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
Parallel
Early goal-directed Cardio-Kidney-Metabolic (CKM) care
Other interventionThe 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/or health care technology 3. Close monitoring of side effects.
Standard care (Comparison arm)
Other interventionThe 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.
Feasibility of the pivotal Randomized Controlled Trial (RCT)
Percentage of consenting participants who are eligible and randomized. Feasibility is defined as ≥40% of consented and screened participants meeting criteria and being randomized.
Prescription and Adherence to Guideline-Directed Medical Therapy (GDMT)
Determined based on the percentage of people prescribed and adherent to GDMT at 12 months when assessed on an ordinal scale from 1 to 4 medications.
Declined/ Unable to Receive Treatment - RASi
Percentage of participants in the intervention group who were recommended a RASi prescription and did not receive treatment for any reason. Participants meeting any of the following criteria are counted toward this single percentage: * Declined due to patient preference * Unable to obtain due to access barriers * Not initiated or titrated to avoid anticipated side effects Unit of Measure: Percent (%)
Declined or Unable to Receive Treatment- SGLT2i
Percentage of participants in the intervention group who were recommended a SGLT2i prescription and did not receive treatment for any reason. Participants meeting any of the following criteria are counted toward this single percentage: * Declined due to patient preference * Unable to obtain due to access barriers * Not initiated or titrated to avoid anticipated side effects Unit of Measure: Percent (%)
Declined or Unable to Receive Treatment - nsMRA
Percentage of participants in the intervention group who were recommended an nsMRA prescription and did not receive treatment for any reason. Participants meeting any of the following criteria are counted toward this single percentage: * Declined due to patient preference * Unable to obtain due to access barriers * Not initiated or titrated to avoid anticipated side effects Unit of Measure: Percent (%)
Declined or Unable to Receive Treatment - GLP1RA
Percentage of participants in the intervention group who were recommended an GLP1RA prescription and did not receive treatment for any reason. Participants meeting any of the following criteria are counted toward this single percentage: * Declined due to patient preference * Unable to obtain due to access barriers * Not initiated or titrated to avoid anticipated side effects Unit of Measure: Percent (%)
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Sunnybrook Health Sciences Centre
Lead sponsor
The Kidney Foundation of Canada
Collaborator
This trial is not recruiting at the moment. You can still explore other options:
