2023-509450-55-01招募中2 期
Prevention of CKD progression in type 1 diabetes with Long term Use of SGLTi avoiding kidney hypOxia (PLUTO)
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 39
- 试验地点
- 1
- 主要终点
- Change from 0 to 12 weeks in dynamic R2*-weighted signal (BOLD) as an indirect measure of renal blood oxygenation after treatment with sotagliflozin compared with placebo.
研究概览
简要总结
The primary aim is to estimate the effect of three months treatment with sotagliflozin on renal oxygenation (MRI) in people with T1D and chronic kidney disease
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 18 years 至 65+ years（18-64 Years, 65+ Years）
- 接受健康志愿者
- 否
入选标准
- •Adults with type 1 diabetes mellitus
- •Chronic Kidney Disease and albuminuria
排除标准
- •Non-diabetic Kidney Disease
- •eGFR<25mL/min/1.73m^2, dialysis or kidney transplantation
- •Previous diabetic ketoacidosis, except at debut
- •Receiving therapy with an SGLT inhibitor within 8 weeks prior to enrolment or previous intolerence of an SGLT inhibitor.
结局指标
主要结局
Change from 0 to 12 weeks in dynamic R2*-weighted signal (BOLD) as an indirect measure of renal blood oxygenation after treatment with sotagliflozin compared with placebo.
Change from 0 to 12 weeks in dynamic R2*-weighted signal (BOLD) as an indirect measure of renal blood oxygenation after treatment with sotagliflozin compared with placebo.
次要结局
- Change in renal fibrosis(From 0 to 12 weeks in each treatment arm. Last measure 30 weeks after randomization)
- Change in renal artery flow(From 0 to 12 weeks in each treatment arm. Last measure 30 weeks after randomization)
- Change in renal parenchymal triglyceride fraction(From 0 to 12 weeks in each treatment arm. Last measure 30 weeks after randomization)
- Change in renal perfusion (medullary and cortical)(From 0 to 12 weeks in each treatment arm. Last measure 30 weeks after randomization)
- Change in renal oxygen consumption(From 0 to 12 weeks in each treatment arm. Last measure 30 weeks after randomization)
- Change in left ventricular ejection fraction(From 0 to 12 weeks in each treatment arm. Last measure 30 weeks after randomization)
- Change in albuminuria(From 0 to 12 weeks in each treatment arm. Last measure 30 weeks after randomization.)
- Change in levels of ketone bodies(From 0 to 12 weeks in each treatment arm. Last measure 30 weeks after randomization.)
- Change in plasma and urine inflammation- and fibrosis biomarkers(From 0 to 12 weeks in each treatment arm. Last measure 30 weeks after randomization.)
- Change in endogenous erythropoietin(From 0 to 12 weeks in each treatment arm. Last measure 30 weeks after randomization.)
- Difference in Kidney Function after 12 weeks treatment with sotagliflozin vs placebo(From 12 to 30 weeks after randomization)
- Change in pro brain natriuretic peptide(From 0 to 12 weeks in each treatment arm. Last measure 30 weeks after randomization.)
研究者
Mette Brouw Iversen
Scientific
Steno Diabetes Center Copenhagen
研究点 (1)
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