Ignite Creation Date:
2025-12-24 @ 5:53 PM
Ignite Modification Date:
2026-01-01 @ 3:33 PM
Study NCT ID:
NCT05043168
Status:
COMPLETED
Last Update Posted:
2022-05-19
First Post:
2021-09-10
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Kidney Histopathology After COVID-19 and SARS-CoV-2 Vaccination
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000086382', 'term': 'COVID-19'}], 'ancestors': [{'id': 'D011024', 'term': 'Pneumonia, Viral'}, {'id': 'D011014', 'term': 'Pneumonia'}, {'id': 'D012141', 'term': 'Respiratory Tract Infections'}, {'id': 'D007239', 'term': 'Infections'}, {'id': 'D014777', 'term': 'Virus Diseases'}, {'id': 'D018352', 'term': 'Coronavirus Infections'}, {'id': 'D003333', 'term': 'Coronaviridae Infections'}, {'id': 'D030341', 'term': 'Nidovirales Infections'}, {'id': 'D012327', 'term': 'RNA Virus Infections'}, {'id': 'D008171', 'term': 'Lung Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITH_DNA', 'description': 'Kidney biopsy'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'OTHER', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 42}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2021-09-18', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-05', 'completionDateStruct': {'date': '2022-05-17', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-05-18', 'studyFirstSubmitDate': '2021-09-10', 'studyFirstSubmitQcDate': '2021-09-13', 'lastUpdatePostDateStruct': {'date': '2022-05-19', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-09-14', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-12-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Frequency of histopathologically confirmed glomerular and tubulointerstitial diseases', 'timeFrame': 'Kidney biopsy obtained during COVID-19 disease and up to 3 months after SARS-CoV-2 vaccination'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Covid19', 'Vaccination Reaction']}, 'referencesModule': {'references': [{'pmid': '32402155', 'type': 'BACKGROUND', 'citation': 'Puelles VG, Lutgehetmann M, Lindenmeyer MT, Sperhake JP, Wong MN, Allweiss L, Chilla S, Heinemann A, Wanner N, Liu S, Braun F, Lu S, Pfefferle S, Schroder AS, Edler C, Gross O, Glatzel M, Wichmann D, Wiech T, Kluge S, Pueschel K, Aepfelbacher M, Huber TB. Multiorgan and Renal Tropism of SARS-CoV-2. N Engl J Med. 2020 Aug 6;383(6):590-592. doi: 10.1056/NEJMc2011400. Epub 2020 May 13. No abstract available.'}, {'pmid': '32660970', 'type': 'BACKGROUND', 'citation': 'Sharma P, Uppal NN, Wanchoo R, Shah HH, Yang Y, Parikh R, Khanin Y, Madireddy V, Larsen CP, Jhaveri KD, Bijol V; Northwell Nephrology COVID-19 Research Consortium. COVID-19-Associated Kidney Injury: A Case Series of Kidney Biopsy Findings. J Am Soc Nephrol. 2020 Sep;31(9):1948-1958. doi: 10.1681/ASN.2020050699. Epub 2020 Jul 13.'}, {'pmid': '34182049', 'type': 'BACKGROUND', 'citation': "Bomback AS, Kudose S, D'Agati VD. De Novo and Relapsing Glomerular Diseases After COVID-19 Vaccination: What Do We Know So Far? Am J Kidney Dis. 2021 Oct;78(4):477-480. doi: 10.1053/j.ajkd.2021.06.004. Epub 2021 Jun 25. No abstract available."}, {'pmid': '36723286', 'type': 'DERIVED', 'citation': 'de Las Mercedes Noriega M, Husain-Syed F, Wulf S, Csala B, Krebs CF, Jabs WJ, Zipfel PF, Grone HJ, Wiech T; CoV-Kidney Investigators. Kidney Biopsy Findings in Patients with SARS-CoV-2 Infection or After COVID-19 Vaccination. Clin J Am Soc Nephrol. 2023 May 1;18(5):613-625. doi: 10.2215/CJN.0000000000000106. Epub 2023 Feb 1.'}]}, 'descriptionModule': {'briefSummary': 'The study aims to summarize kidney histopathological findings in patients with coronavirus disease 2019 (COVID-19) and post-severe acute respiratory syndrome-coronavirus-type 2 (SARS-CoV-2) vaccination.', 'detailedDescription': 'The SARS-CoV-2 pandemic has had substantial global morbidity and mortality. While COVID-19 is most commonly characterized as a respiratory illness, extrapulmonary manifestations are a prominent part its clinical spectrum. Kidney disease is a common finding in COVID-19, and has also been rarely described after SARS-CoV-2 vaccination. The main objective of this study is to summarize kidney histopathological findings in patients with COVID-19 and post-SARS-COV-2 vaccination, in whom native kidney biopsy was performed and samples were obtained by the Nephropathology Section, Institute of Pathology, University Medical Center Hamburg-Eppendorf, Hamburg, Germany.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Primary inpatient and outpatient care', 'eligibilityCriteria': 'Inclusion Criteria:\n\n* being diagnosed with COVID-19 when kidney biopsy was performed\n* history of recent homologous or heterogenous vaccine regimen comprising either vector-based vaccines or messenger ribonucleic acid-based vaccines\n\nExclusion Criteria:\n\n* Patient refuses participation'}, 'identificationModule': {'nctId': 'NCT05043168', 'briefTitle': 'Kidney Histopathology After COVID-19 and SARS-CoV-2 Vaccination', 'organization': {'class': 'OTHER', 'fullName': 'University of Giessen'}, 'officialTitle': 'Kidney Histopathological Features in Patients After COVID-19 and SARS-CoV-2 Vaccination', 'orgStudyIdInfo': {'id': '2021-100682-BO-ff'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Patients with COVID-19', 'description': 'Polymerase Chain Reaction-positive SARS-CoV-2 infection'}, {'label': 'Patients post-SARS-CoV-2 vaccination', 'description': 'Onset of kidney disease potentially relatable to SARS-CoV-2 vaccination based on clinical grounds'}]}, 'contactsLocationsModule': {'locations': [{'zip': '35392', 'city': 'Giessen', 'state': 'Hesse', 'country': 'Germany', 'facility': 'University Clinic Giessen and Marburg - Campus Giessen', 'geoPoint': {'lat': 50.58727, 'lon': 8.67554}}], 'overallOfficials': [{'name': 'Thorsten Wiech, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Nephropathology Section, Institute of Pathology, University Medical Center Hamburg-Eppendorf, Hamburg, Germany'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Giessen', 'class': 'OTHER'}, 'collaborators': [{'name': 'Universitätsklinikum Hamburg-Eppendorf', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}