Ignite Creation Date:
2025-12-24 @ 9:09 PM
Ignite Modification Date:
2026-01-03 @ 6:56 AM
Study NCT ID:
NCT03246204
Status:
UNKNOWN
Last Update Posted:
2017-08-11
First Post:
2017-06-13
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Chinese Observational Prospective Study of Aging Population With Chronic Kidney Disease(C-OPTION)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D051436', 'term': 'Renal Insufficiency, Chronic'}], 'ancestors': [{'id': 'D051437', 'term': 'Renal Insufficiency'}, {'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': 'D002908', 'term': 'Chronic Disease'}, {'id': 'D020969', 'term': 'Disease Attributes'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITH_DNA', 'description': 'serum, whole blood，urine'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 3000}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2017-08', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-08', 'completionDateStruct': {'date': '2023-02', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2017-08-08', 'studyFirstSubmitDate': '2017-06-13', 'studyFirstSubmitQcDate': '2017-08-08', 'lastUpdatePostDateStruct': {'date': '2017-08-11', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-08-11', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-02', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Death', 'timeFrame': '5 year'}, {'measure': 'Incidence of End Stage Renal Disease (ESRD)', 'timeFrame': '5 year', 'description': 'ESRD will be defined as estimated glomerular filtration rate(eGFR)\\<15 mL/min/1.73 m2 or dialysis'}, {'measure': 'eGFR decline≥40%', 'timeFrame': '5 year'}], 'secondaryOutcomes': [{'measure': 'Acute coronary syndrome', 'timeFrame': '5 year'}, {'measure': 'Heart failure', 'timeFrame': '5 year'}, {'measure': 'Cerebral stroke', 'timeFrame': '5 year'}, {'measure': 'Peripheral arterial disease', 'timeFrame': '5 year'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Chronic Kidney Disease']}, 'referencesModule': {'references': [{'pmid': '29478020', 'type': 'DERIVED', 'citation': 'Liang S, Wang WL, Zhu FL, Duan SW, Sun XF, Chen XM, Cai GY; Chinese observational prospective study of ageing population with chronic kidney disease (C-OPTION). Chinese observational prospective study of ageing population with chronic kidney disease (C-OPTION): a study protocol. BMJ Open. 2018 Feb 24;8(2):e019457. doi: 10.1136/bmjopen-2017-019457.'}]}, 'descriptionModule': {'briefSummary': 'The study is an observational, multicenter, prospective cohort study aimed at evaluating a 5-year screening programme for chronic kidney disease(CKD) in a population of elderly patients, aged 65 years or more, in China.To analyze the etiology and composition spectrum, the incidence of complications and co-morbidities.To assess the correlation between daily living ability, mental and physical function, quality of life, nutritional status and prognosis.To develop biomarkers of renal aging.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['OLDER_ADULT'], 'minimumAge': '65 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'subjects with 65 years or older', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* age≥65 years\n* clinical diagnosis of CKD\n* signed informed consent\n\nExclusion Criteria:\n\n* subjects who have a poor compliance and cannot be scheduled for follow-up\n* subjects participating in other interventional clinical trials\n* ESRD or dialysis\n* Acute kidney injury(AKI)\n* history of solid organ or bone marrow transplantation\n* active malignancy within 24 months prior to screening or metastatic cancer\n* life expectancy less than 6 months；\n* severe cognitive impairment（NYHA III or IV）\n* HIV infection or AIDS\n* subjects cannot be able to complete the assessment including dementia or other mental disorders, limited physical activity, severe visual impairment\n* simple hematuria'}, 'identificationModule': {'nctId': 'NCT03246204', 'briefTitle': 'Chinese Observational Prospective Study of Aging Population With Chronic Kidney Disease(C-OPTION)', 'organization': {'class': 'OTHER', 'fullName': 'Chinese PLA General Hospital'}, 'officialTitle': 'Chinese Observational Prospective Study of Aging Population With Chronic Kidney Disease(C-OPTION)', 'orgStudyIdInfo': {'id': '2015BAI12B06'}}, 'contactsLocationsModule': {'centralContacts': [{'name': 'guangyan cai', 'role': 'CONTACT', 'email': 'caiguangyan@sina.com', 'phone': '00861066935462'}, {'name': 'shuang liang', 'role': 'CONTACT', 'email': 'liangshuang301@163.com', 'phone': '008615110246423'}], 'overallOfficials': [{'name': 'xiangmei chen', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Chinese PLA General Hospital'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Chinese PLA General Hospital', 'class': 'OTHER'}, 'collaborators': [{'name': 'First Affiliated Hospital, Sun Yat-Sen University', 'class': 'OTHER'}, {'name': 'Fudan University', 'class': 'OTHER'}, {'name': 'China-Japan Friendship Hospital', 'class': 'OTHER'}, {'name': 'The First Affiliated Hospital of Dalian Medical University', 'class': 'OTHER'}, {'name': 'Shandong Provincial Hospital', 'class': 'OTHER_GOV'}, {'name': 'Beijing Friendship Hospital', 'class': 'OTHER'}, {'name': 'RenJi Hospital', 'class': 'OTHER'}, {'name': 'Hebei Medical University Third Hospital', 'class': 'OTHER'}, {'name': 'Second Hospital of Jilin University', 'class': 'OTHER'}, {'name': 'Renmin Hospital of Wuhan University', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Academician of Chinese Academy of Engineering', 'investigatorFullName': 'Chen Xiangmei', 'investigatorAffiliation': 'Chinese PLA General Hospital'}}}}