Trial Review

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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/NCT00551304




Registration number
NCT00551304
Ethics application status
Date submitted
26/10/2007
Date registered
30/10/2007
Date last updated
6/11/2012

Titles & IDs
Public title
Native Kidney Denervation in Patients With End Stage Renal Disease
Scientific title
Native Kidney Denervation in Patients With End Stage Renal Disease
Secondary ID [1] 0 0
TP-020 & TP-039
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
End Stage Renal Disease 0 0
Condition category
Condition code
Renal and Urogenital 0 0 0 0
Kidney disease

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Devices - Ardian Catheter

Treatment: Devices: Ardian Catheter
Intervention code [1] 0 0
Treatment: Devices
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
To provide confirmation that renal denervation in ESRD patients is safe and feasible.
Timepoint [1] 0 0
Secondary outcome [1] 0 0
To provide evidence of denervation, indication of physiologic response, and assess device performance.
Timepoint [1] 0 0

Eligibility
Key inclusion criteria
- adult >= 18 years of age

- end stage renal disease, undergoing concurrent dialysis treatment

- poorly controlled blood pressure on at least 2 antihypertensive drugs

- agrees to have the study procedure(s) performed and additional procedures and
evaluations, including interventions and follow up visits

- competent and willing to provide written, informed consent to participate in this
clinical study.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
- renal arterial abnormalities

- myocardial infarction, unstable angina pectoris, or a cerebrovascular accident within
six (6) months

- hemodynamically significant valvular heart disease

- implantable cardioverter defibrillator (ICD) or pacemaker

- respiratory support.

- pregnant, nursing or planning to be pregnant

- other

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Phase 1
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/10/2007
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 0 0
The Alfred Hospital - Melbourne
Recruitment postcode(s) [1] 0 0
3004 - Melbourne
Recruitment outside Australia
Country [1] 0 0
Poland
State/province [1] 0 0
Cracow

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
Medtronic Vascular
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
To investigate the utility of renal denervation in the treatment of patients with End Stage
Renal Disease (ESRD).
Trial website
https://clinicaltrials.gov/ct2/show/NCT00551304
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Markus Schlaich, MD
Address 0 0
The Alfred
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/ct2/show/NCT00551304