NL-OMON54022招募中2 期
A Study to Assess the Effects of the Endothelin Receptor Antagonist Zibotentan and the SGLT2 Inhibitor Dapagliflozin in Patients elevated Albuminuria: a Randomized Double Blind Cross-Over Trial - ZODIAC
适应症
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 12
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 18 至 99（—）
入选标准
- •Age >=18 and <=75 years
- •Urinary albumin:creatinine ratio > 100 mg/g and <= 3500 mg/g in a first morning
- •void urine collection
- •eGFR >= 30 mL/min/1.73m2
- •On a stable dose of an ACEi or ARB for at least 4 weeks prior to randomization
- •Willing to sign informed consent
排除标准
- •Diagnosis of type 1 diabetes Minimal change disease, unstable rapidly
- •progressing renal disease, and/or renal disease requiring significant
- •immunosuppression, autosomal dominant or autosomal recessive polycystic kidney
- •disease Hba1c > 12.5% Urinary albuminexcretion > 3500 mg/day Heart Failure NYHA
- •Class III or IV NT-proBNP > 600 pg/ml Acute coronary syndrome event within the
- •preceding 6 months Severe peripheral edema according to investigators opinion
- •Women of childbearing potential (WOCBP). WOCBP is defined as women who have
- •experienced menarche and who have not undergone successful surgical
- •sterilization (hysterectomy, bilateral tubal ligation, or bilateral
- •oophorectomy) or who are not post-menopausal Pregnancy or breastfeeding
- •Indication for high dose immunosuppressants as per the treating physician*s
- •judgment. Active malignancy aside from treated squamous cell or basal cell
- •carcinoma of the skin within the last 5 years. Use of the co-interventional
- •treatments within 6 weeks of screening will not be allowed. 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: o History of active inflammatory bowel disease
- •within the last six months; o Major gastrointestinal tract surgery such as
- •gastrectomy, gastroenterostomy, or bowel resection; o Gastro-intestinal ulcers
- •and/or gastrointestinal or rectal bleeding within last six months; o Pancreatic
- •injury or pancreatitis within the last six months; o Evidence of hepatic
- •disease as determined by any one of the following: ALT or AST values exceeding
- •3x ULN at the screening visit, a history of hepatic encephalopathy, a history
- •of esophageal varices, or a history of portocaval shunt; o Evidence of urinary
- •obstruction or difficulty in voiding at screening Severe hepatic impairment
- •History of epilepsy syndrome History of severe hypersensitivity or
- •contraindications to dapagliflozin History of hypersensitivity or
- •contraindications to iodinated contrast media Subject who, in the assessment of
- •the investigator, may be at risk for dehydration or volume depletion that may
- •affect the interpretation of efficacy or safety data Participation in any
- •clinical investigation within 3 months prior to initial dosing. Donation or
- •loss of 400 ml or more of blood within 8 weeks prior to initial dosing. 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
- •or according to investigator*s assessment. History of noncompliance to medical
- •regimens or unwillingness to comply with the study protocol. Any surgical or
- •medical condition, which in the opinion of the investigator, may place the
- •subject at higher risk from his/her participation in the study, or is likely to
- •prevent the subject from complying with the requirements of the study or
- •completing the study.
研究者
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