DAPARHT: DAPAgliflozin for Renal protection in Heart Transplant recipients - D1699L00015

Oslo University Hospital HF0 个研究点目标入组 220 人开始时间: 2023年9月8日最近更新: 2024年7月22日

适应症

试验速览

暂无简介。

•Heart transplant recipient for = 1 year, Age = 18 years, Informed consent obtained and documented according to Good Clinical Practice (GCP), and national/regional regulations, Estimated glomerular filtration rate = 25 ml/min/1.73 m2 as assessed by the MDRD formula, The subject is, in the opinion of the Investigator, clinically suitable for randomisation to dapagliflozin/placebo

•Contraindications to study medication, Breastfeeding, Female subject who has either (1) not used at least one highly effective method of birth control for at least 1 month prior to screening or (2) is not willing to use such a method during treatment and for an additional 15 weeks after the end of treatment, unless the subject is sterilised or postmenopausal, Estimated GFR < 25 ml/min/m2, Type 1 diabetes, Severe liver failure (Child-Pugh’s score C), Life expectancy reduced to < 2 years as judged by the investigator, Unresolved malignant disease, Failure to obtain written informed consent, SGL2 inhibitor treatment over the four weeks prior to randomisation, Pregnancy

发起方

Oslo University Hospital HF