GOaL Directed-STrategic Approach With New Disease-modifying theraApies to Reduce Kidney and Cardiovascular Risk in Patients With Diabetic Kidney Disease
Trial Snapshot
- Phase
- Not Applicable
- Status
- Recruiting
- Enrollment
- 100
- Locations
- 1
Study Overview
Brief Summary
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.
Detailed Description
The GOLD-STANDARD study will evaluate the feasibility of an early, goal-directed Cardio-Kidney-Metabolic (CKM) care strategy that integrates kidney, cardiovascular, and metabolic risk management within routine nephrology practice. Using a pragmatic randomized design, the study will assess whether a structured approach to CKM care can be implemented safely and effectively within Ontario's healthcare system.
The primary objective of this pilot study is to evaluate feasibility, including recruitment, retention, treatment implementation, and adherence. Safety and treatment uptake measures will also be assessed over 12 months of follow-up. Findings from this study will inform the design and conduct of a future large-scale trial evaluating the impact of early CKM care on clinical kidney and cardiovascular outcomes.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Health Services Research
- Masking
- Single (Outcomes Assessor)
Masking Description
This is an open-label study in which participants and treating clinicians are aware of treatment assignment. Outcome assessments will be performed by an independent adjudicator who is blinded to treatment allocation.
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Age ≥ 18 years
- •CKD (eGFR ≥ 25-60 mL/min/1.73 m² OR UACR ≥ 30 mg/g) - on screening labs
- •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.)
- •Open to start new medications
Exclusion Criteria
- •Type 1 diabetes
- •HbA1c ≥10% within past 12 months
- •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
- •Kidney Transplant
- •In the opinion of the investigator, currently treated with maximum tolerated dose of ≥3 medication classes:: RASi, SGLT2i, nsMRA or GLP1RA
- •Currently prescribed all 4 medication classes : RASi, SGLT2i, nsMRA or GLP1RA
- •Intolerance or allergy to any of RASi, SGLT2i, nsMRA or GLP1RA
- •Known Heart Failure with Reduced Ejection Fraction (HFrEF)
- •Current pregnancy, lactation or women of childbearing potential, unless using highly effective contraception
Arms & Interventions
Early Goal-Directed Cardio-Kidney-Metabolic (CKM) Care
Participants receive a nephrologist-led, goal-directed Cardio-Kidney-Metabolic (CKM) care strategy that includes risk assessment, shared decision-making, guideline-directed therapies, and ongoing safety monitoring.
Intervention: Early goal-directed Cardio-Kidney-Metabolic (CKM) care (Other)
Usual Care
Participants receive standard nephrology care according to routine clinical practice and the judgment of the treating clinician.
Intervention: Standard care (Comparison arm) (Other)
Outcomes
Primary Outcomes
Not specified
Secondary Outcomes
- Medication Prescription(Baseline to 12 months post-randomization (±45-day visit window).)