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

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified February 2014 by Hans Dieperink, Odense University Hospital.
Recruitment status was:  Recruiting
Sponsor:
ClinicalTrials.gov Identifier:
NCT02062671
First Posted: February 14, 2014
Last Update Posted: February 14, 2014
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Hans Dieperink, Odense University Hospital
  Purpose
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.

Condition Intervention
Adult Polycystic Kidney Disease Procedure: renal denervation

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Treatment

Resource links provided by NLM:


Further study details as provided by Hans Dieperink, Odense University Hospital:

Primary Outcome Measures:
  • Pain [ Time Frame: 6 months ]
    Pain from VAS


Secondary Outcome Measures:
  • Quality of Life (QoL) [ Time Frame: 6 months ]
    SF-12v2


Other Outcome Measures:
  • kidney function [ Time Frame: 6 months ]
    creatinine clearance


Estimated Enrollment: 12
Study Start Date: February 2014
Estimated Study Completion Date: February 2015
Estimated Primary Completion Date: February 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: immediate renal denervation
immediate renal denervation
Procedure: renal denervation
Active Comparator: delayed renal denervation
delayed renal denervation
Procedure: renal denervation

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Pain limiting daily activities in spite of pain killers, ADPKD

Exclusion Criteria:

  • Pregnancy
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02062671


Contacts
Contact: Hans Dieperink, MD +4520598851 hans.dieperink@rsyd.dk
Contact: Marie Blicher, MD + 45 65415305 marie.blicher@rsyd.dk

Locations
Denmark
Department of Nephrology Recruiting
Odense, Denmark, 5000
Contact: Hans Dieperink, MD    004520598851    Hans.dieperink@rsyd.dk   
Principal Investigator: Hans Dieperink, MD         
Sponsors and Collaborators
Odense University Hospital
  More Information

Responsible Party: Hans Dieperink, Head of Department, MD, Odense University Hospital
ClinicalTrials.gov Identifier: NCT02062671     History of Changes
Other Study ID Numbers: RePKID
S-20130085 ( Registry Identifier: De Videnskabsetiske komitéer for Region Syddanmark )
First Submitted: February 12, 2014
First Posted: February 14, 2014
Last Update Posted: February 14, 2014
Last Verified: February 2014

Keywords provided by Hans Dieperink, Odense University Hospital:
ADPKD
denervation
renal denervation

Additional relevant MeSH terms:
Kidney Diseases
Polycystic Kidney Diseases
Polycystic Kidney, Autosomal Dominant
Urologic Diseases
Kidney Diseases, Cystic
Abnormalities, Multiple
Congenital Abnormalities
Genetic Diseases, Inborn