An interventional study of Early goal-directed Cardio-Kidney-Metabolic (CKM) care and Standard care (Comparison arm) in Diabetic Kidney Disease (DKD), Type 2 Diabetes Mellitus (T2DM) and Chronic Kidney Disease, sponsored by Sunnybrook Health Sciences Centre. Recruiting at 1 site in Canada. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-09-04.
Sponsored by Sunnybrook Health Sciences Centre · Not applicable, Interventional, and Health services research
Among 34 studies in Diabetic Nephropathies with a site in Canada — 5 open to participants now, 5 under way, 1 of them phase 3. Diabetic Nephropathies · Canada.
Among the 34 studies in Diabetic Nephropathies with a site in Canada, this one is the 24th largest by planned enrollment of the 31 interventional ones that give a count, is one of 2 that started in 2026, is one of 3 with no phase, and was the 34th registered.
543 studies on the registry are indexed under Diabetic Nephropathies; 110 are open to participants now.
Browse Diabetic Nephropathies studies →5 of the 34 studies in Diabetic Nephropathies with a site in Canada are open now. Recruiting first, the newest first:
Nova Scotia Health Authority · Sites in Canada
Ages 18+
Alessandro Doria · Sites in Canada, United States
Ages 18–75
University of Washington · Sites in Canada, United States
Ages 18+
Unity Health Toronto · Sites in Canada
Ages 18+
A study can be open while its sites in Canada have not opened yet or have stopped. Only those recruiting at a site in Canada →
Of the 50 Diabetic Nephropathies studies recruiting now, 23 (46%) set no upper age limit and 16 (32%) stop at 75 or younger; 5 take children under 18; 8 take healthy volunteers.
This study: 18 Years and older · all sexes · no healthy volunteers.
The full table on the hub →This tab as a report to print or save as PDF → With an account.
34 studies; the count open now beside each. This study's row is marked.
First in 2003; this study’s year is marked. 2 started in 2026.
By drug class, each counting the studies that test any of its medicines:
This study's planned enrollment of 100 is above the median of 78 across 388 interventional studies indexed under Diabetic Nephropathies.
Median enrollment 226 across the 31 interventional studies, 500 across the 3 observational. Of the 27 that completed or were terminated, 15 (56%) have results posted.
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20 of 34 have an industry lead sponsor. The 10 most frequent:
Sunnybrook Health Sciences Centre is the lead sponsor of 584 studies on the registry; 135 are open to participants now.
Of its 6 completed or terminated interventional studies of FDA-regulated products, 2 (33%) have results posted.
Sunnybrook Health Sciences Centre has 1 study filed under Diabetic Nephropathies — fewer than ten, so there is no comparison to draw.
1 of the studies in Diabetic Nephropathies with a site in Canada that are under way reach primary completion within a year, 0 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT05822609University of WashingtonTrial of Semaglutide for Diabetic Kidney Disease in Type 1 Diabetes | 2027-06 |
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Among the 34 studies in Diabetic Nephropathies with a site in Canada, from their registry updates:
Nothing recorded among them since 2026-09-25.
This tab as a report to print or save as PDF → With an account.
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.
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.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
GFR (glomerular filtration rate) is how much blood the kidneys filter each minute. It is usually estimated from a blood test — eGFR, by formulas such as CKD-EPI or MDRD — and some studies ask for it to be measured directly instead. Usually given in mL/min/1.73 m².
Check the method, the units and the minimum the study states. A value of 90 or above is in the normal-or-high range, but kidney damage can show in other tests too.
A blood test of average blood sugar over the past two to three months, given as a percentage or in mmol/mol. 6.5% (48 mmol/mol) or more is the usual threshold for diabetes, normally confirmed by a second test.
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
The share of blood the heart’s main pumping chamber (the left ventricle) pushes out with each beat, measured by an echocardiogram (heart ultrasound) or a MUGA scan. About 50–70% is normal.
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
GFR and eGFR (kidney filtering)
GFR (glomerular filtration rate) is how much blood the kidneys filter each minute. It is usually estimated from a blood test — eGFR, by formulas such as CKD-EPI or MDRD — and some studies ask for it to be measured directly instead. Usually given in mL/min/1.73 m².
Check the method, the units and the minimum the study states. A value of 90 or above is in the normal-or-high range, but kidney damage can show in other tests too.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
HbA1c
A blood test of average blood sugar over the past two to three months, given as a percentage or in mmol/mol. 6.5% (48 mmol/mol) or more is the usual threshold for diabetes, normally confirmed by a second test.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Immunosuppression
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
LVEF (left ventricular ejection fraction)
The share of blood the heart’s main pumping chamber (the left ventricle) pushes out with each beat, measured by an echocardiogram (heart ultrasound) or a MUGA scan. About 50–70% is normal.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Childbearing potential
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
Other: Early goal-directed Cardio-Kidney-Metabolic (CKM) care
Participants receive standard nephrology care according to routine clinical practice and the judgment of the treating clinician.
Other: Standard care (Comparison arm)
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.
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.
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.
Time frame: From consent through completion of screening procedures to randomization (maximum 60 days).
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.
Time frame: 12 months after randomization (±45-day window).
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 (%)
Time frame: Baseline to 12 months post-randomization (±45-day visit window).
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 (%)
Time frame: Baseline to 12 months post-randomization (±45-day visit window).
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 (%)
Time frame: Baseline to 12 months post-randomization (±45-day visit window).
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 (%)
Time frame: Baseline to 12 months post-randomization (±45-day visit window).
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 (%)
Time frame: Baseline to 12 months post-randomization (±45-day visit window).
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
Time frame: Baseline and 12 months post-randomization (±45-day visit window)
Waist circumference
Change in waist circumference from baseline to 12 months. Calculated as 12-month value minus baseline value. Unit of Measure: cm
Time frame: Baseline and 12 months post-randomization (±45-day visit window)
Hip circumference
Change in hip circumference from baseline to 12 months. Calculated as 12-month value minus baseline value. Unit of Measure: cm
Time frame: Baseline and 12 months post-randomization (±45-day visit window)
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)
Time frame: Baseline and 12 months post-randomization (±45-day visit window)
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
Time frame: Baseline and 12 months post-randomization (±45-day visit window)
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
Time frame: Baseline and 12 months post-randomization (±45-day visit window)
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.
Time frame: 12 months post-randomization (visit window ±45 days).
All-cause mortality
Death from any cause occurring from baseline to 12 months post-randomization. Unit of Measure: Number of participants
Time frame: Baseline to 12 months post-randomization (±45-day visit window)
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
Time frame: Baseline to 12 months post-randomization (±45-day visit window)
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
Time frame: Baseline to 12 months post-randomization (±45-day visit window)
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
Time frame: Baseline to 12 months post-randomization (±45-day visit window)
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
Time frame: From randomization through 12 months post-randomization (visit windows ±45 days)
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
Time frame: From randomization through 12 months post-randomization (visit windows ±45 days)
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
Time frame: From randomization through 12 months post-randomization (visit windows ±45 days)
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
Time frame: From randomization through 12 months post-randomization (visit windows ±45 days)
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
Time frame: From randomization through 12 months post-randomization (visit windows ±45 days)
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
Time frame: From randomization through 12 months post-randomization (visit windows ±45 days)
Medication Prescription
a) % of participants prescribed maximum indicated dose of RASi
Time frame: Baseline to 12 months post-randomization (±45-day visit window).
Medication Prescription
b) % of participants prescribed maximum indicated dose of SGLT2i
Time frame: Baseline to 12 months post-randomization (±45-day visit window).
Medication Prescription
c) % of participants prescribed maximum indicated dose of nsMRA
Time frame: Baseline to 12 months post-randomization (±45-day visit window).
Medication Prescription
d) % of participants prescribed maximum indicated dose of GLP1RA (oral)
Time frame: Baseline to 12 months post-randomization (±45-day visit window).
Medication Prescription
e) % of participants prescribed maximum indicated dose of GLP1RA (subcutaneous)
Time frame: Baseline to 12 months post-randomization (±45-day visit window).
Plan to share: 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.
Start is estimated for Aug 2026; primary completion for Sep 2028, 25 months later.
Of 49 non-industry interventional studies with no phase under Diabetic Nephropathies, half reached primary completion within 23 months of starting (the median), counting those still running; a quarter within 10 and three quarters within 37. This study's planned 25 months is close to that.
Counting every sponsor, half of 50 studies reached it within 23 months; a quarter within 11 and three quarters within 37.
How these figures are worked out, and which studies are left out of them.
Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.
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Sunnybrook Health Sciences Centre →