Raghavan Murugan, MD, MS, Associate Professor of Critical Care Medicine and Clinical and Translational Science, is the site-Principal Investigator for the STOP-AKI study. This trial, entitled “A Safety, Tolerability, Efficacy and Quality of Life Study of Human Recombinant Alkaline Phosphatase in the Treatment of Patients with Sepsis-associated AKI,” is being spearheaded by AM-PHARMA, a Netherlands-based biopharmaceutical company. The study is being conducted at 53 sites—43 in Europe and 10 in the U.S., with UPMC the only site in Pennsylvania.
Sepsis is the leading cause of AKI in critically ill patients and there are currently no drugs to treat AKI. STOP-AKI is an adaptive clinical trial that is investigating three different dosing regimens of human recombinant alkaline phosphatase or placebo in the treatment of patients with sepsis-associated AKI.
This trial is being facilitated by MACRO and the first patient was enrolled on August 27th in the Neuro-ICU with the help of several study investigators including Drs. Ali Al-Khafaji and David Huang and the unit Attending, Dr. Baldisseri. MACRO personnel Mary Stefanik, Denise Scholl, and Pam Fazio played a key role in screening and enrollment.
Other investigators include Dr. Hyung Kim from Critical Care Medicine and Drs. Chethan Puttarajappa and Jose Barnado from the Renal-Electrolyte Division.