NCT07434791

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

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

• Status: Not Yet Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 100 (estimated)
• Sponsor: Sunnybrook Health Sciences Centre · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

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.

Conditions

• Diabetic Kidney Disease (DKD)

Interventions

Type	Name	Description
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.
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.

Timeline

• Start date: 2026-03-01
• Primary completion: 2028-09-01
• Completion: 2029-03-01
• First posted: 2026-02-27
• Last updated: 2026-02-27