Beneficial effects of Amiloride on progression of Chronic Kidney Disease: A-CKD
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 40
- 试验地点
- 2
- 主要终点
- Urine C3a
研究概览
简要总结
The aim is to preserve kidney function, avoid excess cardiovascular morbidity and mortality and renal replacement therapy in chronic kidney disease. The study objectives are to test if the diuretic amiloride exerts unrecognized renoprotective effects by off-target inhibition of urokinase-type plasminogen activator, uPA. Moreover, to analyze the role of aberrant urine urokinase-type plasminogen activator for filtration barrier injury and progressive, complement-mediated kidney tissue injury The objective it to evaluate the effect of amiloride treatment in patients with chronic kidney disease in regard to tubular complement activation measured in urinary samples and evaluate renal interstitial inflammation (by various biomarkers). Additionally, an inhibitory effect on proteases may protect the kidney by reducing the growth potential of bacterial proliferation
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
- •Participant must be 18 years of age including at the time of signing the informed consent
- •A clinical diagnosis of chronic kidney disease and: o eGFR ≥ 25 but < 60mL/min/1.73m2 at screening o UACR of ≥ 300mg/g at screening
- •Participants must be on stable antihypertensive treatment 2 weeks before start of study drug and throughout study duration
- •Office blood pressure at screening meeting (visit 1) > 110/65mmHg and < 150/90mmHg. If BP > 150/90mmHg at visit 1, screening phase can be prolonged to 12 weeks. # If the office blood pressure varies by approximately ±10 mmHg and is deemed acceptable by the investigator, the participant can be included.
- •Capable of giving signed informed consent
- •Women with childbearing potential can only be included if a pregnancy test is negative at the screening visit. Moreover, women should be using contraception during the study.
排除标准
- •Treatment with amiloride alone or use of other types of K-sparing diuretics will be avoided, MR antagonists (Spironolactone, eplerenone, finerenone)
- •Lactose intolerance
- •Patients who, in the judgement of the investigator may be at risk for dehydration.
- •Known hypersensitivity to the study treatment (active substance or excipients)
- •Known hypersensitivity to resonium
- •Addison´s disease
- •Gastric bypass operation
- •Treatment with immunosuppressive therapy within 6 months prior to screening
- •History of organ transplantation
- •Participation in other interventional trials
- •Plasma potassium > 4.9mmol/L
- •Evidence of current infection (CRP> 50 and temperature > 38◦C)
- •History of unstable or rapidly progressing renal disease (eGFR decreasing > 5ml/min/1.73m2 the last 2 months)
- •Severe hepatic insufficiency classified as Child-Pugh C
- •Patients on hypertension treatment who is not on stable antihypertensive treatment 2 weeks before start of study drug.
- •Pregnancy or breastfeeding participants
- •Congestive heart failure NYHA class IV, unstable or acute congestive heart failure.
- •Ongoing cancer treatment
- •Recent cardiovascular events in a patient: - Less than two months post coronary artery revascularization. - Acute stroke or TIA within two months prior to screening - Acute coronary syndrome within two months prior to screening
结局指标
主要结局
Urine C3a
Urine C3a
Urine soluble C5-9-sTCC/MAC
Urine soluble C5-9-sTCC/MAC
KIM-1
KIM-1
NGAL
NGAL
次要结局
- Urine albumin/creatinine ratio
- Urine protein/creatinine ratio
- Blood pressure
研究者
Gitte Rye Hinrichs
Scientific
Odense University Hospital