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 (RAiSiN)

The Chinese University of Hong Kong

Status and phase: Enrolling; Phase 4

Conditions: Patients with Type 2 Diabetes

Treatments: Drug: Finerenone

Study type: Interventional

Funder types: Other

Identifiers

NCT06727409

CREC number: 2023.615-T (Other Identifier)

RAiSiN

Details and patient eligibility

About

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

Enrollment: 82 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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).

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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82 participants in 1 patient group

Finerenone on top of maximal tolerated RASi and stable SGLT2i therapy

Experimental group

Description:

pre and post Finerenone treatment evaluation

Treatment:

Drug: Finerenone