NCT02062671

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
12

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Feb 2014

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2014

Completed
11 days until next milestone

First Submitted

Initial submission to the registry

February 12, 2014

Completed
2 days until next milestone

First Posted

Study publicly available on registry

February 14, 2014

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2015

Completed
Last Updated

February 14, 2014

Status Verified

February 1, 2014

Enrollment Period

1 year

First QC Date

February 12, 2014

Last Update Submit

February 13, 2014

Conditions

Adult Polycystic Kidney Disease

Keywords

ADPKDdenervationrenal denervation

Outcome Measures

Primary Outcomes (1)

  • Pain

    Pain from VAS

    6 months

Secondary Outcomes (1)

  • Quality of Life (QoL)

    6 months

Other Outcomes (1)

  • kidney function

    6 months

Study Arms (2)

immediate renal denervation

EXPERIMENTAL

immediate renal denervation

Procedure: renal denervation

delayed renal denervation

ACTIVE COMPARATOR

delayed renal denervation

Procedure: renal denervation

Interventions

renal denervationPROCEDURE
delayed renal denervationimmediate renal denervation

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • Pregnancy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Nephrology

Odense, 5000, Denmark

RECRUITING

MeSH Terms

Conditions

Polycystic Kidney, Autosomal Dominant

Condition Hierarchy (Ancestors)

Polycystic Kidney DiseasesKidney Diseases, CysticKidney DiseasesUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital DiseasesAbnormalities, MultipleCongenital AbnormalitiesCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesCiliopathiesGenetic Diseases, Inborn

Central Study Contacts

Hans Dieperink, MD

CONTACT

+4520598851hans.dieperink@rsyd.dk

Marie Blicher, MD

CONTACT

+ 45 65415305marie.blicher@rsyd.dk

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Head of Department, MD

Study Record Dates

First Submitted

February 12, 2014

First Posted

February 14, 2014

Study Start

February 1, 2014

Primary Completion

February 1, 2015

Study Completion

February 1, 2015

Last Updated

February 14, 2014

Record last verified: 2014-02

Locations

DK(1)