EUCTR2019-000134-18-BE进行中（未招募）1 期
Metformin as RenoProtector in Non-Diabetic Patients with Progressive Chronic Kidney Disease (CKD stages 2, 3A and 3B): a multi-centre, practice-oriented, repurposing, double-blind, placebo-controlled, randomized clinical trial. - RenoMet
niversity of Antwerp0 个研究点目标入组 385 人开始时间: 2019年2月13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
- 385
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
- •Patients will be eligible for inclusion in the RenoMet study based on the following inclusion criteria:
- •- Adult patients (18-75 years) of both gender
- •- Seen on a regular base in one of the participating outpatient clinics of renal care with a previous consultation within the last year
- •- Having a chronic kidney disease with:
- •- A CKD stage 2, 3A or 3B ( i.e. with estimated glomerular filtration rate (eGFR) between 30 and 90 ml/min/1.73m2) at the time of the baseline visit
- •- Without proteinuria or with proteinuria below or equal to 2 g/24hrs
- •- Showing a decline of eGFR between 2.0 and 15.0 ml/min/year determined using at least three determinations of eGFR (CKD-Epi formula) within the last three years before inclusion.
- •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 289
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 96
排除标准
- •Patients will be excluded from study participation based on the following exclusion criteria:
- •1. Illiteracy: patients not knowing how to read or write
- •2. Patients not able to communicate in Dutch or French
- •3. Patients with mental deterioration, incapable to give informed consent and to understand the safety instructions of the study (at the discretion of the treating nephrologist)
- •4. Patients with one of the following clinical problems:
- •- Patients with overt proteinuria (more than 2 g/24hrs)
- •- Patients showing a fast decline of renal function (more than 15 ml/min/year) during the preceding three years
- •- Diabetes mellitus (any type: 1, 2, maturity onset diabetes of the young (MODY)…) confirmed by a glycemia level > 126 mg/L (7.0 mmol/L) after a fasting time of 8 hours
- •- Chronic obstructive pulmonary disease ( COPD) stage Gold IV (Oxygene-dependency)
- •- Congestive heart failure (NYHA stage IV)
- •- Inflammatory bowel disease (IBD)
- •- Hepatic insufficiency or cirrhosis, acute alcohol intoxication or alcoholism (> 20 glasses of alcoholic beverages per week)
- •- History of solid organ transplantation
- •- History of metabolic diseases (e.g. mitochondrial encephalomyopathy (MELAS), lactic acidosis, stroke-like episodes, etc…)
- •- Pregnancy and/or lactating women at the time of recruitment and during the study period
- •5. Patient with one of the following medication:
- •- Prior use of metformin within the past 12 months (e.g. glucose intolerance, polycystic ovary syndrome, etc…)
- •- Chronic use of CNI (calcineurine inhibitors) (e.g. psoriasis...)
- •6. Patients showing elevated serum lactate level(s) at the time of recruitment ( i.e. a serum lactate level >2.5 mmol/L at baseline visit or a confirmed serum lactate level > 2.0 mmol/L within a period of 4 weeks)
- •7. Hypersensitivity to metformin or to any of the excipients listed in section 6.1 of the Glucophage SR SmPC (see Attachment A5 Glucophage SR SmPC)
- •8. One of the following diseases during the previous 6 months: myocardial infarction, shock, acute problems of decompensated heart failure or respiratory failure.
研究者
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