EUCTR2018-000757-49-ES进行中（未招募）1 期
A Randomized, Double-Blind, Placebo Controlled, Phase 3 Study to Evaluate the Efficacy and Safety of QPI-1002 for the Prevention of Major Adverse Kidney Events (MAKE) in Subjects at High Risk for Acute Kidney Injury (AKI) Following Cardiac Surgery - QPI-1002 Phase 3 AKI
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 1,043
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. Adult male or female, age = 18 years old
- •3. Have stable pre-operative renal function per Investigator assessment and no known increase in Serum creatinine (SCr) of = 0.3 mg/dL (= 26.4 µmol/L) during preceding 28 days as assessed by the site's local laboratory using standard assay methodology.
- •4. At risk for AKI following cardiac surgery on the basis of at least one of the following pre-operatively
- •assessed risk factors:
- •a) eGFR (defined using Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) SCr formula) of
- •< 60 mL/min/1.73 m2
- •b) Diabetes with ongoing insulin treatment (defined as known type 2 or type 1 diabetes requiring prescribed insulin usage prior to hospitalization for cardiac surgery)
- •c) Albuminuria defined as Urine Albumin/Creatinine ratio > 30 mcg/mg or screening urine dipstick of 1+
- •5. Undergoes non-emergent open chest cavity cardiovascular surgeries, with use of cardiopulmonary bypass (CPB) pump, with or without hypothermic circulatory arrest:
- •a) Combined coronary artery bypass grafting (CABG) surgery and surgery of one or more cardiac valve
- •(valve(s) surgery)
- •b) Only CABG or single valve surgery that is a redo” surgery (i.e. subject had any previous open chest
- •cavity cardiovascular surgery)
- •c) Surgery of more than one cardiac valve (valve surgery)
- •d) Surgery of the aortic root or ascending part of the aorta in combination with CABG and/or valve(s)
- •e) If only CABG or single valve surgery and that surgery is not a redo” surgery (i.e. not the surgery
- •described in Inclusion Criteria #5b), subjects are required to have at least one additional risk factor for
- •AKI: either one additional risk factor from Inclusion Criteria #4 above (for a total of two risk factors
- •from Inclusion Criteria #4 above), OR age = 65 years old, OR history of congestive heart failure
- •requiring hospitalization, OR type 2 diabetes requiring at least 1 oral hypoglycemic agent but not
- •requiring insulin
- •Note: Transcatheter aortic valve implantation (TAVI) or transcatheter aortic valve replacement (TAVR)
- •are allowed only if performed in combination with surgeries defined in Inclusion Criteria #5.
- •6. No known cancer as identified by cancer screening according to site-specific pre-operative standard of care
- •7. 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, or cervical carcinoma in situ
- •8. 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 urine or serum pregnancy test within 48 hours prior to cardiac surgery and be using a highly effective means of contraception (per site-specific guidelines or use 2 methods of birth control concurrently, whichever is more stringent), which will be continued until the Day 90 visit
- •9. Male subjects with female partners of childbearing pote
排除标准
- •1. Have an eGFR = 20 mL/min/1.73 m2 (defined using CKD-EPI SCr formula)
- •2. Subjects with an eGFR < 60 mL/min/1.73 m2 (defined using CKD-EPI SCr formula) requiring intravascular iodinated contrast within 48 hours of surgery initiation as defined by the planned skin incision. However, subjects may be included if the post contrast increase in SCr is < 0.3 mg/dl (< 26.4 µmol/L) in at least 2 SCr evaluations performed not less than 36 hours (post final dose of contrast) 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. Undergoes cardiac surgery off CPB for subjects = 45 years old.(Cardiac Surgery off CPB for subjects < 45 years old is allowed.)
- •6. Undergoes TAVI or TAVR only* or single vessel, minimally invasive direct coronary artery bypass
- •(MIDCAB) off-pump surgeries or left ventricular assist device (LVAD) implantation
- •*Note: See Inclusion Criteria #5
- •7. Have participated in an investigational drug study in the last 30 days
- •8. Have a known allergy to or had participated in a prior study with small interfering ribonucleic acid (siRNA) or prior treatment with QPI-1002
- •9. Have a known history of human immunodeficiency virus (HIV) infection
- •10. 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)
- •11. Have known active Hepatitis C (HCV) (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.)
- •12. 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)
- •13. Post cardiac surgery, have hemodynamic instability despite increasing doses of three types of vasopressors and/or inotropes (see Appendix 1)
- •14. Perioperative or post cardiac surgery, an LVAD is inserted or anticipated (Note: Unplanned intraoperative LVAD that is removed before the end of surgery (i.e. skin closure) is allowed.)
- •15. Post cardiac surgery, have bleeding > 300 mL/hr requiring return to surgery or = 3 units of packed Red Blood Cells (RBC) in the first 2 hours post-surgery
- •16. Have required any of the following within 7 days prior to cardiac surgery: defibrillator, mechanical
- •ventilation, IABP, 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.)
- •17. Have required cardiopulmonary resuscitation (CPR) within 14 days prior to cardiac surgery
- •18. 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
- •19. Have total bilirubin or alanine aminotransferase (ALT) or aspartate aminotransferase (AST) > 2 times the upper limit of normal (ULN) at time of screening
- •20. Have a history of chronic liver disease (i.e. cirrhosis) and Child Pugh Class A liver disease with ALT/AST above the upper limit of normal, or Class B or higher
- •21. Have a history or presence of a medical condition or disease or psychiatric condition that
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