Autosomal Dominant Polycystic Kidney DiseaseNCT02746419
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
A study testing Vessix in people with Autosomal Dominant Polycystic Kidney Disease, run by University of Chicago.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Autosomal Dominant Polycystic Kidney Disease
- What is being tested?
- Vessix
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- Dec 2016to May 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
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- 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
Who cannot join
- 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
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- 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
About this study
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).
Read the 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.
- Being tested
- Vessix
- Medical subject headings
- Polycystic Kidney, Autosomal Dominant
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
VessixDevice
Renal denervation using radio-ablation
| Study group | Role | What they receive |
|---|---|---|
| Experimental | Experimental | Subjects will receive renal denervation. Receives: Device: Vessix |
| Control | Sham comparator | Subjects will receive all procedures as experimental group but renal denervation system will not be turned on. Receives: Device: Vessix |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 6 months
Secondary outcomes (4)
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.
Measured: 12 months
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
Measured: 2 weeks
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
Measured: 12 months
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
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Apr 2016 (estimated)
- Study startDec 2016
- Primary completionMay 2019 (estimated)
- Study completionMay 2020 (estimated)
Why it stopped: The company who was sponsoring devices and funding pulled out before we enrolled any subjects.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Autosomal Dominant Polycystic Kidney DiseaseStudies of the same condition, open and under way.
- More trials run by University of ChicagoThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Chicago
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02746419
- Sponsor's protocol ID
- IRB15-1484
- Status last verified
- Mar 2019
- First submitted
- 8 Apr 2016
- Last updated
- 3 Apr 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Apr 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT02746419
- Acronym / sponsor ID
- IRB15-1484
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: The company who was sponsoring devices and funding pulled out before we enrolled any subjects.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- University of ChicagoUniversity, hospital or other
- Study start
- Dec 2016 (actual)
- Primary completion
- May 2019 (estimated)
- Study completion
- May 2020 (estimated)
- First posted
- 21 Apr 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Experimental | Experimental | Device: VessixSubjects will receive renal denervation. |
| Control | Sham comparator | Device: VessixSubjects will receive all procedures as experimental group but renal denervation system will not be turned on. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- 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
Key exclusion criteria (42 listed)
- Individual has renal artery anatomy that is ineligible for treatment including:
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| VessixRenal denervation using radio-ablation | Device | Control, Experimental |
Primary outcome
Number of adverse events
Time frame: 6 months
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.
4 secondary outcomes
Change in pain
Time frame: 12 months
Change in renal function
Time frame: 2 weeks
Change in Quality of life as measured by quality of life questionnaire
Time frame: 12 months
Change in Quality of life as measured by depression questionnaire
Time frame: 12 months
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Apr 2019.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing Vessix in people with Autosomal Dominant Polycystic Kidney Disease, run by University of Chicago.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 12 inclusion and 42 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 3 Apr 2019. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of adverse events (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Apr 2019.