EUCTR2020-000165-16-NL进行中（未招募）1 期
A single-center, prospective, placebo-controlled, double-blind, randomized, cross-over mechanistic intervention study to investigate the effect of empagliflozin on kidney function in people with either preserved or impaired kidney function with or without type 2 diabetes
Amsterdam University Medical Center - location VU Medical Center0 个研究点目标入组 72 人开始时间: 2020年3月24日最近更新:
适应症
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
- 72
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
- •Caucasian*
- •Both genders (females must be post-menopausal; no menses >1 year; in case of doubt, Follicle-Stimulating Hormone (FSH) will be determined with cut-off defined as >31 U/L)
- •Age: 45 - 80 years
- •BMI: >25 kg/m2
- •For with people with diabetes - a diagnosis of T2DM with glycosylated haemoglobin (HbA1c) =6.5% (=48 mmol/mol) and <10.5% (<91 mmol/mol); and eGFR (CKD-EPI) between =25 and =50 mL/min/1.73m2 or >75 mL/min/1.73m2 at the Screening Visit (Visit 1).
- •In the normoglycemic, hypertensive, individuals: HbA1c <6.5% (<48 mmol/mol) and an eGFR (CKD-EPI) between =25 and =50 mL/min/1.73m2 at the Screening Visit (Visit 1).
- •In the diabetic arm: people with an eGFR >75 ml/min/1.73m2 should be treated with a stable dose of metformin and/or SU, people with an eGFR between =25 and =50 mL/min/1.73m2 should be treated with a stable dose of metformin, SU and/or insulin therapy for at least 3 months prior to inclusion
- •Patient specific antihypertensive dose of an angiotensin receptor blocker (ARB) (as per Investigator’s judgement) for at least 4 weeks prior to Visit 2 (Day 3).
- •Written informed consent
- •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 36
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 36
排除标准
- •History of unstable or rapidly progressing renal disease
- •Diagnosis of polycystic kidney disease.
- •Post renal transplant
- •History of or current lupus nephritis.
- •Abnormal vital signs, after 10 minutes supine rest, definas as any of the following (Visit 1):
- •o Systolic blood pressure above 180 mmHg
- •o Diastolic blood pressure above 110 mmHg
- •Current/chronic use of the following medication: SGLT2 inhibitors,TZD, GLP-1RA, DPP-4 inhibitors, , antimicrobial agents or chemotherapeutics.
- •Volume depleted patients. Patients at risk for volume depletion due to co-existing conditions or concomitant medications, such as loop diuretics should have careful monitoring of their volume status.
- •Chronic use of non-steroidal anti-inflammatory drugs (NSAIDs) will not be allowed, unless used as incidental medication (1-2 tablets) for non-chronic indications (i.e. sports injury, head-ache or back ache). However, no such drug can be taken within a time-frame of 2 weeks prior to renal-testing
- •History of diabetic ketoacidosis (DKA) requiring medical intervention (e.g. emergency room visit and/or hospitalization) within 1 month prior to the Screening visit.
- •Current urinary tract infection and active nephritis
- •Recent (<3 months) history of cardiovascular disease, including:
- •o Acute coronary syndrome
- •o Chronic heart failure (New York Heart Association grade II-IV)
- •o Stroke or transient ischemic neurologic disorder
- •Complaints compatible with neurogenic bladder and/or incomplete bladder emptying (as determined by ultrasonic bladder scan)
- •Severe hepatic insufficiency and/or significant abnormal liver function defined as aspartate aminotransferase (AST) >3x upper limit of normal (ULN) and/or alanine aminotransferase (ALT) >3x ULN
- •History of or actual malignancy (except basal cell carcinoma)
- •History of or actual severe mental disease
- •Substance abuse (alcohol: defined as >4 units/day)
- •Allergy to any of the agents used in the study
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