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

NCT02746419 | Withdrawn DMC FDA Device

• 1 other identifier: IRB15-1484
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

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).

Conditions

Autosomal Dominant Polycystic Kidney Disease

Outcome Measures

Primary Outcomes (1)

• 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.

  6 months

Secondary Outcomes (4)

• Change in pain

  12 months

• Change in renal function

  2 weeks

• Change in Quality of life as measured by quality of life questionnaire

  12 months

• Change in Quality of life as measured by depression questionnaire

  12 months

Study Arms (2)

Experimental

EXPERIMENTAL

Subjects will receive renal denervation.

Device: Vessix

Control

SHAM COMPARATOR

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

Device: Vessix

Interventions

Vessix DEVICE

Renal denervation using radio-ablation

Control; Experimental

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Chicago: lead

MeSH Terms

Conditions

Polycystic Kidney, Autosomal Dominant

Condition Hierarchy (Ancestors)

Polycystic Kidney Diseases; Kidney Diseases, Cystic; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Abnormalities, Multiple; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Ciliopathies; Genetic Diseases, Inborn

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 8, 2016
• First Posted: April 21, 2016
• Study Start: December 1, 2016
• Primary Completion: May 1, 2019
• Study Completion: May 1, 2020
• Last Updated: April 3, 2019

Record last verified: 2019-03

Data Sharing

• IPD Sharing: Will not share