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

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ClinicalTrials.gov Identifier: NCT02062671
Recruitment Status : Unknown
Verified February 2014 by Hans Dieperink, Odense University Hospital.
Recruitment status was:  Recruiting
First Posted : February 14, 2014
Last Update Posted : February 14, 2014
Sponsor:
Information provided by (Responsible Party):

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.

Condition or disease Intervention/treatment
Adult Polycystic Kidney Disease Procedure: renal denervation

Study Design

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 12 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Study Start Date : February 2014
Estimated Primary Completion Date : February 2015
Estimated Study Completion Date : February 2015

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Kidney Diseases
U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
Experimental: immediate renal denervation
immediate renal denervation
Procedure: renal denervation
Active Comparator: delayed renal denervation
delayed renal denervation
Procedure: renal denervation


Outcome Measures

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


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


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


Eligibility Criteria

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 Posted: February 14, 2014    Key Record Dates
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