EUCTR2021-000726-10-IT进行中（未招募）1 期
Evaluating the short-term renal and systemic effects of Dapagliflozin in non-diabetic patients with stage IV CKD at risk of ESKD because of severe renal insufficiency and persistent proteinuria: A prospective, randomized, double-blind, placebo-controlled, cross-over study - Dapagliflozin in non-diabetic stage IV CKD
IRCCS- ISTITUTO DI RICERCHE FARMACOLOGICHE MARIO NEGRI0 个研究点目标入组 32 人开始时间: 2021年6月8日最近更新:
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 32
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
- •1Provision of informed consent prior to any study specific procedures
- •2Male or female more than 18 year old
- •3Non-diabetic Stage-IV CKD
- •4Fasting blood glucose = 125 mg (= 6.9 mmol/l) and HbA1C =6.4% (= 47 mmol/mol)58 without treatment with oral blood glucose lowering medications and/or insulin
- •5Two-hour plasma glucose <200 mg/dl during 75-g oral glucose tolerance test (OGTT)58
- •6Persistent proteinuria (24-hour urinary protein excretion = 0.5 grams in at least two consecutive evaluations >1 week apart) despite RAS inhibitor therapy with ACE inhibitors and/or ARBs (or without RAS inhibitors in patients with specific contraindications to these medications)
- •7eGFR 15 to 30 ml/min/1.73 m2 by CKD-Epi equation
- •8Blood pressure <150/90 mmHg without changes in blood pressure lowering medications over the last four weeks before the randomization
- •9Negative pregnancy test (urine or serum) for female subjects of childbearing potential.
- •10Female subjects must be 1 year post-menopausal, surgically sterile, or using an acceptable method of contraception (an acceptable method of contraception is defined as a barrier method in conjunction with a spermicide) for the duration of the study (from the time they sign consent) and for 3 months after the last dose of dapagliflozin\placebo to prevent pregnancy. In addition, oral contraceptives, approved contraceptive implant, long-term injectable contraception, intrauterine device, or tubal ligation are allowed. Oral contraception alone is not acceptable; additional barrier methods in conjunction with spermicide must be used.
- •11Male subjects must be surgically sterile or using an acceptable method of contraception (defined as barrier methods in conjunction with spermicides) for the duration of the study (from the time they sign consent) and for 3 months after the last dose of IMP to prevent pregnancy in a partner.
- •12Subjects who are blood donors should not donate blood during the study and for 3 months following their last dose of dapagliflozin\placebo.
- •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 16
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 16
排除标准
- •1Involvement in the planning and/or conduct of the study (applies to both Investigator staff and/or staff at the study site)
- •2Participation in another clinical study with an investigational product during the last month
- •3Ischemic kidney disease (because of possible excess risk of acute kidney injury upon SGLT2-inhibitor associated reduction in sodium pool and kidney perfusion pressure)
- •4Rapidly progressive kidney disease (e GFR reduction = 30% over the last three months) and expected risk of progression to end stage kidney failure and need of renal replacement therapy by dialysis or transplantation during the study period.
- •5Active systemic autoimmune diseases;
- •6Concomitant treatment with steroids or any other immunosuppressive agent
- •7Hypersensitivity to the active principle (dapagliflozin) or any of the excipients (e.g. lactose);
- •8Severe/unstable heart failure with or without decreased systolic function requiring hospitalization or changes in pharmacological therapy over the last three months
- •9Uncontrolled hypertension (BP >150/90 mmHg despite optimized pharmacological treatment and diet or symptomatic hypotension
- •10Positive hepatitis C antibody hepatitis B virus surface antigen or hepatitis B virus core antibody, at screening
- •11Known to have tested positive for human immunodeficiency virus
- •12Drug or alcohol abuse
- •13Inability to fully understand the possible risks and benefits related to study participation
- •14If female, the subject is pregnant or lactating or intending to become pregnant before, during, or within 90 days after last dose; or intending to donate ova during such time period;
- •15 If male, the subject intends to donate sperm while on the study this study or for 90 days after last dose;
- •16Participation in another interventional clinical trial within the 4 weeks prior to screening.
研究者
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