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Diabetic Kidney Disease (DKD)GOLD-STANDARDNCT07434791

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

A study testing Early goal-directed Cardio-Kidney-Metabolic (CKM) care in people with Diabetic Kidney Disease (DKD) and Type 2 Diabetes Mellitus (T2DM), run by Sunnybrook Health Sciences Centre at 1 site in Canada.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
Search all trials

Trial 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… Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
Early goal-directed Cardio-Kidney-Metabolic (CKM) care
Could I receive a placebo?
No, everyone receives an active treatment
How many people
100 participants
Where
1 siteCanada
Study dates
26 Aug 2026to Sep 2029
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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
  • Treated with new or intensified immunosuppression therapy for new (or relapse/flare of pre-existing) kidney disease within the last 60 days
  • Kidney Transplant
Show all 11Show fewer
  • 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
  • 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

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Ayodele Odutayo, Doctor contact

416-480-6100

ayodele.odutayo@sunnybrook.ca

GOLD STANDARD Coordinating Centre contact

416-480-6100

GOLD-STANDARD@sunnybrook.ca

Canada1 site, 1 recruiting

  • Sunnybrook Health Sciences Centre

    Toronto, Ontario

    Recruiting

Other trials in Canada

About this study

Official title: 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, 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.

Read the detailed description

The GOLD-STANDARD study will evaluate the feasibility of an early, goal-directed Cardio-Kidney-Metabolic (CKM) care strategy that integrates kidney, cardiovascular, and metabolic risk management within routine nephrology practice. Using a pragmatic randomized design, the study will assess whether a structured approach to CKM care can be implemented safely and effectively within Ontario's healthcare system.

The primary objective of this pilot study is to evaluate feasibility, including recruitment, retention, treatment implementation, and adherence. Safety and treatment uptake measures will also be assessed over 12 months of follow-up. Findings from this study will inform the design and conduct of a future large-scale trial evaluating the impact of early CKM care on clinical kidney and cardiovascular outcomes.

Being tested
Early goal-directed Cardio-Kidney-Metabolic (CKM) care, Standard care (Comparison arm)
Keywords
diabetes, diabetic kidney disease, cardiovascular risk, Cardio-Kidney-Metabolic (CKM) care, CKM Care, Guideline-Directed Medical Therapy
Medical subject headings
Diabetic Nephropathies, Diabetes Mellitus, Type 2, Renal Insufficiency, Chronic, Diabetes Mellitus

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Early goal-directed Cardio-Kidney-Metabolic (CKM) careOther

    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)Other

    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.

Study groups in NCT07434791
Study groupRoleWhat they receive
Early Goal-Directed Cardio-Kidney-Metabolic (CKM) CareExperimentalParticipants 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.
Receives: Other: Early goal-directed Cardio-Kidney-Metabolic (CKM) care
Usual CareActive comparatorParticipants receive standard nephrology care according to routine clinical practice and the judgment of the treating clinician.
Receives: Other: Standard care (Comparison arm)

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: 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.

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

Secondary outcomes (27)

  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 (%)

    Measured: 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 (%)

    Measured: 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 (%)

    Measured: 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 (%)

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

  5. Loss to follow-up

    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 (%)

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

  6. BMI

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

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

  7. Waist circumference

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

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

  8. Hip circumference

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

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

  9. Waist-to-hip ratio

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

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

  10. Blood pressure

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

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

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

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

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

  12. Change in Estimated Glomerular Filtration Rate (eGFR)

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

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

  13. All-cause mortality

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

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

  14. Hospitalization for myocardial infarction

    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

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

  15. Hospitalization for stroke

    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

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

  16. Hospitalization for heart failure

    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

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

  17. All-cause hospitalization

    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

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

  18. Hospitalization for diabetic ketoacidosis (DKA)

    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

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

  19. Hyperkalemia requiring medication discontinuation or dose reduction

    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

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

  20. eGFR dip requiring medication discontinuation or dose reduction

    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

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

  21. Symptomatic hypotension requiring medication discontinuation or dose reduction

    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

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

  22. All-cause medication discontinuation

    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

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

  23. Medication Prescription

    1. % of participants prescribed maximum indicated dose of RASi

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

  24. Medication Prescription

    1. % of participants prescribed maximum indicated dose of SGLT2i

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

  25. Medication Prescription

    1. % of participants prescribed maximum indicated dose of nsMRA

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

  26. Medication Prescription

    1. % of participants prescribed maximum indicated dose of GLP1RA (oral)

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

  27. Medication Prescription

    1. % of participants prescribed maximum indicated dose of GLP1RA (subcutaneous)

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted27 Feb 2026
  2. Study start26 Aug 2026 (estimated)
  3. Primary completionSep 2028 (estimated)
  4. Study completionSep 2029 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Health services research
Allocation
Randomised
Intervention model
Parallel groups
Model description
Participants will be randomized 1:1 to early goal-directed CKM care or usual care. The study is designed to evaluate the feasibility and safety of implementing a structured CKM care strategy within routine nephrology practice.
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
100 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07434791
Sponsor's protocol ID
CTO Project ID 5552
Acronym
GOLD-STANDARD
Status last verified
Aug 2026
First submitted
18 Nov 2025
Last updated
4 Sep 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: Yes - after publication of planned analyses by study leadership, de-identified individual participant data may be made available to qualified researchers upon reasonable request, subject to review and approval by the study investigators and any applicable data-sharing agreements.

Publications

  • Shin JI, Xu Y, Chang AR, Carrero JJ, Flaherty CM, Mukhopadhyay A, Inker LA, Blecker SB, Horwitz LI, Grams ME. Prescription Patterns for Sodium-Glucose Cotransporter 2 Inhibitors in U.S. Health Systems. J Am Coll Cardiol. 2024 Aug 20;84(8):683-693. doi: 10.1016/j.jacc.2024.05.057.

    PubMed 39142721

  • Mata-Cases M, Franch-Nadal J, Gratacos M, Mauricio D. Therapeutic Inertia: Still a Long Way to Go That Cannot Be Postponed. Diabetes Spectr. 2020 Feb;33(1):50-57. doi: 10.2337/ds19-0018.

    PubMed 32116454

  • Mebazaa A, Davison B, Chioncel O, Cohen-Solal A, Diaz R, Filippatos G, Metra M, Ponikowski P, Sliwa K, Voors AA, Edwards C, Novosadova M, Takagi K, Damasceno A, Saidu H, Gayat E, Pang PS, Celutkiene J, Cotter G. Safety, tolerability and efficacy of up-titration of guideline-directed medical therapies for acute heart failure (STRONG-HF): a multinational, open-label, randomised, trial. Lancet. 2022 Dec 3;400(10367):1938-1952. doi: 10.1016/S0140-6736(22)02076-1. Epub 2022 Nov 7.

    PubMed 36356631

  • Savovic J, Jones HE, Altman DG, Harris RJ, Juni P, Pildal J, Als-Nielsen B, Balk EM, Gluud C, Gluud LL, Ioannidis JP, Schulz KF, Beynon R, Welton NJ, Wood L, Moher D, Deeks JJ, Sterne JA. Influence of reported study design characteristics on intervention effect estimates from randomized, controlled trials. Ann Intern Med. 2012 Sep 18;157(6):429-38. doi: 10.7326/0003-4819-157-6-201209180-00537.

    PubMed 22945832

  • Campbell MJ, Julious SA, Altman DG. Estimating sample sizes for binary, ordered categorical, and continuous outcomes in two group comparisons. BMJ. 1995 Oct 28;311(7013):1145-8. doi: 10.1136/bmj.311.7013.1145.

    PubMed 7580713

  • Ong SW, Kitchlu A, Cherney DZI, Leung K, Chan CTM. Virtual Pharmacy: An Integrated Collaborative Redesign Targeting Medication-Related Problems in Patients with Chronic Kidney Disease. Am J Nephrol. 2024;55(2):206-213. doi: 10.1159/000535094. Epub 2023 Nov 8.

    PubMed 37939689

  • Lee JF, Berzan E, Sridhar VS, Odutayo A, Cherney DZI. Cardiorenal Protection in Diabetic Kidney Disease. Endocrinol Metab (Seoul). 2021 Apr;36(2):256-269. doi: 10.3803/EnM.2021.987. Epub 2021 Apr 19.

    PubMed 33873265

  • Sridhar VS, Dubrofsky L, Boulet J, Cherney DZ. Making a case for the combined use of SGLT2 inhibitors and GLP1 receptor agonists for cardiorenal protection. J Bras Nefrol. 2020 Oct-Dec;42(4):467-477. doi: 10.1590/2175-8239-JBN-2020-0100.

    PubMed 32926067

  • Albakr RB, Sridhar VS, Cherney DZI. Novel Therapies in Diabetic Kidney Disease and Risk of Hyperkalemia: A Review of the Evidence From Clinical Trials. Am J Kidney Dis. 2023 Dec;82(6):737-742. doi: 10.1053/j.ajkd.2023.04.015. Epub 2023 Jul 29.

    PubMed 37517546

  • Yau K, Odutayo A, Dash S, Cherney DZI. Biology and Clinical Use of Glucagon-Like Peptide-1 Receptor Agonists in Vascular Protection. Can J Cardiol. 2023 Dec;39(12):1816-1838. doi: 10.1016/j.cjca.2023.07.007. Epub 2023 Jul 8.

    PubMed 37429523

  • Yau K, Dharia A, Alrowiyti I, Cherney DZI. Prescribing SGLT2 Inhibitors in Patients With CKD: Expanding Indications and Practical Considerations. Kidney Int Rep. 2022 May 5;7(7):1463-1476. doi: 10.1016/j.ekir.2022.04.094. eCollection 2022 Jul.

    PubMed 35812300

  • Green JB, Mottl AK, Bakris G, Heerspink HJL, Mann JFE, McGill JB, Nangaku M, Rossing P, Scott C, Gay A, Agarwal R. Design of the COmbinatioN effect of FInerenone anD EmpaglifloziN in participants with chronic kidney disease and type 2 diabetes using a UACR Endpoint study (CONFIDENCE). Nephrol Dial Transplant. 2023 Mar 31;38(4):894-903. doi: 10.1093/ndt/gfac198.

    PubMed 35700142

  • Brahmbhatt DH, Ross HJ, O'Sullivan M, Artanian V, Mueller B, Runeckles K, Steve Fan CP, Rac VE, Seto E; Medly Titrate Study Team. The Effect of Using a Remote Patient Management Platform in Optimizing Guideline-Directed Medical Therapy in Heart Failure Patients: A Randomized Controlled Trial. JACC Heart Fail. 2024 Apr;12(4):678-690. doi: 10.1016/j.jchf.2024.02.008.

    PubMed 38569821

  • Bakris GL, Agarwal R, Anker SD, Pitt B, Ruilope LM, Rossing P, Kolkhof P, Nowack C, Schloemer P, Joseph A, Filippatos G; FIDELIO-DKD Investigators. Effect of Finerenone on Chronic Kidney Disease Outcomes in Type 2 Diabetes. N Engl J Med. 2020 Dec 3;383(23):2219-2229. doi: 10.1056/NEJMoa2025845. Epub 2020 Oct 23.

    PubMed 33264825

  • Perkovic V, Jardine MJ, Neal B, Bompoint S, Heerspink HJL, Charytan DM, Edwards R, Agarwal R, Bakris G, Bull S, Cannon CP, Capuano G, Chu PL, de Zeeuw D, Greene T, Levin A, Pollock C, Wheeler DC, Yavin Y, Zhang H, Zinman B, Meininger G, Brenner BM, Mahaffey KW; CREDENCE Trial Investigators. Canagliflozin and Renal Outcomes in Type 2 Diabetes and Nephropathy. N Engl J Med. 2019 Jun 13;380(24):2295-2306. doi: 10.1056/NEJMoa1811744. Epub 2019 Apr 14.

    PubMed 30990260

Questions about this trial

What is this clinical trial studying?

A study testing Early goal-directed Cardio-Kidney-Metabolic (CKM) care in people with Diabetic Kidney Disease (DKD) and Type 2 Diabetes Mellitus (T2DM), run by Sunnybrook Health Sciences Centre at 1 site in Canada.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 4 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Ayodele Odutayo, Doctor (416-480-6100, ayodele.odutayo@sunnybrook.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the 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).). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07434791, which also lists 25 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Sep 2026.

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