Effect of Empagliflozin in patients with eGFR between 10 and 20 ml/min/1.73m2 - EMPA [10-20]
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 入组人数
- 34
- 试验地点
- 2
- 主要终点
- 1/ Changes in mean UACR on spot morning urine samples between 2 days running at baseline and 2 days running at the end of each 6-week treatment period (empagliflozin 10 mg/d and matching placebo). 2/ Changes in mean UPCR on spot morning urine samples between 2 days running at baseline and 2 days running at the end of each 6-week treatment period (empagliflozin 10 mg/d and matching placebo).
研究概览
简要总结
1/ To show that in type 2 diabetic patients with eGFR between 10 and 20 ml/min/1.73m2, SGLT2i exerts a clinically significant anti-proteinuric effect. 2/ To show that in type 2 diabetic patients with eGFR between 10 and 20 ml/min/1.73m2, SGLT2i exerts a clinically significant anti-proteinuric effect based on UPCR reduction.
入排标准
- 年龄范围
- 18 years 至 65+ years（65+ Years, 18-64 Years）
- 接受健康志愿者
- 否
入选标准
- •Type 2 diabetics.
- •Age between 18 and 80 years.
- •RAS (renin angiotensin system) blockade at maximal tolerated dosage for 1 month.
- •eGFR (CKD-EPI) between 10 and 20 ml/min/1.73m2
- •UACR (urinary albumin creatinine ratio) > 300mg/g creatinine and UPCR (urinary protein creatinine ratio) > 500mg/g creatinine
- •Office systolic blood pressure > 110 mmHg
- •Stable dosage of antihypertensive drugs and diuretics for 1 month
- •For women of child-bearing age, an effective contraception (estroprogestative pill, contraceptive implant, IUD, condoms or tubal ligation) should be used For more than one month before the inclusion in the study. A urine pregnancy test (βHCG in urines) will be performed.
排除标准
- •Any medical condition that, in the opinion of the investigator, makes the participant not suitable for inclusion
- •Description of treatment emergent adverse events (TEAEs) and serious adverse events (SAEs).
- •History of ketoacidosis in the past while on empagliflozin or any other SGLT2i class drugs
- •Participation in another clinical study with an investigational medicinal product (IMP) administered during the month before screening.
- •Known hypersensitivity or intolerance to empagliflozin or any of the excipients of the product
- •Judgment by the investigator that the participant should not participate in the study if the participant is unlikely to comply with study procedures, restrictions, and requirements.
- •No social insurance
- •Unwilling to give informed consent, vulnerable persons (minors, adults under guardianship or trusteeship, pregnant women, persons deprived of their liberty, persons unable to speak French).
- •Changes in serum bicarbonate levels between baseline and every week during each 6-week treatment period (empagliflozin 10 mg/d and matching placebo).
- •Changes in HbA1C between baseline and at the end of each 6-week treatment period (empagliflozin 10 mg/d and matching placebo).
研究组 & 干预措施
Jardiance 10 mg film-coated tablets
干预措施: Jardiance 10 mg film-coated tablets (Drug)
Placebo is identical in composition to empagliflozin but does not contain the iSGLT2 active substance.
干预措施: Placebo is identical in composition to empagliflozin but does not contain the iSGLT2 active substance. (Drug)
结局指标
主要结局
1/ Changes in mean UACR on spot morning urine samples between 2 days running at baseline and 2 days running at the end of each 6-week treatment period (empagliflozin 10 mg/d and matching placebo). 2/ Changes in mean UPCR on spot morning urine samples between 2 days running at baseline and 2 days running at the end of each 6-week treatment period (empagliflozin 10 mg/d and matching placebo).
1/ Changes in mean UACR on spot morning urine samples between 2 days running at baseline and 2 days running at the end of each 6-week treatment period (empagliflozin 10 mg/d and matching placebo). 2/ Changes in mean UPCR on spot morning urine samples between 2 days running at baseline and 2 days running at the end of each 6-week treatment period (empagliflozin 10 mg/d and matching placebo).
次要结局
- 1/Changes in body weight between baseline and at the end of each 6-week treatment period (empagliflozin 10 mg/d and matching placebo).
- 2/a) Changes in mean 24-hour urinary sodium excretion and urinary volume between 3 days running urinary collections at baseline and 3 days after starting each treatment period (empagliflozin 10 mg/d and matching placebo). The measures will be the mean of each 3 days period.
- 2/b) Changes in mean ambulatory systolic blood pressure between 3 days running baseline and 3 days running at the end of each 6-week treatment period (empagliflozin 10 mg/d and matching placebo),
- 2/c) Changes in serum potassium levels between baseline and every week during each 6-week treatment period (empagliflozin 10 mg/d and matching placebo), changes in serum bicarbonate levels between baseline and every week during each 6-week treatment period (empagliflozin 10 mg/d and matching placebo).
- 2/d) Description of treatment emergent adverse events (TEAEs) and serious adverse events (SAEs), (no acute kidney injury or hyperkalaemia > 5.5 mmol/L or acidosis (serum bicarbonate <23 mmol/L))
- 3/ Changes in HbA1C between baseline and at the end of each 6-week treatment period (empagliflozin 10 mg/d and matching placebo).
- 4/ To show that mean 24-hour albuminuria decreases in the empagliflozine group compare to placebo group in the 3 days following the beginning of the treatment compare to the 3 days before. The measures will be the mean of each 3 days period
研究者
Pr Guillaume FAVRE
Scientific
Centre Hospitalier Universitaire De Nice