2025-522503-18-00招募中4 期
Semaglutide and Finerenone for Kidney and Vascular Protection in CKD
Region Midtjylland1 个研究点 分布在 1 个国家目标入组 160 人开始时间: 2025年9月9日最近更新:
适应症
试验速览
- 阶段
- 4 期
- 状态
- 招募中
- 发起方
- 入组人数
- 160
- 试验地点
- 1
- 主要终点
- The difference in the change in urine albumin-to-creatinine ratio (UACR), based on the average of two morning spot urine samples, between the two groups, measured from baseline to the end of both intervention periods (Intervention period I: semaglutide vs. control, followed by Intervention period II: additional finerenone for all participants).
研究概览
简要总结
We aim to investigate the kidney-protective effects of semaglutide and finerenone, individual and in combination, along with their underlying mechanisms of action, in patients with CKD with and without diabetes.
入排标准
- 年龄范围
- 18 years 至 65+ years（18-64 Years, 65+ Years）
- 接受健康志愿者
- 否
入选标准
- •Estimated glomerular filtration rate (eGFR) > 20 ml/min/1.73 m2
- •Urine albumin-creatinine ratio as follows: a) If the participant is receiving treatment with both SGLT2i and ACEi/ARB UACR must be > 30 mg/g. b) If the participant is not receiving treatment with either SGLT2i or ACEi/ARB UACR must be > 100 mg/g. c) If the participant is not receiving treatment with one of the two (SGLT2i OR ACEi/ARB) UACR must be > 50 mg/g.
- •Specific criteria for each subgroups: a) For subgroup 1: Diabetes mellitus type 2 and HbA1c < 86 mmol/mol at screening b) For subgroup 2: BMI: 21 kg/m2 to 30 kg/m2
- •Written informed consent
排除标准
- •Contraindications to semaglutide: a) type 1 diabetes
- •Liver disease with serum concentration of ALAT > thrice the upper limit of normal
- •Any other condition or therapy, which would make the patient unsuitable for this study and will not allow the participation for the full planned study period (e.g., active malignancy or other condition limiting life expectancy to < 12 months)
- •Pregnancy or breastfeeding
- •Unable or unwilling to use secure contraception to avoid pregnancy (women of childbearing potential)
- •Inability to give informed consent
- •Lack of understanding or fluency in either Danish or English
- •Specific for subgroups: a) Subgroup 2: Pre-existing diabetes mellitus defined as: known to have diabetes or treatment with antidiabetic medication other than SGLT2i for cardio- or kidney protective purpose only
- •Contraindications to finerenone: a) treatment with potent cytochrome P450 isoenzyme 3A4 (CYP3A4) inhibitors or inducers, that cannot be discontinued. b) Addison’s disease
- •Known allergy to any of the ingredients in the study medications
- •Renal disease requiring ongoing immunosuppression, including renal transplantation as well as other organ transplantation
- •Active on the waiting list for organ transplantation or expected to become active within 8 months after inclusion
- •Autosomal Dominant Polycystic Kidney Disease
- •Acute or chronic pancreatitis
- •Severe eating disorder (e.g., anorexia nervosa, bulimia nervosa, binge eating disorder)
- •Chronic Heart failure with ejection fraction < 40%
结局指标
主要结局
The difference in the change in urine albumin-to-creatinine ratio (UACR), based on the average of two morning spot urine samples, between the two groups, measured from baseline to the end of both intervention periods (Intervention period I: semaglutide vs. control, followed by Intervention period II: additional finerenone for all participants).
The difference in the change in urine albumin-to-creatinine ratio (UACR), based on the average of two morning spot urine samples, between the two groups, measured from baseline to the end of both intervention periods (Intervention period I: semaglutide vs. control, followed by Intervention period II: additional finerenone for all participants).
次要结局
- Change in urine albumin-to-creatinine ratio from baseline to end of both intervention periods.
- Change in urine albumin-to-creatinine ratio from baseline to 20 weeks semaglutide treatment.
- Change in urine albumin-to-creatinine ratio from baseline to end of combination therapy (semaglutide followed by additional finerenone), compared to the change during semaglutide treatment alone.
研究者
Mette Øhrstrøm
Scientific
Region Midtjylland
研究点 (1)
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