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The Safety and Efficacy of Catheter-based Renal Denervation Using the Vessix™ Renal Denervation System in Autosomal Dominant Polycystic Kidney Disease (ADPKD) Patients With Severe Debilitating Pain

Primary Purpose

Autosomal Dominant Polycystic Kidney Disease

Status
Withdrawn
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Vessix
Sponsored by
University of Chicago
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Autosomal Dominant Polycystic Kidney Disease

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Age ≥ 18 years
  • Diagnosis of ADPKD (meeting Pei's revised criteria24).
  • History of chronic debilitating kidney pain for >6 months due to ADPKD. Other approaches to pain management will have been appropriately considered and used including step wise treatment with non-opiates, opiates, physical therapy and where other non-renal causes of pain have been effectively ruled out (for example: pancreatitis, cholecystitis, etc).
  • Demonstrate either opiate dependence for at least 3 months, OR partial or full medical disability OR self-reported significant decreased quality of life OR a minimum pain rating of 7 out of 10 on three consecutive occasions between screening and intervention
  • Patients must be clinically able to tolerate sedation for the procedure
  • Must be able to travel to study site.
  • Able to provide informed consent
  • No renal artery stenosis > 50% and presence of suitable renal artery calibers; 4-7mm identified at the time of renal artery catheterization
  • Sufficient renal imaging to exclude genitourinary obstruction, tumor or other clinically significant pathologies associated with kidney pain.
  • Stable renal function for a minimum of 1 month prior to study enrollment or already on dialysis
  • No change in antihypertensive therapy for 1 month prior to study enrollment
  • Women of childbearing potential must be using at least 2 acceptable forms of birth control

Exclusion Criteria:

  • Individual has renal artery anatomy that is ineligible for treatment including:

    • Lacks at least one renal artery for each kidney with ≥ 4 mm diameter and with ≥ 20 mm treatable length prior to a significant arterial branch
    • Renal artery stenosis (>50%) or renal artery aneurysm in a renal artery on the intervention side
    • A history of prior renal artery intervention including balloon angioplasty or stenting, or prior renal denervation procedure.
    • Renal arteries which contain calcification or diffuse vessel abnormality which does not allow at least 4 ablations to be delivered
    • Diffuse fibromuscular dysplasia which does not allow at least 4 ablations to be delivered; defined as visible beading of the artery on angiography
    • Solitary or horseshoe kidney
  • The presence of diabetes mellitus
  • Individual has had ≥ 1 episode(s) of orthostatic hypotension not related to medication changes (reduction of systolic blood pressure of ≥20 mmHg or diastolic blood pressure of ≥10 mmHg within 3 minutes of standing), coupled with symptoms, within the past year or during the screening process.
  • Change in systolic blood pressure associated with symptoms of orthostasis
  • Individual requires chronic oxygen support or mechanical ventilation other than nocturnal respiratory support for sleep apnea.
  • The presence of primary pulmonary hypertension
  • The presence of other known secondary forms of hypertension such as pheochromocytoma, Cushing's Disease (adrenal insufficiency), primary hyperaldosteronism, coarctation of the aorta.
  • Individual has experienced a myocardial infarction within 3 months of the screening period, or has experienced unstable angina pectoris, syncope, or a cerebrovascular accident within 3 months of the screening period.
  • Individual has a scheduled or planned surgery within 1 year of study enrollment
  • Inability to complete protocol blood pressure measurements (e.g., arm diameter too large for the cuff).
  • Individual has severe cardiac valve stenosis for which, in the opinion of the investigator, a significant reduction of blood pressure is contraindicated.
  • Subjects on beta blockers and or clonidine
  • Individual has a confounding medical condition, which in the opinion of the investigator, may adversely affect the safety of the participant (e.g., significant peripheral vascular disease, abdominal aortic aneurysm, severe chronic obstructive pulmonary disorder)
  • Significant bleeding diathesis (thrombocytopenia, hemophilia, or significant anemia)
  • Individual is pregnant, nursing or planning to get pregnant within two years of study enrollment.
  • Individual has a known unresolved history of drug use or alcohol dependency, who in the opinion of the Principal Investigator lacks the ability to comprehend or follow instructions, or would be unlikely or unable, in the opinion of the investigator, to comply with study follow-up requirements
  • Individual with a previous solid organ transplant
  • Individual who has had a celiac plexus block or splanchnic nerve block for pain relief Transcutaneous electrical nerve stimulation (TENS), spinal cord stimulation, acupuncture or the use of medical marijuana for pain relief within the past 3 months
  • Hospitalization for non-pain related conditions within the past 3 months
  • Surgical treatment for ADPKD pain relief in the past 24 months (Cyst aspiration, sclerotherapy and cyst fenestration surgery)
  • Individuals with significant kidney stones (> 7-8 mm) on imaging studies
  • Subjects with acute kidney Injury in the past 6 months
  • Subjects with significant renal impairment (defined as glomerular filtration rate < 30 ml/min/1.73m2 determined by chronic kidney disease equation
  • Individual is a participant in another interventional clinical trial
  • Subjects with an additional accessory renal vessel that perfuses more than 25% of the kidney
  • Individuals with terminal illness with expected survival of less than 1 year
  • Current symptoms of cerebral hypoperfusion (e.g. dizziness or lightheadedness, visual blurring or darkening of the visual fields, syncope).
  • Acute coronary syndrome (by standard criteria) within the prior month (established by biomarkers of myocardial anatomy and/or electrocardiogram changes
  • Coronary revascularization procedures within 30 days of screening, or, expected procedures within the next 6 months.
  • Valve surgery within 30 days of screening, or, expected procedures within the next 6 months.
  • Cardiac resynchronization therapy, with or without implantable cardiac defibrillator within 90 days of screening or expected procedures within the next 6 months.
  • Hypertrophic or restrictive cardiomyopathy
  • Constrictive pericarditis
  • Active myocarditis or endocarditis
  • Complex congenital heart disease
  • Severe, advanced heart failure

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Sham Comparator

    Arm Label

    Experimental

    Control

    Arm Description

    Subjects will receive renal denervation.

    Subjects will receive all procedures as experimental group but renal denervation system will not be turned on.

    Outcomes

    Primary Outcome Measures

    Number of adverse events
    Adverse events will be recorded over a 6 month time period (post-procedure) for all subjects. The average number of adverse events in the experimental group will be compared to that of the control (sham) group.

    Secondary Outcome Measures

    Change in pain
    Pain reduction will be measured over a 12 month period at post-procedure by a Visual Analog Scale pain questionnaire. The average change in pain score in the experimental group will be compared to the average change in pain score in the control (sham) group.
    Change in renal function
    Glomerular filtration rate (GFR) will be measured as a test for renal function two weeks after procedure. Change in GFR from experimental group will be compared to the change in GFR from control group
    Change in Quality of life as measured by quality of life questionnaire
    Quality of life will be measured over a 12 month period at using an Autosomal Dominant Polycystic Kidney Disease quality of life questionnaires. Change in scores for questionnaires for experimental group at will be compared to those in control group
    Change in Quality of life as measured by depression questionnaire
    Change in quality of life will be measured using a depression questionnaire. Scores for experimental group will be compared to those in control group

    Full Information

    First Posted
    April 8, 2016
    Last Updated
    April 1, 2019
    Sponsor
    University of Chicago
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    1. Study Identification

    Unique Protocol Identification Number
    NCT02746419
    Brief Title
    The Safety and Efficacy of Catheter-based Renal Denervation Using the Vessix™ Renal Denervation System in Autosomal Dominant Polycystic Kidney Disease (ADPKD) Patients With Severe Debilitating Pain
    Official Title
    The Safety and Efficacy of Catheter-based Renal Denervation Using the Vessix™ Renal Denervation System in Autosomal Dominant Polycystic Kidney Disease (ADPKD) Patients With Severe Debilitating Pain
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    March 2019
    Overall Recruitment Status
    Withdrawn
    Why Stopped
    The company who was sponsoring devices and funding pulled out before we enrolled any subjects.
    Study Start Date
    December 2016 (Actual)
    Primary Completion Date
    May 2019 (Anticipated)
    Study Completion Date
    May 2020 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    University of Chicago

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    Yes
    Data Monitoring Committee
    Yes

    5. Study Description

    Brief Summary
    This study will test the safety and efficacy of the Vessix Renal Denervation system in the reduction of pain in patients with Autosomal Dominant Polycystic Kidney Disease (ADPKD).
    Detailed Description
    This study will employ the Vessix Renal Denervation System (Boston Scientific) to ablate the renal nerve by radio-ablation in patients suffering from severe pain due to Autosomal Dominant Polycystic Kidney Disease (ADPKD). Twenty patients with opiate-dependent, Autosomal Dominant Polycystic Kidney Disease-associated kidney pain will be selected to this double-blind, prospective device study. Subjects will be randomly assigned to an experimental (those who will receive nerve ablation) or control (those who will have a sham procedure in which the ablation device is not turned on) groups. Subjects will complete physical exams and be administered questionnaires regarding their mental status and pain before, during and after the denervation procedure. Renal function and adverse events will be monitored for 1 year after denervation.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Autosomal Dominant Polycystic Kidney Disease

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    ParticipantCare ProviderInvestigatorOutcomes Assessor
    Allocation
    Randomized
    Enrollment
    0 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Experimental
    Arm Type
    Experimental
    Arm Description
    Subjects will receive renal denervation.
    Arm Title
    Control
    Arm Type
    Sham Comparator
    Arm Description
    Subjects will receive all procedures as experimental group but renal denervation system will not be turned on.
    Intervention Type
    Device
    Intervention Name(s)
    Vessix
    Intervention Description
    Renal denervation using radio-ablation
    Primary Outcome Measure Information:
    Title
    Number of adverse events
    Description
    Adverse events will be recorded over a 6 month time period (post-procedure) for all subjects. The average number of adverse events in the experimental group will be compared to that of the control (sham) group.
    Time Frame
    6 months
    Secondary Outcome Measure Information:
    Title
    Change in pain
    Description
    Pain reduction will be measured over a 12 month period at post-procedure by a Visual Analog Scale pain questionnaire. The average change in pain score in the experimental group will be compared to the average change in pain score in the control (sham) group.
    Time Frame
    12 months
    Title
    Change in renal function
    Description
    Glomerular filtration rate (GFR) will be measured as a test for renal function two weeks after procedure. Change in GFR from experimental group will be compared to the change in GFR from control group
    Time Frame
    2 weeks
    Title
    Change in Quality of life as measured by quality of life questionnaire
    Description
    Quality of life will be measured over a 12 month period at using an Autosomal Dominant Polycystic Kidney Disease quality of life questionnaires. Change in scores for questionnaires for experimental group at will be compared to those in control group
    Time Frame
    12 months
    Title
    Change in Quality of life as measured by depression questionnaire
    Description
    Change in quality of life will be measured using a depression questionnaire. Scores for experimental group will be compared to those in control group
    Time Frame
    12 months

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    80 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Age ≥ 18 years Diagnosis of ADPKD (meeting Pei's revised criteria24). History of chronic debilitating kidney pain for >6 months due to ADPKD. Other approaches to pain management will have been appropriately considered and used including step wise treatment with non-opiates, opiates, physical therapy and where other non-renal causes of pain have been effectively ruled out (for example: pancreatitis, cholecystitis, etc). Demonstrate either opiate dependence for at least 3 months, OR partial or full medical disability OR self-reported significant decreased quality of life OR a minimum pain rating of 7 out of 10 on three consecutive occasions between screening and intervention Patients must be clinically able to tolerate sedation for the procedure Must be able to travel to study site. Able to provide informed consent No renal artery stenosis > 50% and presence of suitable renal artery calibers; 4-7mm identified at the time of renal artery catheterization Sufficient renal imaging to exclude genitourinary obstruction, tumor or other clinically significant pathologies associated with kidney pain. Stable renal function for a minimum of 1 month prior to study enrollment or already on dialysis No change in antihypertensive therapy for 1 month prior to study enrollment Women of childbearing potential must be using at least 2 acceptable forms of birth control Exclusion Criteria: Individual has renal artery anatomy that is ineligible for treatment including: Lacks at least one renal artery for each kidney with ≥ 4 mm diameter and with ≥ 20 mm treatable length prior to a significant arterial branch Renal artery stenosis (>50%) or renal artery aneurysm in a renal artery on the intervention side A history of prior renal artery intervention including balloon angioplasty or stenting, or prior renal denervation procedure. Renal arteries which contain calcification or diffuse vessel abnormality which does not allow at least 4 ablations to be delivered Diffuse fibromuscular dysplasia which does not allow at least 4 ablations to be delivered; defined as visible beading of the artery on angiography Solitary or horseshoe kidney The presence of diabetes mellitus Individual has had ≥ 1 episode(s) of orthostatic hypotension not related to medication changes (reduction of systolic blood pressure of ≥20 mmHg or diastolic blood pressure of ≥10 mmHg within 3 minutes of standing), coupled with symptoms, within the past year or during the screening process. Change in systolic blood pressure associated with symptoms of orthostasis Individual requires chronic oxygen support or mechanical ventilation other than nocturnal respiratory support for sleep apnea. The presence of primary pulmonary hypertension The presence of other known secondary forms of hypertension such as pheochromocytoma, Cushing's Disease (adrenal insufficiency), primary hyperaldosteronism, coarctation of the aorta. Individual has experienced a myocardial infarction within 3 months of the screening period, or has experienced unstable angina pectoris, syncope, or a cerebrovascular accident within 3 months of the screening period. Individual has a scheduled or planned surgery within 1 year of study enrollment Inability to complete protocol blood pressure measurements (e.g., arm diameter too large for the cuff). Individual has severe cardiac valve stenosis for which, in the opinion of the investigator, a significant reduction of blood pressure is contraindicated. Subjects on beta blockers and or clonidine Individual has a confounding medical condition, which in the opinion of the investigator, may adversely affect the safety of the participant (e.g., significant peripheral vascular disease, abdominal aortic aneurysm, severe chronic obstructive pulmonary disorder) Significant bleeding diathesis (thrombocytopenia, hemophilia, or significant anemia) Individual is pregnant, nursing or planning to get pregnant within two years of study enrollment. Individual has a known unresolved history of drug use or alcohol dependency, who in the opinion of the Principal Investigator lacks the ability to comprehend or follow instructions, or would be unlikely or unable, in the opinion of the investigator, to comply with study follow-up requirements Individual with a previous solid organ transplant Individual who has had a celiac plexus block or splanchnic nerve block for pain relief Transcutaneous electrical nerve stimulation (TENS), spinal cord stimulation, acupuncture or the use of medical marijuana for pain relief within the past 3 months Hospitalization for non-pain related conditions within the past 3 months Surgical treatment for ADPKD pain relief in the past 24 months (Cyst aspiration, sclerotherapy and cyst fenestration surgery) Individuals with significant kidney stones (> 7-8 mm) on imaging studies Subjects with acute kidney Injury in the past 6 months Subjects with significant renal impairment (defined as glomerular filtration rate < 30 ml/min/1.73m2 determined by chronic kidney disease equation Individual is a participant in another interventional clinical trial Subjects with an additional accessory renal vessel that perfuses more than 25% of the kidney Individuals with terminal illness with expected survival of less than 1 year Current symptoms of cerebral hypoperfusion (e.g. dizziness or lightheadedness, visual blurring or darkening of the visual fields, syncope). Acute coronary syndrome (by standard criteria) within the prior month (established by biomarkers of myocardial anatomy and/or electrocardiogram changes Coronary revascularization procedures within 30 days of screening, or, expected procedures within the next 6 months. Valve surgery within 30 days of screening, or, expected procedures within the next 6 months. Cardiac resynchronization therapy, with or without implantable cardiac defibrillator within 90 days of screening or expected procedures within the next 6 months. Hypertrophic or restrictive cardiomyopathy Constrictive pericarditis Active myocarditis or endocarditis Complex congenital heart disease Severe, advanced heart failure

    12. IPD Sharing Statement

    Plan to Share IPD
    No

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    The Safety and Efficacy of Catheter-based Renal Denervation Using the Vessix™ Renal Denervation System in Autosomal Dominant Polycystic Kidney Disease (ADPKD) Patients With Severe Debilitating Pain

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