CompletedNCT01899456ISAR-denerveUpdated Nov 5, 2015

Impact of Sympathetic Renal Denervation- a Study in Patients After Renal Transplantation

An interventional study of Catheter-based renal denervation in Hypertension, Chronic Kidney Disease and Renal Transplantation, sponsored by Technical University of Munich. Completed at 1 site in Germany. Open to participants aged 18 Years to 85 Years. Per ClinicalTrials.gov, last updated 2015-11-05.

Sponsored by Technical University of Munich · Not applicable, Interventional, and Treatment

Phase: Not applicable
Study type: Interventional
Enrollment: 18
Allocation: Randomized
Ages: 18 Years to 85 Years
Sex: All

Study summary

The study is aiming to document the safety and effectiveness of renal denervation in patients after renal transplantation with hypertension. Catheter-based renal denervation will be performed using CE marked, percutaneous Symplicity catheter.

Conditions studied

Hypertension
Chronic Kidney Disease
Renal Transplantation
Sympathetic Activity

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In context

Kidney Diseases

3,840 studies on the registry are indexed under Kidney Diseases; 500 are open to participants now.

This study's enrollment of 18 is below the median of 70 across 2,640 interventional studies indexed under Kidney Diseases.

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Lead sponsor

Technical University of Munich is the lead sponsor of 315 studies on the registry; 55 are open to participants now.

Counted across the registry records on this site, refreshed daily.

Who can participate

Ages eligible: 18 Years to 85 Years
Sexes eligible: All
Accepts healthy volunteers: No

Inclusion criteria

Patient after renal transplantation (> 6 month) without resection of native kidneys
systolic blood pressure >=150 mmHg
on 3 or more antihypertensive medications
Individual is 18 years of age
Individual agrees to have all procedures performed, and is competent and willing to provide written, informed consent to participate in the registry.

Exclusion criteria

Exclusion Criteria:

secondary causes and a white coat hypertension
renal artery abnormalities
eGFR \< 30mL/min (MDRD)
angina
severe Aortic valve stenosis
Individual is pregnant, nursing or planning to be pregnant
other

Study design

Phase: Not applicable
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel assignment
Masking: None (open label)
Enrollment: 18 participants (actual)

Study arms

No intervention
Medical therapy
Best medical therapy using guideline recommended drugs in each disease state.
Experimental
Catheter-based renal denervation
Renal denervation will be performed in the native renal arteries of patients after renal transplantation. Access side is the contralateral femoral artery.
Device: Catheter-based renal denervation

Interventions

DeviceCatheter-based renal denervation
Also known as: Renal denervation with Symplicity Catheter Medtronic/Ardian

What researchers measure

Primary outcomes

Safety and efficacy of renal denervation in patients after renal transplantation
Effect on blood pressure including office, ABPM, and home-based measurements. Number of adverse events. Changes of antihypertensive medications. Effects on renal function assessed with glomerular filtration rate. Renovascular safety (renal artery stenosis) assessed by duplex ultrasound.
Time frame: Baseline to 6 months

Secondary outcomes

Effect of renal denervation in patients after renal transplantation on different organ systems.
Effects on sympathetic activity assessed by heart rate variability and post extrasystolic potentiation. Glucose metabolism and insulin resistance (fasting and during oGTT). Hospitalization rates (eg. hypertensive emergencies, heart failure, etc).
Time frame: Baseline to 6 month

Study locations

1 site

1. Medizinische Klinik und Poliklinik, Klinikum rechts der Isar, Technische Universität München
Munich, 81675, Germany

References and documents

Publications

Schneider S, Promny D, Sinnecker D, Byrne RA, Muller A, Dommasch M, Wildenauer A, Schmidt G, Heemann U, Laugwitz KL, Baumann M. Impact of sympathetic renal denervation: a randomized study in patients after renal transplantation (ISAR-denerve). Nephrol Dial Transplant. 2015 Nov;30(11):1928-36. doi: 10.1093/ndt/gfv311. Epub 2015 Sep 1. PubMed 26333545 ↗

Updates

Tracking since Sep 25, 2026

No changes since tracking began. The registry record was last updated on Nov 5, 2015, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗

Registry details

Key details

Study ID: NCT01899456
Lead sponsor: Technical University of Munich
Responsible party: Simon Schneider (Simon Schneider, MD; 1.Medizinische Klinik und Poliklinik, Klinikum rechts der Isar, Technical University of Munich) — Principal investigator
First posted: Jul 15, 2013
Start date: Jul 2013
Primary completion: Mar 2015
Completion: Nov 2015
Last update: Nov 5, 2015

Study contacts

Simon Schneider, MD

principal investigator · 1. Medizinische Klinik und Poliklinik, Klinikum rechts der Isar, Technische Unversität München

Oversight

Data monitoring committee: No

View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Nov 2015. You cannot join it, but the record below documents what was studied.

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