Recruiting

CKM Care Strategy

Sponsor:

Sunnybrook Health Sciences Centre

Code:

NCT07434791

Conditions

Diabetic Kidney Disease (DKD)

Type 2 Diabetes Mellitus (T2DM)

Chronic Kidney Disease

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Early goal-directed Cardio-Kidney-Metabolic (CKM) care

Standard care (Comparison arm)

Study Details

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.

Conditions

Diabetic Kidney Disease (DKD)

Type 2 Diabetes Mellitus (T2DM)

Chronic Kidney Disease

Study ID

NCT07434791

Start date

Aug 26, 2026

Status verified date

Aug, 2026

Completion date

Sep, 2029

Anticipated

Primary completion date

Sep, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

100 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Health Services Research

Interventions and Outcome Measures

Arms

experimental: 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.

active comparator: Usual Care

Participants receive standard nephrology care according to routine clinical practice and the judgment of the treating clinician.

Interventions

Early goal-directed Cardio-Kidney-Metabolic (CKM) care

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)

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.

Primary outcome measure

  • Feasibility of the pivotal Randomized Controlled Trial (RCT) [ Time Frame: From consent through completion of screening procedures to randomization (maximum 60 days). ]
  • Prescription and Adherence to Guideline-Directed Medical Therapy (GDMT) [ Time Frame: 12 months after randomization (±45-day window). ]

Central Contacts and Locations

Central contacts

GOLD STANDARD Coordinating Centre

416-480-6100GOLD-STANDARD@sunnybrook.ca

Locations

Sunnybrook Health Sciences Centre

Recruiting

Toronto, Ontario, Canada

More Information

Sponsor

Sunnybrook Health Sciences Centre

Last update posted

Sep 4, 2026

Last verified

Aug, 2026

Keywords

  • diabetes
  • diabetic kidney disease
  • cardiovascular risk
  • Cardio-Kidney-Metabolic (CKM) care
  • CKM Care
  • Guideline-Directed Medical Therapy

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Sunnybrook Health Sciences Centre on 2026-09-04.