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

Recruiting now · Phase 4

Conditions studied: Patients With Type 2 Diabetes

In brief

To evaluate triple therapy with nsMRA, RASi and SGLT2i on albuminuria in individuals with T2D and CKD

Key facts

Study ID

NCT06727409

Run by

Chinese University of Hong Kong

People needed

82

Starts

2024-12-12

Expected to finish

2026-12-31

Last updated by the study team

2025-03-05

Who can join

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

You may qualify if…

• 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.

You may not qualify if…

• Type 1 diabetes
• Allergy, contraindications or intolerance to ACEi/ARB
• Contraindications or intolerance to mineralocorticoid receptor antagonists
• Allergy, contraindications to SGLT2is
• Currently pregnant or planning pregnancy
• HbA1c >9% at enrolment
• Uncontrolled hypertension SBP > 160mmHg or hypotension <90 mmHg at enrolment
• 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
• Adrenal insufficiency
• 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).

Where it is running

• 3M, Diabetes and Endocrine Research Center — Hong Kong, Hong Kong (enrolling)

Full record on ClinicalTrials.gov

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