified: Change from baseline in mean office SBP at 4 weeks (crossover)

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    End point title
    		 Change from baseline in mean office SBP at 4 weeks (crossover)
    End point description
    End point type
    Other pre-specified
    End point timeframe
    4 weeks
    End point values
    		 Treatment arm (renal denervation)
    Number of subjects analysed
    21
    Units: mmHg
        arithmetic mean (standard deviation)
    143.3 ( 14.3 )
    No statistical analyses for this end point

    Other pre-specified: Change from baseline in mean office SBP at 6 months (crossover

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    End point title
    		 Change from baseline in mean office SBP at 6 months (crossover
    End point description
    End point type
    Other pre-specified
    End point timeframe
    6 months
    End point values
    		 Treatment arm (renal denervation)
    Number of subjects analysed
    21
    Units: mmHg
        arithmetic mean (standard deviation)
    141.4 ( 18.6 )
    No statistical analyses for this end point

    Other pre-specified: Change from baseline in mean office DBP at 4 weeks (crossover)

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    End point title
    		 Change from baseline in mean office DBP at 4 weeks (crossover)
    End point description
    End point type
    Other pre-specified
    End point timeframe
    4 weeks
    End point values
    		 Treatment arm (renal denervation)
    Number of subjects analysed
    21
    Units: mmHg
        arithmetic mean (standard deviation)
    88.3 ( 10.8 )
    No statistical analyses for this end point

    Other pre-specified: Change from baseline in mean office DBP at 6 months (crossover)

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    End point title
    		 Change from baseline in mean office DBP at 6 months (crossover)
    End point description
    End point type
    Other pre-specified
    End point timeframe
    6 months
    End point values
    		 Treatment arm (renal denervation)
    Number of subjects analysed
    21
    Units: mmHg
        arithmetic mean (standard deviation)
    87.1 ( 11.2 )
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    24 months
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    23.1
    Reporting groups
    Reporting group title
    Treatment arm (renal denervation)
    Reporting group description
    		 Double-blind phase where participants were randomized in a 1:1 ratio to one of the following 2 groups via central randomization (stratified by study site): • Treatment Arm: renal denervation (using the Peregrine Kit) performed with alcohol (0.6 mL per treated renal artery) infused through the Peregrine Catheter (minimum treatment: the 2 main renal arteries [1 per side]; physician was also permitted to treat up to 1 additional accessory renal artery on each side. Thus, the planned maximum total dose was 4 × 0.6 mL = 2.4 mL). • Sham Control Arm: only renal angiography performed. No renal denervation and no alcohol infusion has been performed.

    Reporting group title
    Sham control
    Reporting group description
    		 Sham Control Arm: only renal angiography performed. No renal denervation and no alcohol infusion has been performed.

    Serious adverse events
    		 Treatment arm (renal denervation) Sham control
    Total subjects affected by serious adverse events
         subjects affected / exposed
    10 / 50 (20.00%)
    10 / 56 (17.86%)
         number of deaths (all causes)
    0
    0
         number of deaths resulting from adverse events
    0
    0
    Investigations
    Haemoglobin decreased
         subjects affected / exposed
    0 / 50 (0.00%)
    1 / 56 (1.79%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    Gastric cancer
         subjects affected / exposed
    1 / 50 (2.00%)
    0 / 56 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hepatic cancer
         subjects affected / exposed
    0 / 50 (0.00%)
    1 / 56 (1.79%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Squamous cell carcinoma of the cervix
         subjects affected / exposed
    1 / 50 (2.00%)
    0 / 56 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Injury, poisoning and procedural complications
    Post procedural haematoma
         subjects affected / exposed
    1 / 50 (2.00%)
    0 / 56 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Vascular pseudoaneurysm
         subjects affected / exposed
    0 / 50 (0.00%)
    1 / 56 (1.79%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Vascular disorders
    Aneurysm
         subjects affected / exposed
    1 / 50 (2.00%)
    0 / 56 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Haematoma
         subjects affected / exposed
    1 / 50 (2.00%)
    0 / 56 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hypertensive crisis
         subjects affected / exposed
    1 / 50 (2.00%)
    0 / 56 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pulmonary embolism
         subjects affected / exposed
    0 / 50 (0.00%)
    1 / 56 (1.79%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cardiac disorders
    Angina unstable
         subjects affected / exposed
    1 / 50 (2.00%)
    0 / 56 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Atrial fibrillation
         subjects affected / exposed
    2 / 50 (4.00%)
    0 / 56 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Surgical and medical procedures
    Mitral valve repair
         subjects affected / exposed
    0 / 50 (0.00%)
    1 / 56 (1.79%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Nervous system disorders
    Sciatica
         subjects affected / exposed
    0 / 50 (0.00%)
    1 / 56 (1.79%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Respiratory, thoracic and mediastinal disorders
    Lung neoplasm malignant
         subjects affected / exposed
    0 / 50 (0.00%)
    1 / 56 (1.79%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Nasal septum deviation
         subjects affected / exposed
    0 / 50 (0.00%)
    1 / 56 (1.79%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Renal and urinary disorders
    Urethral stenosis
         subjects affected / exposed
    1 / 50 (2.00%)
    0 / 56 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Musculoskeletal and connective tissue disorders
    Lumbar vertebral fracture
         subjects affected / exposed
    0 / 50 (0.00%)
    1 / 56 (1.79%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Rhabdomyolysis
         subjects affected / exposed
    0 / 50 (0.00%)
    1 / 56 (1.79%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Infections and infestations
    Abdominal abscess
         subjects affected / exposed
    1 / 50 (2.00%)
    0 / 56 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Appendicitis perforated
         subjects affected / exposed
    1 / 50 (2.00%)
    0 / 56 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Metabolism and nutrition disorders
    Hyponatraemia
         subjects affected / exposed
    0 / 50 (0.00%)
    1 / 56 (1.79%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    		 Treatment arm (renal denervation) Sham control
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    45 / 50 (90.00%)
    44 / 56 (78.57%)
    Investigations
    Blood pressure increased
         subjects affected / exposed
    2 / 50 (4.00%)
    3 / 56 (5.36%)
         occurrences all number
    2
    3
    Glomerular filtration rate decreased
         subjects affected / exposed
    2 / 50 (4.00%)
    6 / 56 (10.71%)
         occurrences all number
    2
    6
    Injury, poisoning and procedural complications
    Post procedural haematoma
         subjects affected / exposed
    6 / 50 (12.00%)
    4 / 56 (7.14%)
         occurrences all number
    6
    4
    Vascular disorders
    Dizziness
         subjects affected / exposed
    2 / 50 (4.00%)
    3 / 56 (5.36%)
         occurrences all number
    2
    3
    Haematoma
         subjects affected / exposed
    5 / 50 (10.00%)
    2 / 56 (3.57%)
         occurrences all number
    5
    2
    Hypertension
         subjects affected / exposed
    3 / 50 (6.00%)
    5 / 56 (8.93%)
         occurrences all number
    3
    5
    Hypertensive crisis
         subjects affected / exposed
    1 / 50 (2.00%)
    3 / 56 (5.36%)
         occurrences all number
    1
    3
    Cardiac disorders
    Atrial fibrillation
         subjects affected / exposed
    3 / 50 (6.00%)
    4 / 56 (7.14%)
         occurrences all number
    3
    4
    Nervous system disorders
    Headache
         subjects affected / exposed
    11 / 50 (22.00%)
    7 / 56 (12.50%)
         occurrences all number
    11
    7
    General disorders and administration site conditions
    Oedema peripheral
         subjects affected / exposed
    1 / 50 (2.00%)
    3 / 56 (5.36%)
         occurrences all number
    1
    3
    Musculoskeletal and connective tissue disorders
    Back pain
         subjects affected / exposed
    2 / 50 (4.00%)
    4 / 56 (7.14%)
         occurrences all number
    2
    4
    Infections and infestations
    COVID-19
         subjects affected / exposed
    5 / 50 (10.00%)
    9 / 56 (16.07%)
         occurrences all number
    5
    9
    Nasopharyngitis
         subjects affected / exposed
    2 / 50 (4.00%)
    4 / 56 (7.14%)
         occurrences all number
    2
    4
    Urinary tract infection
         subjects affected / exposed
    3 / 50 (6.00%)
    0 / 56 (0.00%)
         occurrences all number
    3
    0

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    29 Jun 2018
    Amendment before any participants were enrolled. Addition of serum creatinine sample and eGFR calculation for all participants prior to imaging at screening to exclude participants with eGFR ≤ 45 mL/min/1.73 m2 before undergoing any imaging; this eGFR value replaced the historical eGFR value to determine whether participant should have post-contrast serum creatinine measurement 48 to 96 hours after imaging at screening. Other study details updated.
    05 Sep 2018
    Response to a request by the UK Medicines and Healthcare products Regulatory Agency to clarify that, if required, the unblinding of a participant could be performed by the investigator without consultation with the medical monitor, and that the investigator has direct access to the code via the IWRS for this purpose.
    24 Oct 2018
    Response to requests from BfArM, UK Medicines and Healthcare Products Regulatory Agency. Updates made to the information reported from the post market study.
    16 Sep 2019
    Amended based on v4.0 to v5.0 to increase the time window for MRA/CTA images that could be reviewed by the core laboratory at screening from 6 months to 12 months prior to enrolment in order to minimize participants’ radiation exposure to generate the current version of the protocol
    01 Jul 2020
    To include the United States as a study site
    14 Dec 2022
    To update the timeframe of the possible crossover from 6 months to 1 year post-procedure

    Interruptions (globally)
    Were there any global interruptions to the trial? No

    Limitations and caveats
    Limitations of the trial such as small numbers of subjects analysed or technical problems leading to unreliable data.
    Recruitment and conduct of the study occurred during the COVID-19 pandemic.

    Online references
    http://www.ncbi.nlm.nih.gov/pubmed/37427416
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