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临床试验/EUCTR2019-004625-24-FR
EUCTR2019-004625-24-FR进行中（未招募）1 期

A Randomized, Double-Blind, Placebo-Controlled, Two-Arm Parallel Group, Multi-Center Phase 3 Pivotal Trial to Investigate the Efficacy and Safety of Recombinant Human Alkaline Phosphatase for Treatment of Patients with Sepsis-Associated Acute Kidney Injury

AM-Pharma B.V.0 个研究点目标入组 1,600 人开始时间: 2020年7月20日最近更新:
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适应症

试验速览

阶段
1 期
状态
进行中（未招募）
发起方
入组人数
1,600
研究概览入排标准研究者记录与标识符相似试验

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

  • •To be eligible for this trial, a patient must meet all of the following inclusion criteria:
  • •1. 18 years or older.
  • •2. In the ICU or intermediate care unit for clinical reasons.
  • •3. Have sepsis requiring vasopressor (norepinephrine, epinephrine, dopamine, phenylephrine, vasopressin, or angiotensin II) therapy, i.e.:
  • •a) suspected or proven bacterial or viral infection and
  • •b) on vasopressor therapy (=0.1 µg/kg/min norepinephrine or equivalent) for sepsis-induced hypotension for at least one hour despite adequate fluid resuscitation according to clinical judgement. Following the initial one hour on at least 0.1 µg/kg/min norepinephrine or equivalent, any dose of vasopressor counts as vasopressor therapy.
  • •4. Have AKI according to at least one of the below Kidney Disease Improving Global Outcomes (KDIGO) criteria, a) to d):
  • •a) An absolute increase in serum or plasma creatinine (CR) by =0.3 mg/dL (=26.5 µmol/L) within 48 hours or
  • •b) A relative increase in CR to =1.5 times pre-AKI reference CR value (see Section 8.3.3.3), which is known or presumed to have occurred within prior 7 days or
  • •c) A decrease in urinary output to <0.5 mL/kg/hour for a minimum of 6 hours following adequate fluid resuscitation or
  • •d) If the patient does not have a known history of CKD and there is no pre-AKI reference CR value (see Section 8.3.3.3) available from the past 12 months: a CR value greater or equal to the levels presented in Table 1, with the increase in CR presumed to have occurred within prior 7 days. For Table 1, please refer to the Protocol.
  • •5. Provision of signed and dated informed consent form (ICF) in accordance with local regulations.
  • •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 900
  • •F.1.3 Elderly (>=65 years) yes
  • •F.1.3.1 Number of subjects for this age range 700

排除标准

  • •A patient who meets any of the following criteria is excluded from participation in this trial:
  • •1. Documented CKD as specified below:
  • •a) At selected sites where enrolment of ‘moderate’ CKD patients is allowed:
  • •'Severe' CKD defined as a pre-AKI reference eGFR <25 mL/min/1.73 m2.
  • •- For patients with known CKD, the most recent eGFR prior to index hospitalization needs to be documented as =25 mL/min/1.73 m2.
  • •- For patients with known CKD but no known eGFR prior to hospitalization, presentation eGFR between 25-60 mL/min/1.73 m2 can also be used to rule out ‘severe’ CKD.
  • •b) At all other sites:
  • •'Moderate' and 'severe' CKD defined as a pre-AKI reference eGFR <45 mL/min/1.73 m2.
  • •- For patients with known CKD, the most recent eGFR prior to index hospitalization needs to be documented as =45 mL/min/1.73 m2.
  • •- For patients with known CKD but no known eGFR prior to hospitalization, presentation eGFR between 45-60 mL/min/1.73 m2 can also be used to rule out 'moderate' and 'severe' CKD.
  • •2. Advanced chronic liver disease, defined as a Child-Pugh score of 10 to 15 (Class C).
  • •3. Acute pancreatitis with no established source of infection.
  • •4. Urosepsis related to suspected or proven urinary tract obstruction.
  • •5. Main cause of AKI not sepsis.
  • •6. Proven or suspected SARS-CoV-2 infection. This exclusion criterion does not apply to patients in the COVID-19 population.
  • •7. Severe burns requiring ICU treatment.
  • •8. Severely immunosuppressed, e.g. due to:
  • •- hematopoietic cell transplantation within past 6 months prior to Screening or acute or chronic graft-versus-host disease
  • •- solid organ transplantation
  • •- leukopenia not related to sepsis, i.e., preceding sepsis
  • •- Human Immunodeficiency Virus (HIV)/Acquired Immune Deficiency Syndrome (AIDS)
  • •- receiving chemotherapy within 30 days prior to Screening.
  • •9. At high risk of being lost to follow-up (LTFU), e.g., due to known current or recent (within the last 6 months) IV drug abuse or known to be homeless.
  • •10. Limitations to use of MV, RRT or vasopressors and inotropes (NOTE: limitation of cardiopulmonary resuscitation (CPR) only is not an exclusion criterion).
  • •11. Previous administration of recAP.
  • •12. Use of a non-marketed drug within the last month or concurrent or planned participation in a clinical trial for a non-marketed drug or device. (NOTE: Co-enrollment or concurrent participation in observational, non-interventional trials using no protocolized treatments or procedures are always allowed. Co-enrollment or concurrent participation in trials using protocolized treatments or procedures, e.g. blood draws, requires pre-approval by the TSC).
  • •13. Current or planned extracorporeal membrane oxygenation (ECMO).
  • •14. On RRT >24 hours before start of trial drug.
  • •15. No longer on vasopressor therapy at time of randomization.
  • •16. On continuous vasopressor therapy for >72 hours before start of trial drug.
  • •17. Estimated glomerular filtration rate (eGFR) >60 mL/min/1.73 m2 based on the most recent available CR sample at time of screening (NOTE: will often be the sample used to diagnose AKI). eGFR should be calculated using the Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) formula.
  • •18. Not feasible to start trial drug within:
  • •a) 48 hours from AKI diagnosis, when AKI diagnosis precedes start of vasopressor therapy or
  • •b) 24 hours from AKI diagnosis, when AKI is diagnosed after start of vasopressor therapy.
  • •19. Pregnant or nursing women.

研究者

发起方
AM-Pharma B.V.

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