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

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dc.contributor.author박성하-
dc.contributor.author유태현-
dc.date.accessioned2018-07-20T12:02:50Z-
dc.date.available2018-07-20T12:02:50Z-
dc.date.issued2017-
dc.identifier.urihttps://ir.ymlib.yonsei.ac.kr/handle/22282913/161693-
dc.description.abstractBACKGROUND: 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.statementOfResponsibilityopen-
dc.languageEnglish-
dc.publisherBioMed Central-
dc.relation.isPartOfTRIALS-
dc.rightsCC BY-NC-ND 2.0 KR-
dc.rightshttps://creativecommons.org/licenses/by-nc-nd/2.0/kr/-
dc.titleFimAsartaN proTeinuriA SusTaIned reduCtion in comparison with losartan in diabetic chronic kidney disease (FANTASTIC): study protocol for randomized controlled trial.-
dc.typeArticle-
dc.contributor.collegeCollege of Medicine-
dc.contributor.departmentDept. of Internal Medicine-
dc.contributor.googleauthorJang-Young Kim-
dc.contributor.googleauthorJung-Woo Son-
dc.contributor.googleauthorSungha Park-
dc.contributor.googleauthorTea-Hyun Yoo-
dc.contributor.googleauthorYong-Jin Kim-
dc.contributor.googleauthorDong-Ryeol Ryu-
dc.contributor.googleauthorHo Jun Chin-
dc.identifier.doi10.1186/s13063-017-2375-8-
dc.contributor.localIdA01512-
dc.contributor.localIdA02526-
dc.relation.journalcodeJ02759-
dc.identifier.eissn1745-6215-
dc.identifier.pmid29284530-
dc.subject.keywordChronic kidney disease-
dc.subject.keywordDiabetes mellitus-
dc.subject.keywordHypertension-
dc.subject.keywordProteinuria-
dc.contributor.alternativeNamePark, Sung Ha-
dc.contributor.alternativeNameYoo, Tae Hyun-
dc.contributor.affiliatedAuthorPark, Sung Ha-
dc.contributor.affiliatedAuthorYoo, Tae Hyun-
dc.citation.volume18-
dc.citation.startPage632-
dc.identifier.bibliographicCitationTRIALS, Vol.18 : 632, 2017-
dc.identifier.rimsid61715-
dc.type.rimsART-
Appears in Collections:
1. College of Medicine (의과대학) > Dept. of Internal Medicine (내과학교실) > 1. Journal Papers

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