EUCTR2018-000757-49-AT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
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 1,088
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+
- •Note: If albuminuria is the only possible risk factor (i.e. eGFR is = 60
- •mL/min/1.73 m2 and subject does not have a history of diabetes
- •requiring prescribed insulin usage), a dipstick must be confirmed by
- •urinalysis as > 30 mcg albumin/mg creatinine. If the urine albumin
- •creatinine ratio is not available, and albuminuria is the only possible risk
- •factor, a dipstick value of = 2+ for protein or equivalent may be
- •considered as meeting the albuminuria definition (> 30 mcg albumin/mg
- •creatinine).
- •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 Criterion #4 above
- •(for a total of two risk factors
- •from Inclusion Criterion #4 above), OR age = 65 years old, OR history of
- •congestive heart failure
- •requiring hospitalization, OR type 2 diabetes requiring at least 1 oral
- 另有 16 项未显示
排除标准
- •1. Have an eGFR = 20 mL/min/1.73 m2 (defined using CKD-EPI SCr
- •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
- •4. Emergent surgeries, including aortic dissection, and major congenital
- •heart defects
- •*Note: See Inclusion #5. Also, emergent surgeries are defined as
- •cardiac operations that are not elective and must be done promptly to
- •address an immediately life-threatening condition.
- •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 Criterion #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)
- •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
- 另有 8 项未显示
研究者
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