EUCTR2020-000828-19-PL进行中（未招募）1 期
Renal mode of action of semaglutide in patients with type 2 diabetes and chronic kidney disease - REMODE
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 105
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
- •- Male or female, age 18 years or older at the time of signing informed consent.
- •- Diagnosed with T2D at least 180 days prior to the day of screening.
- •- Glycosylated haemoglobin (HbA1c) equal to or below 9.0% (equal to or below 75 mmol/mol).
- •Depending on biopsy/non-biopsy population:
- •-For subjects in the non-biopsy population: Serum creatinine-based eGFR = 30 and =75 mL/min/1.73 m2 (CKD-EPI).
- •For subjects in the biopsy sub-population: Serum creatinine-based eGFR = 40 and =75 mL/min/1.73 m2 (CKD-EPI).
- •- Serum creatinine-based estimated glomerular filtration rate (eGFR) equal to or above 40 and equal to or below 75 mL/min/1.73 m^2 (Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI)).
- •- Urine albumin-to-creatinine ratio (UACR) equal to or above 30 and below 5000 mg/g.
- •- Treatment with maximum labelled or tolerated dose of a reninangiotensin-aldosterone system (RAAS) blocking agent including an angiotensin converting enzyme (ACE) inhibitor or angiotensin II receptor blocker (ARB)) unless such treatment is contraindicated or not tolerated. Treatment dose must be stable for at least 28 days prior to screening.
- •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 63
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 42
排除标准
- •- Use of any glucagon-like peptide 1 receptor agonist (GLP-1 RA) within 30 days prior to screening.
- •- A prior solid organ transplant or awaiting solid organ transplant.
- •- Myocardial infarction, stroke, hospitalisation for unstable angina pectoris or transient ischaemic attack within 180 days prior to the day of screening.
- •- Presence or history of malignant neoplasms (other than basal or squamous cell skin cancer, in situ carcinomas of the cervix, or in situ prostate cancer) within 5 years prior to the day of screening.
- •- Congenital or hereditary kidney diseases including polycystic kidney disease, autoimmune kidney diseases including glomerulonephritis or congenital urinary tract malformations.
- •- Uncontrolled and potentially unstable diabetic retinopathy or maculopathy. Verified by a fundus examination performed within the past 90 days prior to screening or in the period between screening and randomisation. Pharmacological pupil-dilation is a requirement unless using a digital fundus photography camera specified for non-dilated examination.
- •- Treatment with systemic anti-inflammatory or immunosuppressant drugs within 90 days prior to screening. Stable treatment with acetylsalicylic acid for prevention of cardiovascular events and occasional use of propionic acid derivatives drugs (e.g. ibuprofen) is allowed.
- •Any contraindication for MRI according to standard checklist used in clinical routine, including claustrophobia or metallic foreign bodies, metallic implants, internal electrical devices, or permanent makeup/tattoos that cannot be declared magnetic resonance (MR) compatible.
- •Combination use of an ACE inhibitor and an ARB.
研究者
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