Ignite Creation Date:
2025-12-25 @ 2:00 AM
Ignite Modification Date:
2026-02-22 @ 3:05 PM
Study NCT ID:
NCT01430494
Status:
COMPLETED
Last Update Posted:
2015-04-23
First Post:
2011-07-29
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Observational Study in Patients With Autosomal Dominant Polycystic Kidney Disease
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D016891', 'term': 'Polycystic Kidney, Autosomal Dominant'}], 'ancestors': [{'id': 'D007690', 'term': 'Polycystic Kidney Diseases'}, {'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'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 3409}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2011-06'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-04', 'completionDateStruct': {'date': '2014-10', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2015-04-22', 'studyFirstSubmitDate': '2011-07-29', 'studyFirstSubmitQcDate': '2011-09-06', 'lastUpdatePostDateStruct': {'date': '2015-04-23', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2011-09-08', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2014-10', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Correlation of change in total kidney volume with ADPKD-related outcomes', 'timeFrame': '1 year'}], 'secondaryOutcomes': [{'measure': 'Patient-reported pain', 'timeFrame': 'every 6 months'}, {'measure': 'SF-12 Scores', 'timeFrame': 'every 6 months'}, {'measure': 'ADPKD-Impact Scale Score', 'timeFrame': 'every 6 months'}, {'measure': 'Cost of care', 'timeFrame': 'every 6 months'}, {'measure': 'EQ-5D Scores', 'timeFrame': 'Every 6 months'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Autosomal Dominant Polycystic Kidney Disease (ADPKD)']}, 'referencesModule': {'references': [{'pmid': '39752236', 'type': 'DERIVED', 'citation': 'Gitomer BY, Chonchol M, Zhou X, Garbinsky D, Wang J, Nunna S, Fernandes AW, Oberdhan D. Kidney Stone Disease and Progression Risk in Autosomal Dominant Polycystic Kidney Disease: A Post Hoc Analysis of OVERTURE. Kidney360. 2024 Sep 1;5(9):1364-1366. doi: 10.34067/KID.0000000000000524. Epub 2024 Jul 24. No abstract available.'}, {'pmid': '37349694', 'type': 'DERIVED', 'citation': 'Lioudis M, Zhou X, Davenport E, Nunna S, Krasa HB, Oberdhan D, Fernandes AW. Effects of tolvaptan discontinuation in patients with autosomal dominant polycystic kidney disease: a post hoc pooled analysis. BMC Nephrol. 2023 Jun 22;24(1):182. doi: 10.1186/s12882-023-03247-6.'}, {'pmid': '37250503', 'type': 'DERIVED', 'citation': 'Chebib FT, Zhou X, Garbinsky D, Davenport E, Nunna S, Oberdhan D, Fernandes A. Tolvaptan and Kidney Function Decline in Older Individuals With Autosomal Dominant Polycystic Kidney Disease: A Pooled Analysis of Randomized Clinical Trials and Observational Studies. Kidney Med. 2023 Apr 14;5(6):100639. doi: 10.1016/j.xkme.2023.100639. eCollection 2023 Jun.'}, {'pmid': '37180499', 'type': 'DERIVED', 'citation': 'Perrone RD, Oberdhan D, Ouyang J, Bichet DG, Budde K, Chapman AB, Gitomer BY, Horie S, Ong ACM, Torres VE, Turner AN, Krasa H. OVERTURE: A Worldwide, Prospective, Observational Study of Disease Characteristics in Patients With ADPKD. Kidney Int Rep. 2023 Feb 13;8(5):989-1001. doi: 10.1016/j.ekir.2023.02.1073. eCollection 2023 May.'}]}, 'descriptionModule': {'briefSummary': 'To collect characteristics of patients with ADPKD across a broad population, over time to better understand disease progression (signs, symptoms and outcomes). Association with total kidney volume changes and other measures of disease progression will be determined in order to identify a population at increased risk for disease progression. The economic and quality life impact of ADPKD will be assessed. Subjects who terminated participation early from clinical trials with tolvaptan may also be followed.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '12 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Subjects will be identified by participating clinics (primarily nephrology clinics) treating patients with ADPKD.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* existing diagnosis of ADPKD by modified-Ravine criteria\n* Total kidney volume \\>= 300 cc/m height by ultrasound or \\>= 250 cc/m height by MRI\n\nExclusion Criteria:\n\n* Current or expected (within the next six months) interventions for the treatment of ADPKD affecting kidney volume'}, 'identificationModule': {'nctId': 'NCT01430494', 'acronym': 'OVERTURE', 'briefTitle': 'Observational Study in Patients With Autosomal Dominant Polycystic Kidney Disease', 'organization': {'class': 'INDUSTRY', 'fullName': 'Otsuka Pharmaceutical Development & Commercialization, Inc.'}, 'officialTitle': 'A Multi-center, Longitudinal, Observational Study of Patients With Autosomal Dominant Polycystic Kidney Disease (ADPKD) to Establish the Rate, Characteristics, and Determinants of Disease Progression', 'orgStudyIdInfo': {'id': '156-10-291'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'No treatment'}]}, 'contactsLocationsModule': {'locations': [{'zip': '85381', 'city': 'Peoria', 'state': 'Arizona', 'country': 'United States', 'facility': 'Otsuka Investigational Site 1', 'geoPoint': {'lat': 33.5806, 'lon': -112.23738}}, {'zip': '85381', 'city': 'Peoria', 'state': 'Arizona', 'country': 'United States', 'facility': 'Otsuka Investigational Site 2', 'geoPoint': {'lat': 33.5806, 'lon': -112.23738}}, {'zip': '85284', 'city': 'Tempe', 'state': 'Arizona', 'country': 'United States', 'facility': 'Otsuka Investigational Site', 'geoPoint': {'lat': 33.41477, 'lon': -111.90931}}, {'zip': '91702', 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