Ignite Creation Date:
2025-12-24 @ 7:51 PM
Ignite Modification Date:
2026-01-04 @ 8:37 AM
Study NCT ID:
NCT00551304
Status:
COMPLETED
Last Update Posted:
2012-11-06
First Post:
2007-10-26
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Native Kidney Denervation in Patients With End Stage Renal Disease
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D007676', 'term': 'Kidney Failure, Chronic'}], 'ancestors': [{'id': 'D051436', 'term': 'Renal Insufficiency, Chronic'}, {'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': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2007-10'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2012-11', 'lastUpdateSubmitDate': '2012-11-02', 'studyFirstSubmitDate': '2007-10-26', 'studyFirstSubmitQcDate': '2007-10-26', 'lastUpdatePostDateStruct': {'date': '2012-11-06', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2007-10-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'To provide confirmation that renal denervation in ESRD patients is safe and feasible.'}], 'secondaryOutcomes': [{'measure': 'To provide evidence of denervation, indication of physiologic response, and assess device performance.'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'conditions': ['End Stage Renal Disease']}, 'referencesModule': {'references': [{'pmid': '22457244', 'type': 'DERIVED', 'citation': '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': '21714604', 'type': 'DERIVED', 'citation': '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': '19822798', 'type': 'DERIVED', 'citation': '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.'}]}, 'descriptionModule': {'briefSummary': 'To investigate the utility of renal denervation in the treatment of patients with End Stage Renal Disease (ESRD).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* adult \\>= 18 years of age\n* end stage renal disease, undergoing concurrent dialysis treatment\n* poorly controlled blood pressure on at least 2 antihypertensive drugs\n* agrees to have the study procedure(s) performed and additional procedures and evaluations, including interventions and follow up visits\n* competent and willing to provide written, informed consent to participate in this clinical study.\n\nExclusion Criteria:\n\n* renal arterial abnormalities\n* myocardial infarction, unstable angina pectoris, or a cerebrovascular accident within six (6) months\n* hemodynamically significant valvular heart disease\n* implantable cardioverter defibrillator (ICD) or pacemaker\n* respiratory support.\n* pregnant, nursing or planning to be pregnant\n* other'}, 'identificationModule': {'nctId': 'NCT00551304', 'briefTitle': 'Native Kidney Denervation in Patients With End Stage Renal Disease', 'organization': {'class': 'INDUSTRY', 'fullName': 'Medtronic Vascular'}, 'officialTitle': 'Native Kidney Denervation in Patients With End Stage Renal Disease', 'orgStudyIdInfo': {'id': 'TP-020 & TP-039'}}, 'armsInterventionsModule': {'interventions': [{'name': 'Ardian Catheter', 'type': 'DEVICE'}]}, 'contactsLocationsModule': {'locations': [{'zip': '3004', 'city': 'Melbourne', 'state': 'Victoria', 'country': 'Australia', 'facility': 'The Alfred Hospital', 'geoPoint': {'lat': -37.814, 'lon': 144.96332}}, {'city': 'Krakow', 'country': 'Poland', 'facility': 'John Paull II Hosptial', 'geoPoint': {'lat': 50.06143, 'lon': 19.93658}}], 'overallOfficials': [{'name': 'Markus Schlaich, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'The Alfred'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Medtronic Vascular', 'class': 'INDUSTRY'}}}}