Overview
To evaluate triple therapy with nsMRA, RASi and SGLT2i on albuminuria in individuals with T2D and CKD
Eligibility
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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).
