Goal-Directed Therapy to Reduce Kidney and Cardiovascular Risk in Diabetic Kidney Disease (GOLD-STANDARD)
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorSunnybrook Health Sciences Centre
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Age ≥ 18 years
T2DM
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.)
Disqualifiers
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
Trial design
Design model
Parallel
Treatments tested in this trial
Early goal-directed Cardio-Kidney-Metabolic (CKM) care
Other interventionParticipants 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 interventionParticipants 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.
Treatment groups
100 Participants
are divided into 2 treatment groupsGroup A: Early Goal-Directed Cardio-Kidney-Metabolic (CKM) CareExperimental treatment 1 intervention
Group B: Usual CareActive comparator 1 intervention
Trial outcomes
Primary outcomes
1
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.
Time frame
From consent through completion of screening procedures to randomization (maximum 60 days).2
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.
Time frame
12 months after randomization (±45-day window).Secondary outcomes
1
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 (%)
Time frame
Baseline to 12 months post-randomization (±45-day visit window).2
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 (%)
Time frame
Baseline to 12 months post-randomization (±45-day visit window).3
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 (%)
Time frame
Baseline to 12 months post-randomization (±45-day visit window).4
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 (%)
Time frame
Baseline to 12 months post-randomization (±45-day visit window).Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Sunnybrook Health Sciences Centre
Lead sponsor
The Kidney Foundation of Canada
Collaborator
Novo Nordisk A/S
Collaborator
Source ClinicalTrials.gov