Ignite Creation Date:
2025-12-25 @ 2:08 AM
Ignite Modification Date:
2025-12-26 @ 3:17 AM
Study NCT ID:
NCT01022060
Status:
COMPLETED
Last Update Posted:
2010-02-04
First Post:
2009-11-27
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Renalof in the Dissolution of Renal Calculi in Patients With Recurrent Calcic Lithiasis
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D007669', 'term': 'Kidney Calculi'}], 'ancestors': [{'id': 'D053040', 'term': 'Nephrolithiasis'}, {'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': 'D052878', 'term': 'Urolithiasis'}, {'id': 'D014545', 'term': 'Urinary Calculi'}, {'id': 'D052801', 'term': 'Male Urogenital Diseases'}, {'id': 'D002137', 'term': 'Calculi'}, {'id': 'D020763', 'term': 'Pathological Conditions, Anatomical'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 110}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2009-11'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2010-02', 'completionDateStruct': {'date': '2010-02', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2010-02-03', 'studyFirstSubmitDate': '2009-11-27', 'studyFirstSubmitQcDate': '2009-11-27', 'lastUpdatePostDateStruct': {'date': '2010-02-04', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2009-12-01', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2010-02', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Size of calculi at week 12 (end of the treatment); week 0 refers to the beginning of treatment)', 'timeFrame': '12 weeks'}, {'measure': 'Number of calculi at week 12 (end of the treatment); week 0 refers to the beginning of treatment', 'timeFrame': '12 weeks'}, {'measure': 'Lithiasic activity at week 12 (end of the treatment); week 0 refers to the beginning of treatment', 'timeFrame': '12 weeks'}], 'secondaryOutcomes': [{'measure': 'Calciuria at week 12', 'timeFrame': '12 weeks'}, {'measure': 'Uricosuria at week 12', 'timeFrame': '12 weeks'}, {'measure': 'Blood Uric acid at week 12', 'timeFrame': '12 weeks'}, {'measure': 'Oxaluria at week 12', 'timeFrame': '12 weeks'}, {'measure': 'Citraturia at week 12', 'timeFrame': '12 weeks'}, {'measure': 'Phosphatemia at week 12', 'timeFrame': '12 weeks'}, {'measure': 'Calcemia at week 12', 'timeFrame': '12 weeks'}, {'measure': 'Total plasmatic calcium at week 12', 'timeFrame': '12 weeks'}, {'measure': 'Blood ionic calcium at week 12', 'timeFrame': '12 weeks'}, {'measure': 'Calcium Oxalate crystallization risk at week 12', 'timeFrame': '12 weeks'}, {'measure': 'Calcium phosphate activity product at week 12', 'timeFrame': '12 weeks'}, {'measure': 'Calcium Oxalate activity product at week 12', 'timeFrame': '12 weeks'}, {'measure': 'pH of urine at week 12', 'timeFrame': '12 weeks'}, {'measure': 'Presence of adverse effects at any moment of treatment', 'timeFrame': '12 weeks'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Dietary supplement', 'Renalof', 'Recurrent calcic urolithiasis', 'Renal calculi'], 'conditions': ['Recurrent Calcic Urolithiasis']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to determine whether Renalof administration promotes partial or total dissolution of urinary calculi and improves physicochemical parameters and metabolic activity in patients with recurrent calcic urolithiasis. The duration of this double-blind placebo controlled phase 3 clinical trial will be 12 weeks. The estimated number of patients to be recruited and randomized for the study is 110. Ultrasonographic and humoral parameters will be assessed every 4 weeks.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Idiopathic calcic lithiasis\n* Calculus size lesser than or equal to 2.0 cm (0.79 inches)\n* Signed informed consent\n\nExclusion Criteria:\n\n* Calculus size greater than 2,0 cm (0.79 inches)\n* Pregnancy\n* Malignant neoplastic conditions\n* Previous treatment for destruction of calculi in the urinary tract'}, 'identificationModule': {'nctId': 'NCT01022060', 'briefTitle': 'Renalof in the Dissolution of Renal Calculi in Patients With Recurrent Calcic Lithiasis', 'organization': {'class': 'INDUSTRY', 'fullName': 'Catalysis SL'}, 'officialTitle': 'Efficacy of Renalof in the Dissolution of Renal Calculi in Patients With Recurrent Calcic Lithiasis', 'orgStudyIdInfo': {'id': 'CAT-0913-CU'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'A', 'description': 'Renalof', 'interventionNames': ['Dietary Supplement: Renalof']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'B', 'description': 'Placebo', 'interventionNames': ['Dietary Supplement: Placebo']}], 'interventions': [{'name': 'Renalof', 'type': 'DIETARY_SUPPLEMENT', 'description': 'One Renalof tablet (Orally administered) three times a day (just before each meal: breakfast, lunch and dinner), for 12 weeks', 'armGroupLabels': ['A']}, {'name': 'Placebo', 'type': 'DIETARY_SUPPLEMENT', 'description': 'One Placebo tablet (Orally administered) three time a day (just before each meal: breakfast, lunch and dinner), for 12 weeks', 'armGroupLabels': ['B']}]}, 'contactsLocationsModule': {'locations': [{'zip': '10400', 'city': 'Havana', 'state': 'La Habana', 'country': 'Cuba', 'facility': 'Institute of Nephrology', 'geoPoint': {'lat': 23.13302, 'lon': -82.38304}}], 'overallOfficials': [{'name': 'Mirna Atiés Sánchez, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Institute of Nephrology'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Catalysis SL', 'class': 'INDUSTRY'}, 'responsibleParty': {'oldNameTitle': 'Mirna Atiés Sánchez', 'oldOrganization': 'Institute of Nephrology'}}}}