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

May 1, 2026 updated by: Sunnybrook Health Sciences Centre

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

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Detailed Description

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.

Study Type

Interventional

Enrollment (Estimated)

100

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria

  1. Age ≥ 18 years
  2. T2DM
  3. CKD (eGFR ≥ 25-60 OR UACR ≥ 30 mg/g)
  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), 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% on screening labs
  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. Use of ≥3 medication classes: Participants already prescribed three or more of the following classes of medications: RASi, SGLT2i, nsMRA or GLP1RA
  8. Intolerance or allergy to any of RASi, SGLT2i, nsMRA or GLP1RA
  9. Known Heart Failure with Reduced Ejection Fraction (HFrEF)
  10. Current pregnancy, lactation or women of childbearing potential, unless using highly effective contraception

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Comparison Arm
Standard of care
Other: Standard care (Comparison arm)
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.
Experimental: Intervention arm
CKM
Other: Early goal-directed Cardio-Kidney-Metabolic (CKM) care
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
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).
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.
12 months after randomization (±45-day window).

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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 (%)
Baseline to 12 months post-randomization (±45-day visit window).
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 (%)
Baseline to 12 months post-randomization (±45-day visit window).
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 (%)
Baseline to 12 months post-randomization (±45-day visit window).
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 (%)
Baseline to 12 months post-randomization (±45-day visit window).
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 (%)
Baseline to 12 months post-randomization (±45-day visit window).
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
Baseline and 12 months post-randomization (±45-day visit window)
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
Baseline and 12 months post-randomization (±45-day visit window)
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
Baseline and 12 months post-randomization (±45-day visit window)
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)
Baseline and 12 months post-randomization (±45-day visit window)
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
Baseline and 12 months post-randomization (±45-day visit window)
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
Baseline and 12 months post-randomization (±45-day visit window)
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.
12 months post-randomization (visit window ±45 days).
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
Baseline to 12 months post-randomization (±45-day visit window)
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
Baseline to 12 months post-randomization (±45-day visit window)
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
Baseline to 12 months post-randomization (±45-day visit window)
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
Baseline to 12 months post-randomization (±45-day visit window)
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
From randomization through 12 months post-randomization (visit windows ±45 days)
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
From randomization through 12 months post-randomization (visit windows ±45 days)
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
From randomization through 12 months post-randomization (visit windows ±45 days)
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
From randomization through 12 months post-randomization (visit windows ±45 days)
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
From randomization through 12 months post-randomization (visit windows ±45 days)
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
From randomization through 12 months post-randomization (visit windows ±45 days)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sunnybrook Health Sciences Centre

Collaborators

The Kidney Foundation of Canada

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

June 1, 2026

Primary Completion (Estimated)

September 1, 2028

Study Completion (Estimated)

March 1, 2029

Study Registration Dates

First Submitted

November 18, 2025

First Submitted That Met QC Criteria

February 19, 2026

First Posted (Actual)

February 27, 2026

Study Record Updates

Last Update Posted (Actual)

May 7, 2026

Last Update Submitted That Met QC Criteria

May 1, 2026

Last Verified

April 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CTO Project ID 5552

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

Individual participant data (IPD) collected during this study will not be shared.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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