Univ of Calgary Joins Phase II LSALT Trial for Cardiac Surgery Kidney Injury

Photo:Representative Image

Arch Biopartners Inc, a late-stage clinical trial company focused on preventing inflammation and acute organ injury, has announced that a research team from the University of Calgary’s Cumming School of Medicine has joined the phase II trial for LSALT peptide targeting the prevention and treatment of cardiac surgery-associated acute kidney injury (CS-AKI).

LSALT peptide is the Company’s lead drug candidate for preventing and treating inflammation injury in the kidneys, lungs and liver.“We know that acute kidney injury impairs recovery and can negatively affect long-term outcomes following heart surgery. 

Our research team is excited to participate in a study working towards improving kidney health in our patients,” said Alex Gregory MD, Assistant Professor and Director of Research, Division of Cardiovascular Anesthesia at the Libin Cardiovascular Institute at the Cumming School of Medicine, and site principal investigator for the LSALT Phase II CS-AKI trial.

Dr. Gregory’s clinical team has submitted an application to the local Research Ethics Board for permission to participate in the trial.

Adding the first Canadian clinical site increases the number of trial sites to four, with three hospitals in Turkey currently recruiting patients. There are three additional hospital sites in Turkey pending activation into the trial. The Arch Biopartners team is working with two other hospital sites in Canada to prepare for participating in this phase II trial.

The CS-AKI phase II trial is an international multi-center, randomized, double-masked, placebo-controlled study of LSALT peptide. 

The enrollment target for the clinical trial was 240 patients. The primary objective of this trial was to assess the proportion of subjects with AKI within seven days of on-pump cardiac (heart-lung machine) surgery, according to the Kidney Disease: Improving Global Outcomes (KDIGO) criteria. And damage kidney cells.

 When blood flow returns to normal (reperfusion), inflammation occurs, and kidney cells are damaged. In severe cases of AKI, kidney function may decline, leading to kidney failure or kidney transplantation. There is currently no drug on the market to prevent the type of acute kidney injury that occurs in patients undergoing on-pump heart surgery.