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.
The 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.
Age ≥ 18 years
T2DM
CKD (eGFR ≥ 25-60 OR UACR ≥ 30 mg/g)
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/L OR on cholesterol lowering medication), hypertension (≥130/80 mmHg or on BPLMs), or atrial fibrillation.)
Type 1 diabetes
HbA1c ≥10% on screening labs
Serum potassium ≥ 5.2 mmol/L on screening labs
Baseline Blood Pressure (BP) < 100/60 mmHg at screening
Sunnybrook Health Sciences Centre
Lead sponsor
The Kidney Foundation of Canada
Collaborator