NCT07434791Recruiting
Goal-Directed Therapy to Reduce Kidney and Cardiovascular Risk in Diabetic Kidney Disease (GOLD-STANDARD)
GOaL Directed-STrategic Approach With New Disease-modifying theraApies to Reduce Kidney and Cardiovascular Risk in Patients With Diabetic Kidney Disease
Source: ClinicalTrials.gov · Last updated 4 Sept 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Study type
- Interventional
- Enrollment
- 100 (estimated)
- First submitted
- 18 Nov 2025
- Start date
- 26 Aug 2026
- Primary completion date
- Sept 2028
- Lead sponsor
- Sunnybrook Health Sciences Centre
- Diseases
- Chronic kidney disease, Type 2 diabetes
- NCT number
- NCT07434791
What you commit to
- Study type: Interventional
- Planned participants: 100
- From 26 Aug 2026 to the primary completion date, Sept 2028
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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
Other illness
- Type 1 diabetes
- Intolerance or allergy to any of RASi, SGLT2i, nsMRA or GLP1RA
Lab values
- HbA1c ≥10% within past 12 months
- Serum potassium ≥ 5.2 mmol/L on screening labs
- Known Heart Failure with Reduced Ejection Fraction (HFrEF)
Other
- Baseline Blood Pressure (BP) \< 100/60 mmHg at screening
- Current pregnancy, lactation or women of childbearing potential, unless using highly effective contraception
Who the study is looking for
- 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.)
- Open to start new medications
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Sunnybrook Health Sciences Centre Coordinator of this site? Confirm its status | Toronto | Canada | Recruiting |
Related publications
- Cardiovascular-Kidney-Metabolic Conditions and Population Health: The Need for an Integrated Care Strategy.Clin J Am Soc Nephrol · 2026 · PMID 42560777
This page is information, not medical advice. Discuss any trial with your doctor.