EUCTR2018-002547-29-NL进行中（未招募）1 期
Phase 2 randomized, double-blind, placebo-controlled, parallel-group study to evaluate the safety and efficacy of Reltecimod as compared to placebo in addition to standard of care in patients with sepsis-associated acute kidney injury (SA-AKI) - REAKT
Atox Bio0 个研究点目标入组 120 人开始时间: 2019年4月30日最近更新:
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 120
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 Age: 18 up to and including 85 years
- •2 Has either suspected or confirmed diagnosis of abdominal sepsis requiring treatment with parenteral antibiotics and planned or completed surgical (laparotomy or laparoscopy) or interventional radiologic procedures within 24h of evaluation by medical personnel. Recommended surgical or interventional radiologic procedures be performed within 12h of evaluation by medical personnel
- •Suspected clinical diagnosis of abdominal infection as evaluated by the attending surgeon including any of the following clinical criteria:
- •- Abdominal pain and/or tenderness
- •- Localized or diffuse abdominal wall rigidity
- •- Any of the following radiologic findings
- •Intraabdominal abscess
- •Free peritoneal fluid
- •Confirmed diagnosis of abdominal infection by any of the of the following criteria:
- •- Perforation and/or necrotic bowel with surgical confirmation of peritonitis
- •- Presence of intraabdominal abscess by surgical confirmation or drainage of purulent fluid from interventional radiologic procedure
- •3 Planned or current admission to a hospital ward (preferably to an ICU but step down unit or equivalent or general ward are also considered eligible)
- •4 Initial diagnosis of AKI established either upon presentation to medical care at the study site in those patients with suspected abdominal sepsis or in those patients in whom the initial diagnosis of AKI is established during the 48-hour period from the suspected diagnosis of abdominal sepsis.
- •AKI Stage 2 or 3 according to the following KDIGO AKI criteria:
- •Increase in serum creatinine to > 200% (= 2.0–fold) from a reference creatinine value (see below) in the absence of primary underlying renal disease
- •Urine output < 0.5ml/kg/hr x 12h following adequate fluid resuscitation. Urine output should be calculated using IBW (using the Miller formula)
- •Increase in serum creatinine to > 300% (= 3.0–fold) from a reference creatinine value in the absence of primary underlying renal disease
- •Serum creatinine =4 mg/dL
- •Planned or initiation of RRT for acute AKI
- •Urine output < 0.3ml/kg/hr x 24h or anuria x 12h following adequate fluid resuscitation.
- •The reference creatinine value is the serum creatinine value according to the following order:
- •o Value within 3 months of the hospital admission.
- •If 1 value available, then use this value for reference
- •If 2 values available, then use average of 2 values for reference
- •If 3 or more values available, then use the median of the 3 most recent values for reference
- •o Value between 3-12 months prior to hospital admission
- •If 1 value available, then use this value for reference
- •If 2 values available, then use average of 2 values for reference
- •If 3 or more values available, then use the median of the 3 most recent values for reference
- •o At hospital admission
- •Patients without a reference creatinine value would also be considered to have Stage 2 or 3 AKI if they have a serum creatinine =200% (>2.0-fold) the normal creatinine value for age, race, and gender and a renal ultrasound or computed tomography showing normal kidney size within the past 90 days. Normal kidney size is defined as:
- •o Renal Ultrasound
- •<60 years if either kidney >10 cm length
- •>60 years if either kidney >9.5 cm length
- •o Computed Tomographic Scan
- •If either kidney is >9 cm length
- •5 Study medication must be administered within 6 hours of confirmation of o
排除标准
- •1. Has known prior history of CKD with a documented estimated GFR (eGFR) < 30 mL/min by a commonly used formula such as Modification of Diet in Renal Disease (MDRD) or Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI), or known GFR < 30 mL/min.
- •Exception: Patients with history of CKD but no available prior estimated GFR who have documented normal kidney size on ultrasound or computed tomographic (normal size defined above) evaluation (performed within 90 days of screening) will be eligible
- •2. Patients receiving RRT for chronic kidney disease: either hemodialysis, peritoneal dialysis, hemofiltration such as Continuous Veno-Venous Hemofiltration (CVVH) or hemodiafiltration.
- •3. (removed)
- •4. Previously diagnosed with documented AKI in the last 30 days.
- •5. Documented primary glomerular disease or toxic tubulo-interstitial nephritis or other underlying renal diseases significantly effecting renal function (e.g., renal amyloidosis, polycystic kidney disease, renal cancer, renal abscess) at the time of AKI diagnosis
- •6. Current condition of: (a) Inability to maintain a mean arterial pressure > 50 mmHg and/or systolic blood pressure > 70 mmHg for at least 1 hour prior to dosing despite the presence of vasopressors and IV fluids or (b) a patient with respiratory failure such that an SaO2 of 80% for at least 1 hour prior to dosing cannot be achieved or (c) a patient with refractory coagulopathy (INR >5) or thrombocytopenia (platelet count <20,000) that does not partially correct for at least 1 hour prior to dosing with administration of appropriate factors or blood products
- •7. Severe neurological impairment due to cerebrovascular accident or cardiac arrest.
- •8. Recent cerebrovascular accident in the last 3 months.
- •9. Patients with cardiac arrest requiring cardiopulmonary resuscitation within the past 30 days.
- •10. Patient is not expected to survive throughout 28 days of study due to underlying medical condition, such as poorly controlled neoplasm (e.g. Stage III or IV cancer).
- •11. Classified as Do Not Resuscitate”, or Do Not Treat”, or the patient’s family is not committed to aggressive management of the patient’s condition. A no cardiopulmonary resuscitation (CPR)” order is acceptable if the patient and/or the family are still committed to aggressive care short of CPR.
- •12. Any concurrent medical condition, which in the opinion of the Investigator, may compromise the safety of the patient or the objectives of the study or the patient will not benefit from treatment such as:
- •Congestive heart failure (CHF) {New York Heart Association (NYHA) class III-IV}
- •Very severe chronic obstructive pulmonary disease (COPD) {GOLD stage III-IV. or chronic hypoxemia (PaO2 <55 mmHg) on room air, or chronic use of home ventilation, or unable to climb stairs or perform household duties due to chronic obstructive disease resulting in severe exercise restriction, or use of continuous home oxygen prior to hospital admission (sleep apnoea treated with continuous positive airway pressure or biphasic positive airway pressure oxygen during sleep is acceptable)}
- •Liver dysfunction {Childs-Pugh class C}
- •Primary or acquired immunodeficiency or immunosuppression due to treatment with immunosuppressive medications (see Appendix G for list of excluded immunosuppressive medications)
- •Known HIV infection with CD4 count < 200 cells/mm3 or < 14% of all lymphocytes
- •Neutropenia < 1,000 cells/mm3 not due to the underlying infection
- •Receiving or a
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