Use of Clinical-trials and Simulation Models to Estimate Cost-effectiveness of Non-steroidal Mineralocorticoid Antagonists, RASi and SGLT2i as Triple Therapy With Type 2 Diabetes and Chronic Kidney Disease

Ki vehet részt

• Adults aged 18 years or above
• Diagnosis of type 2 diabetes at least 6 months
• CKD (eGFR by CKD-EPI 25-90 ml/min/1.73m2 with uACR 30 to <300 mg/g) and/or those with severely elevated albuminuria (uACR 30-5000 mg/g) and eGFR > 60 ml/min/1.73m2
• Patients should have a serum potassium <4.8 mmol/l at screening
• On SGLT2i (dapagliflozin or empaglifozin) at screening at stable doses for at least 4 weeks
• On ACEi or ARB at maximum tolerated dose per manufacturer's label that did not cause unacceptable side effects
• In the opinion of the investigator, absence of any physical limitations, addictive diseases, or underlying medical conditions (including mental health) that may preclude the patient from being a suitable study candidate

Ki nem vehet részt

• Concomitant therapy with eplenerone, spironolactone that cannot be discontinued
• History of stroke or worsening heart failure in the past 6 months prior to screening
• Diabetic ketoacidosis, hyperosmolar hyperglycaemic state or myocardial infarction in the six months prior to screening
• Patients on renal replacement therapy or likely require kidney transplant or dialysis during the study period
• On concomitant strong CYP3A4 inhibitors that cannot be discontinued
• Type 1 diabetes
• Allergy, contraindications or intolerance to ACEi/ARB
• Allergy, contraindications to SGLT2is
• Uncontrolled hypertension SBP > 160mmHg or hypotension <90 mmHg at enrolment
• Adrenal insufficiency
• HbA1c >9% at enrolment
• Contraindications or intolerance to mineralocorticoid receptor antagonists
• Currently pregnant or planning pregnancy
• Currently participating in another investigational study protocol where the testing or results may interfere with study compliance, diagnostic results, or data collection
• An identified protected vulnerable patient (including but not limited to those in detention, or a prisoner)