EUCTR2017-001090-16-NL进行中（未招募）1 期
A Study to Assess the Renoprotective Effects of the SGLT2 Inhibitor Dapagliflozin in Non-Diabetic Patients With Proteinuria: a Randomized Double Blind 6-Weeks Cross-Over Trial - DIAMOND
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 53
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •- Age =18 and =75 years
- •- Urinary protein excretion > 500 mg/g and = 3500 mg/g in a 24hour urine collection
- •- eGFR = 25 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
- •- Women of Child-Bearing Potential (WOCBP) must be using an acceptable method of contraception to avoid pregnancy throughout the study and for up to 4 weeks after the last dose of study drug in such a manner that the risk of pregnancy is minimized.
- •- WOCBP must have a negative serum or urine pregnancy test result (minimum sensitivity 25 IU/L or equivalent units of HCG) within 0 to 72 hours before the first dose of study drug.
- •- Women must not be breast-feeding
- •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 13
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 40
排除标准
- •- Diagnosis of type 1 or type 2 diabetes mellitus
- •- Urinary protein excretion > 3500 mg/day
- •- Peripheral Vascular Disease
- •- Autosomal dominant polycystic kidney disease or autosomal recessive polycystic kidney disease, lupus nephritis, or ANCA-associated vasculitis
- •- Indication for immunosuppressants as per the treating physician’s judgment.
- •- Receiving cytotoxic therapy, immunosuppressive therapy, or other immunotherapy for primary or secondary renal disease within 6 months prior to enrolment.
- •- Active malignancy aside from treated squamous cell or basal cell carcinoma of the skin.
- •- 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:
- •oHistory of active inflammatory bowel disease within the last six months;
- •oMajor gastrointestinal tract surgery such as gastrectomy, gastroenterostomy, or bowel resection;
- •oGastro-intestinal ulcers and/or gastrointestinal or rectal bleeding within last six months;
- •oPancreatic injury or pancreatitis within the last six months;
- •oEvidence 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;
- •oEvidence of urinary obstruction of difficulty in voiding at screening
- •- History of severe hypersensitivity or contraindications to dapagliflozin
- •- History of hypersensitivity or contraindications to iodinated contrast media
- •- Subject who 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.
- •- 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 patient at higher risk from his/her participation in the study, or is likely to prevent the patient from complying with the requirements of the study or completing the study.
- •- Pregnancy or breastfeeding
- •- WOCBP who are unwilling or unable to use an acceptable method to avoid pregnancy for the entire study period and up to 4 weeks after the last dose of study drug.
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