jRCT1071220024尚未招募不适用
Dapagliflozin protects eGFR decline in normoproteuric non-diabetic patients with CKD; DEFENCE trial (DEFENCE trial)
未提供0 个研究点目标入组 260 人开始时间: 待定最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 260
- 主要终点
- -
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized Controlled Trial
- 干预模型
- Parallel Assignment
- 主要目的
- Treatment Purpose
- 盲法
- Open(masking Not Used)
入排标准
- 年龄范围
- 20age old over 至 84age old under（—）
- 性别
- All
入选标准
- •Female or male aged between 20 and 84
- •eGFR 30 or more AND less than 60 mL/min/1.73
- •Urinary protein to creatinine ratio less than 0.50g/gCr OR negative in dip stick method
- •Patients who have given written consent to participate in the study from the individual (or a surrogate)
排除标准
- •Patients with eGFR decline within 1mL/min/1.73 per year or whose renal function has not deteriorated over the past several years and is unlikely to deteriorate in the future, as judged by investigators
- •BMI less than 20
- •Receiving therapy with a SGLT2 inhibitor within 8 weeks prior to enrolment or previous intolerance of an SGLT2 inhibitor
- •Receiving therapy with immune suppressive drugs within 6 months prior to enrolment
- •History of renal transplantation
- •New York Heart Association(NYHA) class 4 Congestive Heart Failure at the time of enrolment
- •MI, unstable angina, stroke or transient ischemic attack(TIA) within 12 weeks prior to enrolment
- •Coronary revascularization(percutaneous coronary intervention:PCI or coronary artery bypass grafting:CABG) within 12 weeks prior to enrolment or is planned to undergo any of these procedures after randomization
- •Any condition outside the renal and cardiovascular disease area, such as but not limited to malignancy, with a life expectancy of less than 2 years based on investigator's clinical judgement
- •Active malignancy requiring treatment at the time of inclusion
- •Hepatic impairment(aspartate trasaminase:AST or alanine transaminase:ALT]more than 3times the upper limit of normal; or total bilirubin more than 2times upper limit of normal at the time of enrolment)
- •Women of child-bearing potential or women who have a positive pregnancy test at enrolment or women who are breast-feeding
- •Participation in another clinical study
- •Inability of the patient, in the opinion of the investigator, to understand and/or comply with investigational product.
- •In principle, employees of Kurume University School of Medicine and students of Kurume University are excluded.
结局指标
主要结局
-
The rate of change in eGFR between 1 month and 12month after the beginning of study
次要结局
- Composite renal outcome
研究者
相似试验
尚未招募
不适用
Dapagliflozin in Heart FailureCTRI/2022/11/047725Sanjay Kumar R
尚未招募
不适用
Dapagliflozin is a licensed medicine used for reducing blood sugar in people with diabetes and this study will test whether it can also reduce the stiffness in the liver which commonly occurs in diabetes.CTRI/2019/05/019286Dr Shashi Panicker
招募中
不适用
Examination of the efficacy of dapagliflozin in patients with type 2 diabetesType 2 diabetesJPRN-UMIN000021954Tonami general hospital Department of diabetes mellitus and endocrinology200
已完成
4 期
Comparing Dapagliflozin and Glimepiride in treating patients with type 2 Diabetes.Type 2 Diabetes Mellitus.E11.9Type 2 DiabetesIRCT20220408054450N1Bahria University Medical & Dental College200
进行中（未招募）
1 期
Study to evaluate if dapagliflozin treatment is effective in patients with heart failure by reducing the number of hospitalizations and urgent visits due to heart failure, and by reducing the risk of death.Chronic Heart Failure (HF) with Reduced Ejection FractionEUCTR2016-003897-41-PLAstraZeneca AB4,500