Phase 2 Randomized, Double-Blind, Placebo-Controlled, Parallel-Group 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
Synopsis: You have been diagnosed with acute kidney injury caused by an infection in your abdomen. The kidney is an organ in your body that cleans the blood by filtering out waste products. Acute kidney injury occurs when your kidney experiences a sudden loss of function which can be affected by an overreaction of your body’s immune system. This can occur in patients with serious infections, such as infections in the abdomen (also called intra-abdominal infections).
Researchers want to find out if Reltecimod, an investigational drug, can help people with acute kidney injury caused by serious infections. The researchers want to do this by observing the number of patients in this study whose kidney function returns back to its original level (also called “complete recovery”). Reltecimod is not yet approved by the Food and Drug Administration (FDA) but is being used under an Investigational New Drug (IND) application allowed by the FDA.
The purpose of the study is to test the effectiveness and safety of Reltecimod and compare it to placebo (a substance that looks like Reltecimod but has no treatment effect, in this study placebo is normal saline, or a salt solution). You will receive a single treatment of either Reltecimod or placebo administered intravenously (through a plastic tube or catheter inserted into one of your veins) over 10 minutes within 6 hours after the doctors have determined that you have suffered acute kidney injury.
Be aware that this form refers to Reltecimod and placebo as “study drug”.
- 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 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 onset5. 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 of AKI
- Has known prior history of 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 RRT for chronic kidney disease
- Patients that are treated with RRT for acute kidney dysfunction, starting prior to study drug administration or in whom there is an immediate plan to initiate RRT upon diagnosis of AKI
- 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
- Pregnant or lactating women
- Concurrent or previous enrollment in a clinical trial involving investigational drug or a medical device