[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100591699":3},{"organization":4,"armGroups":7,"interventions":22,"overallOfficials":43,"centralContacts":48,"locations":54,"responsibleParty":76,"collaborators":34,"id":78,"slug":79,"hasResults":80,"nctId":81,"briefTitle":82,"officialTitle":83,"acronym":84,"eligibilityCriteria":85,"healthyVolunteers":80,"sex":86,"minAge":87,"maxAge":34,"enrollmentInfo":88,"targetDuration":34,"studyType":91,"phases":92,"briefSummary":94,"conditions":95,"keywords":98,"overallStatus":69,"whyStopped":34,"lastUpdateSubmitDate":108,"lastUpdatePostDateStruct":109,"startDateStruct":112,"completionDateStruct":114,"leadSponsor":116,"locationsCount":117},{"fullName":5,"class":6},"Ottawa Hospital Research Institute","OTHER",[8,16],{"label":9,"type":10,"description":11,"interventionNames":12},"Intervention Arm","EXPERIMENTAL","IV Cyclophosphamide x 2 doses AND Rituximab AND Prednisone x 4 weeks",[13,14,15],"Drug: Cyclophosphamide","Drug: Prednisone","Drug: Rituximab (R)",{"label":17,"type":18,"description":19,"interventionNames":20},"Standard of care","ACTIVE_COMPARATOR","Participants in this arm receive standard of care treatment induction agent and glucocorticoid dose\u002Fduration, left to the discretion of the investigator",[21],"Drug: Standard of Care (SOC)",[23,30,35,39],{"type":24,"name":25,"description":26,"armGroupLabels":27,"otherNames":28},"DRUG","Cyclophosphamide","IV Cyclophosphamide 15mg\u002Fkg\u002Fdose (age and eGFR adjusted), 2 doses 2 weeks apart",[9],[29],"Cytoxan",{"type":24,"name":31,"description":32,"armGroupLabels":33,"otherNames":34},"Standard of Care (SOC)","Participants will receive standard of care induction agent and glucocorticoid taper, at investigator discretion",[17],null,{"type":24,"name":36,"description":37,"armGroupLabels":38,"otherNames":34},"Prednisone","4 weeks prednisone taper",[9],{"type":24,"name":40,"description":41,"armGroupLabels":42,"otherNames":34},"Rituximab (R)","Rituximab infusions, dosing and schedule at clinician\u002Finvestigator discretion",[9],[44],{"name":45,"affiliation":46,"role":47},"David Massicotte-Azarniouch, MD, MSc","The Ottawa Hospital","PRINCIPAL_INVESTIGATOR",[49],{"name":45,"role":50,"phone":51,"phoneExt":52,"email":53},"CONTACT","613-738-8400","82891","damassicotte@toh.ca",[55,68],{"facility":56,"status":57,"city":58,"state":59,"zip":34,"country":60,"countryCode":61,"cosmosGeoPoint":62,"geoPoint":67,"contacts":34},"St-Joseph's Hospital","NOT_YET_RECRUITING","Hamilton","Ontario","Canada","CA",{"type":63,"coordinates":64},"Point",[65,66],-79.84963,43.25011,{"lat":66,"lon":65},{"facility":46,"status":69,"city":70,"state":59,"zip":34,"country":60,"countryCode":61,"cosmosGeoPoint":71,"geoPoint":75,"contacts":34},"RECRUITING","Ottawa",{"type":63,"coordinates":72},[73,74],-75.69812,45.41117,{"lat":74,"lon":73},{"type":77,"investigatorFullName":34,"investigatorTitle":34,"investigatorAffiliation":34,"oldNameTitle":34,"oldOrganization":34},"SPONSOR","100591699","phase-3-safe-effective-therapy-with-low-dose-glucocorticoid-in-anca-associated-vasculitis-safe-low-100591699",false,"NCT06983821","Safe Effective Therapy With Low-Dose Glucocorticoid in ANCA-Associated Vasculitis (SAFE-LOW)","Safe Effective Therapy With Low-Dose Glucocorticoid in ANCA-Associated Vasculitis (SAFE-LOW) Trial","SAFE-LOW","* New diagnosis of, or relapse of, granulomatosis with polyangiitis (GPA) or microscopic polyangiitis (MPA), consistent with Chapel-Hill consensus definitions\n* Positive ELISA test for anti-meyloperoxidase (MPO) or anti-proteinase 3 (PR3)\n* Severe kidney involvement from active AAV, characterised by both of the following:\n* eGFR \\\u003C 40ml\u002Fmin\u002F1.73m2 (Patients known to have a stable eGFR \\\u003C40 ml\u002Fmin\u002F1.73m2 for \\>3 months prior to enrollment are NOT eligible)\n* Biopsy proven at least focal necrotizing\u002Fcrescentic glomerulonephritis OR active urinary sediment by microscopy (greater than or equal to 10 red blood cells \\[RBC\\]\u002Fhigh power field with erythrocyte casts or greater than or equal to 20% dysmorphic RBCs or greater than or equal to 5% acanthocytes without an alternative cause.\n\nExclusion Criteria (any of the following)\n\n* A diagnosis of vasculitis other than GPA or MPA (including eosinophilic granulomatosis with polyangiitis, IgA vasculitis, cryoglobulinemic vasculitis, rheumatoid vasculitis)\n* Positive anti-glomerular basement membrane antibody test or renal biopsy demonstrating linear glomerular immunoglobulin deposition\n* A diagnosis of systemic lupus erythematosus or Sjögren's syndrome\n* Receipt of dialysis for \\>21 days immediately prior to randomization or prior renal transplant\n* Age \\\u003C18\n* Pregnant at time of screening\n* Treatment with \\>1 IV dose of CYC and\u002For \\>14 days PO CYC and\u002For \\>14 days of prednisone\u002Fprednisone (less than or equal to 30mg\u002Fday) and\u002For \\>1 dose of RTX within the 28 days immediately prior to randomization\n* Chronic viral infection: HIV. HBV or HCV\n* Untreated latent mycobacterium tuberculosis infection\n* Active infection at time of presentation\n* A comorbidity or condition that, in the opinion of the investigator, precludes the use of GC, CYC or RTX","ALL","18 Years",{"count":89,"type":90},36,"ESTIMATED","INTERVENTIONAL",[93],"PHASE3","The purpose of this study is to determine the safety and efficacy of a therapeutic regimen consisting of 4 weeks of glucocorticoids given with a combination of the usual induction agents for ANCA-associated vasculitis. The trial will compare this regimen to the current standard of care treatment and glucocorticoid dosing for ANCA-associated vasculitis with severe kidney involvement. This trial will begin as a pilot to assess feasibility of recruitment and of adherence to the intervention.",[96,97],"Granulomatosis With Polyangiitis","Microscopic Polyangiitis (MPA)",[99,100,101,102,103,104,105,106,107],"ANCA-associated vasculitis","cyclophosphamide","glucoccorticoid","rituximab","vasculitis","granulomatosis with polyangiitis","microscopic polyangiitis","GPA","MPA","2026-01-28",{"date":110,"type":111},"2026-01-30","ACTUAL",{"date":113,"type":111},"2025-11-10",{"date":115,"type":90},"2029-02",{"name":5,"class":6},2]