Ignite Creation Date:
2025-12-25 @ 3:56 AM
Ignite Modification Date:
2026-02-24 @ 3:01 PM
Study NCT ID:
NCT04029402
Status:
RECRUITING
Last Update Posted:
2021-04-30
First Post:
2019-07-21
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Molecular Analysis of Diabetic Kidney Disease Biopsies
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003928', 'term': 'Diabetic Nephropathies'}, {'id': 'D051436', 'term': 'Renal Insufficiency, Chronic'}], 'ancestors': [{'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': 'D048909', 'term': 'Diabetes Complications'}, {'id': 'D003920', 'term': 'Diabetes Mellitus'}, {'id': 'D004700', 'term': 'Endocrine System 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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D017423', 'term': 'Sequence Analysis, RNA'}, {'id': 'D016626', 'term': 'Shadowing Technique, Histology'}], 'ancestors': [{'id': 'D017421', 'term': 'Sequence Analysis'}, {'id': 'D005821', 'term': 'Genetic Techniques'}, {'id': 'D008919', 'term': 'Investigative Techniques'}, {'id': 'D013194', 'term': 'Staining and Labeling'}, {'id': 'D016591', 'term': 'Histocytological Preparation Techniques'}, {'id': 'D003584', 'term': 'Cytological Techniques'}, {'id': 'D019411', 'term': 'Clinical Laboratory Techniques'}, {'id': 'D019937', 'term': 'Diagnostic Techniques and Procedures'}, {'id': 'D003933', 'term': 'Diagnosis'}, {'id': 'D006652', 'term': 'Histological Techniques'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'CASE_CONTROL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 500}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2019-07-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-04', 'completionDateStruct': {'date': '2025-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2021-04-27', 'studyFirstSubmitDate': '2019-07-21', 'studyFirstSubmitQcDate': '2019-07-21', 'lastUpdatePostDateStruct': {'date': '2021-04-30', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-07-23', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Interstitial fibrosis', 'timeFrame': 'Baseline biopsy', 'description': 'Extent of interstitial fibrosis in kidney biopsy assessed using a semi-quantitative scale on light microscopy of biopsy sections'}, {'measure': 'Glomerulosclerosis', 'timeFrame': 'Baseline biopsy', 'description': 'Extent of glomerulosclerosis in kidney biopsy assessed using a semi-quantitative scale on light microscopy of biopsy sections'}, {'measure': 'Renal function change', 'timeFrame': 'Baseline biopsy', 'description': 'Slope of eGFR decline'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Diabetic Nephropathies', 'Kidney Disease, Chronic']}, 'descriptionModule': {'briefSummary': 'Despite decades of research, the pathogenesis of human diabetic kidney disease remains largely unclear. Our goal is to use archived human kidney biopsy tissue from patients with and with diabetic nephropathy to identify new molecules that drive and/or protect against disease progression. We will use RNA sequencing to identify transcriptomic changes that associate with histologic and functional outcomes.', 'detailedDescription': "RESEARCH OBJECTIVES A. To identify differences in transcription profiles obtained from residual kidney tissue which was obtained for clinical purposes.\n\nB. To identify differences in transcription profile between patients whose loss of kidney function progresses rapidly (eGFR decline ≥4ml/min/year) and in whom it progresses more slowly (eGFR decline \\<4ml/min/year).\n\nC. To identify differences in transcription profile between predominantly glomerular and predominantly tubulointerstitial histopathological types .\n\nD. To identify new pathogenetic pathways that may become targets for therapeutic intervention\n\nMETHODS The planned study centres on the use of archival biopsy material that is superfluous to what is or would be needed for clinical care (01/01/1995 to 31/05/2018 , n= approximately 400-500). Archived samples will be collected from St. Michael's Hospital and a number of collaborating centres, including but not limited to University of British Columbia, the University of Manitoba, and the University of Ottawa.\n\nRNA will be extracted from the biopsy material using either the core that has been used for immunofluorescence microscopy and is stored at -80˚C, and/or the core that is formalin-fixed, embedded in paraffin wax and stored at room temperature. The RNA thereby extracted will be subjected to detailed interrogation by RNASeq to quantify the expression level of mRNAs (transcriptome) and compare differences, as indicated in the research objectives detailed above. The transcriptome will then be related to the clinical course (eGFR decline) and histopathological changes, in addition to examining potentially pathogenetically important and that are amenable to therapeutic intervention.\n\nHistopathology will also be performed and classified according to established systems.\n\nClinical information that would be retrieved from patients' medical records are listed below.\n\nClinical data\n\n1. Age\n2. Gender\n3. Ethnicity\n4. Diabetes history\n5. Diabetes type: 1, 2\n6. Retinopathy history\n7. Smoking history\n8. Medications\n9. Comorbidities\n10. Past medical history\n11. Primary nephrologist Laboratory data (prior to biopsy, at biopsy and post-biopsy)\n12. Renal function measures and calculations. For example:\n\n i. Serum creatinine, eGFR ii. Change in creatinine and eGFR iii. Urinary albumin:creatinine values and ratio (ACR) iv. Urine protein:creatinine values and ratio (PCR) v. Urinary protein excretion rate (UPEx) vi. Changes in ACR, PCR, UPEx\n13. Diabetes measures and calculations. Biopsy data\n14. Biopsy related data\n\nEach site will locally maintain a confidential Master Linking Log.\n\nDe-identified data will be entered into a secure REDCap database that is hosted by St. Michael's Hospital."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'genderBased': True, 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': '1. Cases: A group of patients with diabetic kidney disease\n2. Controls: A group of healthy control patients', 'eligibilityCriteria': 'Inclusion Criteria (diabetic kidney disease cases):\n\n* history of type 1 or type 2 diabetes\n* at least 1 archived native kidney biopsy that demonstrates either pure diabetic kidney disease or features of non-specific vascular disease, including glomerulosclerosis, non-inflammatory vascular disease,\n* sufficient remaining archived kidney biopsy tissue for RNA sequencing (100 um thick tissue section) and histologic analysis (PAS and Masson Trichrome staining)\n\nExclusion Criteria (diabetic kidney disease cases):\n\n* less than 3 eGFR values post-biopsy\n* latest recorded eGFR values less than 6 months post-biopsy\n\nInclusion Criteria (healthy controls):\n\n\\- at least 1 native kidney disease biopsy with no diagnostic abnormality'}, 'identificationModule': {'nctId': 'NCT04029402', 'briefTitle': 'Molecular Analysis of Diabetic Kidney Disease Biopsies', 'organization': {'class': 'OTHER', 'fullName': 'Unity Health Toronto'}, 'officialTitle': 'Molecular Analysis of Diabetic Kidney Disease Biopsies', 'orgStudyIdInfo': {'id': '16-118'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Diabetic kidney disease', 'description': 'Patients with archived biopsies with a pathologic diagnosis of diabetic kidney disease, interstitial fibrosis/tubular atrophy, or nephrosclerosis.', 'interventionNames': ['Other: RNA sequencing']}, {'label': 'Healthy controls', 'description': 'Potential living donors with archived biopsies performed as part of their donor workup and with no diagnostic abnormalities', 'interventionNames': ['Other: RNA sequencing']}], 'interventions': [{'name': 'RNA sequencing', 'type': 'OTHER', 'otherNames': ['Histology', 'Slope of eGFR decline'], 'description': 'Transcriptomic analysis of kidney biopsy tissue, and linking with slope of eGFR decline', 'armGroupLabels': ['Diabetic kidney disease', 'Healthy controls']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Vancouver', 'state': 'British Columbia', 'status': 'NOT_YET_RECRUITING', 'country': 'Canada', 'contacts': [{'name': 'Sean Barbour, MD', 'role': 'CONTACT'}], 'facility': 'University of British Columbia', 'geoPoint': {'lat': 49.24966, 'lon': -123.11934}}, {'city': 'Winnipeg', 'state': 'Manitoba', 'status': 'NOT_YET_RECRUITING', 'country': 'Canada', 'contacts': [{'name': 'Claudio Rigatto, MD', 'role': 'CONTACT'}], 'facility': 'University of Manitoba', 'geoPoint': {'lat': 49.8844, 'lon': -97.14704}}, {'city': 'Ottawa', 'state': 'Ontario', 'status': 'NOT_YET_RECRUITING', 'country': 'Canada', 'contacts': [{'name': 'Kevin Burns, MD', 'role': 'CONTACT'}], 'facility': 'University of Ottawa', 'geoPoint': {'lat': 45.41117, 'lon': -75.69812}}, {'zip': 'M5B 1W8', 'city': 'Toronto', 'state': 'Ontario', 'status': 'RECRUITING', 'country': 'Canada', 'contacts': [{'name': 'Michelle Nash', 'role': 'CONTACT', 'email': 'nashm@smh.ca', 'phone': '416-864-6060', 'phoneExt': '3692'}], 'facility': "St. Michael's Hospital", 'geoPoint': {'lat': 43.70643, 'lon': -79.39864}}], 'centralContacts': [{'name': 'Richard Gilbert, MD PhD', 'role': 'CONTACT', 'email': 'richard.gilbert@utoronto.ca', 'phone': '416-864-3747'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Unity Health Toronto', 'class': 'OTHER'}, 'collaborators': [{'name': 'University of Ottawa', 'class': 'OTHER'}, {'name': 'University of British Columbia', 'class': 'OTHER'}, {'name': 'University of Manitoba', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}