Full metadata record
DC Field | Value | Language |
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dc.contributor.author | 류동열 | * |
dc.date.accessioned | 2018-02-08T16:31:04Z | - |
dc.date.available | 2018-02-08T16:31:04Z | - |
dc.date.issued | 2017 | * |
dc.identifier.issn | 1745-6215 | * |
dc.identifier.other | OAK-21909 | * |
dc.identifier.uri | https://dspace.ewha.ac.kr/handle/2015.oak/239829 | - |
dc.description.abstract | 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. | * |
dc.language | English | * |
dc.publisher | BIOMED CENTRAL LTD | * |
dc.subject | Proteinuria | * |
dc.subject | Chronic kidney disease | * |
dc.subject | Hypertension | * |
dc.subject | Diabetes mellitus | * |
dc.title | FimAsartaN proTeinuriA SusTaIned reduCtion in comparison with losartan in diabetic chronic kidney disease (FANTASTIC): study protocol for randomized controlled trial | * |
dc.type | Article | * |
dc.relation.volume | 18 | * |
dc.relation.index | SCIE | * |
dc.relation.index | SCOPUS | * |
dc.relation.journaltitle | TRIALS | * |
dc.identifier.doi | 10.1186/s13063-017-2375-8 | * |
dc.identifier.wosid | WOS:000419147900003 | * |
dc.identifier.scopusid | 2-s2.0-85039735034 | * |
dc.author.google | Kim, Jang-Young | * |
dc.author.google | Son, Jung-Woo | * |
dc.author.google | Park, Sungha | * |
dc.author.google | Yoo, Tea-Hyun | * |
dc.author.google | Kim, Yong-Jin | * |
dc.author.google | Ryu, Dong-Ryeol | * |
dc.author.google | Chin, Ho Jun | * |
dc.contributor.scopusid | 류동열(7103144218;56997547400;56669926200) | * |
dc.date.modifydate | 20240123102517 | * |