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    Summary
    EudraCT Number:2016-002545-32
    Sponsor's Protocol Code Number:CR0002
    National Competent Authority:Belgium - FPS Health-DGM
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2019-09-13
    Trial results
    Index
    A. PROTOCOL INFORMATION
    B. SPONSOR INFORMATION
    C. APPLICANT IDENTIFICATION
    D. IMP IDENTIFICATION
    D.8 INFORMATION ON PLACEBO
    E. GENERAL INFORMATION ON THE TRIAL
    F. POPULATION OF TRIAL SUBJECTS
    G. INVESTIGATOR NETWORKS TO BE INVOLVED IN THE TRIAL
    N. REVIEW BY THE COMPETENT AUTHORITY OR ETHICS COMMITTEE IN THE COUNTRY CONCERNED
    P. END OF TRIAL
    Expand All   Collapse All
    A. Protocol Information
    A.1Member State ConcernedBelgium - FPS Health-DGM
    A.2EudraCT number2016-002545-32
    A.3Full title of the trial
    A Pivotal, Multicenter, Blinded, Sham Procedure-Controlled Trial of Renal Denervation by the Peregrine System™ Kit, in Subjects with Hypertension.
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Study of the Effect of Kidney Denervation on Blood Pressure in Subjects with High Blood Pressure
    A.3.2Name or abbreviated title of the trial where available
    The TARGET BP I Trial
    A.4.1Sponsor's protocol code numberCR0002
    A.5.2US NCT (ClinicalTrials.gov registry) numberNCT02910414
    A.7Trial is part of a Paediatric Investigation Plan No
    A.8EMA Decision number of Paediatric Investigation Plan
    B. Sponsor Information
    B.Sponsor: 1
    B.1.1Name of SponsorAblative Solutions, Inc
    B.1.3.4CountryUnited States
    B.3.1 and B.3.2Status of the sponsorCommercial
    B.4 Source(s) of Monetary or Material Support for the clinical trial:
    B.4.1Name of organisation providing supportAblative Solutions, Inc.
    B.4.2CountryUnited States
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationAblative Solutions, Inc.
    B.5.2Functional name of contact pointClinical & Regulatory Affairs
    B.5.3 Address:
    B.5.3.1Street Address301 Edgewater Place, Suite 100
    B.5.3.2Town/ cityWakefield
    B.5.3.3Post codeMA 01880
    B.5.3.4CountryUnited States
    B.5.4Telephone number+14084212496
    B.5.5Fax number+493221122682723
    B.5.6E-mailEU-Regulatory@ablativesolutions.com
    D. IMP Identification
    D.IMP: 1
    D.1.2 and D.1.3IMP RoleTest
    D.2 Status of the IMP to be used in the clinical trial
    D.2.1IMP to be used in the trial has a marketing authorisation No
    D.2.5The IMP has been designated in this indication as an orphan drug in the Community No
    D.2.5.1Orphan drug designation number
    D.3 Description of the IMP
    D.3.1Product nameDehydrated Alcohol Injection
    D.3.4Pharmaceutical form Solution for injection
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPRoute of administration not applicable
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNDehydrated Alcohol
    D.3.9.1CAS number 64-17-5
    D.3.9.3Other descriptive nameDEHYDRATED ALCOHOL
    D.3.9.4EV Substance CodeSUB22667
    D.3.10 Strength
    D.3.10.1Concentration unit % percent
    D.3.10.2Concentration typenot less then
    D.3.10.3Concentration number99
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin Yes
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) No
    The IMP is a:
    D.3.11.3Advanced Therapy IMP (ATIMP) No
    D.3.11.3.1Somatic cell therapy medicinal product No
    D.3.11.3.2Gene therapy medical product No
    D.3.11.3.3Tissue Engineered Product No
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) No
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product No
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy Yes
    D.3.11.5Radiopharmaceutical medicinal product No
    D.3.11.6Immunological medicinal product (such as vaccine, allergen, immune serum) No
    D.3.11.7Plasma derived medicinal product No
    D.3.11.8Extractive medicinal product No
    D.3.11.9Recombinant medicinal product No
    D.3.11.10Medicinal product containing genetically modified organisms No
    D.3.11.11Herbal medicinal product No
    D.3.11.12Homeopathic medicinal product No
    D.3.11.13Another type of medicinal product No
    D.8 Information on Placebo
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Hypertension
    E.1.1.1Medical condition in easily understood language
    High blood pressure
    E.1.1.2Therapeutic area Diseases [C] - Cardiovascular Diseases [C14]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.0
    E.1.2Level PT
    E.1.2Classification code 10020772
    E.1.2Term Hypertension
    E.1.2System Organ Class 10047065 - Vascular disorders
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To evaluate the efficacy of renal denervation by alcohol-mediated neurolysis using the Peregrine Kit in uncontrolled hypertensive subjects when used in combination with antihypertensive medications
    E.2.2Secondary objectives of the trial
    To evaluate the acute and chronic safety of renal denervation by alcohol-mediated neurolysis using the Peregrine Kit in uncontrolled hypertensive subjects when used in combination with antihypertensive medications.

    To evaluate the sustained efficacy of renal denervation by alcohol-mediated neurolysis using the Peregrine Kit in uncontrolled hypertensive subjects when used in combination with antihypertensive medications.

    To evaluate the performance of the Peregrine Kit (co-packaged combination of the alcohol and the Peregrine Catheter) for its intended use.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Prior to run-in period
    1. Subject has provided written informed consent
    2. Male or female subject, aged ≥18 and ≤80 years at time of enrollment
    3. Subject is taking 2-5 antihypertensive medications (labeled for hypertension) at time of enrollment, and is willing to adhere to a stable
    (no change) medication regimen during the 4-week run-in period and 3 months post-procedure. Antihypertensive medications must be as follows:
    • Two of the antihypertensive medications must be at least at 50% of their maximally labelled dose prior to the planned procedure
    • In subjects on 2 medications, one should be an ACE inhibitor or ARB, except where subjects have documented intolerance to each of these drug classes.
    • All subjects must currently be taking, or have documentation that they failed or cannot tolerate, a diuretic
    • In the case of the thiazide agents hydrochlorothiazide and chlorthalidone, doses should be 25 mg daily, reflecting the usual maximum doses in contemporary medical practice when these diuretic agents are used in combination treatment.In countries where thiazide like agents are used in line with current local prescribing practice, these agents should also be administered at the usual maximum dose in contemporary medical practice when used in combination treatment.
    • For subjects on 2 non-diuretic antihypertensive medications, because they either failed or have been unable to tolerate a diuretic, the 2
    medications should consist of any of the classes of antihypertensive agents listed below, with the preferred choice of an ACE inhibitor or ARB and a CCB. In the latter case, if both ACE inhibitor/ARB and CCB are contraindicated or not tolerated, such reasons must be documented.
    Note: The following classes of antihypertensive agents that would count towards the minimum number of agents are: ACE inhibitors, ARBs, CCBs, thiazide diuretics, loop diuretics, aldosterone antagonists, beta-blockers, centrally active agents, alpha receptor blockers, direct vasodilators, direct renin inhibitors and hydralazine.
    4. Subject meets blood pressure criteria at time of enrollment and prior to the 4-week run-in period: has 3 office blood pressure measurements with a mean office SBP of ≥150 mmHg and ≤180 mmHg, AND a mean office DBP ≥90 mmHg.
    5. Investigator judges that the subject can be managed safely during the 4-week run-in period and 3 months post-procedure period without any changes to their current antihypertensive medication regimen
    6. Female subjects of childbearing potential must agree to use acceptable methods of contraception, from the time of informed consent through to the last follow-up visit
    7. Subject agrees to have all study procedures performed and is able and willing to comply with all study follow-up visits and protocol requirements

    End of run-in period
    8. Subject has maintained the same antihypertensive medication regimen for at least 4 weeks (28 days) prior to the procedure
    9. Subject meets blood pressure criteria:
    • Has 3 office blood pressure measurements with a mean office SBP of ≥150 mmHg and ≤180 mmHg AND mean office DBP ≥90 mmHg AND
    • Has a mean 24-hour ambulatory SBP of ≥135 mmHg and ≤170 mmHg with ≥70% valid readings (as determined by ABPM measurement device)
    E.4Principal exclusion criteria
    1. Subject has documented severe untreated obstructive sleep apnea
    2. Subject has documented diagnosis of the following causes of hypertension: Cushing’s disease or Cushing’s Syndrome, hyperaldosteronism, pheochromocytoma, thyroid and parathyroid abnormalities, or onset of hypertension prior to the age of 18
    3. Subject has a history of pre-eclampsia within the 5 years prior to study entry.
    4. Subject has orthostatic hypotension at baseline, or documented history of orthostatic hypotension within 12 months prior to the planned procedure
    5. Any contraindication to the imaging as required per the protocol.
    6. Subject has imaging-assessed renal artery anatomy abnormalities or variations based on investigator’s evaluation of the screening images (i.e. MRA/CTA examination) meeting one of the following criteria:
    • Main renal artery that has a diameter of <4 mm or >7 mm and length of <5 mm
    • Accessory renal arteries with diameter >2 mm or <4 mm, which supply >20% of the whole kidney parenchyma on that side, per the investigator’s judgment
    • Renal artery stenosis >50% of the normal diameter segment
    • Any renal artery abnormality or disease that, per the physician assessment, precludes the safe insertion of the guiding catheter
    • Previous renal angioplasty associated with stenting or other implants, that, per the physician’s assessment, precludes the safe deployment of the Peregrine Catheter components in the target treatment segment of the renal artery
    • Previous renal denervation
    • Fibromuscular dysplasia of the renal arteries
    7. Subject has a renal transplant, or is known to have a non-functioning kidney or unequal renal size
    8. Subject has a history of nephrectomy, a single kidney or kidney tumor, or urinary tract obstruction
    9. Subject has a history of recurrent kidney stones, or history of kidney stones within 12 months prior to the planned procedure
    10. Subject has an eGFR of ≤45 mL/min/1.73 m2, based on the CKD-EPI equation; or is on chronic renal replacement therapy
    11. Subject has nephrotic syndrome
    12. Subject for whom an ABPM device cannot be used due to arm size or other reasons as identified by the investigator
    13. Subject has any of the following conditions: severe cardiac valve stenosis, heart failure (NYHA Class III or IV), chronic atrial fibrillation, and known primary pulmonary hypertension
    14. Subject has an acute or sub-acute infection that the investigator judges would pose unacceptable procedural risks to the subject
    15. Subject has Type 1 diabetes mellitus, or uncontrolled Type 2 diabetes mellitus
    16. Subject has a contraindication known for conventional percutaneous interventional procedures such as: intolerance for antiplatelet/anticoagulant therapy, known hypersensitivity to contrast media that cannot be adequately pre-medicated, bleeding/coagulation disorders, occlusive peripheral vascular disease that would preclude percutaneous femoral access for the procedure
    17. Subject has a known hypersensitivity to the neurolytic agent
    18. Subject has a known history of substance (drug) use or alcohol dependence, or lacks the ability to comprehend or follow instructions, or for any reason, in the opinion of the investigator, would be unlikely or unable to comply with study protocol requirements
    19. Subject is being treated chronically (e.g. daily use) with NSAIDs, immunosuppressive medications, or immunosuppressive doses of steroids
    20. Subject has a history of myocardial infarction, unstable angina pectoris, or stroke/transient ischemic attack (TIA) within 6 months prior to the planned procedure.
    21. If female, subject is pregnant or lactating at the time of enrollment or planning to become pregnant during the trial time period.
    22. Subject has any other acute or chronic condition that the investigator believes will adversely affect the ability to interpret the data or will prevent the subject from completing the trial procedures, or has a life expectancy of <12 months.
    23. Subject is participating or has participated in another clinical study involving an investigational drug or investigational device within 30 days prior to enrollment or is scheduled to participate in another clinical study involving an investigational drug or investigational device during the course of this study
    24. Subject is in custody or institutions
    25. Subject has close affiliation with the study site or sponsor
    E.5 End points
    E.5.1Primary end point(s)
    Change in mean 24-hour ambulatory SBP
    E.5.1.1Timepoint(s) of evaluation of this end point
    From baseline to 3 months post-procedure
    E.5.2Secondary end point(s)
    Secondary efficacy endpoints
    1. and 3. Change in mean office SBP
    2. Change in mean 24-hour ambulatory SBP
    4. and 5. Change in mean daytime (07:00 to 21:59) ambulatory SBP
    6. Change in mean office DBP
    7. Change in mean 24-hour ambulatory DBP
    8. Change in mean daytime ambulatory DBP
    9. 10. and 16. Changes (decreases or increases) in antihypertensive medication regimen
    11. Change in mean nighttime (22:00 to 06:59) ambulatory SBP
    12. Change in mean nighttime ambulatory DBP
    13. ABPM Responders, defined as the proportion of subjects with a drop of ≥5 mmHg in 24-hour ambulatory SBP
    14. Office BP Responders, defined as the proportion of subjects with a drop of ≥10 mmHg in office SBP
    15. Reduction of both office SBP and DBP to normal (<140/90 mmHg)
    16. Changes (any decrease or increase) in antihypertensive medication regimen

    Secondary Safety endpoints
    • Major adverse events (MAEs)
    • Renal artery stenosis >60% diameter as indicated by imaging
    • Changes in eGFR
    • Decreases in eGFR >25%
    • Rate of adverse events (serious and non-serious)
    • Device success (defined as the ability to insert the Peregrine Catheter into the lumen of the renal artery [target vessel], deploy the guide tubes inside the renal artery, deploy the needles through the arterial wall, deliver the intended dose of alcohol, retract the needles and the guide tubes back in the catheter, and remove the catheter from the access site without any related complications or events)
    • Procedure success (defined as device success with freedom from peri-procedural MAEs)
    E.5.2.1Timepoint(s) of evaluation of this end point
    Secondary efficacy endpoints
    1., 4., 13. and 14. At 3 months compared with baseline
    2., 3., and 5. At 6 months compared with baseline
    6., 7., 8., 11. and 12. From baseline to 3 months and then 6 months post-procedure
    9. From 3 to 6 months post-procedure
    10. From procedure to 6 months post-procedure
    15. At 3, 6 and 12 months as compared to baseline
    16. From procedure to 3 months post-procedure

    Secondary safety endpoints
    • Through 30 days post-procedure, at 3, 6, and 12 months and 2 and 3 years
    • At 6 months
    • From baseline to 3 months and 6 months post-procedure
    • From baseline to 3 months and 6 months post-procedure
    • Peri-procedural, at discharge, and at each of the follow-up time points
    • During the procedure
    • During the procedure
    E.6 and E.7 Scope of the trial
    E.6Scope of the trial
    E.6.1Diagnosis No
    E.6.2Prophylaxis No
    E.6.3Therapy Yes
    E.6.4Safety Yes
    E.6.5Efficacy Yes
    E.6.6Pharmacokinetic No
    E.6.7Pharmacodynamic No
    E.6.8Bioequivalence No
    E.6.9Dose response No
    E.6.10Pharmacogenetic No
    E.6.11Pharmacogenomic No
    E.6.12Pharmacoeconomic No
    E.6.13Others No
    E.7Trial type and phase
    E.7.1Human pharmacology (Phase I) No
    E.7.1.1First administration to humans No
    E.7.1.2Bioequivalence study No
    E.7.1.3Other No
    E.7.1.3.1Other trial type description
    E.7.2Therapeutic exploratory (Phase II) No
    E.7.3Therapeutic confirmatory (Phase III) Yes
    E.7.4Therapeutic use (Phase IV) No
    E.8 Design of the trial
    E.8.1Controlled Yes
    E.8.1.1Randomised Yes
    E.8.1.2Open No
    E.8.1.3Single blind Yes
    E.8.1.4Double blind No
    E.8.1.5Parallel group Yes
    E.8.1.6Cross over Yes
    E.8.1.7Other No
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) No
    E.8.2.2Placebo No
    E.8.2.3Other Yes
    E.8.2.3.1Comparator description
    Diagnostic renal angiography only, performed for confirmation of anatomical eligibility
    E.8.2.4Number of treatment arms in the trial3
    E.8.3 The trial involves single site in the Member State concerned No
    E.8.4 The trial involves multiple sites in the Member State concerned Yes
    E.8.4.1Number of sites anticipated in Member State concerned7
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA40
    E.8.6 Trial involving sites outside the EEA
    E.8.6.1Trial being conducted both within and outside the EEA Yes
    E.8.6.2Trial being conducted completely outside of the EEA No
    E.8.6.3If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned
    Austria
    Belgium
    France
    Germany
    Ireland
    Monaco
    Netherlands
    Sweden
    Switzerland
    United Kingdom
    United States
    E.8.7Trial has a data monitoring committee Yes
    E.8.8 Definition of the end of the trial and justification where it is not the last visit of the last subject undergoing the trial
    The end of the study is defined as the date of final approved CSR.
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years6
    E.8.9.1In the Member State concerned months
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial years6
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 No
    F.1.1.1In Utero No
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) No
    F.1.1.3Newborns (0-27 days) No
    F.1.1.4Infants and toddlers (28 days-23 months) No
    F.1.1.5Children (2-11years) No
    F.1.1.6Adolescents (12-17 years) No
    F.1.2Adults (18-64 years) Yes
    F.1.2.1Number of subjects for this age range: 420
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 180
    F.2 Gender
    F.2.1Female Yes
    F.2.2Male Yes
    F.3 Group of trial subjects
    F.3.1Healthy volunteers No
    F.3.2Patients Yes
    F.3.3Specific vulnerable populations Yes
    F.3.3.1Women of childbearing potential not using contraception No
    F.3.3.2Women of child-bearing potential using contraception Yes
    F.3.3.3Pregnant women No
    F.3.3.4Nursing women No
    F.3.3.5Emergency situation No
    F.3.3.6Subjects incapable of giving consent personally No
    F.3.3.7Others Information not present in EudraCT
    F.4 Planned number of subjects to be included
    F.4.1In the member state15
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 300
    F.4.2.2In the whole clinical trial 600
    F.5 Plans for treatment or care after the subject has ended the participation in the trial (if it is different from the expected normal treatment of that condition)
    After the end of the study, subjects in the RCT and Safety Cohort will continue to receive the normal standard-of-care assessments per their treating physician’s standard of practice. There will be no protocol-specific aftercare once these subjects have completed their last follow-up assessment for this study. For subjects in the Sham Control Arm, there may be the possibility of entering a crossover phase (which they can undergo once they have at least completed their 1 year follow-up visit) .
    G. Investigator Networks to be involved in the Trial
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2019-10-04
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2020-02-17
    P. End of Trial
    P.End of Trial StatusOngoing
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