EUCTR2020-004202-60-ITActive, not recruitingPhase 1
A RAndomized pilot study comparing short-term CER-001 infusions at different doses to prevent Sepsis-induced acute kidney injury - RACERS STUDY
CERENIS THERAPEUTICS0 sites20 target enrollmentStarted: August 31, 2021Last updated:
Trial Snapshot
- Phase
- Phase 1
- Status
- Active, not recruiting
- Sponsor
- Enrollment
- 20
Study Overview
Brief Summary
No summary available.
Study Design
- Study Type
- Interventional clinical trial of medicinal product
Eligibility Criteria
- Sex
- All
Inclusion Criteria
- •1. Male or non-pregnant female adult =18 years of age at time of enrollment;
- •2. Patients affected by sepsis sustained by Gram negative bacteria (positive body fluid cultures and/or documented endotoxin activity) on antibiotic treatment
- •3. Meets Sepsis 3 criteria, defined as an acute increase of at least 2 points in SOFA score relative to the SOFA score upon admission;
- •4. Endotoxin level (EEA™) >0.6;
- •5. Signed and dated informed consent by the patient itself or by a legal representative.
- •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 10
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 10
Exclusion Criteria
- •1. Patients weighing more than 100 kg;
- •2. Alanine transaminase/aspartate transaminase (ALT/AST) > 5 times the upper limit of normal;
- •3. Stage 4 severe chronic kidney disease or requiring dialysis (i.e. estimated glomerular filtration rate (eGFR) < 30 ml /min/1.73 m2);
- •4. Patients who have AKI and have received nephrotoxic drugs since hospital admission that are known to cause acute tubular necrosis (e.g., vancomycin, aminoglycosides, IV immunoglobulin, mannitol), or with a history of hypovolemic conditions (vomiting, diarrhea, bleeding).
- •5. Leukocytes<2.0×10^9;
- •6. Pregnancy or breast feeding;
- •7. Undergone organ transplantation during the past one year;
- •8. Anticipated transfer to another hospital, which is not a study site within 72 hours;
- •9. Terminally ill, including metastases or hematological malignancy, with a life expectancy less than 30 days (as assessed by the attending physician) or have been classified as Do Not Resuscitate;
- •10. Previous history of end stage chronic organ failure(s);
- •11. Diagnosed with HIV;
- •12. Uncontrolled hemorrhage within the last 24 h;
- •13. History of drug hypersensitivity, including history of adverse reactions to radiocontrast agents.
- •14. Patients who have used an investigational drug or device within 30 days of the first dose of CER-001.
Investigators
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