Ignite Creation Date:
2025-12-25 @ 1:16 AM
Ignite Modification Date:
2026-01-01 @ 7:24 AM
Study NCT ID:
NCT04948593
Status:
COMPLETED
Last Update Posted:
2021-07-02
First Post:
2021-06-07
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Risks of Percutaneous Native Kidney Biopsy in Italy: a Prospective Cohort Study
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D007674', 'term': 'Kidney Diseases'}], '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'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 5304}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2012-01-03', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-06', 'completionDateStruct': {'date': '2021-05-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-06-24', 'studyFirstSubmitDate': '2021-06-07', 'studyFirstSubmitQcDate': '2021-06-24', 'lastUpdatePostDateStruct': {'date': '2021-07-02', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-07-02', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-08-04', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Any major post-biopsy complication event', 'timeFrame': 'one week follow-up after native kidney biopsy', 'description': 'The cecked of major post-biopsy complication events were clinically relevant hematomas, macrohematuria, decrease of haemoglobin levels after 24 hours \\> 2 g /dL, the need for blood transfusion, a large and persistent AV fistula, a post-biopsy anuria, an increase in serum creatinine greater than 50% in the week following biopsy, the need for invasive post-biopsy procedure related to the procedure including nephrectomy, the death related to biopsy'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Kidney Diseases']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'http://www.irrb.net/', 'label': 'Italian Registry Renal Biopsy'}]}, 'descriptionModule': {'briefSummary': 'The estimates risks and benefits of the percutaneous kidney biopsy have been reported mainly from retrospective studies. So far no prospective multicentre studies has been designed to identify rates of biopsy related complications. The aim of this prospective multicentre study was to evaluate safety and complication events related to biopsies on native kidney in Italy.', 'detailedDescription': 'Kidney biopsies performed in 54 italian nephrology centres from 2012 to 2020 were included.\n\nPrimary outcome of the study was any major complication, such as haemoglobin decrease more than 2 g/dL, macroematuria, gross ematoma, blood transfusion, artero-venous fistula, invasive intervention, pain, symptomatic hypotension, and/or rapid serum creatinine increase.\n\nCentre and individual patient risk predictors were analysed using multivariate logistic regression analysis.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Data collection of native kidney biopsies was centralized and takes place via Web by means of an ad hoc web-database linked to the National Italian Renal Biopsy Registry (http://www.irrb.net/). As this is an observational study, we collect information already available and typical of usual clinical practice. There are no particular requested exams.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* adult or pediatric patients with a kidney disease\n* informed Consent\n\nExclusion Criteria:\n\n* patient with a transplanted kidney'}, 'identificationModule': {'nctId': 'NCT04948593', 'briefTitle': 'The Risks of Percutaneous Native Kidney Biopsy in Italy: a Prospective Cohort Study', 'organization': {'class': 'OTHER', 'fullName': 'A. Manzoni Hospital'}, 'officialTitle': 'The Risks of Percutaneous Native Kidney Biopsy in Italy in the Third Millennium: a Prospective Cohort Study', 'orgStudyIdInfo': {'id': 'KidneyBiopsyRisk in Italy'}}, 'armsInterventionsModule': {'interventions': [{'name': 'Native kidney biopsy', 'type': 'PROCEDURE'}]}, 'contactsLocationsModule': {'locations': [{'city': 'Agrigento', 'country': 'Italy', 'facility': 'San Giovanni di Dio Hospital', 'geoPoint': {'lat': 37.31065, 'lon': 13.57661}}, {'city': 'Bari', 'country': 'Italy', 'facility': 'Giovanni XXIII pediatric Hospital', 'geoPoint': {'lat': 41.12066, 'lon': 16.86982}}, {'city': 'Bari', 'country': 'Italy', 'facility': 'Policlinico Hospital', 'geoPoint': {'lat': 41.12066, 'lon': 16.86982}}, {'city': 'Bologna', 'country': 'Italy', 'facility': 'S. Orsola Hospital', 'geoPoint': {'lat': 44.49381, 'lon': 11.33875}}, {'city': 'Catania', 'country': 'Italy', 'facility': 'Cannizzaro Hospital', 'geoPoint': {'lat': 37.49223, 'lon': 15.07041}}, {'city': 'Chieti', 'country': 'Italy', 'facility': 'S. Camillo Hospital', 'geoPoint': {'lat': 42.34827, 'lon': 14.16494}}, {'city': 'Cuneo', 'country': 'Italy', 'facility': 'Santa Croce Hospital', 'geoPoint': {'lat': 44.39071, 'lon': 7.54828}}, {'city': 'Eboli', 'country': 'Italy', 'facility': 'Maria SS. Addolorata Hospital', 'geoPoint': {'lat': 40.61747, 'lon': 15.05693}}, {'city': 'Foggia', 'country': 'Italy', 'facility': 'University Hospital', 'geoPoint': {'lat': 41.45845, 'lon': 15.55188}}, {'city': 'Messina', 'country': 'Italy', 'facility': 'Policlinico Hospital', 'geoPoint': {'lat': 38.19394, 'lon': 15.55256}}, {'city': 'Palermo', 'country': 'Italy', 'facility': 'Cervello Hospital', 'geoPoint': {'lat': 38.1166, 'lon': 13.3636}}, {'city': 'Parma', 'country': 'Italy', 'facility': 'Riuniti Hospital', 'geoPoint': {'lat': 44.79935, 'lon': 10.32618}}, {'city': 'Pesaro', 'country': 'Italy', 'facility': 'Ospedali Riuniti Marche Nord Hospital', 'geoPoint': {'lat': 43.90921, 'lon': 12.9164}}, {'city': 'Pisa', 'country': 'Italy', 'facility': 'Cisanello Hospital', 'geoPoint': {'lat': 43.70853, 'lon': 10.4036}}, {'city': 'Roma', 'country': 'Italy', 'facility': 'Umberto 1° Hospital', 'geoPoint': {'lat': 44.99364, 'lon': 11.10642}}, {'city': 'Rozzano', 'country': 'Italy', 'facility': 'Istituto Clinico Humanitas', 'geoPoint': {'lat': 45.38193, 'lon': 9.1559}}, {'city': 'San Giovanni Rotondo', 'country': 'Italy', 'facility': 'Sollievo Sofferenza Hospital', 'geoPoint': {'lat': 41.70643, 'lon': 15.7277}}, {'city': 'Viterbo', 'country': 'Italy', 'facility': 'Belcolle Hospital', 'geoPoint': {'lat': 42.41937, 'lon': 12.1056}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Simeone Andrulli, MD', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'Simeone Andrulli, MD', 'investigatorFullName': 'Simeone Andrulli, MD', 'investigatorAffiliation': 'A. Manzoni Hospital'}}}}