Ignite Creation Date:
2025-12-24 @ 11:30 PM
Ignite Modification Date:
2026-02-25 @ 4:17 AM
Study NCT ID:
NCT01899456
Status:
COMPLETED
Last Update Posted:
2015-11-05
First Post:
2013-07-10
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Impact of Sympathetic Renal Denervation- a Study in Patients After Renal Transplantation
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006973', 'term': 'Hypertension'}, {'id': 'D051436', 'term': 'Renal Insufficiency, Chronic'}], 'ancestors': [{'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D051437', 'term': 'Renal Insufficiency'}, {'id': 'D007674', 'term': 'Kidney Diseases'}, {'id': 'D014570', 'term': 'Urologic Diseases'}, {'id': 'D052776', 'term': 'Female Urogenital Diseases'}, {'id': 'D005261', 'term': 'Female Urogenital Diseases and Pregnancy Complications'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D052801', 'term': 'Male Urogenital Diseases'}, {'id': 'D002908', 'term': 'Chronic Disease'}, {'id': 'D020969', 'term': 'Disease Attributes'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 18}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2013-07'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-11', 'completionDateStruct': {'date': '2015-11', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2015-11-03', 'studyFirstSubmitDate': '2013-07-10', 'studyFirstSubmitQcDate': '2013-07-12', 'lastUpdatePostDateStruct': {'date': '2015-11-05', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2013-07-15', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2015-03', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Safety and efficacy of renal denervation in patients after renal transplantation', 'timeFrame': 'Baseline to 6 months', 'description': '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.'}], 'secondaryOutcomes': [{'measure': 'Effect of renal denervation in patients after renal transplantation on different organ systems.', 'timeFrame': 'Baseline to 6 month', 'description': '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).'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Hypertension', 'Chronic Kidney Disease', 'Renal Transplantation', 'Sympathetic Activity']}, 'referencesModule': {'references': [{'pmid': '26333545', 'type': 'RESULT', 'citation': '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.'}]}, 'descriptionModule': {'briefSummary': '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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '85 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patient after renal transplantation (\\> 6 month) without resection of native kidneys\n* systolic blood pressure \\>=150 mmHg\n* on 3 or more antihypertensive medications\n* Individual is 18 years of age\n* Individual agrees to have all procedures performed, and is competent and willing to provide written, informed consent to participate in the registry.\n\nExclusion Criteria:\n\n* secondary causes and a white coat hypertension\n* renal artery abnormalities\n* eGFR \\< 30mL/min (MDRD)\n* angina\n* severe Aortic valve stenosis\n* Individual is pregnant, nursing or planning to be pregnant\n* other'}, 'identificationModule': {'nctId': 'NCT01899456', 'acronym': 'ISAR-denerve', 'briefTitle': 'Impact of Sympathetic Renal Denervation- a Study in Patients After Renal Transplantation', 'organization': {'class': 'OTHER', 'fullName': 'Technical University of Munich'}, 'officialTitle': 'A Randomized Safety and Efficacy Study Investigating the Effects of Catheter-based Renal Denervation in Patients After Renal Transplantation', 'orgStudyIdInfo': {'id': '5548/12'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'NO_INTERVENTION', 'label': 'Medical therapy', 'description': 'Best medical therapy using guideline recommended drugs in each disease state.'}, {'type': 'EXPERIMENTAL', 'label': 'Catheter-based renal denervation', 'description': 'Renal denervation will be performed in the native renal arteries of patients after renal transplantation. Access side is the contralateral femoral artery.', 'interventionNames': ['Device: Catheter-based renal denervation']}], 'interventions': [{'name': 'Catheter-based renal denervation', 'type': 'DEVICE', 'otherNames': ['Renal denervation with Symplicity Catheter Medtronic/Ardian'], 'armGroupLabels': ['Catheter-based renal denervation']}]}, 'contactsLocationsModule': {'locations': [{'zip': '81675', 'city': 'Munich', 'country': 'Germany', 'facility': '1. Medizinische Klinik und Poliklinik, Klinikum rechts der Isar, Technische Universität München', 'geoPoint': {'lat': 48.13743, 'lon': 11.57549}}], 'overallOfficials': [{'name': 'Simon Schneider, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': '1. Medizinische Klinik und Poliklinik, Klinikum rechts der Isar, Technische Unversität München'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Technical University of Munich', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Simon Schneider, MD; 1.Medizinische Klinik und Poliklinik, Klinikum rechts der Isar', 'investigatorFullName': 'Simon Schneider', 'investigatorAffiliation': 'Technical University of Munich'}}}}