2023-507449-27-01招募中4 期
A biomarker-targeted clinical trial to optimize treatment for patients with chronic kidney disease
适应症
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 招募中
- 入组人数
- 115
- 试验地点
- 6
- 主要终点
- Chronic eGFR slope, defined as mean annual rate of change in eGFR from week 26 to week 104.
研究概览
简要总结
To compare the effect of a biomarker-targeted treatment approach versus standard of care on chronic eGFR slope.
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
- •Age ≥ 18 and ≤ 75 years
- •UACR 100-5000 mg/g (11.3-565 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.)
- •Stable treatment with maximum tolerated dose of an angiotensin-converting enzyme inhibitor or angiotensin receptor blocker for at least four weeks prior to randomization. (Unless such treatment is contraindicated or not tolerated.)
- •Ability to communicate with the study staff and understand and sign the informed consent.
排除标准
- •eGFR < 25 mL/min/1.73m2 at screening
- •Concomitant treatment with strong CYP3A4 inhibitors (e.g., itraconazole, ketoconazole, ritonavir, cobicistat, clarithromycin)
- •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 at screening, 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
- •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 or dialysis
- •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 five 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.
- •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.
- •Treatment with two or all of the three study drugs
- •Known or suspected abuse of narcotics
- •Participant in another intervention study.
- •Vulnerable (i.e. under guardianship) or mentally incapacitated subjects (i.e. not able to understand and sign the informed consent).
- •History of pancreatitis at screening
- •Body mass index < 18.5 kg/m2 at screening
- •Type 1 diabetes
- •Myocardial infarction, unstable angina, stroke, or transient ischemic attack within 12 weeks prior to enrolment
- •NYHA class IV Congestive Heart Failure at screening
- •Serum potassium > 5.0 mmol/L at screening
- •Addison’s Disease
结局指标
主要结局
Chronic eGFR slope, defined as mean annual rate of change in eGFR from week 26 to week 104.
Chronic eGFR slope, defined as mean annual rate of change in eGFR from week 26 to week 104.
次要结局
- Change in eGFR from baseline to week 112 (end of study).
- Change in eGFR from baseline to week 104 (end of treatment).
- Change in albuminuria from baseline to week 104.
- Change in KidneyIntelX score from baseline to week 104.
研究者
Peter Rossing
Scientific
Steno Diabetes Center Copenhagen
研究点 (6)
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