2024-513765-40-00招募中2 期
Acute effects of SGLT2 inhibitor on kidney allograft oxygen tension: A randomized, double-blind, placebo controlled crossover trial
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 8
- 试验地点
- 1
- 主要终点
- • Kidney allograft cortical and medullary oxygen tension, estimated by BOLD-MRI based renal T2* relaxation rate.
研究概览
简要总结
To evaluate the acute effect of SGLT2i on kidney allograft oxygen tension in cortex and medulla.
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
- •Written informed consent must be provided before participation
- •Male or female patients ≥ 18 years of age
- •Non-diabetic kidney transplant recipients, > 6 months post-transplant
- •Stable eGFR> 20 ml/min (stable defined as eGFR 20 ml/min ± 5 ml/min variation in the last 3 months)
- •Tacrolimus(Adport) and Mycophenolatmofetile (Myfenax, cellcept) as part of immunosuppressive treatment
排除标准
- •Diabetic kidney disease type 1 or 2 (World Health Organization (WHO) criteria)
- •Renal allograft failure (eGFR< 20 ml/min)
- •Alanine aminotransferase (ALAT) > 3 x upper normal limit or bilirubin > 2 x upper normal limit
- •Pregnancy or breastfeeding
- •Exclusion criteria for MRI o Claustrophobia/physical not able to lie in MR-scanner for 2 hours o MRI safety hazards such as cardiac pacemaker, implantable cardioverter defibrillator (ICD), non-MRI compatible implants and implanted devices, intraorbital or intracranial metallic foreign bodies.
- •Allergy towards SGLT2i or the content substance
- •Known intestinal bowel disease
- •Prednisone treatment
结局指标
主要结局
• Kidney allograft cortical and medullary oxygen tension, estimated by BOLD-MRI based renal T2* relaxation rate.
• Kidney allograft cortical and medullary oxygen tension, estimated by BOLD-MRI based renal T2* relaxation rate.
次要结局
- • Systolic blood pressure (SysBP) and diastolic blood pressure (DiaBP) mmHg
- • Heart rate (HR), beats min-1
- • Renal cortical and medullary perfusion ml/100 g/min
- • Renal artery blood flow ml/min
- • Blood glucose mmol/L
研究者
Claus Bistrup
Scientific
Odense University Hospital
研究点 (1)
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