Ignite Creation Date:
2025-12-24 @ 4:47 PM
Ignite Modification Date:
2025-12-27 @ 5:03 AM
Study NCT ID:
NCT05036850
Status:
RECRUITING
Last Update Posted:
2023-03-06
First Post:
2021-08-27
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
China Kidney Patient Trials Network
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D007674', 'term': 'Kidney Diseases'}, {'id': 'D051436', 'term': 'Renal Insufficiency, Chronic'}, {'id': 'D003928', 'term': 'Diabetic Nephropathies'}, {'id': 'C563161', 'term': 'Hypertensive Nephropathy'}, {'id': 'D005921', 'term': 'Glomerulonephritis'}, {'id': 'D005923', 'term': 'Glomerulosclerosis, Focal Segmental'}, {'id': 'D015433', 'term': 'Glomerulonephritis, Membranous'}, {'id': 'D009402', 'term': 'Nephrosis, Lipoid'}, {'id': 'D005922', 'term': 'Glomerulonephritis, IGA'}], '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'}, {'id': 'D051437', 'term': 'Renal Insufficiency'}, {'id': 'D002908', 'term': 'Chronic Disease'}, {'id': 'D020969', 'term': 'Disease Attributes'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D048909', 'term': 'Diabetes Complications'}, {'id': 'D003920', 'term': 'Diabetes Mellitus'}, {'id': 'D004700', 'term': 'Endocrine System Diseases'}, {'id': 'D009393', 'term': 'Nephritis'}, {'id': 'D001327', 'term': 'Autoimmune Diseases'}, {'id': 'D007154', 'term': 'Immune System Diseases'}, {'id': 'D009401', 'term': 'Nephrosis'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 1200}, 'targetDuration': '5 Years', 'patientRegistry': True}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2021-09-27', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-03', 'completionDateStruct': {'date': '2031-02-28', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2023-03-03', 'studyFirstSubmitDate': '2021-08-27', 'studyFirstSubmitQcDate': '2021-09-07', 'lastUpdatePostDateStruct': {'date': '2023-03-06', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-09-08', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-09-15', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'eGFR (estimated Glomerular Filtration Rate)', 'timeFrame': 'Collected six monthly, up to 5 years', 'description': 'Routine results'}, {'measure': 'Albuminuria', 'timeFrame': 'Collected six monthly, up to 5 years', 'description': 'Routine results'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Chronic Kidney Disease', 'Diabetic Nephropathy', 'Hypertensive Kidney Disease', 'Glomerulonephritis', 'GN', 'Focal Segmental Glomerulosclerosis', 'FSGS', 'Membranous Nephropathy', 'Minimal Change Disease', 'IgA Nephropathy', 'Glomerulonephritis not otherwise specified'], 'conditions': ['Kidney Diseases']}, 'referencesModule': {'references': [{'pmid': '29904224', 'type': 'BACKGROUND', 'citation': 'Luyckx VA, Tonelli M, Stanifer JW. The global burden of kidney disease and the sustainable development goals. Bull World Health Organ. 2018 Jun 1;96(6):414-422D. doi: 10.2471/BLT.17.206441. Epub 2018 Apr 20.'}, {'pmid': '22717317', 'type': 'BACKGROUND', 'citation': 'Tonelli M, Muntner P, Lloyd A, Manns BJ, Klarenbach S, Pannu N, James MT, Hemmelgarn BR; Alberta Kidney Disease Network. Risk of coronary events in people with chronic kidney disease compared with those with diabetes: a population-level cohort study. Lancet. 2012 Sep 1;380(9844):807-14. doi: 10.1016/S0140-6736(12)60572-8. Epub 2012 Jun 19.'}, {'pmid': '15385656', 'type': 'BACKGROUND', 'citation': 'Go AS, Chertow GM, Fan D, McCulloch CE, Hsu CY. Chronic kidney disease and the risks of death, cardiovascular events, and hospitalization. N Engl J Med. 2004 Sep 23;351(13):1296-305. doi: 10.1056/NEJMoa041031.'}, {'pmid': '21068142', 'type': 'BACKGROUND', 'citation': 'McGrogan A, Franssen CF, de Vries CS. The incidence of primary glomerulonephritis worldwide: a systematic review of the literature. Nephrol Dial Transplant. 2011 Feb;26(2):414-30. doi: 10.1093/ndt/gfq665. Epub 2010 Nov 10.'}, {'pmid': '14747388', 'type': 'BACKGROUND', 'citation': 'Strippoli GF, Craig JC, Schena FP. The number, quality, and coverage of randomized controlled trials in nephrology. J Am Soc Nephrol. 2004 Feb;15(2):411-9. doi: 10.1097/01.asn.0000100125.21491.46.'}, {'pmid': '30675428', 'type': 'BACKGROUND', 'citation': 'Perkovic V, Craig JC, Chailimpamontree W, Fox CS, Garcia-Garcia G, Benghanem Gharbi M, Jardine MJ, Okpechi IG, Pannu N, Stengel B, Tuttle KR, Uhlig K, Levey AS. Action plan for optimizing the design of clinical trials in chronic kidney disease. Kidney Int Suppl (2011). 2017 Oct;7(2):138-144. doi: 10.1016/j.kisu.2017.07.009. Epub 2017 Sep 20.'}, {'pmid': '28797748', 'type': 'BACKGROUND', 'citation': 'de Zeeuw D, Heerspink HJL, Jardine M, Perkovic V. Renal trials in diabetes need a platform: time for a global approach? Lancet Diabetes Endocrinol. 2018 May;6(5):356-358. doi: 10.1016/S2213-8587(17)30263-2. Epub 2017 Aug 7. No abstract available.'}]}, 'descriptionModule': {'briefSummary': 'This is a prospective multi-centre, observational cohort study of incident and prevalent patients diagnosed with a kidney disease in China.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'minimumAge': '2 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Participants will be recruited from units that provide a comprehensive nephrology service', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Documented diagnosis of primary kidney disease\n2. Regular visits (at least 6 monthly) with a physician at a participating site\n3. eGFR \\> 15 ml/min/1.73 m2\n4. ≥ 2 years of age\n5. Willing and able to sign informed consent\n6. Willing to be approached about participation in interventional research studies\n\nExclusion Criteria:\n\n* 1\\. Life-expectancy of less than 6 months'}, 'identificationModule': {'nctId': 'NCT05036850', 'acronym': 'CKPTN', 'briefTitle': 'China Kidney Patient Trials Network', 'organization': {'class': 'INDUSTRY', 'fullName': 'Emerald Clinical Inc.'}, 'officialTitle': 'China Kidney Patient Trials Network', 'orgStudyIdInfo': {'id': 'CKPTN2019'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Incident and Prevalent Patients', 'description': 'Incident and prevalent patients diagnosed with a kidney disease at participating centres'}]}, 'contactsLocationsModule': {'locations': [{'zip': '100125', 'city': 'Beijing', 'state': 'Beijing Municipality', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Shengkun Sun', 'role': 'CONTACT', 'email': 'CKPTN@georgeclincial.com', 'phone': '+(86)10 82800864'}], 'facility': 'George Clinical (Beijing)', 'geoPoint': {'lat': 39.9075, 'lon': 116.39723}}], 'centralContacts': [{'name': 'FanHan Hsu', 'role': 'CONTACT', 'email': 'CKPTN@georgeclinical.com', 'phone': '+61 2 8052 4300'}, {'name': 'Dan Yuan', 'role': 'CONTACT', 'email': 'CKPTN@georgeclinical.com', 'phone': '+86 201082800476'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': 'The current plan is that only aggregate data will be shared for research purposes. IPD would only be reviewed in incidental findings and only be discussed with the participant in question.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'George (Beijing) Clinical Research Co. Ltd.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}