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 (SA-AKI)

Principal Investigator: Lynn Gries, MD    

Funding Source: Atox Bio Ltd.

Start Date: June 2018 – September 2020

Enrolling: 120 patients

More Information: https://clinicaltrials.gov/ct2/show/NCT03403751

AKI is a common medical condition and results in hospital complications in critically ill patients. Its occurrence in intensive care unit (ICU) patients has been reported to range between 16-67%1, and in the US, it occurs in approximately 20% of hospital admissions.2 AKI results in an abrupt decrease in kidney function and is associated with poor prognosis, morbidity, increased short-term and long-term mortality, and significant health care expenditures. AKI is one of the most serious and common health complications; in the critical care setting, AKI is associated with a mortality rate of 60%.3 Despite advances in supportive care, mortality rates associated with AKI remain high. Reltecimod is being developed for the treatment of SA-AKI in conjunction with standard of care, antibiotic therapy and supportive care.

Purpose: the purpose of this study is to determine if Reltecimod is effective, in conjunction with the standard treatment, at treating patients with sepsis-induced acute kidney injury when compared to patients treated with placebo and standard treatment.

For questions about this study, please contact Andrea Seach at 520-626-2876 or aseach@surgery.arizona.edu.

1.) Alobaidi R, Basu RK, Goldstein SL, Bagshaw SM. Sepsis-associated acute kidney injury. Semin Nephrol. 2015;35(1):2-11. doi:10.1016/j.semnephrol.2015.01.002.

2.) Uchino S. The epidemiology of acute renal failure in the world. Curr Opin Crit Care. 2006;12(6):538-543. doi:10.1097/01.ccx.0000247448.94252.5a.

3.) Uchino S, Kellum JA, Bellomo R, et al. Acute renal failure in critically ill patients: a multinational, multicenter study. JAMA. 2005;294(7):813-818. doi:10.1001/jama.294.7.813.