Ignite Creation Date:
2025-12-24 @ 4:49 PM
Ignite Modification Date:
2026-01-02 @ 6:59 AM
Study NCT ID:
NCT06223750
Status:
ENROLLING_BY_INVITATION
Last Update Posted:
2025-09-02
First Post:
2023-12-19
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Virtual Kidney Check and Follow-up
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': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'SCREENING', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 3356}}, 'statusModule': {'overallStatus': 'ENROLLING_BY_INVITATION', 'startDateStruct': {'date': '2024-11-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-08', 'completionDateStruct': {'date': '2029-04', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-08-25', 'studyFirstSubmitDate': '2023-12-19', 'studyFirstSubmitQcDate': '2024-01-15', 'lastUpdatePostDateStruct': {'date': '2025-09-02', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2024-01-25', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2029-04', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'The proportion of individuals who undergo screening for Chronic Kidney Disease (CKD)', 'timeFrame': '6 months', 'description': 'The proportion of individuals screened for Chronic Kidney Disease using one screening strategy is compared to the proportion of individuals screened using the other screening strategy.'}], 'secondaryOutcomes': [{'measure': 'New diagnosis of CKD (Chronic Kidney Disease)', 'timeFrame': '5 years', 'description': 'The proportion of individuals with a new diagnosis of CKD by estimated glomerular filtration rate (eGFR) or albuminuria for each screening strategy'}, {'measure': 'Anti-hyperintensive therapy', 'timeFrame': '5 years', 'description': 'The proportion of individuals treated with anti-hyperintensive therapy for each screening strategy'}, {'measure': 'Renin angiotensin aldosterone inhibitor blockade treatment', 'timeFrame': '5 years', 'description': 'The proportion of individuals treated with renin angiotensin aldosterone inhibitor blockade for each screening strategy'}, {'measure': 'Sodium Glucose Cotransporter 2 (SGLT2) inhibition treatment', 'timeFrame': '5 years', 'description': 'The proportion of individuals treated with Sodium Glucose Cotransporter 2 (SGLT2) inhibition for each screening strategy'}, {'measure': 'Mineral corticoid receptor antagonist treatment', 'timeFrame': '5 years', 'description': 'The proportion of individuals treated with a mineral corticoid receptor antagonist for each screening strategy'}, {'measure': 'Statins treatment', 'timeFrame': '5 years', 'description': 'The proportion of individuals treated with statins for each screening strategy'}, {'measure': 'Anti-platelet agents treatment', 'timeFrame': '5 years', 'description': 'The proportion of individuals treated with anti-platelet agents for each screening strategy'}, {'measure': 'Hospitalizations for diseases', 'timeFrame': '5 years', 'description': 'The proportion of individuals treated with hospitalizations for acute coronary syndrome, peripheral vascular disease, cerebrovascular disease or heart failure rate. Urine albumin to creatinine ratio, kidney failure risk equation (KFRE) measurements are also calculated for each screening strategy'}, {'measure': 'The number of antihypertensive medications', 'timeFrame': '5 years', 'description': 'The number of antihypertensive medications per individual for each screening strategy'}, {'measure': 'Change in estimated Glomerular Filtration Rate, urine albumin to creatinine ratio, kidney failure risk equation measurements', 'timeFrame': '5 years', 'description': 'Change in estimated Glomerular Filtration Rate, urine albumin to creatinine ratio, kidney failure risk equation measurements for each individual'}, {'measure': 'estimated Glomerular Filtration Rate slope', 'timeFrame': '5 years', 'description': 'Tracking changes in estimated Glomerular Filtration Rate over time indicates progression of chronic kidney disease for each individual'}, {'measure': 'Number of individuals with 40 % decline in estimated Glomerular Filtration Rate', 'timeFrame': '5 years', 'description': 'Number of individuals with 40 % decline in estimated Glomerular Filtration Rate'}, {'measure': 'Number of individuals with kidney failure', 'timeFrame': '5 years', 'description': 'Number of individuals with kidney failure'}, {'measure': 'Number of individuals on dialysis', 'timeFrame': '5 years', 'description': 'Number of individuals on dialysis'}, {'measure': 'Number of individuals to receive kidney transplant', 'timeFrame': '5 years', 'description': 'Number of individuals to receive kidney transplant'}, {'measure': 'Number of individuals who have died', 'timeFrame': '5 years', 'description': 'Number of individuals who have died'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Kidney Disease, Chronic']}, 'descriptionModule': {'briefSummary': 'The goal of this clinical trial is to determine the most effective way to complete population-based screening for chronic kidney disease (CKD) in First Nations adults in Manitoba. The main questions it aims to answer are:\n\n* To identify chronic kidney disease in First Nations adults in Manitoba\n* To risk stratify patients as low, moderate and high risk of kidney failure and organize active surveillance by risk category\n* To initiate treatments to prevent to progression of chronic kidney disease in individuals at risk of kidney failure\n\nParticipants will be randomized to:\n\n1. Patient contact via mail with a letter and laboratory requisition for serum creatinine and urine Albumin Creatinine Ratio\n2. Patient and primary care network contact via mail with a letter but no laboratory requisition\n\nThe primary outcome is the difference between groups in the proportion of individuals who undergo screening for chronic kidney disease within 6 months.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age\\>= 18 years\n* Resident of Manitoba\n* First Nations\n* Urban, rural or remote location\n\nExclusion Criteria:\n\n* Kidney failure (dialysis or transplant)\n* chronic kidney disease (estimated Glomerular Filtration Rate \\<60 milliliter/1.73square meter for 3 months)\n* Screening for chronic kidney disease with estimated Glomerular Filtration Rate or Albumin to Creatinine ratio in the last 2 years'}, 'identificationModule': {'nctId': 'NCT06223750', 'briefTitle': 'Virtual Kidney Check and Follow-up', 'organization': {'class': 'OTHER', 'fullName': 'University of Manitoba'}, 'officialTitle': 'Virtual Kidney Check and Follow-up', 'orgStudyIdInfo': {'id': 'HS24845 (H2021:170)'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': 'Patient contact via mail with a letter and laboratory requisition', 'description': 'Patient contact via mail with a letter and laboratory requisition for serum creatinine and urine albumin to creatinine ratio', 'interventionNames': ['Other: population-based screening for chronic kidney disease']}, {'type': 'OTHER', 'label': 'Patient and primary care network contact via mail with a letter but no laboratory requisition', 'interventionNames': ['Other: population-based screening for chronic kidney disease']}], 'interventions': [{'name': 'population-based screening for chronic kidney disease', 'type': 'OTHER', 'description': 'Randomized controlled trial that uses an integrated health platform for eligibility and outcome assessments', 'armGroupLabels': ['Patient and primary care network contact via mail with a letter but no laboratory requisition', 'Patient contact via mail with a letter and laboratory requisition']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Winnipeg', 'country': 'Canada', 'facility': 'Chronic Disease Innovation Centre', 'geoPoint': {'lat': 49.8844, 'lon': -97.14704}}], 'overallOfficials': [{'name': 'David Collister, MD, PhD, FRCPC', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Manitoba'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Manitoba', 'class': 'OTHER'}, 'collaborators': [{'name': 'Boehringer Ingelheim', 'class': 'INDUSTRY'}, {'name': 'Research Manitoba', 'class': 'OTHER'}, {'name': 'Manitoba Health, Seniors and Long-Term Care, Province of Manitoba', 'class': 'UNKNOWN'}, {'name': 'First Nations Health and Social Secretariat of Manitoba', 'class': 'UNKNOWN'}, {'name': 'Shared Health Manitoba', 'class': 'UNKNOWN'}, {'name': 'Seven Oaks General Hospital', 'class': 'UNKNOWN'}], 'responsibleParty': {'type': 'SPONSOR'}}}}