A parallel-group treatment, Phase 2, double-blind, three-arm study to assess efficacy and safety of finerenone plus empagliflozin compared with either finerenone or empagliflozin in participants with chronic kidney disease and type 2 diabetes. - CONFIDENCE

Fortrea Development India Private Limited0 个研究点目标入组 0 人开始时间: 待定最近更新: 2024年4月29日

研究概览

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•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.

•- > 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.

发起方

Fortrea Development India Private Limited