Combination of finerenone and empagliflozin in participants with CKD and T2D

Phase 2

Recruiting

• Conditions: Chronic Kidney Disease and Type 2 Diabetes

• Registration Number: JPRN-jRCT2071220067
• Lead Sponsor: Myoishi Masafumi

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2022-11-04
• Last Update Posted: 1 April 2024

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 807

Inclusion Criteria

Participant with a clinical diagnosis of chronic kidney disease (CKD) and the following:
-In Part A: eGFR 40-90 ml/min/1.73m2 (with no more than 20% having an eGFR >75 ml/min/1.73m2) using Chronic Kidney Disease Epidemiology Collaboration (CKD EPI) formula at screening visit and at least one historical value of eGFR <60 mL/min/1.73 m2 within 3 months or have a registered diagnosis of CKD.
-In Part B: eGFR 30-90 ml/min/1.73m2 (with no more than 20% having an eGFR >75 ml/min/1.73m2) using CKD-EPI formula at screening visit and at least one historical value of eGFR <60 mL/min/1.73 m2 within 3 months or have a registered diagnostic of CKD.
-300 <=UACR <5000 mg/g at screening visit (mean value from 3 morning void samples) and documentation of albuminuria/proteinuria (quantitative or semi-quantitative measurement) in the participant's medical records at least 3 months prior to screening
-Participant with type 2 diabetes (T2D) as defined by the American Diabetes Association (ADA 2021), with glycated hemoglobin (HbA1c) at screening <11%.
-Participant treated with the clinically maximum tolerated dose, as per investigator judgment, of angiotensin-converting enzyme inhibitor (ACEi) or angiotensin receptor blocker (ARB), but not both, for more than 1 month at screening visit.

Exclusion Criteria

-Participants with type 1 diabetes (T1D).
-Participant with hepatic insufficiency classified as Child-Pugh C.
-Participant with blood pressure at Day 1 visit higher than 160/100 or systolic blood pressure lower than 90 mmHg.
-Participant currently treated with a sodium/glucose cotransporter-2 inhibitor (SGLT2i) or SGLT-1/2i or who received a SGLT2i or SGLT-1/2i which cannot be discontinued at least 8 weeks prior to the screening visit and during study intervention treatment.
-Participant treated with another mineralocorticoid receptor antagonist (MRA) (e.g., eplerenone, esaxerenone, spironolactone, canrenone), a renin inhibitor, potassium supplements, a potassium sparing diuretic (e.g., amiloride, triamterene), a potassium binder agent, or angiotensin receptor-neprilysin inhibitor (ARNI) which cannot be discontinued at least 8 weeks prior to the screening visit and during study intervention treatment.
-Participants currently treated or who were treated with Finerenone (Kerendia) within 8 weeks prior to the screening visit.
-Participant with serum/plasma potassium (K+) above 4.8 mmol/L at screening.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
-Relative change from baseline in UACR at 180 days in combination therapy group versus empagliflozin alone [ Time Frame: Up to 180 days ]<br>Urinary albumin to-creatinine ratio (UACR)<br>-Relative change from baseline in UACR at 180 days in combination therapy group versus finerenone alone [ Time Frame: Up to 180 days ]