Ignite Creation Date:
2025-12-25 @ 2:17 AM
Ignite Modification Date:
2026-01-08 @ 3:58 AM
Study NCT ID:
NCT03007160
Status:
UNKNOWN
Last Update Posted:
2018-02-01
First Post:
2016-12-13
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Study on the Effection of Potassium Citrate Extended-release Tablets on Urolithiasis Formation or Recurrence
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'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'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 2001}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2016-07'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-01', 'completionDateStruct': {'date': '2020-09', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2018-01-31', 'studyFirstSubmitDate': '2016-12-13', 'studyFirstSubmitQcDate': '2016-12-29', 'lastUpdatePostDateStruct': {'date': '2018-02-01', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-01-02', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2020-09', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Rate of Urolithiasis recurrence', 'timeFrame': 'through study completion, an average of 1 year'}], 'secondaryOutcomes': [{'measure': 'Time of stone recurrence', 'timeFrame': 'through study completion, an average of 1 year'}, {'measure': 'The changes of urine citric acid content compared with baseline', 'timeFrame': 'through study completion, an average of 1 year'}, {'measure': 'The changes of Urine pH value compared with baseline', 'timeFrame': 'through study completion, an average of 1 year'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Urolithiasis']}, 'referencesModule': {'references': [{'pmid': '25881654', 'type': 'BACKGROUND', 'citation': 'Sfoungaristos S, Gofrit ON, Yutkin V, Pode D, Duvdevani M. Prevention of renal stone disease recurrence. A systematic review of contemporary pharmaceutical options. Expert Opin Pharmacother. 2015 Jun;16(8):1209-18. doi: 10.1517/14656566.2015.1037740. Epub 2015 Apr 16.'}, {'pmid': '12028622', 'type': 'BACKGROUND', 'citation': 'Soygur T, Akbay A, Kupeli S. Effect of potassium citrate therapy on stone recurrence and residual fragments after shockwave lithotripsy in lower caliceal calcium oxalate urolithiasis: a randomized controlled trial. J Endourol. 2002 Apr;16(3):149-52. doi: 10.1089/089277902753716098.'}, {'pmid': '10210371', 'type': 'BACKGROUND', 'citation': 'Lee YH, Huang WC, Tsai JY, Huang JK. The efficacy of potassium citrate based medical prophylaxis for preventing upper urinary tract calculi: a midterm followup study. J Urol. 1999 May;161(5):1453-7.'}, {'pmid': '20576821', 'type': 'BACKGROUND', 'citation': 'Fabris A, Lupo A, Bernich P, Abaterusso C, Marchionna N, Nouvenne A, Gambaro G. Long-term treatment with potassium citrate and renal stones in medullary sponge kidney. Clin J Am Soc Nephrol. 2010 Sep;5(9):1663-8. doi: 10.2215/CJN.00220110. Epub 2010 Jun 24.'}, {'pmid': '17726345', 'type': 'BACKGROUND', 'citation': 'Bartoletti R, Cai T, Mondaini N, Melone F, Travaglini F, Carini M, Rizzo M. Epidemiology and risk factors in urolithiasis. Urol Int. 2007;79 Suppl 1:3-7. doi: 10.1159/000104434.'}]}, 'descriptionModule': {'briefSummary': 'Assess the efficacy and safety of potassium citrate extended-release tablets on Urolithiasis formation or recurrence.', 'detailedDescription': 'This study takes "Rate of stone recurrence" as primary outcome measure, by random, blank control, and multicenter clinical trial design method, assess the efficacy and safety of potassium citrate extended-release tablets on Urolithiasis formation or recurrence, provide evidence for drug re-registration, and observe its efficacy on Urinary calculi such as renal tubular acidosis with calcium stone, and uric acid stones with or without calcium stone, urinary tract stone of effectiveness.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients with upper urinary tract calculi surgery and/or ESWL within 3 months；\n* Stone free or had residual stone fragments with a less than 4 mm diamete；\n* 18-70 years of age; the gender is not limited；\n* Agree to take effective contraceptive measures during the study period, and female of childbearing age whose pregnancy test is negative；\n* Subjects with no mental illness and language dysfunction, can understand the situation of the study and have signed informed consent.\n\nExclusion Criteria:\n\n* Patients with infectious stones, medical stones and urinary tract obstruction；\n* Patients with hyperkalemia (K+\\>5.5mmol/L) (or patients with factors or disease that can cause hyperkalemia), because the further increase in blood potassium can lead to cardiac arrest. These factors include disease or strenuous exercise, chronic renal failure, uncontrolled diabetes, acute dehydration, excessive, adrenal insufficiency, extensive tissue failure. Patients who takes potassium sparing diuretics (such as triamterene, spironolactone, amiloride)；\n* Patients with gastrointestinal disorders, such as peptic ulcer, severe vomiting, diarrhea, delayed gastric emptying, intestinal obstruction, etc.；\n* Combined with cardiovascular, liver, kidney, hematopoietic system, such as severe primary disease, or known to affect the survival of serious diseases (such as cancer or AIDS), or patients with with disabilities mentally or legally；\n* Patients with renal insufficiency (1.2 times the upper limit of the normal value of serum creatinine and urea nitrogen)；\n* The recent (within 6 months) with family planners；\n* Allergic to this product；\n* To participate in other clinical trials in the past three months.'}, 'identificationModule': {'nctId': 'NCT03007160', 'briefTitle': 'A Study on the Effection of Potassium Citrate Extended-release Tablets on Urolithiasis Formation or Recurrence', 'organization': {'class': 'INDUSTRY', 'fullName': 'Dawnrays Pharmaceutical (Holdings) Limited'}, 'officialTitle': 'A Randomized, Blank Controlled, Multicenter Clinical Trial of the Effection of Potassium Citrate Extended-release Tablets on Urolithiasis Formation or Recurrence', 'orgStudyIdInfo': {'id': 'DAWNRAYS101'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Experimental group', 'description': 'Potassium Citrate Extended-release Tablets', 'interventionNames': ['Drug: Potassium Citrate Extended-release Tablets']}, {'type': 'NO_INTERVENTION', 'label': 'Blank control group', 'description': 'Subjects do not take the investigational product'}], 'interventions': [{'name': 'Potassium Citrate Extended-release Tablets', 'type': 'DRUG', 'otherNames': ['Juyuansuanjia Huanshi Pian'], 'description': 'Daily 3.24g, Po ,Tid, each 1.08g/tablets', 'armGroupLabels': ['Experimental group']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Guangzhou', 'state': 'Guangdong', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Dehui LAI', 'role': 'CONTACT', 'email': 'dehuilai@hotmail.com', 'phone': '(+86)13570508863'}, {'name': 'Yongzhong HE', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'Dehui LAI', 'role': 'SUB_INVESTIGATOR'}], 'facility': 'The Fifth Affiliated Hospital of Guangzhou Medical University', 'geoPoint': {'lat': 23.11667, 'lon': 113.25}}, {'city': 'Zhengzhou', 'state': 'Henan', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Changwei LIU', 'role': 'CONTACT', 'email': 'lcw8001@126.com', 'phone': '(+86)13526709425'}, {'name': 'Changbao XU', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'Changwei LIU', 'role': 'SUB_INVESTIGATOR'}], 'facility': 'The Second Affiliated Hospital of Zhengzhou University', 'geoPoint': {'lat': 34.75778, 'lon': 113.64861}}, {'zip': '430030', 'city': 'Wuhan', 'state': 'Hubei', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Xiaolin GUO, M.D.', 'role': 'CONTACT', 'email': 'guoxiaolin0488@sina.com', 'phone': '(+86)13886042051'}, {'name': 'Zhangqun YE, M.D.', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'Xiaolin GUO, M.D.', 'role': 'SUB_INVESTIGATOR'}], 'facility': 'Tongji Hospital of Tongji Medical College, Huazhong University of Science and Technology', 'geoPoint': {'lat': 30.58333, 'lon': 114.26667}}, {'city': 'Wuhan', 'state': 'Hubei', 'status': 'ACTIVE_NOT_RECRUITING', 'country': 'China', 'facility': 'Wuhan No.1 Hospital（Wuhan Integrated TCM & Western Medicine Hospital）', 'geoPoint': {'lat': 30.58333, 'lon': 114.26667}}, {'city': 'Shanghai', 'state': 'Shanghai Municipality', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Mingxi XU', 'role': 'CONTACT', 'email': 'xuhuaneric@126.com', 'phone': '(+86)18221683312'}, {'name': 'Zhong WANG', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'Mingxi XU', 'role': 'SUB_INVESTIGATOR'}], 'facility': "Shanghai Ninth People's Hospital,Shanghai Jiaotong University School of Medicine", 'geoPoint': {'lat': 31.22222, 'lon': 121.45806}}, {'city': 'Hangzhou', 'state': 'Zhejiang', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Xing WANG', 'role': 'CONTACT', 'email': 'fly115135@sohu.com', 'phone': '(+86)18058806706'}, {'name': 'Yi FAN', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'Xing WANG', 'role': 'SUB_INVESTIGATOR'}], 'facility': 'Zhejiang Xiaoshan Hospital', 'geoPoint': {'lat': 30.29365, 'lon': 120.16142}}], 'centralContacts': [{'name': 'Zhangqun YE, M.D.', 'role': 'CONTACT', 'email': 'zhangqun_ye@163.com', 'phone': '(+86)13507191761'}], 'overallOfficials': [{'name': 'Zhangqun YE, M.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Tongji Hospital'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Dawnrays Pharmaceutical (Holdings) Limited', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}