Study of Empagliflozin in Patients with Autosomal Dominant Polycystic Kidney Disease

Medizinische Hochschule Hannover0 个研究点目标入组 44 人开始时间: 2023年12月20日最近更新: 2024年7月22日

适应症

试验速览

暂无简介。

•Male and female patients = 18 of age, Screening eGFR = 25 and = 90 mL/min/1.73 m2 if age = 18 and =50 years or Screening eGFR = 25 and = 65 mL/min/1.73 m2 if age > 50 years, ADPKD diagnosed by unified criteria (combination of family history, ultrasound, MRI/CT, genotyping as needed), Mayo Class I C, D, E, Patients with and without tolvaptan use will be included. Patients with tolvaptan use will be included if tolvaptan has been taken for = 3 months at study entry., Willing and able to comply with scheduled visits, treatment plan, laboratory tests and other study procedures, Evidence of signed written informed consent

•Kidney or any other solid organ transplant recipient, Women who are pregnant or breastfeeding, Unwilling to practice acceptable methods of birth control during study participation, Participation in another clinical trial (other investigational drugs or devices at the time of enrolment or within 30 days prior to enrolment), Currently receiving SGLT2-inhibitor, Concomitant treatment with steroids or any other immunosuppressive agent, Hypersensitivity to the active principle (Empagliflozin) or any of the excipients (e.g. lactose), Ketoacidosis (laboratory based) in the past 5 years, Type 1 diabetes mellitus, Uncontrolled urinary tract- or genital infections, Inability to fully understand the possible risks and benefits related to study participation, Inability to undergo MRI exam (e.g. implanted medical devices)

发起方

Medizinische Hochschule Hannover