Phase 3 Randomized, Double-blind 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)
试验速览
- 阶段
- 3 期
- 状态
- 终止
- 发起方
- Atox Bio Ltd
- 入组人数
- 58
- 试验地点
- 56
- 主要终点
- Freedom From Durable Loss of Renal Function at Day 28
研究概览
简要总结
Phase 3 multicenter study to be conducted in up to 90 qualified participating sites globally to assess the efficacy and safety of Reltecimod vs placebo in patients with sepsis-associated Stage 2/3 AKI.
详细描述
Phase 3 randomized, placebo controlled study assessing the efficacy (complete recovery from AKI) and safety of Reltecimod in patients with suspected or confirmed abdominal sepsis (planned or completed surgical (laparotomy or laparoscopy) or interventional radiologic procedures for control of underlying abdominal infection within 24 hours of evaluation by medical personnel) or patients with surgically confirmed necrotizing soft tissue infection (NSTI), requiring intensive care unit (ICU) or step down unit admission and in whom the diagnosis of Stage 2/3 acute kidney injury (AKI; as defined by Kidney Disease Improving Global Outcomes (KDIGO) criteria) is established at initial presentation for medical evaluation or up to 48 hours from the suspected diagnosis of abdominal sepsis or from surgically confirmed diagnosis of NSTI.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
盲法说明
Sponsor personnel and clinical research associates (CRAs) will also be blinded to study treatment.
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
- •Has either suspected or documented diagnosis of abdominal sepsis requiring treatment with parenteral antibiotics and planned or completed surgical (laparotomy or laparoscopy) or interventional radiologic procedures within 24 hours of evaluation by medical personnel. Recommended surgical or interventional radiologic procedures be performed with 12 hours of evaluation by medical personnel.
- •Initial diagnosis of AKI Stage 2 or 3 according to KDIGO AKI criteria established either upon presentation to medical care 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.
- •Study medication must be administered within 6 hours of confirmation of onset of Stage 2 or 3 AKI as established at the study site, under the following criteria:
- •After the decision is made by the attending surgeon at the study site for a surgical or interventional radiology procedure for the abdominal infection OR
- •After confirmed diagnosis of abdominal infection has been established by a surgical or interventional radiology procedure
排除标准
- •Has known prior history of chronic kidney disease (CKD( with a documented estimated GFR (eGFR) < 30 mL/min
- •Exception: Patients with history of CKD but no available prior eGFR who have documented normal kidney size on ultrasound or computed tomography evaluation (performed within 90 days of screening) will be eligible
- •Patients receiving renal replacment therapy (RRT) for CKD
- •. Previously diagnosed with documented AKI in the last 30 days
- •Documented primary glomerular disease or toxic tubulo-interstitial nephritis at the time of AKI diagnosis
- •Patient is not expected to survive throughout 28 days of study due to significant underlying medical condition
- •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}
- •Severe chronic obstructive pulmonary disease (COPD) {GOLD - Global Initiative for Chronic Obstructive Lung Disease - stage IV. or chronic hypoxemia)
- •Liver dysfunction {Childs-Pugh class C}
- •Primary or acquired immunodeficiency or immunosuppression due to treatment with 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 about to receive chemotherapy or biologic anti-cancer treatment,
- •Hematological and lymphatic malignancies in the last 5 years
- •Patient has acute pancreatitis with no established source of infection, uncomplicated appendicitis, or cholangitis or cholecystitis without peritonitis;
- •Pregnant or lactating women
- •Concurrent or previous enrollment in a clinical trial involving investigational drug or a medical device
研究组 & 干预措施
Placebo
Single IV infusion of 0.9% Sodium Chloride Injection (Normal Saline)
干预措施: Placebo (Drug)
Reltecimod 0.5 mg/kg
Single IV infusion of Reltecimod 0.5 mg/kg
干预措施: Reltecimod 0.5 mg/kg (Drug)
结局指标
主要结局
Freedom From Durable Loss of Renal Function at Day 28
时间窗: 28 Days
Freedom from durable loss of renal function at Day 28 required all of the following 3 components: alive at Day 28, free of dialysis at Day 28, and less than 37% loss of estimated glomerular filtration rate (eGFR) at Day 28 from patient reference eGFR (measured by Modification of Diet in Renal Disease \[MDRD\] formula).
Serious Adverse Events (SAEs)
时间窗: 28 Days
Number of patients experiencing at least one SAE
Adverse Events (AEs)
时间窗: 28 Days
The number of patients experiencing at least one AE.
次要结局
- ICU-free Days by Day 14 Modified Sequential Organ Failure Assessment (mSOFA) Category(28 Days)
- Intensive Care Unit (ICU)-Free Days(28 Days)
- Freedom From Durable Loss of Renal Function at Day 14(14 Days)
- Vasopressor-free Days(28 Days)
- Ventilator-free Days(28 Days)
- Hospital Days(90 Days)
- Cumulative Number of Deaths(90 Days)
- Secondary Infections(28 Days)
- Ventilator-free Days by Day 14 mSOFA Category(28 Days)
- Vasopressor-free Days by Day 14 mSOFA Category(28 Days)
- Hospital Days by Day 14 mSOFA Category(90 Days)
- Hospital Discharge Location by Day 14 mSOFA Category(90 Days)