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 · NCT06727409 · Interventional (participants receive a specific treatment)

Interventions studied

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

Age range

18 Years and older

Sex

All (male and female)

Healthy volunteers

No - a diagnosis or condition is required

Phase

Phase 4

Study type

Interventional (participants receive a specific treatment)

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.

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).

2 locations listed.