End Stage Renal DiseasePhase 1NCT00551304
Native Kidney Denervation in Patients With End Stage Renal Disease
A Phase 1 study testing Ardian Catheter in people with End Stage Renal Disease, run by Medtronic Vascular at 2 sites in 2 countries.
Trial summary
To investigate the utility of renal denervation in the treatment of patients with End Stage Renal Disease (ESRD). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- End Stage Renal Disease
- What is being tested?
- Ardian Catheter
- Type of treatment
- Medical device
- How many people
- Not given
- Where
- 2 sitesin 2 countries
- Study dates
- Oct 2007to not given
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
2 sites in 2 countries.
2 sites in 2 countries
About this study
To investigate the utility of renal denervation in the treatment of patients with End Stage Renal Disease (ESRD).
- Conditions
- End Stage Renal Disease
- Being tested
- Ardian Catheter
- Medical subject headings
- Kidney Failure, Chronic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ardian CatheterDevice
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Oct 2007 (estimated)
- Study startOct 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for End Stage Renal DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
Sponsor and investigators
- Lead sponsor
- Medtronic Vascular
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Markus Schlaich, MD, Principal investigator, The Alfred
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00551304
- Sponsor's protocol ID
- TP-020 & TP-039
- Status last verified
- Nov 2012
- First submitted
- 26 Oct 2007
- Last updated
- 6 Nov 2012
- Results posted
- No
- Data monitoring committee
- Yes
Publications
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.
PubMed 22457244Hering 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.
PubMed 21714604Schlaich 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.
PubMed 19822798
Study at a glance
From the registry record, last updated by the sponsor on 6 Nov 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Native Kidney Denervation in Patients With End Stage Renal Disease
- ClinicalTrials.gov ID
- NCT00551304
- Acronym / sponsor ID
- TP-020 & TP-039
- Conditions
- End Stage Renal Disease
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Lead sponsor
- Medtronic VascularIndustry (pharma, biotech, devices)
- Study start
- Oct 2007
- First posted
- 30 Oct 2007 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
To investigate the utility of renal denervation in the treatment of patients with End Stage Renal Disease (ESRD).
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (7 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Ardian Catheter | Device | – |
Primary outcome
To provide confirmation that renal denervation in ESRD patients is safe and feasible.
1 secondary outcome
To provide evidence of denervation, indication of physiologic response, and assess device performance.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Nov 2012.
- Derived from this study: PubMed 22457244Schlaich 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.
- Derived from this study: PubMed 21714604Hering 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.
- Derived from this study: PubMed 19822798Schlaich 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Markus Schlaich, MD principal investigator
The Alfred
2 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Ardian Catheter in people with End Stage Renal Disease, run by Medtronic Vascular at 2 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Nov 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Australia, Poland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To provide confirmation that renal denervation in ESRD patients is safe and feasible.. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00551304, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Nov 2012.