Ignite Creation Date:
2025-12-24 @ 10:39 PM
Ignite Modification Date:
2026-01-04 @ 4:39 PM
Study NCT ID:
NCT02229435
Status:
COMPLETED
Last Update Posted:
2014-09-01
First Post:
2014-08-26
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Urologic-nephrological Care of Chronic Kidney Disease in Saxony-Anhalt/Magdeburg.
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': {'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 1031336}, 'targetDuration': '1 Year', 'patientRegistry': True}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2004-12'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2014-08', 'completionDateStruct': {'date': '2014-08', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2014-08-28', 'studyFirstSubmitDate': '2014-08-26', 'studyFirstSubmitQcDate': '2014-08-28', 'lastUpdatePostDateStruct': {'date': '2014-09-01', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2014-09-01', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2014-08', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Chronic kidney disease', 'timeFrame': '1 year', 'description': '% of outpatient patients with eGFR \\< 60 ml/min and interdisciplinary urological and nephrological care in metropolitan area Magdeburg, Saxony-Anhalt, Germany.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Chronic kidney disease', 'Urological care', 'Nephrological care'], 'conditions': ['Chronic Kidney Disease (CKD)']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'http://www.schenk-ansorge.de/Kontakt.aspx', 'label': 'Medical Laboratory Schenk-Ansorge Magdeburg, Germany.'}, {'url': 'http://urologie.uni-magdeburg.de/urologie.html', 'label': 'Department of Urology University Magdeburg, Germany.'}]}, 'descriptionModule': {'briefSummary': 'Statement:\n\nPatients with Chronic kidney disease (CKD) with an estimated glomerular filtration rate (eGFR) under 60 ml/min using the MDRD-6 (Modification of Diet in Renal Disease) formula and/or CKD-EPI (Chronic Kidney Disease Epidemiology Collaboration) formula should undergo nephrological and urological care (diagnosis and treatment) to prevent chronic kidney failure. This is recommended by the National Kidney Foundation Kidney Disease Outcomes Quality Initiative (KDOQI), Kidney Disease Improving Global Outcomes (KDIGO) and European Urological Association (EAU). Renal and postrenal diseases can cause or worsen CKD. Internistic and intrarenal diseases can caused or worsen CKD. All diseases affecting CKD should be treated and the medical care should be optimized.\n\nHypothesis:\n\nNot all patients with CKD receive urological and nephrological care. Interdisciplinary work of outpatient working urologists and nephrologists in the metropolitan area Magdeburg / Saxony-Anhalt Germany is unknown. An descriptive analysis of interdisciplinary treatment connection of CKD patients for an orientating statement is needed.', 'detailedDescription': 'The Medical Laboratory Schenk-Ansorge Magdeburg Saxony-Anhalt Germany receives all blood samples of outpatient patients of the medical practices of the metropolitan area Magdeburg Saxony-Anhalt Germany. Every patient has a lifetime identification number Independent of the submitting practice. Every submitting medical doctor has a lifetime identification number and is identified by her/his medical subject /specialization. This analysis is based on that laboratory database. For that study a cohort of 1.031.336 patients from 12/2004 to 08/2014 is evaluated, that had been received blood tests with measurement of serum creatinine. For every serum creatinine an eGGR is calculated with the guideline recommended formula.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'All sampled outpatient patients (blood tests with measurement of serum creatinine) 12/2004-08/2014 of the medical laboratory Prof. Schenk / Dr. Ansorge and Colleagues, GbR, Am Neustädter Feld 47, 39124 Magdeburg, metroplitan area Magdeburg Saxony-Anhalt, Germany.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Measured serum creatinine and estimated glomerular filtration rate\n* eGFR \\< 60 ml/min\n\nExclusion Criteria:\n\n* dialysis\n* no serum creatinine measured\n* Age \\< 18 years'}, 'identificationModule': {'nctId': 'NCT02229435', 'acronym': 'UroCKDisS', 'briefTitle': 'Urologic-nephrological Care of Chronic Kidney Disease in Saxony-Anhalt/Magdeburg.', 'organization': {'class': 'OTHER', 'fullName': 'University of Magdeburg'}, 'officialTitle': 'Laboratory Database-based Analysis of the Interdisciplinary Urologic-nephrological Care of the Chronic Kidney Disease (CKD) With Estimated Glomerular Filtration Rate (eGFR) Under 60 ml/Min of the Population in Saxony-Anhalt / Metropolitan Area Magdeburg.', 'orgStudyIdInfo': {'id': 'URO-MD-040'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'eGFR <60ml/min', 'description': 'Patients with CKD with eGFR \\<60 ml/min (CKD-EPI or MDRD) 12/2004-08/2014 of Medical Laboratory, Prof. Schenk / Dr. Ansorge and Colleagues, GbR, Am Neustädter Feld 47, 39124 Magdeburg, Germany.'}]}, 'contactsLocationsModule': {'locations': [{'zip': '39108', 'city': 'Magdeburg', 'state': 'Saxony-Anhalt', 'country': 'Germany', 'facility': 'Department of Urology University Magdeburg', 'geoPoint': {'lat': 52.13129, 'lon': 11.63189}}], 'overallOfficials': [{'name': 'Johann J Wendler, Dr.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Urology University Magdeburg'}, {'name': 'Martin Schostak, Prof. Dr.', 'role': 'STUDY_CHAIR', 'affiliation': 'Urology University Magdeburg'}, {'name': 'Herwart Schenk, Prof. Dr.', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Medical Laboratory Am Neustädter Feld 47, 39124 Magdeburg, Saxony-Anhalt, Germany.'}, {'name': 'Constanze Tienken, Cand. med.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Doctorand Urology University Magdeburg'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Magdeburg', 'class': 'OTHER'}, 'collaborators': [{'name': 'Medical Laboratory Schenk-Ansorge Magdeburg Germany.', 'class': 'UNKNOWN'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Dr. med.', 'investigatorFullName': 'Johann J. Wendler, MD', 'investigatorAffiliation': 'University of Magdeburg'}}}}