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Withdrawn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
About this trial
This is an interventional treatment trial for Autosomal Dominant Polycystic Kidney Disease
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
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
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
Learn more about this trial
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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