JPRN-jRCTs071180033已完成未知
rate lowering drugs RandomIzed parallel-group Comparison study in the Chronic Kidney Disease patients with hypertension and hyperuricemia - URIC CKD study
Kohagura Kentaro0 个研究点目标入组 88 人开始时间: 2019年3月7日最近更新:
适应症
试验速览
- 阶段
- 未知
- 状态
- 已完成
- 发起方
- 入组人数
- 88
研究概览
简要总结
Patients with stage 3 chronic kidney disease complicated with hypertension and hyperuricemia were enrolled and initiated treatment with benzbromarone or febuxostat. There were no significant differences in the rate of change in eGFR between the groups by week 52 after initiation of treatment. Febuxostat significantly reduced xanthine oxidase activity compared to benzbromarone. There were no significant differences between the groups in the other secondary endpoints of blood pressure, albuminuria, inflammati
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- >= 20age old 至 ot applicable（—）
- 性别
- All
入选标准
- •1) Serum uric acid >7.0 mg/dL
- •2) Patients with hypertension defined as blood pressure measurements of equal or more than 140 mm Hg systolic and/or equal or more than 90 mm Hg diastolic or treatment with antihypertensive agents. No changes in prescription of antihypertensive agent 8 weeks before initiating the study drug.
- •3) CKD stage 3a and 3b
- •4) Age equal to or more than 20 years at obtaining informed consent
- •5) Outpatient
- •6) No history of gout
- •7) Obtained written informed consent from the patient for participation to the study
排除标准
- •1) History of hypersensitivity to febuxostat or benzbromarone
- •2) AST or ALT is more than twice the upper limit of institutional normal range
- •3) eGFR <30ml/min/1.73m2 or dialysis patients.
- •4) Under treatment with thiazide diuretics or loop diuretics
- •5) History of treatment with urate lowering drugs within 2 weeks before determination of eligibility
- •6) History of coronary heart disease within 3 month before determination of eligibility
- •7) Patients with neoplasm, History of neoplasm except for the cured patients without recurrence within 5 years before determination of eligibility
- •8) Under treatment with the following: mercaptopurine,azathioprine, pyrazinamide, ethanbutol
- •9) Under treatment with warfarin
- •10) Women who are or may be pregnant, or brest-feeding
- •11) Participants of other clinical trials within 6 month before determination of eligibility
- •12) Urolithiasis
- •13) A patient who are judged inadequate for enrollment by an attending physician
- •14) A patient whose serum uric acid level is equal to or less than 7 mg/dl at Visit2 after randomization
- •15) A patient has been suffered from any of following: acute myocardial infarction, acute coronary syndrome, patients undergoing percutaneous coronary intervention or coronary artery bypass grafting, vetricular tachycarida, mutifocal ventricular arrhythmia and acute heart failure within three months before the eligibility assessment. This exclusion criteria was added since recent study suggested febuxostat may be associated with increased cardiovascular mortality compared with allopurinol among gout patients with major cardiovascular disease (N Engl J Med 2018;378:1200-10)
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