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)

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

Study Overview

• Status: Recruiting
• Conditions: Patients with Type 2 Diabetes
• Intervention / Treatment: Drug: Finerenone

• Study Type: Interventional
• Enrollment (Estimated): 82
• Phase: Phase 4

Contacts and Locations

• Study Contact: Name: Elaine Chow; Phone Number: +852 35051641; Email: e.chow@cuhk.edu.hk

Study Locations

• Hong Kong
  • Hong Kong, Hong Kong
    • Recruiting
    • 3M, Diabetes and Endocrine Research Center
    • Contact: Elaine Chow, MD
    • Contact: Elaine Chow, MD; Phone Number: +852 35051641; Email: e.chow@cuhk.edu.hk
    • Contact: Shun Ling KONG, MN; Phone Number: +852 35052648; Email: slkong@cuhk.edu.hk

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Finerenone on top of maximal tolerated RASi and stable SGLT2i therapy; pre and post Finerenone treatment evaluation	Drug: Finerenone; Finerenone 10mg or 20 mg as tolerated on top of maximal tolerated RASi and stable SGLT2i therapy

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in urine albumin creatinine ratio (uACR)	urine ACR between baseline and end of study (26 weeks)	26 weeks

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Chinese University of Hong Kong

Study record dates

Study Major Dates

• Study Start (Actual): December 12, 2024
• Primary Completion (Estimated): July 31, 2026
• Study Completion (Estimated): December 31, 2026

Study Registration Dates

• First Submitted: November 29, 2024
• First Submitted That Met QC Criteria: December 6, 2024
• First Posted (Actual): December 10, 2024

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: March 1, 2025
• Last Verified: December 1, 2024

More Information

Terms related to this study

• Keywords: Finereone, Triple therapy, Type 2 Diabetes, Chronic kidney disease
• Additional Relevant MeSH Terms: Urogenital Diseases; Endocrine System Diseases; Pathologic Processes; Male Urogenital Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Chronic Disease; Disease Attributes; Metabolic Diseases; Glucose Metabolism Disorders; Renal Insufficiency; Diabetes Mellitus, Type 2; Diabetes Mellitus; Kidney Diseases; Renal Insufficiency, Chronic
• Other Study ID Numbers: RAiSiN; CREC number: 2023.615-T (Other Identifier: CUHK Clinical Research Ethics Committee)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: Yes