Ignite Creation Date:
2025-12-24 @ 11:48 PM
Ignite Modification Date:
2025-12-25 @ 9:42 PM
Study NCT ID:
NCT04398251
Status:
UNKNOWN
Last Update Posted:
2020-05-21
First Post:
2020-05-07
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
A Randomized Clinical Trail of The Effect of Postoperative Uric Acid Control on Stone Recurrence and Renal Function in Patients With Hyperuricemia of Urolithiasis.
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'C537757', 'term': 'Renal hypouricemia'}, {'id': 'D052878', 'term': 'Urolithiasis'}], 'ancestors': [{'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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000069465', 'term': 'Febuxostat'}], 'ancestors': [{'id': 'D013844', 'term': 'Thiazoles'}, {'id': 'D013457', 'term': 'Sulfur Compounds'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D001393', 'term': 'Azoles'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE', 'maskingDescription': 'Make a random table, and the patients are divided into the group according to the random table according to the order of enrollment.'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL', 'interventionModelDescription': '2020.1 -2020.12 patients with urolithiasis and hyperuricemia were enrolled in the urology department of our hospital (100 cases). The patients were informed of this study before operation and randomly divided into uric acid drug control group (n = 50) and non-drug control group (n = 50).\n\nFor non-drug control group: Patients are advised to live regularly after operation, drink plenty of water, drink more than 2000ml every day, reduce the intake of high purine food and fructose-rich beverages, increase the intake of fresh vegetables, control weight and exercise regularly.\n\nUric acid drug control group:or the uric acid control group, except that lifestyle changes were the same as those in the uric acid non-drug control group, non-drug uric acid control group was given febuxostat to reduce uric acid synthesis. Febuxostat is taken at a dose of 20 mg three times a week'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 100}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'ENROLLING_BY_INVITATION', 'startDateStruct': {'date': '2020-04-10', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-05', 'completionDateStruct': {'date': '2022-05-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2020-05-19', 'studyFirstSubmitDate': '2020-05-07', 'studyFirstSubmitQcDate': '2020-05-19', 'lastUpdatePostDateStruct': {'date': '2020-05-21', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-05-21', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-03-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Serum uric acid level', 'timeFrame': 'Chage from the base line at 3 months after the operation', 'description': 'Serum uric acid level'}, {'measure': 'Serum uric acid level', 'timeFrame': 'Chage from the base line at 6 months after the operation', 'description': 'Serum uric acid level'}, {'measure': 'Serum uric acid level', 'timeFrame': 'Chage from the base line at 12 months after the operation', 'description': 'Serum uric acid level'}, {'measure': 'Serum uric acid level', 'timeFrame': 'Chage from the base line at 18 months after the operation', 'description': 'Serum uric acid level'}], 'primaryOutcomes': [{'measure': 'Stone burdern stone burdern', 'timeFrame': "Change from the base line of the stone's volume and quantity at 3 months.", 'description': 'Use ultrasound or kub or CT plain scan to follow up the patients.'}, {'measure': 'Stone burdern stone burdern', 'timeFrame': "Change from the base line of the stone's volume and quantity at 6 months.", 'description': 'Use ultrasound or kub or CT plain scan to follow up the patients.'}, {'measure': 'Stone burdern stone burdern', 'timeFrame': "Change from the base line of the stone's volume and quantity at 12 months.", 'description': 'Use ultrasound or kub or CT plain scan to follow up the patients.'}, {'measure': 'Stone burdern stone burdern', 'timeFrame': "Change from the base line of the stone's volume and quantity at 18 months.", 'description': 'Use ultrasound or kub or CT plain scan to follow up the patients.'}], 'secondaryOutcomes': [{'measure': 'Renal function', 'timeFrame': 'Change from the base line of GFR at 6 months after the operation.', 'description': 'Total and partial renal function'}, {'measure': 'Renal function', 'timeFrame': 'Change from the base line of GFR at 12 months after the operation.', 'description': 'Total and partial renal function'}, {'measure': 'Renal function', 'timeFrame': 'Change from the base line of GFR at 18 months after the operation.', 'description': 'Total and partial renal function'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Stone prevention', 'Renal function', 'Febuxostat'], 'conditions': ['Hypouricemia, Renal', 'Urolithiasis']}, 'descriptionModule': {'briefSummary': 'The purpose of this study was to explore the effects of uric acid control on stone recurrence and renal function in patients with calculi of hyperuricemia through a prospective controlled study.', 'detailedDescription': '2020.1 -2020.12 patients with urolithiasis and hyperuricemia were enrolled in the urology department of our hospital (100 cases). The patients were informed of this study before operation and randomly divided into uric acid drug control group (n = 50) and non-drug control group (n = 50). The patients were followed up for 3 months, 6 months, 12 months and 18 months after operation.\n\nInformations as age, sex, height, weight, calculation BMI, past medical history, history of gout, diabetes, hyperthyroidism, calcium supplements will be recorded.\n\nRapid blood glucose, serum total cholesterol, high density cholesterol, thyroid hormone detection, androgen, estrogen detection, serum sodium, potassium, chlorine, calcium, magnesium, phosphorus, serum uric acid will be tested.\n\nRenogram test to evaluate the change of single renal function. The stones burden will be followed-up with ultrasound or kub or CT plain scan.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* .Over 18 years old, under 70 years old, regardless of sex .The subjects had no mental illness or language dysfunction, could understand the situation of this study and had signed an informed consent form.\n\n.No clinical manifestations of urinary tract infection, urinary routine examination showed urinary tract infection, but urinary etiology test was negative (urinary routine leukocytosis), treated with broad-spectrum antibiotics for more than 3 days.\n\n.Clinical manifestations of urinary tract infection, urine routine examination showed urinary tract infection, and patients with positive urinary etiology were treated with sensitive antibiotics for more than 7 days.\n\n* Serum uric acid value ≥480 µmol / L\n* urinary stones\n\nExclusion Criteria:\n\n* Transplanted kidney\n* Fever or urinary tract infection is not treated according to the inclusion criteria\n* Pregnant women and female menstruation\n* Unable to tolerate anesthesia or surgery due to severe systemic disease, heart disease, pulmonary insufficiency and important organ failure\n* Patients with renal insufficiency Clcr \\<30 mL/min\n* Those who take side effects of febuxostat，Patients with side effects of febuxostat, patients with a previous history of coronary heart disease'}, 'identificationModule': {'nctId': 'NCT04398251', 'briefTitle': 'A Randomized Clinical Trail of The Effect of Postoperative Uric Acid Control on Stone Recurrence and Renal Function in Patients With Hyperuricemia of Urolithiasis.', 'organization': {'class': 'OTHER', 'fullName': 'Xuhui Central Hospital, Shanghai'}, 'officialTitle': 'Department of Urology, Shanghai Xu-hui Central Hospital', 'orgStudyIdInfo': {'id': '2020-043'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Uric acid drug control group', 'description': 'For the uric acid control group, except that lifestyle changes were the same as those in the uric acid non-drug control group, non-drug uric acid control group was given febuxostat to reduce uric acid synthesis. Febuxostat is taken at a dose of 40 mg three times a week', 'interventionNames': ['Drug: Febuxostat 40mg Tab']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Non-drug control group', 'description': 'They are advised to live regularly after operation, drink plenty of water, drink more than 2000ml every day, reduce the intake of high purine food and fructose-rich beverages, increase the intake of fresh vegetables, control weight and exercise regularly.', 'interventionNames': ['Behavioral: Non-drug control group']}], 'interventions': [{'name': 'Febuxostat 40mg Tab', 'type': 'DRUG', 'description': 'For the uric acid control group, except that lifestyle changes were the same as those in the uric acid non-drug control group, non-drug uric acid control group was given febuxostat to reduce uric acid synthesis. Febuxostat is taken at a dose of 40 mg three times a week.', 'armGroupLabels': ['Uric acid drug control group']}, {'name': 'Non-drug control group', 'type': 'BEHAVIORAL', 'description': 'All patients in the group are advised to live regularly after operation, drink plenty of water, drink more than 2000ml every day, reduce the intake of high purine food and fructose-rich beverages, increase the intake of fresh vegetables, control weight and exercise regularly', 'armGroupLabels': ['Non-drug control group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '200031', 'city': 'Shanghai', 'state': 'Shanghai Municipality', 'country': 'China', 'facility': 'Shanghai Xuhui Central Hospital', 'geoPoint': {'lat': 31.22222, 'lon': 121.45806}}], 'overallOfficials': [{'name': 'JianMing Guo, PHD,M.D', 'role': 'STUDY_CHAIR', 'affiliation': 'Department of Urology, Zhongshan Hospital, Shanghai'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': 'Subject information, test results'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Xuhui Central Hospital, Shanghai', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Department of Urology', 'investigatorFullName': 'Zhao Hong', 'investigatorAffiliation': 'Xuhui Central Hospital, Shanghai'}}}}