Phase 3 Study of Reltecimod vs Placebo in Patients With Sepsis-associated Acute Kidney Injury (NCT03403751) | Clinical Trial Compass
TerminatedPhase 3
Phase 3 Study of Reltecimod vs Placebo in Patients With Sepsis-associated Acute Kidney Injury
Stopped: Very slow enrollment of target patient population
United States58 participantsStarted 2018-05-24
Plain-language summary
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.
Who can participate
Age range18 Years – 85 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
✓. 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:
Exclusion criteria
✕. Has known prior history of chronic kidney disease (CKD( with a documented estimated GFR (eGFR) \< 30 mL/min
✕. 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:
What they're measuring
1
Freedom From Durable Loss of Renal Function at Day 28
✕. Patient has acute pancreatitis with no established source of infection, uncomplicated appendicitis, or cholangitis or cholecystitis without peritonitis;