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Renal Denervation with a catheter-based procedure

Phase 1

Kidney Failure, Chronic | Unknown | Nephrology |Medtronic plc.|Last Updated: Nov 6, 2012

Success Probability

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Market & Valuation

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Trial Design

UNCONTROLLEDDMC
Total Trials1
Total Enrollment20

FDA Designations

No designations recorded

Clinical trial landscape

Renal Denervation with a catheter-based procedure · 1 trial · 2 indications

Phase 1 1
NCT00753116Renal Denervation in End Stage Renal Disease Patients With Refractory HypertensionKidney Failure, Chronic
COMPLETED20 Analytics
PHASE1COMPLETED
Renal Denervation in End Stage Renal Disease Patients With Refractory Hypertension
Kidney Failure, ChronicUnlock trial analytics

Study Endpoints

Primary Endpoints

Safety - complications associated with delivery and/or use of the Ardian Catheter, adverse renal events, electrolyte disturbances, hemodynamic events.
Through 1 year

Secondary Endpoints

Physiologic response to denervation (e.g., blood pressure reduction)
Through 1 year
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Study Design & Arms

AllocationNON_RANDOMIZED
MaskingNONE
ModelSINGLE_GROUP
PurposeTREATMENT

Interventions

NameTypeDescription
Renal Denervation with a catheter-based procedureDEVICEDisruption of the renal nerves with a catheter-based procedure
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Eligibility Criteria

Age Range18 Years to N/A
SexALL
Healthy VolunteersNo
Study Sites1

Inclusion Criteria: * Systolic blood pressure of 160 mmHg or greater * On 3 or more antihypertensive medications * On dialysis for more than 6 months Exclusion Criteria: * Renal artery abnormalities * Known secondary hypertension attributable to a cause other than sleep apnea * MI, angina, CVA wi...

Countries:United States
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Frequently asked questions about Renal Denervation with a catheter-based procedure

What is Renal Denervation with a catheter-based procedure used for?

Renal Denervation with a catheter-based procedure is used for chronic kidney failure, specifically in patients with end stage renal disease who also have refractory hypertension. The procedure is being studied as a potential treatment for this patient population.

Who makes Renal Denervation with a catheter-based procedure?

Renal Denervation with a catheter-based procedure is being developed by Medtronic plc, a medical technology company traded on the New York Stock Exchange under the ticker symbol MDT.

What phase is Renal Denervation with a catheter-based procedure in?

Renal Denervation with a catheter-based procedure is in Phase 1 clinical development. It is an investigational procedure and has not been approved by the FDA. One Phase 1 trial has been completed.

What clinical trials is Renal Denervation with a catheter-based procedure in?

Renal Denervation with a catheter-based procedure has one completed clinical trial, identified as NCT00753116. This trial was titled 'Renal Denervation in End Stage Renal Disease Patients With Refractory Hypertension' and enrolled 20 participants in the United States.

Is Renal Denervation with a catheter-based procedure the same as renal denervation?

Renal Denervation with a catheter-based procedure is a specific form of renal denervation, a technique that uses a catheter to disrupt renal nerves. The trial NCT00753116 studied this procedure in patients with chronic kidney failure and refractory hypertension.