Native Kidney Denervation in Patients With End Stage Renal Disease

NCT00551304 | Completed Phase 1 DMC

• 1 other identifier: TP-020 & TP-039
• Study Type: interventional
• Target: N/A
• Locations: 2 countries
• Sites: 2

Brief Summary

To investigate the utility of renal denervation in the treatment of patients with End Stage Renal Disease (ESRD).

Conditions

End Stage Renal Disease

Outcome Measures

Primary Outcomes (1)

• To provide confirmation that renal denervation in ESRD patients is safe and feasible.

Secondary Outcomes (1)

• To provide evidence of denervation, indication of physiologic response, and assess device performance.

Interventions

Ardian Catheter DEVICE

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Medtronic Vascular: lead

Study Sites (2)

The Alfred Hospital

Melbourne, Victoria, 3004, Australia

Location

John Paull II Hosptial

Krakow, Poland

Location

Related Publications (3)

• Schlaich MP, Hering D, Sobotka PA, Krum H, Esler MD. Renal denervation in human hypertension: mechanisms, current findings, and future prospects. Curr Hypertens Rep. 2012 Jun;14(3):247-53. doi: 10.1007/s11906-012-0264-9.

  PMID: 22457244 DERIVED

• Hering D, Esler MD, Krum H, Mahfoud F, Bohm M, Sobotka PA, Schlaich MP. Recent advances in the treatment of hypertension. Expert Rev Cardiovasc Ther. 2011 Jun;9(6):729-44. doi: 10.1586/erc.11.71.

  PMID: 21714604 DERIVED

• Schlaich MP, Sobotka PA, Krum H, Whitbourn R, Walton A, Esler MD. Renal denervation as a therapeutic approach for hypertension: novel implications for an old concept. Hypertension. 2009 Dec;54(6):1195-201. doi: 10.1161/HYPERTENSIONAHA.109.138610. Epub 2009 Oct 12. No abstract available.

  PMID: 19822798 DERIVED

MeSH Terms

Conditions

Kidney Failure, Chronic

Condition Hierarchy (Ancestors)

Renal Insufficiency, Chronic; Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Markus Schlaich, MD

  The Alfred

  PRINCIPAL INVESTIGATOR

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: October 26, 2007
• First Posted: October 30, 2007
• Study Start: October 1, 2007
• Last Updated: November 6, 2012

Record last verified: 2012-11

Locations

AU (1); PL (1)