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

Phase 4

Recruiting

• Conditions: Patients with Type 2 Diabetes
• Interventions: Drug: Finerenone

• Registration Number: NCT06727409
• Lead Sponsor: Chinese University of Hong Kong

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2024-11-29
• Status Verified: 2024-12
• Study First Submitted QC: 2024-12-06
• Study First Posted: 2024-12-10
• Study Start: 2024-12-12
• Last Update Submitted: 2025-03-01
• Last Update Posted: 2025-03-05
• Primary Completion: 2026-07-31
• Study Completion: 2026-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 82

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).

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Finerenone on top of maximal tolerated RASi and stable SGLT2i therapy	Finerenone	pre and post Finerenone treatment evaluation

Primary Outcome Measures

Name	Time	Method
Change in urine albumin creatinine ratio (uACR)	26 weeks	urine ACR between baseline and end of study (26 weeks)

Secondary Outcome Measures

Name	Time	Method
Change in estimated glomerular filtration rate (eGFR)	26 weeks	eGFR calculated from plasma creatinine from baseline to end of study in ml/min/1.73m2
Change in potassium	26 weeks	Change in plasma potassium (mmol/l) from baseline to end of study
Change in blood pressure	26 weeks	Change in systolic and diastolic blood pressure (mmHg) from baseline to end of study
Change in heath related quality of life	26 weeks	change in HRQoL from baseline to end of study using EQ5D
Change in body weight	26 weeks	Change in body weight (kg) from baseline to end of study

Trial Locations

Locations (1)

3M, Diabetes and Endocrine Research Center; 🇭🇰 Hong Kong, Hong Kong