Back to resultsRenal Sympathetic Denervation for Reduction of Pain and Improvement of Insulin Sensitivity in Adult Polycystic Kidney Disease
Primary Purpose
Adult Polycystic Kidney Disease
Status
Unknown status
Phase
Not Applicable
Locations
Denmark
Study Type
Interventional
Intervention
renal denervation
Sponsored by
About this trial
This is an interventional treatment trial for Adult Polycystic Kidney Disease focused on measuring ADPKD, denervation, renal denervation
Eligibility Criteria
Inclusion Criteria:
- Pain limiting daily activities in spite of pain killers, ADPKD
Exclusion Criteria:
- Pregnancy
Sites / Locations
- Department of NephrologyRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
immediate renal denervation
delayed renal denervation
Arm Description
immediate renal denervation
delayed renal denervation
Outcomes
Primary Outcome Measures
Pain
Pain from VAS
Secondary Outcome Measures
Quality of Life (QoL)
SF-12v2
Full Information
NCT ID
NCT02062671
First Posted
February 12, 2014
Last Updated
February 13, 2014
Sponsor
Odense University Hospital
1. Study Identification
Unique Protocol Identification Number
NCT02062671
Brief Title
Renal Sympathetic Denervation for Reduction of Pain and Improvement of Insulin Sensitivity in Adult Polycystic Kidney Disease
Study Type
Interventional
2. Study Status
Record Verification Date
February 2014
Overall Recruitment Status
Unknown status
Study Start Date
February 2014 (undefined)
Primary Completion Date
February 2015 (Anticipated)
Study Completion Date
February 2015 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Odense University Hospital
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Adult Polycystic Kidney Disease
Keywords
ADPKD, denervation, renal denervation
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
12 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
immediate renal denervation
Arm Type
Experimental
Arm Description
immediate renal denervation
Arm Title
delayed renal denervation
Arm Type
Active Comparator
Arm Description
delayed renal denervation
Intervention Type
Procedure
Intervention Name(s)
renal denervation
Primary Outcome Measure Information:
Title
Pain
Description
Pain from VAS
Time Frame
6 months
Secondary Outcome Measure Information:
Title
Quality of Life (QoL)
Description
SF-12v2
Time Frame
6 months
Other Pre-specified Outcome Measures:
Title
kidney function
Description
creatinine clearance
Time Frame
6 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Pain limiting daily activities in spite of pain killers, ADPKD
Exclusion Criteria:
Pregnancy
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Hans Dieperink, MD
Phone
+4520598851
Email
hans.dieperink@rsyd.dk
First Name & Middle Initial & Last Name or Official Title & Degree
Marie Blicher, MD
Phone
+ 45 65415305
Email
marie.blicher@rsyd.dk
Facility Information:
Facility Name
Department of Nephrology
City
Odense
ZIP/Postal Code
5000
Country
Denmark
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Hans Dieperink, MD
Phone
004520598851
Email
Hans.dieperink@rsyd.dk
First Name & Middle Initial & Last Name & Degree
Hans Dieperink, MD
12. IPD Sharing Statement
Learn more about this trial
Renal Sympathetic Denervation for Reduction of Pain and Improvement of Insulin Sensitivity in Adult Polycystic Kidney Disease
We'll reach out to this number within 24 hrs