EUCTR2015-003113-15-DE进行中（未招募）1 期
A Randomized, Double-Blind, Placebo Controlled, Phase 2 Study to Evaluate the Efficacy and Safety of QPI-1002 for the Prevention of Acute Kidney Injury in Subjects at High Risk for AKI following Cardiac Surgery - QPI-1002 Phase 2 AKI
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 340
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
- •1. Have the ability to understand the requirements of the study, are able to provide written informed consent (including consent for the use and disclosure of research related health information) and are willing and able to comply with the requirements of the study (including required study visits).
- •2. Male or female, age = 45 years old.
- •3. Have stable renal function per Investigator assessment and no known increase in serum creatinine of = 0.3 mg/dL (= 26.4 µmol/l) during preceding 4 weeks.
- •4. Scheduled to undergo non-emergent open chest cavity cardiovascular surgeries, including use of coronary pulmonary bypass (CPB) and no CPB:
- •a. Combined coronary artery bypass grafting (CABG) surgery and surgery of one or more cardiac valve (valve(s) surgery) and at least 1 AKI Risk Factor;
- •b. Surgery of more than one cardiac valve (valve surgery) and at least 1 AKI Risk Factor;
- •c. Surgery of the aortic root or ascending part of the aorta, or aortic valve, including circulatory arrest and at least 1 AKI Risk Factor;
- •d. Aortic root or ascending part of the aorta, combined with CABG and/or valve(s) surgery, including circulatory arrest and at least 1 AKI Risk Factor;
- •e. If only CABG or single valve surgery, subjects are required to have at least 2 AKI Risk Factors:
- •Note: TAVI/TAVR are allowed only if performed in combination with surgeries defined in Inclusion
- •Criteria #4.AKI Risk Factors:
- •Age = 70 years
- •eGFR = 60 ml/min/1.73m2 by CKD-EPI formula at Screening.
- •Diabetes (Type 1 or 2), requiring at least 1 oral hypoglycemic agent or insulin
- •Proteinuria = 0.3g/d, spot UPCR = 0.3g/gm or urine dip stick = +2
- •History of congestive heart failure requiring hospitalization
- •5. Are up-to-date on cancer screening according to site-specific pre-operative standard of care and past medical history must be negative for malignancy within 5 years of randomization, with the exception of adequately treated basal cell or squamous cell carcinoma in situ or cervical carcinoma in situ.
- •6. A female subject is eligible to enter the study if she is:
- •a. Not pregnant or nursing
- •b. Of non-childbearing potential (i.e. post-menopausal defined as having been amenorrheic for at least l year prior to screening, or has had a bilateral tubal ligation at least 6 months prior to administration of study drug or bilateral oophorectomy or complete hysterectomy).
- •c. If of childbearing potential, must have a negative serum pregnancy test within 48 hours prior to cardiac surgery and be using a highly effective means of contraception or using 2 methods of birth control concurrently, whichever is more stringent, which will be continued until the Day 90 visit.
- •7. A male subjects with female partners of childbearing potential must agree to use an effective means of contraception (per the site-specific guidelines or use 2 methods of birth control concurrently, whichever is more stringent), which will be continued until the Day 90 visit.
- •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 300
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 40
排除标准
- •1. Have an eGFR = 20 mL/min/1.73 m2
- •2. Subjects with an eGFR = 60 mL/min/1.73 m2 requiring intravascular iodinated contrast within 48 hours of the day of surgery. However, subjects may be included if the post contrast increase in serum creatinine is < 0.3 mg/dl (< 26.4 µmol/l) in at least 2 serum creatinine evaluations performed not less than 36 hours apart.
- •3. Have a history of any organ or cellular transplant which requires active immunosuppressive treatment which can interfere with kidney function
- •4. Emergent surgeries, including aortic dissection, and major congenital heart defects
- •5. Scheduled to undergo transcatheter aortic valve implantation (TAVI) or transcatheter aortic valve
- •replacement (TAVR) only* or single vessel, mid-CAB off-pump surgeries or left ventricular assist device
- •(LVAD) implantation
- •*Note: See Inclusion Criteria #4.
- •6. Have participated in an investigational drug study in the last 30 days
- •7. Have a known allergy to or had participated in a prior study with siRNA
- •8. Have a history of human immunodeficiency virus (HIV) infection
- •9. Have known active Hepatitis B (HBV) (Note: Subjects with a serological profile suggestive of clearance, or prior antiviral treatment of HBV infection may be enrolled)
- •10. Are HCV-positive (detectable HCV RNA) (Note: Subjects at least 24 weeks from completion of treatment with an antiviral regimen and who remain free of HCV as determined by HCV RNA testing may be enrolled.
- •11. Cardiogenic shock or hemodynamic instability within the 24 hours prior to surgery, requiring inotropes or vasopressors or other mechanical devices such as intra-aortic balloon counter-pulsation (IABP)
- •12. Have required any of the following within a week prior to cardiac surgery: defibrillator or permanent pacemaker, mechanical ventilation, IABP, left ventricular assist device (LVAD), other forms of mechanical circulatory support (MCS) (Note: The prophylactic insertion of an IABP preoperatively for reasons not related to existing LV pump function is not exclusionary).
- •13. Are receiving = 3 concurrent vasopressors to maintain hemodynamic stability (as defined in the protocol)
- •14. Have required cardiopulmonary resuscitation within 14 days prior to cardiac surgery
- •15. Have ongoing sepsis or history of sepsis within the past 2 weeks or untreated diagnosed infection prior to Screening visit. Sepsis is defined as presence of a confirmed pathogen, along with fever or hypothermia, and hypoperfusion or hypotension
- •16. Have total bilirubin or alanine aminotransferase (ALT) or aspartate aminotransferase (AST) > 2 times the upper limit of normal (ULN) at time of screening
- •17. Have Child Pugh Class A liver disease with ALT/AST above the upper limit of normal or Class B or higher
- •18. Have a history or presence of a medical condition or disease or psychiatric condition that in the investigator’s assessment would render the subject ineligible for study participation.
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