CTIS2023-507449-27-00进行中（未招募）1 期
Clinical validation study of urinary clusterin and EGF in patients with chronic kidney disease
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 125
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 65+（—）
- 性别
- All
入选标准
- •Age = 18 and = 75 years, eGFR = 25 mL/min/1.73m2, UACR > 100 mg/g (10 mg/mmol) in two consecutive first-morning void urine samples. UACR 80-100 mg/g is accepted if historical measurements are above 100 mg/g and if it cannot be explained by any new treatment., Participants must be on a maximum tolerated dose of an angiotensin-converting enzyme (ACE) inhibitor or angiotensin receptor blocker (ARB) for at least four weeks before enrollment., Ability to communicate with the study staff and understand and sign the informed consent.
排除标准
- •Age < 18 years or > 75 years, Lupus nephritis or ANCA-associated vasculitis, or any other primary or secondary kidney disease requiring immunosuppressive therapy within 6 months prior to screening, Kidney transplant, Dialysis, Addison's disease, Concomitant treatment with strong CYP3A4 inhibitors (e.g., itraconazole, ketoconazole, ritonavir, cobicistat, clarithromycin), Idiopathic pulmonary fibrosis, Type 1 diabetes, Known or suspected hypersensitivity to the study medications or related products, Presence or history of malignant neoplasms (except basal cell skin cancer or squamous cell skin cancer) within 5 years before screening., Any other history, condition, therapy, or uncontrolled intercurrent illness that could, as judged by the investigator, affect participant safety or compliance with study requirements., Eligible to receive at least two of three study treatments. Participants meeting two or more of the following criteria will be excluded: a.Potassium > 5.0 mmol/L b.Heart failure NYHA class III or IV or NT-proBNP > 600 pg/ml c.Not a candidate for treatment with an SGLT2 inhibitor, e.g., due to contraindications (according to the Forxiga SmPC) or previously experienced side effects from an SGLT2 inhibitor., A female who is pregnant, breastfeeding, or intends to become pregnant, or women of childbearing potential (WOCBP) who are not using highly effective contraceptive methods., A female who is pregnant, breastfeeding, or intends to become pregnant, or women of childbearing potential (WOCBP) who are not using highly effective contraceptive methods., Participant in another intervention study., NT-proBNP > 1200 pg/ml, Severe peripheral or facial edema (according to the investigator's opinion), Diagnosis of unstable angina pectoris and/or myocardial infarction within the last six months., Already receiving treatment with two of the three study drugs (for example, an SGLT2 inhibitor and finerenone)., Treatment with a potassium-sparing diuretic or a mineralocorticoid receptor antagonist, except for finerenone (e.g., spironolactone, eplerenone, or amiloride), Elevated Alanine Aminotransferase (ALT) > 3 x upper normal limit, autoimmune hepatitis, and/or severe hepatic impairment (including but not limited to a history of hepatic encephalopathy, a history of esophageal varices or a history of portocaval shunt.), Autosomal dominant or autosomal recessive polycystic kidney disease
研究者
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