Journal Article

FimAsartaN proTeinuriA SusTaIned reduCtion in comparison with losartan in diabetic chronic kidney disease (FANTASTIC): study protocol for randomized controlled trial

Ryu, Dong-Ryeol, Yoo, Tea-Hyun, Kim, Jang-Young, Park, Sungha, Chin, Ho Jun, Kim, Yong-Jin, Son, Jung-Woo

2017

Overview

Background Fimasartan is the ninth angiotensin receptor blocker to be developed. However, it has not yet been evaluated for reno-protective effects in hypertensive diabetic chronic kidney disease (CKD). The target blood pressure (BP) for hypertensive diabetic CKD is also a controversial topic. This trial was designed to assess the reno-protective effects of fimasartan compared to those of losartan as a primary outcome. This study also compares the two drugs with regard to cardiovascular and renal outcomes in accordance with target systolic BP (SBP) (as secondary outcomes). Methods This study is a prospective, phase III, randomized, double-blind, active-controlled, non-inferiority, four-parallel group, dose-titration, multicenter trial. We recruit patients with hypertensive diabetic CKD with overt proteinuria. Participants will be randomized into four groups (1:1:1:1): fimasartan standard SBP control (SBP < 140 mmHg); fimasartan strict SBP control (SBP < 130 mmHg); losartan standard SBP control; and losartan strict SBP control. After 24 weeks, all individuals are treated with fimasartan for an additional 120 weeks in an open-label design, maintaining their assigned SBP control groups as randomized. The primary endpoint is the rate of change in proteinuria, which is assessed using the spot urine albumin–creatinine ratio at 24 weeks. The secondary endpoints are the cardiovascular and renal outcomes at 144 weeks compared between the strict SBP and standard SBP control groups. Discussion The FANTASTIC is a clinical study to provide: (1) the reno-protective effect of fimasartan; and (2) the target BP to reduce adverse outcomes in hypertensive diabetic CKD with overt proteinuria. Trial registration Clinicaltrials.gov, NCT02620306. Registered on 1 December 2015.

• Publisher: BioMed Central,BioMed Central Ltd,Springer Nature B.V,BMC
• Subject: Adult / Aged / Albumin / Angina pectoris / Angiotensins / Antihypertensive Agents - therapeutic use / Antihypertensives / Biomedicine / Biphenyl Compounds - adverse effects / Biphenyl Compounds - therapeutic use / Blood pressure / Blood Pressure - drug effects / Cardiology / Cardiovascular disease / Chronic kidney disease / Chronic kidney failure / Clinical trials / Clinical Trials, Phase III as Topic / Comparative analysis / Consent / Coronary vessels / Creatinine / Diabetes / Diabetes Complications / Diabetes Mellitus / Diabetic retinopathy / Double-Blind Method / Drug dosages / Endpoint Determination / Enzymes / Health Sciences / Heart attacks / Heart failure / Humans / Hypertension / Hypertension, Renal - drug therapy / Hypertension, Renal - etiology / Hypertension, Renal - physiopathology / Kidney diseases / Losartan - adverse effects / Losartan - therapeutic use / Medical research / Medicine / Medicine & Public Health / Middle Aged / Mortality / Multicenter Studies as Topic / Nephritis - drug therapy / Nephritis - etiology / Nephritis - physiopathology / Patients / Prospective Studies / Proteins / Proteinuria / Proteinuria - drug therapy / Pyrimidines - adverse effects / Pyrimidines - therapeutic use / Randomized Controlled Trials as Topic / Renal Insufficiency, Chronic - drug therapy / Renal Insufficiency, Chronic - etiology / Renal Insufficiency, Chronic - physiopathology / Research centers / Statistics for Life Sciences / Stroke / Study Protocol / Substance abuse treatment / Tetrazoles - adverse effects / Tetrazoles - therapeutic use / Type 2 diabetes / Urine / Vein & artery diseases