Trial record 45 of 97 for:    polycystic kidney disease

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

This study is currently recruiting participants. (see Contacts and Locations)
Verified February 2014 by Odense University Hospital
Sponsor:
Information provided by (Responsible Party):
Hans Dieperink, Odense University Hospital
ClinicalTrials.gov Identifier:
NCT02062671
First received: February 12, 2014
Last updated: February 13, 2014
Last verified: February 2014
  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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Treatment

Resource links provided by NLM:


Further study details as provided by Odense University Hospital:

Primary Outcome Measures:
  • Pain [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    Pain from VAS


Secondary Outcome Measures:
  • Quality of Life (QoL) [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    SF-12v2


Other Outcome Measures:
  • kidney function [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]
    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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • Pregnancy
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

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
Study First Received: February 12, 2014
Last Updated: February 13, 2014
Health Authority: Denmark: The Ethics Comitee for Southern Denmark

Keywords provided by Odense University Hospital:
ADPKD
denervation
renal denervation

Additional relevant MeSH terms:
Kidney Diseases
Multicystic Dysplastic Kidney
Polycystic Kidney Diseases
Polycystic Kidney, Autosomal Dominant
Congenital Abnormalities
Kidney Diseases, Cystic
Urogenital Abnormalities
Urologic Diseases

ClinicalTrials.gov processed this record on October 23, 2014