Ignite Creation Date:
2025-12-25 @ 2:03 AM
Ignite Modification Date:
2026-01-25 @ 6:47 PM
Study NCT ID:
NCT01279460
Status:
COMPLETED
Last Update Posted:
2011-01-19
First Post:
2011-01-17
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Aortic Stiffness in Chronic Kidney Disease Stage 2 to 4
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': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 167}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2007-10'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2011-01', 'completionDateStruct': {'date': '2010-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2011-01-17', 'studyFirstSubmitDate': '2011-01-17', 'studyFirstSubmitQcDate': '2011-01-17', 'lastUpdatePostDateStruct': {'date': '2011-01-19', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2011-01-19', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2010-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'combined renal end-point (>25% decline in renal function or start of renal replacement therapy)', 'timeFrame': '24 months'}], 'secondaryOutcomes': [{'measure': 'mortality', 'timeFrame': '24 months'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['chronic kidney disease', 'CKD', 'pulse wave velocity', 'PWV'], 'conditions': ['Decline in Renal Function']}, 'referencesModule': {'references': [{'pmid': '20107490', 'type': 'BACKGROUND', 'citation': 'Pan CR, Roos M, Schmaderer C, Lutz J, Wang JG, Heemann U, Baumann M. Interrelationship between aortic stiffness and proteinuria in chronic kidney disease. J Hum Hypertens. 2010 Sep;24(9):593-9. doi: 10.1038/jhh.2009.108. Epub 2010 Jan 28.'}, {'pmid': '20019670', 'type': 'BACKGROUND', 'citation': 'Townsend RR, Wimmer NJ, Chirinos JA, Parsa A, Weir M, Perumal K, Lash JP, Chen J, Steigerwalt SP, Flack J, Go AS, Rafey M, Rahman M, Sheridan A, Gadegbeku CA, Robinson NA, Joffe M. Aortic PWV in chronic kidney disease: a CRIC ancillary study. Am J Hypertens. 2010 Mar;23(3):282-9. doi: 10.1038/ajh.2009.240. Epub 2009 Dec 17.'}]}, 'descriptionModule': {'briefSummary': 'This study aimed to investigate in a cohort with chronic kidney disease the longitudinal relationship between aortic stiffness and renal function and mortality.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients were enrolled in a prospective study of vascular stiffness and CV risk in patients with CKD stages 2 to 4. They were predominantly recruited from outpatients attending nephrology clinics at the Klinikum rechts der Isar der Technischen Universität München and at a private nephrological clinic in Weissenburg October 2007 to December 2008.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age 18 or older\n* CKD 2-4\n\nExclusion Criteria:\n\n* pregnancy\n* history of malignant disease with a prognostic life expectancy less than 24 months\n* missing of written and informed consent'}, 'identificationModule': {'nctId': 'NCT01279460', 'briefTitle': 'Aortic Stiffness in Chronic Kidney Disease Stage 2 to 4', 'organization': {'class': 'OTHER', 'fullName': 'Technical University of Munich'}, 'officialTitle': 'Evaluation of Aortic Stiffness in CKD II to IV', 'orgStudyIdInfo': {'id': 'Munich-CKD-PWA'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'CKD Cohort of patients with renal insufficiency', 'description': 'patients with renal insufficiency grade II-IV'}]}, 'contactsLocationsModule': {'locations': [{'zip': '81675', 'city': 'München', 'state': 'Bavaria', 'country': 'Germany', 'facility': 'Klinikum rechts der Isar', 'geoPoint': {'lat': 48.69668, 'lon': 13.46314}}, {'zip': '91781', 'city': 'Weißenburg in Bayern', 'state': 'Bavaria', 'country': 'Germany', 'facility': 'Klinikum Weissenburg', 'geoPoint': {'lat': 49.03095, 'lon': 10.97221}}], 'overallOfficials': [{'name': 'Marcus Baumann, M.D. PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Klinikum rechts der Isar of the Technical University Munich'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Technical University of Munich', 'class': 'OTHER'}, 'collaborators': [{'name': 'Department of Nephrology, Klinikum rechts der Isar, München', 'class': 'UNKNOWN'}], 'responsibleParty': {'oldNameTitle': 'PD. Dr. med. Marcus Baumann, M.D., PhD', 'oldOrganization': 'Technical University of Munich, Klinikum rechts der Isar, Department of nephrology'}}}}