Ignite Creation Date:
2025-12-24 @ 6:47 PM
Ignite Modification Date:
2026-01-25 @ 6:45 AM
Study NCT ID:
NCT01009957
Status:
TERMINATED
Last Update Posted:
2015-06-23
First Post:
2009-11-06
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Everolimus on CKD Progression in ADPKD Patients
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D007690', 'term': 'Polycystic Kidney Diseases'}, {'id': 'D016891', 'term': 'Polycystic Kidney, Autosomal Dominant'}], 'ancestors': [{'id': 'D052177', 'term': 'Kidney Diseases, Cystic'}, {'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': 'D000015', 'term': 'Abnormalities, Multiple'}, {'id': 'D000013', 'term': 'Congenital Abnormalities'}, {'id': 'D009358', 'term': 'Congenital, Hereditary, and Neonatal Diseases and Abnormalities'}, {'id': 'D000072661', 'term': 'Ciliopathies'}, {'id': 'D030342', 'term': 'Genetic Diseases, Inborn'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000068338', 'term': 'Everolimus'}, {'id': 'D000091203', 'term': 'MTOR Inhibitors'}], 'ancestors': [{'id': 'D020123', 'term': 'Sirolimus'}, {'id': 'D018942', 'term': 'Macrolides'}, {'id': 'D007783', 'term': 'Lactones'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D047428', 'term': 'Protein Kinase Inhibitors'}, {'id': 'D004791', 'term': 'Enzyme Inhibitors'}, {'id': 'D045504', 'term': 'Molecular Mechanisms of Pharmacological Action'}, {'id': 'D020228', 'term': 'Pharmacologic Actions'}, {'id': 'D020164', 'term': 'Chemical Actions and Uses'}, {'id': 'D007166', 'term': 'Immunosuppressive Agents'}, {'id': 'D007155', 'term': 'Immunologic Factors'}, {'id': 'D045505', 'term': 'Physiological Effects of Drugs'}, {'id': 'D000970', 'term': 'Antineoplastic Agents'}, {'id': 'D045506', 'term': 'Therapeutic Uses'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2', 'PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 71}}, 'statusModule': {'whyStopped': 'After primary completition date, experimental drug was no longer available', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2008-06'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-06', 'completionDateStruct': {'date': '2015-06', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2015-06-22', 'studyFirstSubmitDate': '2009-11-06', 'studyFirstSubmitQcDate': '2009-11-06', 'lastUpdatePostDateStruct': {'date': '2015-06-23', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2009-11-09', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2014-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Reduction of GFR (according to MDRD formula) during a two-year follow up', 'timeFrame': 'Two year-followup'}], 'secondaryOutcomes': [{'measure': 'reduction of creatinine clearance and GFR (according to Cockcroft-Gault formula) during a two-year follow up', 'timeFrame': 'Two year-followup'}, {'measure': 'changes in kidney size and renal and liver cysts dimensions evaluated by NMR at basal and at the end of the study', 'timeFrame': 'Two year-followup'}, {'measure': 'safety profile of everolimus (leucopenia, thrombocytopenia, lipid profile and other adverse events', 'timeFrame': 'Two year-followup'}, {'measure': 'evaluation of phosphatemia, phosphaturia and urinary cytokines on primary end point', 'timeFrame': 'Two year-followup'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['ADPKD', 'CKD', 'Renal disease progression', 'Everolimus'], 'conditions': ['Polycystic Kidney Diseases']}, 'descriptionModule': {'briefSummary': 'The study will evaluate whether the administration of everolimus (1.5 mg/day) can slow down the progression of CKD in ADPKD patients.', 'detailedDescription': 'Considering the inhibitor activity of Everolimus on mTOR, our hypothesis is to evaluate its possible utility on the progression of CKD in ADPKD patients by reducing the rate of increase of renal cysts.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Subjects over 18 years of both genders\n2. Clinical diagnosis of autosomal dominant polycystic kidney disease (ADPKD)\n3. GFR, according to MDRD formula, between 30 and 90 ml/min/1.73 mq\n4. Previous follow up of two years, with a creatinine evaluation at least once a year\n5. GFR reduction of at least 2.5 ml/min/year (according to MDRD formula)\n\nExclusion Criteria:\n\n1. Pregnancy, lactating, males and females without adequate contraception\n2. Leucopenia (\\< 3,000 leucocytes/mm3) or thrombocytopenia (\\< 100,000 platelets/mm3)\n3. Dyslipidemia (cholesterol or triglycerides \\> 260 mg/dl with treatment)\n4. Urinary tract infection\n5. Patients who cannot undergoing NMR'}, 'identificationModule': {'nctId': 'NCT01009957', 'briefTitle': 'Everolimus on CKD Progression in ADPKD Patients', 'organization': {'class': 'OTHER', 'fullName': 'A. Manzoni Hospital'}, 'officialTitle': 'Everolimus on CKD (Chronic Kidney Disease) Progression in ADPKD Patients', 'orgStudyIdInfo': {'id': 'PolEver'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Everolimus', 'description': 'Everolimus + standard therapy for CKD', 'interventionNames': ['Drug: Everolimus']}, {'type': 'NO_INTERVENTION', 'label': 'Control', 'description': 'Standard therapy for CKD'}], 'interventions': [{'name': 'Everolimus', 'type': 'DRUG', 'otherNames': ['mTOR inhibitors'], 'description': '0.75 mg x 2 / day', 'armGroupLabels': ['Everolimus']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Brescia', 'country': 'Italy', 'facility': 'A.O. Spedali Civili Di Brescia', 'geoPoint': {'lat': 45.53558, 'lon': 10.21472}}, {'zip': '23900', 'city': 'Lecco', 'country': 'Italy', 'facility': 'Alessandro Manzoni Hospital, Nephrology and Dialysis Department', 'geoPoint': {'lat': 45.85589, 'lon': 9.39704}}, {'zip': '41100', 'city': 'Modena', 'country': 'Italy', 'facility': 'Modena Hospital', 'geoPoint': {'lat': 44.64783, 'lon': 10.92539}}, {'zip': '80138', 'city': 'Napoli', 'country': 'Italy', 'facility': 'Dipartimento di Patologia Sistematica - Università Federico 2°', 'geoPoint': {'lat': 40.87618, 'lon': 14.5195}}, {'zip': '29100', 'city': 'Piacenza', 'country': 'Italy', 'facility': 'Ospedale "Guglielmo da Saliceto" - Nephrology and Dialysis Department', 'geoPoint': {'lat': 45.05242, 'lon': 9.69342}}, {'zip': '10152', 'city': 'Torino', 'country': 'Italy', 'facility': 'C.M.I.D. - Presidi Ospedalieri ASL 4', 'geoPoint': {'lat': 44.88856, 'lon': 11.99138}}, {'city': 'Vicenza', 'country': 'Italy', 'facility': 'Ospedale Civile San Bortolo Vicenza', 'geoPoint': {'lat': 45.54672, 'lon': 11.5475}}], 'overallOfficials': [{'name': 'Francesco Locatelli, MD', 'role': 'STUDY_CHAIR', 'affiliation': 'Nephrology and Dialysis Department - A. Manzoni Hospital'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'A. Manzoni Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Prof. Francesco Locatelli', 'investigatorFullName': 'Prof. Francesco Locatelli', 'investigatorAffiliation': 'A. Manzoni Hospital'}}}}