Renal Sympathetic Denervation for Reduction of Pain and I... | NCT02062671

Studies
Renal Sympathetic Denervation for Reduction of Pain and Improvement of Insulin Sensitivity in Adult Polycystic Kidney Disease

NCT02062671

Sponsor

Odense University Hospital

Status

Unknown status

Last Update Posted

Feb 14, 2014Estimated

Enrollment

12Estimated

Phase

Not Applicable

Conditions

Adult Polycystic Kidney Disease

Interventions

renal denervation

Countries

Denmark

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

ID	Type	Description	Link
S-20130085	Registry Identifier	De Videnskabsetiske komitéer for Region Syddanmark

Status Module

Record Verification Date

Feb 2014

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Feb 2014

Primary Completion Date

Feb 2015Estimated

Completion Date

Feb 2015Estimated

First Submitted Date

Feb 12, 2014

First Submission Date that Met QC Criteria

Feb 13, 2014

First Posted Date

Feb 14, 2014Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Feb 13, 2014

Last Update Posted Date

Feb 14, 2014Estimated

Sponsor/Collaborators Module

Responsible Party, by Official Title

Hans Dieperink, Head of Department, MD, Odense University HospitalPrincipal Investigator

Lead Sponsor

Odense University HospitalOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

In patients with polycystic kidney disease, pain may be resistant to drug therapy and may reduce quality of life. This study investigate the effect of renal denervation on this pain.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

12Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
immediate renal denervation	Experimental	immediate renal denervation	Procedure: renal denervation
delayed renal denervation	Active Comparator	delayed renal denervation	Procedure: renal denervation

Interventions

Name	Type	Description	Arm Group Labels	Other Names
renal denervation	Procedure		delayed renal denervation immediate renal denervation

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Pain	Pain from VAS	6 months

Secondary Outcomes

Measure	Description	Time Frame
Quality of Life (QoL)	SF-12v2	6 months

Other Outcomes

Measure	Description	Time Frame
kidney function	creatinine clearance	6 months

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Pain limiting daily activities in spite of pain killers, ADPKD

Exclusion Criteria:

Pregnancy

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Hans Dieperink, MD	Contact	+4520598851		hans.dieperink@rsyd.dk
Marie Blicher, MD	Contact	+ 45 65415305		marie.blicher@rsyd.dk

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Department of Nephrology	Recruiting	Odense		5000	Denmark

Condition Browse Module

MeSH Terms

ID	Term
D016891	Polycystic Kidney, Autosomal Dominant

Ancestor Terms

ID	Term
D007690	Polycystic Kidney Diseases
D052177	Kidney Diseases, Cystic
D007674	Kidney Diseases
D014570	Urologic Diseases

Browse Leaves

Not provided

Browse Branches

Not provided