Pragmatic Trial of Messaging to Providers About Treatment of Chronic Kidney Disease

Starting soon · Not applicable

Conditions studied: Chronic Kidney Diseases

In brief

This study is a cluster-randomized clinical trial to evaluate whether a tailored, user-centered, clinical decision support (CDS) tool can positively influence prescriber behavior and increase prescription of guideline-directed medical therapy (GDMT) among patients with Chronic Kidney Disease (CKD) across a single healthcare center.

Key facts

Study ID

NCT07430930

Run by

Yale University

People needed

1000

Starts

2026-06-01

Expected to finish

2028-06-01

Last updated by the study team

2026-05-26

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Male or female, aged ≥18 years
• Diagnosed with CKD defined by an eGFR ≤60 mL/min/1.732 on two occasions at least ≥3 months apart with most recent being ≤60 or eGFR 60-90 mL/min/1.73m2 with an uACR ≥30 mg/g or eGFR >90 mL/min/1.73m2 with an uACR ≥30 mg/g.
• Eligible to receive at least 1 of the following CKD GDMT: ACEi/ARB, SGLT2i, MRA or GLP-1 RA based on the following criteria.
• To receive an ACEi/ARB: eGFR ≥15 ml/min/1.732 and have diagnosis of hypertension based on ICD10 code or proteinuria (uACR ≥30 mg/g).
• To receive an SGLT2i: have heart failure (defined by ICD10 code); or T2D; or uACR ≥200 mg/g; or eGFR ≥20 ml/min/1.732.
• To receive an MRA: ns-MRA: have an eGFR ≥25 ml/min/1.732, diagnosis of T2D, normal serum potassium (≤4.8 mmol/L) and albuminuria (>30 mg/g). s-MRA: have an eGFR ≥45 ml/min/1.732 and heart failure, hyperaldosteronism, or refractory hypertension.
• To receive a GLP-1 RA: have T2D.
• Ability to take oral medication.

You may not qualify if…

• Allergy to the GDMT for which the patient is eligible
• End-stage kidney disease
• CKD stage 5 (eGFR <15 ml/min/1.73m2)
• Glomerulonephritis (by ICD-10 code)
• Polycystic kidney disease (by ICD-10 code)
• History of kidney transplant
• End-stage heart failure
• Eligible to receive ACEi/ARB but having blood pressure <110/70 mmHg or have known renal artery stenosis
• Eligible to receive SGLT2i but pregnant or breastfeeding, type 1 DM, history of euglycemic diabetic ketoacidosis or Fournier's gangrene based on ICD10 code.
• Eligible to receive MRA but serum potassium ≥5 mmol/L, have office SBP <100 mmHg, adrenal insufficiency based on ICD10 code or concomitant treatment with CYP3A4 inhibitors (Strong: grapefruit, grapefruit juice, itraconazole. Moderate: erythromycin. Weak: amiodarone).
• Eligible to receive GLP-1 RA but pregnant; or found to have personal history of pancreatitis; or personal or family history of medullary thyroid cancer or MEN type 2 based on ICD10 code or gastroparesis based on ICD10 code.
• Opted out of EHR-based research.

Where it is running

• Yale New Haven Health — New Haven, Connecticut, United States

Full record on ClinicalTrials.gov

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