Cited 2 times in
FimAsartaN proTeinuriA SusTaIned reduCtion in comparison with losartan in diabetic chronic kidney disease (FANTASTIC): study protocol for randomized controlled trial.
DC Field | Value | Language |
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dc.contributor.author | 박성하 | - |
dc.contributor.author | 유태현 | - |
dc.date.accessioned | 2018-07-20T12:02:50Z | - |
dc.date.available | 2018-07-20T12:02:50Z | - |
dc.date.issued | 2017 | - |
dc.identifier.uri | https://ir.ymlib.yonsei.ac.kr/handle/22282913/161693 | - |
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.description.statementOfResponsibility | open | - |
dc.language | English | - |
dc.publisher | BioMed Central | - |
dc.relation.isPartOf | TRIALS | - |
dc.rights | CC BY-NC-ND 2.0 KR | - |
dc.rights | https://creativecommons.org/licenses/by-nc-nd/2.0/kr/ | - |
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.contributor.college | College of Medicine | - |
dc.contributor.department | Dept. of Internal Medicine | - |
dc.contributor.googleauthor | Jang-Young Kim | - |
dc.contributor.googleauthor | Jung-Woo Son | - |
dc.contributor.googleauthor | Sungha Park | - |
dc.contributor.googleauthor | Tea-Hyun Yoo | - |
dc.contributor.googleauthor | Yong-Jin Kim | - |
dc.contributor.googleauthor | Dong-Ryeol Ryu | - |
dc.contributor.googleauthor | Ho Jun Chin | - |
dc.identifier.doi | 10.1186/s13063-017-2375-8 | - |
dc.contributor.localId | A01512 | - |
dc.contributor.localId | A02526 | - |
dc.relation.journalcode | J02759 | - |
dc.identifier.eissn | 1745-6215 | - |
dc.identifier.pmid | 29284530 | - |
dc.subject.keyword | Chronic kidney disease | - |
dc.subject.keyword | Diabetes mellitus | - |
dc.subject.keyword | Hypertension | - |
dc.subject.keyword | Proteinuria | - |
dc.contributor.alternativeName | Park, Sung Ha | - |
dc.contributor.alternativeName | Yoo, Tae Hyun | - |
dc.contributor.affiliatedAuthor | Park, Sung Ha | - |
dc.contributor.affiliatedAuthor | Yoo, Tae Hyun | - |
dc.citation.volume | 18 | - |
dc.citation.startPage | 632 | - |
dc.identifier.bibliographicCitation | TRIALS, Vol.18 : 632, 2017 | - |
dc.identifier.rimsid | 61715 | - |
dc.type.rims | ART | - |
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