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Goal-Directed Therapy to Reduce Kidney and Cardiovascular Risk in Diabetic Kidney Disease (GOLD-STANDARD)

Sponsor: Sunnybrook Health Sciences Centre • ClinicalTrials.gov ID: NCT07434791

Registry updated: 2026-09-04

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Description

GOLD-STANDARD is a pragmatic, open-label pilot randomized controlled trial evaluating the feasibility, safety, and implementation of an early goal-directed Cardio-Kidney-Metabolic (CKM) care strategy compared with usual care in adults with type 2 diabetes and diabetic kidney disease who are at increased cardiovascular risk. Participants will be followed for 12 months to assess treatment uptake, adherence, retention, and safety outcomes, and to inform the design of a future definitive trial.

Interventions

Early goal-directed Cardio-Kidney-Metabolic (CKM) care (Other)
Participants will be referred to a nephrologist and receive a structured Cardio-Kidney-Metabolic (CKM) care strategy that includes iterative assessment of kidney and cardiovascular risk, early shared decision-making regarding guideline-directed medical therapies (RASi, SGLT2i, nsMRA, and GLP-1 RA), and close monitoring of treatment implementation, tolerability, and adverse effects throughout the study follow-up period.
Standard care (Comparison arm) (Other)
Participants will receive standard nephrology care according to routine clinical practice. Medication initiation and adjustment will be based on clinician judgment and relevant clinical parameters, with treatments introduced incrementally as part of usual care.

Eligibility criteria

Inclusion Criteria 1. Age ≥ 18 years 2. T2DM 3. CKD (eGFR ≥ 25-60 mL/min/1.73 m² OR UACR ≥ 30 mg/g) - on screening labs 4. 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 - within past 24 months), hypertension (≥130/80 mmHg or on BPLMs), or atrial fibrillation.) 5. Open to start new medications Exclusion Criteria: 1. Type 1 diabetes 2. HbA1c ≥10% within past 12 months 3. Serum potassium ≥ 5.2 mmol/L on screening labs 4. Baseline Blood Pressure (BP) \< 100/60 mmHg at screening 5. Treated with new or intensified immunosuppression therapy for new (or relapse/flare of pre-existing) kidney disease within the last 60 days 6. Kidney Transplant 7. In the opinion of the investigator, currently treated with maximum tolerated dose of ≥3 medication classes:: RASi, SGLT2i, nsMRA or GLP1RA 8. Currently prescribed all 4 medication classes : RASi, SGLT2i, nsMRA or GLP1RA 9. Intolerance or allergy to any of RASi, SGLT2i, nsMRA or GLP1RA 10. Known Heart Failure with Reduced Ejection Fraction (HFrEF) 11. Current pregnancy, lactation or women of childbearing potential, unless using highly effective contraception

Conditions

Diabetic Kidney Disease (DKD) Type 2 Diabetes Mellitus (T2DM) Chronic Kidney Disease

Locations

Sunnybrook Health Sciences Centre — Toronto, Ontario, Canada

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Official Source

Data sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

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