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    Summary
    EudraCT Number:2018-000036-96
    Sponsor's Protocol Code Number:CR0014
    National Competent Authority:Belgium - FPS Health-DGM
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2018-05-16
    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 number2018-000036-96
    A.3Full title of the trial
    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
    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 Without Medication
    A.3.2Name or abbreviated title of the trial where available
    The TARGET BP OFF-MED Trial
    A.4.1Sponsor's protocol code numberCR0014
    A.5.2US NCT (ClinicalTrials.gov registry) numberNCT03503773
    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 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.
    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 hypertensive subjects, up to 2 years post-treatment.
    • To evaluate the efficacy of renal denervation by alcohol-mediated neurolysis using the Peregrine Kit on blood pressure in hypertensive subjects, up to 1 year post-treatment.
    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. If subject has a documented history of uncontrolled hypertension (see definition in Definition of Terms section of protocol) and is currently taking no (0) antihypertensive medications, he/she must:
    • Have 3 office blood pressure measurements with a mean office systolic blood pressure (SBP) of ≥140 mmHg and ≤180 mmHg AND mean office diastolic blood pressure (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-treatment period).
    4. If subject has a documented history of uncontrolled hypertension (see definition in Definition of Terms section of protocol) and is currently taking 1 or 2 antihypertensive medications, he/she must:
    • Have 3 office blood pressure measurements with a mean office SBP of ≥120 mmHg and ≤180 mmHg and
    • Be willing to discontinue his/her antihypertensive medication(s), and to adhere to the no-medication regimen for at least 12 weeks (4-week run-in period and 8-week post-treatment period).
    5. Investigator judges that the subject can be discontinued safely from all current antihypertensive medication (where applicable) and managed safely for at least 12 weeks (4-week run-in period and 8-week post-treatment period) without antihypertensive medication intake.
    6. Female subjects of childbearing potential must agree to use acceptable methods of contraception (as defined in the protocol), 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 3 office blood pressure measurements with a mean office SBP of ≥140 mmHg and ≤180 mmHg AND mean office DBP ≥90 mmHg.
    9. Subject 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 a contraindication known for conventional percutaneous interventional procedures such as: Intolerance for antiplatelet/anticoagulant therapy, Known allergy to contrast media that cannot be adequately pre-medicated, Bleeding/coagulation disorders (such as bleeding diathesis, thrombocytopenia, and severe anemia), Occlusive peripheral vascular disease that would preclude percutaneous femoral access for the procedure
    2. Subject has an acute or sub-acute infection that the Investigator judges would pose unacceptable risks to the subject
    3. Subject has imaging-assessed renal artery anatomy abnormalities or variations based on Investigator's evaluation of the screening images (i.e. MRA/CTA examination and/or renal angiography)
    4. Subject has documented severe untreated obstructive sleep apnea (AHI ≥30 per hour)
    5. 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
    6. Subject has a history of pre-eclampsia
    7. Subject has orthostatic hypotension at screening, or documented history of orthostatic hypotension within 12 months prior to the planned procedure, defined as a drop in blood pressure that is >20mmHg in SBP and/or >10mmHg in DBP within 3 minutes upon standing from sitting or from a lying down face-up (supine) position
    8. Subject has Type 1 diabetes mellitus, or uncontrolled Type 2 diabetes mellitus (defined as hemoglobin A1c [HbA1c] ≥9.0%)
    9. Subject has an eGFR of ≤45 mL/min/1.73 m2, based on the CKD-EPI equation; or is on chronic renal replacement therapy
    10. Subject has nephrotic syndrome
    11. Subject has a history of recurrent (>1 episode) kidney stones, or history of kidney stones within 12 months prior to the planned procedure
    12. Subject has a history of nephrectomy, a single kidney or kidney tumor, or urinary tract obstruction (with potential for hydronephrosis).
    13. Subject has a renal transplant, or is known to have a non-functioning kidney or unequal renal size (>2cm difference in renal length between kidneys associated with a chronic kidney disease or a deterioration of the kidney function)
    14. Subject has a history of myocardial infarction, unstable angina pectoris, or stroke/TIA within 6 months prior to the planned procedure
    15. Subject has any of the following conditions: severe cardiac valvestenosis, heart failure (NYHA Class III or IV), chronic atrial fibrillation, and known primary pulmonary hypertension (>60mmHg PA
    or RV systolic pressure)
    16. Subject is allergic or intolerant to the neurolytic agent (dehydrated alcohol)
    17. Subject is being treated chronically (e.g. daily use) with NSAIDs, immunosuppressive medications, or immunosuppressive doses of steroids. Aspirin therapy and nasal pulmonary inhalants are allowed
    18. Any contraindication to the imaging as required per the protocol
    19. Subject for whom an ABPM device cannot be used due to arm size (>42cm arm circumference) or other reasons
    20. 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
    21. Subject has a known history of drug use or alcohol dependency, 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
    22. If female, subject is pregnant or lactating at the time of enrollment or planning to become pregnant during the trial time period.
    23. Subject 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. Subjects enrolled in observational registries not involving renal denervation may still be eligible.
    24. Subject is in custody or an institution.
    25. Subject has close affiliation with the study site or sponsor (e.g. employee, close relative of an employee).
    26. Subject has a history of hypertensive emergency in the previous 3 months (see definition of hypertensive emergencies in Definition of Terms section of protocol).
    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 8 weeks post-treatment
    E.5.2Secondary end point(s)
    Secondary efficacy endpoints:
    1. Change in mean 24-hour, daytime (07:00 to 21:59), and nighttime (22:00 to 6:59) ambulatory SBP and DBP
    2. Change in mean office SBP and DBP
    3. Percentage of subjects controlled to target blood pressure values
    4. Use of antihypertensive medication(s) (emergency use medication)
    5. Use of antihypertensive medication(s) (including increases/decreases, titrated according to standardized formula to maintain a target SBP of <140 mmHg and ≥90 mmHg)
    6. Compliance with not taking antihypertensive medications

    Secondary safety endpoints:
    1. Major adverse events (MAEs), as adjudicated by the Clinical Events Committee (CEC)
    2. Changes in eGFR
    3. Decreases in eGFR >25%
    4. Rate of adverse events (serious and non-serious), peri-procedurally
    5. 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)
    6. 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 & 2. from baseline to time points post-treatment
    3 & 6. throughout the study
    4. from time of procedure to 8 weeks post-treatment
    5. from 8 week to 6 months and 1 year post-treatment
    6. through 8 weeks post-treatment

    Secondary safety endpoints:
    1 & 6. through 30 days post-treatment
    2 & 3. from baseline to 8 weeks, 6 months, and 1 year post-treatment
    4. at discharge and at each of the follow-up time points
    5. at the time of 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) Yes
    E.7.3Therapeutic confirmatory (Phase III) No
    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
    Sham-procedure (only renal angiography performed)
    E.8.2.4Number of treatment arms in the trial2
    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 concerned1
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA24
    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
    United States
    France
    Netherlands
    Germany
    Belgium
    Ireland
    United Kingdom
    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 database lock for the study.
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years5
    E.8.9.1In the Member State concerned months0
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years5
    E.8.9.2In all countries concerned by the trial months0
    E.8.9.2In all countries concerned by the trial days0
    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: 300
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 100
    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 No
    F.4 Planned number of subjects to be included
    F.4.1In the member state60
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 400
    F.4.2.2In the whole clinical trial 400
    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 Treatment Arm will continue to receive the normal standard-of-care assessments per their treating physician’s standard of practice. 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) or they will continue to receive the normal standard-of-care assessments per their treating physician’s standard of practice.
    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 Decision2018-06-05
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2018-09-06
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2024-01-19
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