NL-OMON49123撤回4 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 - REGROUP
适应症
试验速览
- 阶段
- 4 期
- 状态
- 撤回
- 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
入排标准
- 年龄范围
- 18 至 99（—）
入选标准
- •* 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
- •* Written informed consent
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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