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

NCT06727409 | Recruiting Phase 4 DMC FDA Drug

• 2 other identifiers: RAiSiNCREC number: 2023.615-T
• Study Type: interventional
• Target: 82
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Patients With Type 2 Diabetes

Keywords

Finereone, Triple therapy, Type 2 Diabetes, Chronic kidney disease

Outcome Measures

Primary Outcomes (1)

• Change in urine albumin creatinine ratio (uACR)

  urine ACR between baseline and end of study (26 weeks)

  26 weeks

Secondary Outcomes (5)

• Change in estimated glomerular filtration rate (eGFR)

  26 weeks

• Change in potassium

  26 weeks

• Change in blood pressure

  26 weeks

• Change in heath related quality of life

  26 weeks

• Change in body weight

  26 weeks

Study Arms (1)

Finerenone on top of maximal tolerated RASi and stable SGLT2i therapy

EXPERIMENTAL

pre and post Finerenone treatment evaluation

Drug: Finerenone

Interventions

Finerenone DRUG

Finerenone 10mg or 20 mg as tolerated on top of maximal tolerated RASi and stable SGLT2i therapy

Finerenone on top of maximal tolerated RASi and stable SGLT2i therapy

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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).

Sponsors & Collaborators

• Chinese University of Hong Kong: lead

Study Sites (1)

3M, Diabetes and Endocrine Research Center

Hong Kong, Hong Kong

RECRUITING

MeSH Terms

Conditions

Diabetes Mellitus, Type 2; Renal Insufficiency, Chronic

Interventions

finerenone

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Elaine Chow

CONTACT

+852 35051641; e.chow@cuhk.edu.hk

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Associate Professor

Model Details: in parallel fashion to optimise tolerated doses of Finerenone

Study Record Dates

• First Submitted: November 29, 2024
• First Posted: December 10, 2024
• Study Start: December 12, 2024
• Primary Completion (Estimated): July 31, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: March 5, 2025

Record last verified: 2024-12

Data Sharing

• IPD Sharing: Will share

Locations

HK (1)