Tirzepatide Study of Renal Function in People with Overweight or Obesity and Chronic Kidney Disease with or without Type 2 Diabetes: Focus on Kidney Hypoxia in Relation to Fatty Kidney Disease using Multiparametric Magnetic Resonance Imaging (TREASURE-CKD)

Eli Lilly and Company0 个研究点目标入组 140 人开始时间: 2022年5月23日最近更新: 2024年4月15日

试验速览

暂无简介。

•1.Participants without diabetes must have HbA1c of = 6.5 %.
•2.Participants with diabetes must have HbA1c = 7 % to = 10.5 % at screening visit.
•3.Participants must be at least 18 years of age or the legal age of consent in the juristiction where the study is taking place.
•4.Participants must have a BMI = 27kg/cm2 at screening visit
•5.Participants must be diagnosed with CKD having a eGFR =30 to = 60 mL/min1.73 m2 or eGFR = 30 to 75 mL/min/1.73 m2 if UACR > 30 mg/g, calculated by CKD-EPI eqn., as determined by central labs at screening visit.
•6.Participants must have been receiving an ACE or ARBi that is considered the maximal appropriate dose by the investigator for treatment of CKD or hypertension (unless patient has low blood pressure or hypotension), The dose must have been unchanged for 30 days before screening 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 130
•F.1.3 Elderly (>=65 years) no
•F.1.3.1 Number of subjects for this age range 10

•1.For participants with T2D the following exclusion criteria apply:
•2.Participants have a history of proliferative diabetic retinopathy or diabetic macular edema or non-proliferative edema or non-proliferative diabetic retinopathy that requires acute treatment.
•3.Participants who have uncontrolled diabtes (such as diabetic ketoacidosis) at screening or randomization, in the judgement of the physician
•4.For participants without T2D the following exclusion criteria apply:
•5.Have T1DM or a history of ketoacidosis ot hypersmolar state/coma
•6.Have self reported change in body weight >5kgs within the 90 days prior to screening visit
•7.Have had or plan to have surgical treatment for obesity (excluding liposuction or abdominoplasty if performed >1 year prior to screening)
•8.Have or plan to have endoscopic and or device based therapy for obesity or have had device removal within the last 180 days e.g. mucosal ablation, gastric artery, ambolization, intragastric balloon and duodenal jejunal bypass device.
•9.Have eGFr < 30 mL/min/1.73 m2 calculated by CKD-EPI equation.
•10.Have a history of unstable or rapidly progressing renal disease according to investigator judgement.
•11.Have a history of a congenital or hereditary kidney disease, like polycystic kidney disease or congenital urinary tract malformations

发起方