Ignite Creation Date:
2025-12-25 @ 2:15 AM
Ignite Modification Date:
2026-01-03 @ 1:14 AM
Study NCT ID:
NCT01418560
Status:
UNKNOWN
Last Update Posted:
2019-03-19
First Post:
2011-08-15
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Renal Sympathetic Modification in Patients With Chronic Renal Failure
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': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 200}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2011-08', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-03', 'completionDateStruct': {'date': '2020-06', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2019-03-18', 'studyFirstSubmitDate': '2011-08-15', 'studyFirstSubmitQcDate': '2011-08-16', 'lastUpdatePostDateStruct': {'date': '2019-03-19', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2011-08-17', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2019-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'the incident of uremia and dialysis requirement', 'timeFrame': 'three years'}], 'secondaryOutcomes': [{'measure': 'serum creatinine increases into multiples in 1 month follow-up', 'timeFrame': 'three years'}, {'measure': 'effect of urine microalbumin, urine microalbumin/creatinine, serum creatinine, or 24 hrs urine protein value', 'timeFrame': 'three years'}, {'measure': 'incidence of composite cardiovascular events', 'timeFrame': 'three years'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['renal artery', 'sympathetic nerves', 'modification', 'chronic renal failure'], 'conditions': ['Chronic Renal Failure']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to observe the incident of uremia and dialysis requirement after renal sympathetic modification using THERMOCOOL® catheter in patients with chronic renal failure, and evaluate safety and efficacy of the intervention.', 'detailedDescription': 'Chronic renal failure is serial clinical manifestations because of kidney damage. Previous studies found sympathetic nerves over activity in chronic renal failure patients. Traditional therapies included medications and dialysis replacement therapy need to spend much money. Renal ablation for sympathetic modification is a new method which is proved to be effective in decreasing sympathetic nerves activity. We assume that modifying renal sympathetic activity by ablation is effective and safe in treatment of chronic renal failure. This trial is going to recruit 200 patients (Ablation group VS Control group = 1:1) with a follow-up duration of 3 years. Patients in ablation group will receive additional necessary medications besides expectant intervention, and patients in control group will receive appropriate medications only. We aim to observe the effect of serum creatinine, creatinine clearance rate, glomerular filtration rate, urine microalbumin, urine microalbumin/creatinine, and composite cardio cerebrovascular events after renal sympathetic modification using THERMOCOOL® catheter, and evaluate safety and efficacy of the intervention.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* ≥ 18 years old, and ≤ 75 years old of age\n* at least three months history of definite kidney damage\n* renal function of serum creatinine of \\< 354umol/L, and/or creatinine clearance rate of ≥ 30ml/min, and/or estimated glomerular filtration rate of ≥ 45ml/min for recent 2-3 times evaluation. Besides, the value of creatinine clearance rate fluctuated no more than 30% in recent three months, and 15% in the following two weeks.\n* urine microalbumin, and/or urine microalbumin/creatinine is abnormal, and/or quantity of 24 hrs urine protein suggests kidney damage.\n* is competent and willing to provide written, informed consent to participate in this clinical study\n\nExclusion Criteria:\n\n* congenital renal diseases cause to chronic renal damage\n* estimated glomerular filtration rate (eGFR) of \\< 45mL/min\n* taking medicine of glucocorticosteroids, non-steroid anti-inflammatory drugs (NSAIDs), or cytotoxic drugs at present\n* value of 24 hrs urine protein is of \\> 10g at least once in recent three months, or serum albumin of \\< 25g/L\n* has the history of renal restenosis or renal stents implantation\n* has experienced AMI (old myocardial infarction is not excluded), unstable angina pectoris, cerebrovascular accidents, and alimentary tract hemorrhage within 3 months\n* carcinoma patients\n* patients with sick sinus syndrome\n* pregnant women\n* mental disorders\n* patients that have allergy to contrast agent\n* patients that do not go with follow-up\n* others such as researcher considers it is not appropriate to be included into the study'}, 'identificationModule': {'nctId': 'NCT01418560', 'briefTitle': 'Renal Sympathetic Modification in Patients With Chronic Renal Failure', 'organization': {'class': 'OTHER', 'fullName': 'The Second Affiliated Hospital of Chongqing Medical University'}, 'officialTitle': 'Renal Sympathetic Modification in Patients With Chronic Renal Failure', 'orgStudyIdInfo': {'id': 'SWAN-RF'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'renal sympathetic modification', 'description': 'Renal artery ablation to modify sympathetic activity in patients with chronic renal failure.', 'interventionNames': ['Procedure: renal sympathetic modification']}, {'type': 'NO_INTERVENTION', 'label': 'Absolute medicine therapy', 'description': 'Maintenance of anti-renal failure medications only'}], 'interventions': [{'name': 'renal sympathetic modification', 'type': 'PROCEDURE', 'otherNames': ['renal denervation'], 'description': 'Device: THERMOCOOL® Catheter Renal sympathetic modification with a catheter-based procedure', 'armGroupLabels': ['renal sympathetic modification']}]}, 'contactsLocationsModule': {'locations': [{'zip': '400010', 'city': 'Chongqing', 'state': 'Chongqing Municipality', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Yuehui Yin, MD', 'role': 'CONTACT', 'email': 'yinyh63@163.com', 'phone': '0086-23-63693766'}, {'name': 'Yuehui Yin, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': '2ndChongqingMU', 'geoPoint': {'lat': 29.56026, 'lon': 106.55771}}], 'centralContacts': [{'name': 'Yuehui Yin, MD', 'role': 'CONTACT', 'email': 'yinyh63@163.com', 'phone': '0086-13508335502'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'The Second Affiliated Hospital of Chongqing Medical University', 'class': 'OTHER'}, 'collaborators': [{'name': "Jiangsu Provincial People's Hospital", 'class': 'OTHER'}, {'name': 'Chongqing Medical University', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Director and Professor, Dept. of Cardiology, the second affiliated hospital of Chongqing Medical University, Chongqing Cardiac arrhythmias service center', 'investigatorFullName': 'Yuehui Yin', 'investigatorAffiliation': 'The Second Affiliated Hospital of Chongqing Medical University'}}}}