Ignite Creation Date:
2025-12-24 @ 3:23 PM
Ignite Modification Date:
2025-12-25 @ 7:40 PM
Study NCT ID:
NCT00892892
Status:
WITHDRAWN
Last Update Posted:
2015-03-17
First Post:
2009-05-01
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Sympathetic Nerve Activity in Renal Failure
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D051436', 'term': 'Renal Insufficiency, Chronic'}, {'id': 'D006973', 'term': 'Hypertension'}], 'ancestors': [{'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'}, {'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000077769', 'term': 'Rilmenidine'}, {'id': 'D009568', 'term': 'Nitrendipine'}], 'ancestors': [{'id': 'D010080', 'term': 'Oxazoles'}, {'id': 'D001393', 'term': 'Azoles'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D004095', 'term': 'Dihydropyridines'}, {'id': 'D011725', 'term': 'Pyridines'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 0}}, 'statusModule': {'overallStatus': 'WITHDRAWN', 'startDateStruct': {'date': '2009-11'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-03', 'completionDateStruct': {'date': '2011-06', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2015-03-16', 'studyFirstSubmitDate': '2009-05-01', 'studyFirstSubmitQcDate': '2009-05-01', 'lastUpdatePostDateStruct': {'date': '2015-03-17', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2009-05-05', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2011-06', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'sympathetic activation for the development and progression of chronic renal failure', 'timeFrame': '3 months'}], 'secondaryOutcomes': [{'measure': 'effects of a sympatholytic agent on cardiovascular reactivity to various stressors', 'timeFrame': '3 months'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['sympatholytic treatment', 'sympathetic nerve activity'], 'conditions': ['Chronic Kidney Disease', 'Hypertension']}, 'descriptionModule': {'briefSummary': 'The primary purpose is to assess the role of sympathetic activation for the development and progression of chronic renal failure. Using microneurography sympathetic activity will be registered in various stages of kidney affection or failure and hypertension.\n\nA sympatholytic agent will be compared with a non-sympatholytic drug to asses the effect sympathetic activation and on the progression of kidney disease.\n\nThe effects of a sympatholytic agent on cardiovascular reactivity to various stressors wil be examined.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* chronic renal failure stages I-IV\n\nExclusion Criteria:\n\n* pregnancy and lactation\n* severe heart failure or ischemic heart disease\n* patients with NYHA III-IV'}, 'identificationModule': {'nctId': 'NCT00892892', 'acronym': 'SNS in CRF', 'briefTitle': 'Sympathetic Nerve Activity in Renal Failure', 'organization': {'class': 'OTHER', 'fullName': 'University of Erlangen-Nürnberg Medical School'}, 'officialTitle': 'Role of the Sympathetic Nerve System for the Pathogenesis and Progression of Chronic Kidney Failure', 'orgStudyIdInfo': {'id': 'Re-No. 3186'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Arm 1', 'description': 'Rilmenidine as a sympatholytic agent for three months', 'interventionNames': ['Drug: Rilmenidine']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Arm 2', 'description': 'Nitrendipine as a non-sympatholytic agent for three months', 'interventionNames': ['Drug: Nitrendipine']}], 'interventions': [{'name': 'Rilmenidine', 'type': 'DRUG', 'otherNames': ['Hyperium'], 'description': '1 mg Rilmenidine per day versus', 'armGroupLabels': ['Arm 1']}, {'name': 'Nitrendipine', 'type': 'DRUG', 'otherNames': ['Bayotensin'], 'description': '20 mg Nitrendipine per day', 'armGroupLabels': ['Arm 2']}]}, 'contactsLocationsModule': {'locations': [{'zip': '91054', 'city': 'Erlangen', 'state': 'Bavaria', 'country': 'Germany', 'facility': 'University of Erlangen-Nuremberg, CRC, med. Clinic 4', 'geoPoint': {'lat': 49.59099, 'lon': 11.00783}}], 'overallOfficials': [{'name': 'Roland E Schmieder, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Erlangen-Nurnberg'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Erlangen-Nürnberg Medical School', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}