Clinical trial in which people are allocated by chance to receive one of several clinical treatments, different doses, to prevent sepsis-induced acute kidney injury

Phase 1

• Conditions: Sepsis due to intra-abdominal cavity infection or urosepsis; MedDRA version: 21.1Level: LLTClassification code 10073462Term: Injection site allergic reactionSystem Organ Class: 100000004867; Therapeutic area: Diseases [C] - Bacterial Infections and Mycoses [C01]

• Registration Number: EUCTR2020-004202-60-IT
• Lead Sponsor: CERENIS THERAPEUTICS

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2021-08-31
• Last Update Posted: 11 September 2023

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 20

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.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified