Conestat Alfa (a Recombinant Human C1 Esterase Inhibitor) for the Prevention of Acute Kidney Injury After Non-ST Elevation Myocardial Infarction: a Randomized, Double-blind, Placebo-controlled, Multicenter, Phase 2, Dose-finding Study
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 入组人数
- 29
- 试验地点
- 4
- 主要终点
- Urinary NGAL
研究概览
简要总结
A randomized, double-blind, placebo-controlled, multi-center, phase 2 clinical study in patients with NSTEMI undergoing urgent coronary angiography. Approximately 220 patients with CKD and acute NSTEMI, who are scheduled for an urgent coronary angiography (within 72 hours after admission and/or diagnosis of NSTEMI).
详细描述
Approximately 220 patients with chronic kidney disease (CKD) and acute NSTEMI, who are scheduled for an urgent coronary angiography (within 72 hours after admission and/or diagnosis of NSTEMI) will be screened for the study. Only patients with acute NSTEMI presumed to be a spontaneous myocardial infarction, related to atherosclerotic plaque rupture, ulceration, fissuring, erosion, or dissection (i.e. type 1) are eligible. Written informed consent will be obtained before urgent coronary angiography. Patients with NSTEMI will typically undergo coronary angiography within 72 hours after admission and/or diagnosis of NSTEMI. It is estimated that 70% of these patients will have PCI. Randomization will continue until the 160th patient has had a PCI.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Informed Consent as documented by a signature and date of the patient
- •Age 18-85 years
- •Acute NSTEMI as anticipated to be type 1 (expert opinion by the cardiologist before coronary angiography) and scheduled for urgent coronary angiography
- •Documented kidney disease existing for ≥3 months OR Two estimated glomerular filtration rate (eGFR) measurements of <60ml/min/1.73m2 as calculated by the CKD-EPI (Chronic Kidney Disease Epidemiology Collaboration) study equation and at least 6 hours apart OR eGFR of <50 mL/min//1.73m2 as calculated by using the CKD-EPI study equation at presentation
- •At least one of the following risk factors for AKI: diabetes mellitus, age >60 years, established cardiovascular disease, heart failure with reduced ejection fraction, anemia
排除标准
- •Contraindications to the class of drugs under study (C1 esterase inhibitors), e.g. known hypersensitivity or allergy to class of drugs or the IMP
- •History or suspicion of allergy to rabbits
- •Women who are pregnant or breast feeding
- •ST elevation myocardial infarction or unstable angina
- •Cardiogenic shock requiring mechanical support
- •Non-cardiac comorbidity with expected survival <6 months
- •Acute urinary tract infection (e.g. cystitis, pyelonephritis).
- •Liver cirrhosis (any Child-Pugh score)
- •Dialysis or eGFR <20 and >59mL/min/1.73 m2 at baseline (d0)
- •Incapacity or inability to provide informed consent
- •Participation in another study with investigational drug within 30 days preceding, and during the present study
- •Previous enrolment into the current study
研究组 & 干预措施
Conestat alfa 50 U/kg - Placebo
50 U/kg conestat alfa pre-angiography and placebo 3 hours after the first dose
干预措施: conestat alfa or placebo (Drug)
Conestat alfa 50 U/kg - Conestat alfa 50 U/kg
50 U/kg conestat alfa pre-angiography and 3 hours after the first dose
干预措施: conestat alfa or placebo (Drug)
Conestat alfa 100 U/kg - Conestat alfa 50 U/kg
100 U/kg conestat alfa pre-angiography and 50 U/kg conestat alfa 3 hours after the first dose
干预措施: conestat alfa or placebo (Drug)
Placebo - Placebo
Placebo pre-angiography and 3 hours after the first dose
干预措施: conestat alfa or placebo (Drug)
结局指标
主要结局
Urinary NGAL
时间窗: 24 hours after PCI
Evaluation of the peak change of urinary NGAL, an established biomarker of AKI, within 24 hours after PCI
次要结局
- Troponin T(measured once at 72 hours after angiography)
- Urinary NGAL(within 24 hours after angiography)
- Creatine kinase(measured once at 72 hours after angiography)
- Serum creatinine(within 72 hours after angiography)
- N-terminal pro-brain natriuretic peptide(at 72 hours after angiography)
- Serum cystatin C(24 hours after angiography)