NCT00753116

Brief Summary

The purpose of this this study is to investigate the clinical utility of renal denervation in the treatment of ESRD patients with refractory hypertension.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
20

participants targeted

Target at P25-P50 for phase_1

Timeline
Completed

Started Sep 2008

Geographic Reach
1 country

1 active site

Status
completed

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2008

Completed
11 days until next milestone

First Submitted

Initial submission to the registry

September 12, 2008

Completed
4 days until next milestone

First Posted

Study publicly available on registry

September 16, 2008

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2008

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2009

Completed
Last Updated

November 6, 2012

Status Verified

November 1, 2012

Enrollment Period

3 months

First QC Date

September 12, 2008

Last Update Submit

November 2, 2012

Conditions

Kidney Failure, ChronicRenal Dialysis

Outcome Measures

Primary Outcomes (1)

  • Safety - complications associated with delivery and/or use of the Ardian Catheter, adverse renal events, electrolyte disturbances, hemodynamic events.

    Through 1 year

Secondary Outcomes (1)

  • Physiologic response to denervation (e.g., blood pressure reduction)

    Through 1 year

Interventions

Renal Denervation with a catheter-based procedureDEVICE

Disruption of the renal nerves with a catheter-based procedure

Eligibility Criteria

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

You may qualify if:

  • Systolic blood pressure of 160 mmHg or greater
  • On 3 or more antihypertensive medications
  • On dialysis for more than 6 months

You may not qualify if:

  • Renal artery abnormalities
  • Known secondary hypertension attributable to a cause other than sleep apnea
  • MI, angina, CVA within 6 months
  • Others

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hennepin County Medical Center

Minneapolis, Minnesota, 55415, United States

Location

MeSH Terms

Conditions

Kidney Failure, Chronic

Condition Hierarchy (Ancestors)

Renal Insufficiency, ChronicRenal InsufficiencyKidney DiseasesUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

September 12, 2008

First Posted

September 16, 2008

Study Start

September 1, 2008

Primary Completion

December 1, 2008

Study Completion

December 1, 2009

Last Updated

November 6, 2012

Record last verified: 2012-11

Locations

US(1)