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•University of Chicago

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.

Eligibility

Age

18 - 80 years

Sex

ALL

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
+2 more criteria

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
+32 more criteria

Key Dates

Start Date

December 1, 2016

Primary Completion Date

May 1, 2019

Completion Date

May 1, 2020

Last Updated

April 3, 2019

Conditions

Autosomal Dominant Polycystic Kidney Disease

Interventions

Vessix

DEVICE

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Autosomal Dominant Polycystic Kidney Disease (ADPKD)

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RECRUITING

National Registry of Rare Kidney Diseases

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: April 3, 2019Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

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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

Inclusion Criteria

Exclusion Criteria

Metabolic Impacts of Ren-Nu: A Dietary Program for Polycystic Kidney Disease

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