Combination of finerenone and empagliflozin in participants with Kidney disease and Type 2Diabetes

Phase 2

Recruiting

• Conditions: Health Condition 1: E112- Type 2 diabetes mellitus with kidney complications

• Registration Number: CTRI/2023/09/057826
• Lead Sponsor: Fortrea Development India Private Limited

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 29 April 2024

Recruitment & Eligibility

• Status: Open to Recruitment
• Sex: Not specified
• Target Recruitment: 0

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 semiquantitative 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 <br/ ><br>Relative change from baseline in UACR at 180 days in combination therapy group versus finerenone aloneTimepoint: Up to 180 days