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NCT Number: NCT07434791

Goal-Directed Therapy to Reduce Kidney and Cardiovascular Risk in Diabetic Kidney Disease (GOLD-STANDARD)

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.

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Key information

Conditions

Diabetic Kidney Disease (DKD) Diabetes Complications Diabetes Mellitus Diabetic Nephropathies Endocrine System Diseases Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Glucose Metabolism Disorders Kidney Diseases Male Urogenital Diseases Metabolic Diseases Nutritional and Metabolic Diseases Urogenital Diseases Urologic Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

About this study

GOLD-STANDARD is a parallel-group pilot randomized controlled trial designed to test early goal-directed CKM care in a real-world clinical setting. Participants will be randomized equally to the intervention or usual care arms.

Intervention Arm:

  • Provides iterative assessment of kidney and cardiovascular risk to guide treatment decisions.
  • Implements early shared decision-making regarding initiation of guideline-directed medical therapies, following a structured 6-month protocol. The goal is to ensure each participant is offered timely treatment, though not all medications are expected to be initiated in every participant.
  • Supports close monitoring of side effects and treatment tolerance through multidisciplinary kidney care teams.

Usual Care Arm:

  • Participants receive treatment according to standard clinical practice, with medication decisions made by the treating clinician.
  • Adjustments are incremental, guided by routine clinic visits and relevant biomarkers.
  • The trial is conducted within Ontario's health care infrastructure to evaluate the feasibility of early CKM care implementation across different clinical settings.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.)
  • Open to start new medications

Exclusion criteria

  • 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
  • Treated with new or intensified immunosuppression therapy for new (or relapse/flare of pre-existing) kidney disease within the last 60 days
  • Kidney Transplant
  • Use of ≥3 medication classes: Participants already prescribed three or more of the following classes of medications: 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

Treatment and study plan

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

Other

The 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

The 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.

Primary outcomes

  1. Feasibility of the pivotal Randomized Controlled Trial (RCT)

    Time frame: From consent through completion of screening procedures to randomization (maximum 60 days).

    Percentage of consenting participants who are eligible and randomized. Feasibility is defined as ≥40% of consented and screened participants meeting criteria and being randomized.

  2. Prescription and Adherence to Guideline-Directed Medical Therapy (GDMT)

    Time frame: 12 months after randomization (±45-day window).

    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.

Secondary outcomes

  1. Declined/ Unable to Receive Treatment - RASi

    Time frame: Baseline to 12 months post-randomization (±45-day visit window).

    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 (%)

  2. Declined or Unable to Receive Treatment- SGLT2i

    Time frame: Baseline to 12 months post-randomization (±45-day visit window).

    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 (%)

  3. Declined or Unable to Receive Treatment - nsMRA

    Time frame: Baseline to 12 months post-randomization (±45-day visit window).

    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 (%)

  4. Declined or Unable to Receive Treatment - GLP1RA

    Time frame: Baseline to 12 months post-randomization (±45-day visit window).

    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 (%)

  5. Loss to follow-up

    Time frame: Baseline to 12 months post-randomization (±45-day visit window).

    Percentage of participants who are lost to follow-up from baseline through 12 months post-randomization. The target for loss to follow-up is <10% over the duration of the study.

    Unit of Measure: Percent (%)

  6. BMI

    Time frame: Baseline and 12 months post-randomization (±45-day visit window)

    Change in body mass index (BMI) from baseline to 12 months. Calculated as 12-month value minus baseline value. Unit of Measure: kg/m²

  7. Waist circumference

    Time frame: Baseline and 12 months post-randomization (±45-day visit window)

    Change in waist circumference from baseline to 12 months. Calculated as 12-month value minus baseline value. Unit of Measure: cm

  8. Hip circumference

    Time frame: Baseline and 12 months post-randomization (±45-day visit window)

    Change in hip circumference from baseline to 12 months. Calculated as 12-month value minus baseline value. Unit of Measure: cm

  9. Waist-to-hip ratio

    Time frame: Baseline and 12 months post-randomization (±45-day visit window)

    Change in waist-to-hip ratio from baseline to 12 months. Calculated as 12-month value minus baseline value. Unit of Measure: Ratio (unitless)

  10. Blood pressure

    Time frame: Baseline and 12 months post-randomization (±45-day visit window)

    Change in systolic and diastolic blood pressure from baseline to 12 months. Calculated as 12-month value minus baseline value. Unit of Measure: mmHg

  11. Change in Urine Albumin-to-Creatinine Ratio (UACR)

    Time frame: Baseline and 12 months post-randomization (±45-day visit window)

    Change in UACR from baseline to 12 months. Change will be calculated as 12-month value minus baseline value. Unit of Measure: mg/g

  12. Change in Estimated Glomerular Filtration Rate (eGFR)

    Time frame: 12 months post-randomization (visit window ±45 days).

    Change in eGFR from baseline to 12 months. Change will be calculated as the 12-month value minus the baseline value.

  13. All-cause mortality

    Time frame: Baseline to 12 months post-randomization (±45-day visit window)

    Death from any cause occurring from baseline to 12 months post-randomization. Unit of Measure: Number of participants

  14. Hospitalization for myocardial infarction

    Time frame: Baseline to 12 months post-randomization (±45-day visit window)

    Any hospitalization for myocardial infarction occurring from baseline to 12 months post-randomization. Both incident and recurrent events will be captured. Unit of Measure: Number of participants

  15. Hospitalization for stroke

    Time frame: Baseline to 12 months post-randomization (±45-day visit window)

    Any hospitalization for stroke occurring from baseline to 12 months post-randomization. Both incident and recurrent events will be captured.

    Unit of Measure: Number of participants

  16. Hospitalization for heart failure

    Time frame: Baseline to 12 months post-randomization (±45-day visit window)

    Any hospitalization for heart failure occurring from baseline to 12 months post-randomization. Both incident and recurrent events will be captured.

    Unit of Measure: Number of participants

  17. All-cause hospitalization

    Time frame: From randomization through 12 months post-randomization (visit windows ±45 days)

    Any hospitalization for any cause occurring from randomization to 12 months post-randomization. Ascertainment via Connecting Ontario administrative health data.

    Unit of Measure: Number of participants

  18. Hospitalization for diabetic ketoacidosis (DKA)

    Time frame: From randomization through 12 months post-randomization (visit windows ±45 days)

    Any hospitalization for DKA occurring from randomization to 12 months post-randomization. Ascertainment via Connecting Ontario administrative health data.

    Unit of Measure: Number of participants

  19. Hyperkalemia requiring medication discontinuation or dose reduction

    Time frame: From randomization through 12 months post-randomization (visit windows ±45 days)

    Occurrence of hyperkalemia leading to discontinuation or dose reduction of study medications (RASi, SGLT2i, nsMRA, GLP1RA) from randomization to 12 months post-randomization. Ascertainment via review of clinic notes and medication records.

    Unit of Measure: Number of participants

  20. eGFR dip requiring medication discontinuation or dose reduction

    Time frame: From randomization through 12 months post-randomization (visit windows ±45 days)

    Occurrence of an eGFR decline requiring discontinuation or dose reduction of study medications from randomization to 12 months post-randomization. Ascertainment via review of clinic notes and medication records.

    Unit of Measure: Number of participants

  21. Symptomatic hypotension requiring medication discontinuation or dose reduction

    Time frame: From randomization through 12 months post-randomization (visit windows ±45 days)

    Occurrence of symptomatic hypotension (SBP <90 mmHg) leading to discontinuation or dose reduction of study medications from randomization to 12 months post-randomization. Ascertainment via review of clinic notes and medication records.

    Unit of Measure: Number of participants

  22. All-cause medication discontinuation

    Time frame: From randomization through 12 months post-randomization (visit windows ±45 days)

    Discontinuation of any study medication for any reason from randomization to 12 months post-randomization. Ascertainment via review of clinic notes and medication records.

    Unit of Measure: Number of participants

Study contacts

Contact information is provided by the study sponsor or research team.

Kristina Hyunjee Lee, M.Ed

CONTACT

[email protected]

437-869-7138

Sponsors and collaborators

Lead sponsor

Sunnybrook Health Sciences Centre

Other

Collaborators

  • The Kidney Foundation of Canada

Registry information

Official study title

GOaL Directed-STrategic Approach With New Disease-modifying theraApies to Reduce Kidney and Cardiovascular Risk in Patients With Diabetic Kidney Disease

Acronym: GOLD-STANDARD

Important dates

Study start
2026
Primary completion
2028
Study completion
2029
First posted
Feb 27, 2026
Registry last updated
May 7, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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