EUCTR2021-000995-13-DK进行中（未招募）1 期
A 6-Month, Randomized, Double-Blind Study to Evaluate the Effect of Dapagliflozin on EChOcardiographic Measures of CarDiac StructurE and Function in Patients with Chronic Kidney Disease (DECODE-CKD) - DECODE-CKD
Department of Cardiology, Herlev and Gentofte hospital0 个研究点目标入组 260 人开始时间: 2022年1月26日最近更新:
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 260
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •-Signed informed consent
- •-= 18 years of age
- •For those not undergoing dialysis
- •-Chronic Kidney Disease (CKD), defined as evidence of decreased eGFR (eGFR >=20 and <60 mL/min/1.73 m2) or evidence of albuminuria present for > 3 months if eGFR >60 at least 3 months before and at the time of screening
- •-Stable treatment with clinically appropriate doses of ACEi/ARB among CKD patients with proteinuria and uptitrated to maximal recommended or tolerated dose for at least 4 weeks before randomization, if not medically contraindicated
- •-For patients with type 2 diabetes:
- •oStable antihyperglycemic treatment > 30 days before screening
- •-Female patients should either not be of childbearing potential, defined as postmenopausal for at least 1 year or surgically sterile, or is of childbearing potential and practicing one of the following methods of contraception throughout the study and for 30 days after study completion: Hormonal contraception (oral contraceptives, contraceptive implant, injectable birth control, contraceptive patch, or vaginal ring) or intrauterine device
- •-Ability to understand and read Danish
- •-For those undergoing hemodialysis:
- •- Initation of hemodialysis within 1 year of the randomization visit
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 111
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 111
排除标准
- •-Type 1 diabetes
- •For patients with type 2 diabetes:
- •-History of diabetic ketoacidosis
- •-History of organ transplant
- •-Treatment with SGLT2 inhibitor within 8 weeks (not undergoing dialysis) or 4 weeks (undergoing dialysis) prior to enrolment
- •-Known allergy or hypersensitivity to SGLT2 inhibitors or Placebo ingredients
- •-Myocardial infarction, unstable angina, stroke or transient ischemic attack within 12 weeks of enrolment
- •-Coronary revascularization (percutaneous coronary intervention or coronary artery bypass grafting) or valvular repair/replacement within 12 weeks prior to enrolment
- •-Any condition outside the renal and cardiovascular study area with a life expectancy of <2 years based on investigator’s clinical judgement
- •For non-dialysis participants
- •-Hepatic impairment (aspartate transaminase or alanine transaminase >3 times the upper limit of normal [ULN] or total bilirubin >2 times the ULN at the time of enrolment)
- •For dialysis participants
- •- Known hepatic impairment documented in the participants electronic health record
- •-Known blood-borne diseases, such as Hepatitis A, B, C, D, and E, and Human immunodeficiency virus (HIV) types 1 and 2, Ebola, Lassa fever virus.
- •-Female patients who are pregnant, lactating, or are considering becoming pregnant during the study or for 6 months after study completion
- •-Participation in another clinical study with an investigational product within the last month prior to enrolment
- •-Inability to understand or comply with the investigational product, procedures, and/or follow-up or any conditions that may prevent the participant to complete the study
研究者
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