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

NCT07434791 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 100

Last updated 2026-09-04

No results posted yet for this study

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 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.

Conditions

Interventions

OTHER

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

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.

OTHER

Standard care (Comparison arm)

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.

Sponsors & Collaborators

  • The Kidney Foundation of Canada

    collaborator OTHER

  • Novo Nordisk A/S

    collaborator INDUSTRY

  • Sunnybrook Health Sciences Centre

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
HEALTH_SERVICES_RESEARCH
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-08-26
Primary Completion
2028-09-30
Completion
2029-09-30

Countries

  • Canada

Study Locations

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Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07434791 on ClinicalTrials.gov