Goal-Directed Therapy to Reduce Kidney and Cardiovascular Risk in Diabetic Kidney Disease (GOLD-S… (NCT07434791) | Clinical Trial Compass
Not Yet RecruitingNot Applicable
Goal-Directed Therapy to Reduce Kidney and Cardiovascular Risk in Diabetic Kidney Disease (GOLD-STANDARD)
100 participantsStarted 2026-06
Plain-language summary
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.
Who can participate
Age range18 Years
SexALL
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Inclusion criteria
✓. 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.)
✓. Open to start new medications
Exclusion criteria
✕. 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
✕. Treated with new or intensified immunosuppression therapy for new (or relapse/flare of pre-existing) kidney disease within the last 60 days
What they're measuring
1
Feasibility of the pivotal Randomized Controlled Trial (RCT)
Timeframe: From consent through completion of screening procedures to randomization (maximum 60 days).
2
Prescription and Adherence to Guideline-Directed Medical Therapy (GDMT)
Timeframe: 12 months after randomization (±45-day window).
✕. Use of ≥3 medication classes: Participants already prescribed three or more of the following classes of medications: RASi, SGLT2i, nsMRA or GLP1RA
✕. Intolerance or allergy to any of RASi, SGLT2i, nsMRA or GLP1RA