2025-522742-46-00招募中4 期
CANIDIAP; CANagliflozin In DIAlysis Patients
适应症
试验速览
- 阶段
- 4 期
- 状态
- 招募中
- 入组人数
- 10
- 试验地点
- 1
- 主要终点
- The overall percentage of receptor occupancy.
研究概览
简要总结
The main objective of this exploratory study is to investigate specific tissue distribution of SGLT2 inhibitors in patients on dialysis with-and without residual diuresis and visualize this by the use of 18F- canagliflozin.
入排标准
- 年龄范围
- 18 years 至 65+ years（65+ Years, 18-64 Years）
- 接受健康志愿者
- 否
入选标准
- •Dialysis for more than 3 months both HD and PD (5 also with residual diuresis) 2) Age ≥18 years of age 3) Willing to sign informed consent
排除标准
- •Mentally incapacitated subjects (i.e. not able to sign informed consent) 2) Subjects who participated in a trial with exposure to radiation before, are only allowed to participate if the total cumulative radiation burden in their life does not exceed 1 mSv per year, counting from the age of 18 years. 3) Pregnant women and women of child-bearing potential who are not using reliable contraception 4) Subjects on diuretics are allowed to participate but the dose should be stable for at least 4 weeks prior to screening 5) Subjects already on a SGLT2 inhibitor are allowed to participate, but the drug should be interrupted 1 week prior to the first study day till the end of the second study day 6) History of hypersensitivity to canagliflozin or another SGLT2 inhibitor 7) Severe claustrophobia 8) History of drug or alcohol abuse within the 12 months prior to dosing, or evidence of such abuse as indicated by the laboratory assays conducted during the screening. 9) Any medication, surgical or medical condition which might significantly alter the absorption, distribution, metabolism, or excretion of medications including, but not limited to any of the following: Major gastrointestinal tract surgery such as gastrectomy, gastroenterostomy, or bowel resection Gastro-intestinal ulcers and/or gastrointestinal or rectal bleeding within last six months Pancreatic injury or pancreatitis within the last six months Evidence of hepatic disease as determined by any one of the following: ALT or AST values exceeding 3x ULN at inclusion visit, a history of hepatic encephalopathy, a history of esophageal varices, or a history of portocaval shunt 10) Established peripheral arterial disease 11) Active cardiovascular disease: myocardial infarction, angina pectoris, percutaneous transluminal coronary angioplasty, coronary artery bypass grafting, stroke, or heart failure (NYHA I-IV) admission < 3 months before inclusion 12) People using digoxin 13) Patients with an active malignancy
结局指标
主要结局
The overall percentage of receptor occupancy.
The overall percentage of receptor occupancy.
次要结局
- The percentage of receptor occupancy in the specific regions of interest.
- The overall percentage of receptor occupancy compared between dialysis patients that have and that do not have residual diuresis.
研究者
Prof dr. H.J. Lambers Heerspink
Scientific
Universitair Medisch Centrum Groningen
研究点 (1)
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