FimAsartaN proTeinuriA SusTaIned reduCtion in comparison with losartan in diabetic chronic kidney disease...

Area of Science:

• Nephrology
• Cardiology
• Pharmacology

Background:

• Fimasartan, a novel angiotensin receptor blocker, has not been assessed for reno-protective effects in hypertensive diabetic chronic kidney disease (CKD).
• Optimal blood pressure (BP) targets for managing hypertensive diabetic CKD remain debated.
• This study addresses the need to evaluate fimasartan's efficacy and optimal BP control in this patient population.

Purpose of the Study:

• To assess the reno-protective effects of fimasartan compared to losartan in patients with hypertensive diabetic CKD and proteinuria.
• To compare cardiovascular and renal outcomes between strict (SBP < 130 mmHg) and standard (SBP < 140 mmHg) systolic blood pressure control groups.
• To determine the optimal target BP for reducing adverse outcomes in this specific patient group.

Main Methods:

• A prospective, phase III, randomized, double-blind, active-controlled, multicenter trial involving patients with hypertensive diabetic CKD and overt proteinuria.
• Four parallel groups: fimasartan or losartan with either standard or strict systolic blood pressure (SBP) control.
• Primary endpoint: change in proteinuria (urine albumin-creatinine ratio) at 24 weeks; secondary endpoints: cardiovascular and renal outcomes at 144 weeks.

Main Results:

• The study is designed to provide data on the primary endpoint of proteinuria change at 24 weeks.
• Secondary endpoints will assess cardiovascular and renal outcomes at 144 weeks.
• The comparison between strict and standard SBP control groups will be analyzed.

Conclusions:

• The FANTASTIC clinical study aims to elucidate the reno-protective potential of fimasartan.
• It will provide evidence regarding the optimal target blood pressure for managing hypertensive diabetic CKD with proteinuria.
• Findings will inform clinical practice for this vulnerable patient population.