[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100626373":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":25,"centralContacts":30,"locations":25,"responsibleParty":36,"collaborators":38,"id":41,"slug":42,"hasResults":43,"nctId":44,"briefTitle":45,"officialTitle":46,"acronym":47,"eligibilityCriteria":48,"healthyVolunteers":43,"sex":49,"minAge":50,"maxAge":25,"enrollmentInfo":51,"targetDuration":25,"studyType":54,"phases":55,"briefSummary":57,"conditions":58,"keywords":60,"overallStatus":65,"whyStopped":25,"lastUpdateSubmitDate":66,"lastUpdatePostDateStruct":67,"startDateStruct":70,"completionDateStruct":72,"leadSponsor":74,"locationsCount":25},{"fullName":5,"class":6},"Sunnybrook Health Sciences Centre","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Comparison Arm","ACTIVE_COMPARATOR","Standard of care",[13],"Other: Standard care (Comparison arm)",{"label":15,"type":16,"description":17,"interventionNames":18},"Intervention arm","EXPERIMENTAL","CKM",[19],"Other: Early goal-directed Cardio-Kidney-Metabolic (CKM) care",[21,26],{"type":6,"name":22,"description":23,"armGroupLabels":24,"otherNames":25},"Early goal-directed Cardio-Kidney-Metabolic (CKM) care","The participants in the intervention arm will be referred to a Nephrologist and receive: 1. Iterative assessment of kidney and CV risk; 2. Early shared decision making regarding starting RASi, SGLT2i, nsMRA and GLP1RA, to reduce kidney and cardiovascular risk in diabetic kidney disease (DKD). This will be informed by a 6-month GDMT protocol and supported by multidisciplinary teams and\u002For health care technology 3. Close monitoring of side effects.",[15],null,{"type":6,"name":27,"description":28,"armGroupLabels":29,"otherNames":25},"Standard care (Comparison arm)","The standard care group will be prescribed medications based on clinical judgment by the clinician as usual care. Usual care involves incremental addition of treatment based on clinical judgment or specialty specific biomarkers (e.g. UACR) at clinic visits often spaced 3-12 months apart.",[9],[31],{"name":32,"role":33,"phone":34,"phoneExt":25,"email":35},"Kristina Hyunjee Lee, M.Ed","CONTACT","437-869-7138","Gold-standard@sunnybrook.ca",{"type":37,"investigatorFullName":25,"investigatorTitle":25,"investigatorAffiliation":25,"oldNameTitle":25,"oldOrganization":25},"SPONSOR",[39],{"name":40,"class":6},"The Kidney Foundation of Canada","100626373","goal-directed-therapy-to-reduce-kidney-and-cardiovascular-risk-in-diabetic-kidney-disease-gold-standard-100626373",false,"NCT07434791","Goal-Directed Therapy to Reduce Kidney and Cardiovascular Risk in Diabetic Kidney Disease (GOLD-STANDARD)","GOaL Directed-STrategic Approach With New Disease-modifying theraApies to Reduce Kidney and Cardiovascular Risk in Patients With Diabetic Kidney Disease","GOLD-STANDARD","Inclusion Criteria\n\n1. Age ≥ 18 years\n2. T2DM\n3. CKD (eGFR ≥ 25-60 OR UACR ≥ 30 mg\u002Fg)\n4. High Cardiovascular (CV) Risk: Defined as a history of prior myocardial infarction (MI), stroke, or peripheral artery disease (PAD), or the presence of cardiovascular risk factors, (specifically age 40 years or older and at least one of the following: cholesterol above target (LDL≥1.8 mmol\u002FL OR on cholesterol lowering medication), hypertension (≥130\u002F80 mmHg or on BPLMs), or atrial fibrillation.)\n5. Open to start new medications\n\nExclusion Criteria:\n\n1. Type 1 diabetes\n2. HbA1c ≥10% on screening labs\n3. Serum potassium ≥ 5.2 mmol\u002FL on screening labs\n4. Baseline Blood Pressure (BP) \\\u003C 100\u002F60 mmHg at screening\n5. Treated with new or intensified immunosuppression therapy for new (or relapse\u002Fflare of pre-existing) kidney disease within the last 60 days\n6. Kidney Transplant\n7. Use of ≥3 medication classes: Participants already prescribed three or more of the following classes of medications: RASi, SGLT2i, nsMRA or GLP1RA\n8. Intolerance or allergy to any of RASi, SGLT2i, nsMRA or GLP1RA\n9. Known Heart Failure with Reduced Ejection Fraction (HFrEF)\n10. Current pregnancy, lactation or women of childbearing potential, unless using highly effective contraception","ALL","18 Years",{"count":52,"type":53},100,"ESTIMATED","INTERVENTIONAL",[56],"NA","GOLD-STANDARD is a pragmatic, open-label pilot randomized controlled trial evaluating the feasibility and safety of early goal-directed Cardio-Kidney-Metabolic (CKM) care compared with usual care in patients with diabetic kidney disease. Participants will be randomized 1:1 and managed by nephrologists.\n\nThe intervention includes structured kidney and cardiovascular risk assessment, early shared decision-making regarding guideline-directed medical therapies, and close monitoring for adverse effects. The usual care group will receive standard clinical management at the discretion of the treating clinician. The study will be conducted in Ontario using existing health care infrastructure.",[59],"Diabetic Kidney Disease (DKD)",[61,62,63,64],"diabetes","diabetic kidney disease","cardiovascular risk","Cardio-Kidney-Metabolic (CKM) care","NOT_YET_RECRUITING","2026-05-01",{"date":68,"type":69},"2026-05-07","ACTUAL",{"date":71,"type":53},"2026-06",{"date":73,"type":53},"2029-03",{"name":5,"class":6}]