Arch Biopartners has initiated subject recruitment and dosing in Turkey for its Phase II clinical trial of LSALT peptide to prevent and treat cardiac surgery-associated acute kidney injury (CS-AKI).
LSALT is the company’s leading drug candidate designed to mitigate inflammation injuries in vital organs such as the kidneys, lungs, and liver.
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Three hospital sites in the country are currently screening cardiac surgery patients for this trial, including Koşuyolu Research Hospital and Kocaeli University Research Hospital within and near Istanbul, respectively.
Another site Erciyes University, Faculty of Medicine Organ Transplant & Dialysis Hospital in central Turkey will also recruit patients.
Additionally, three more Turkish hospital sites will become part of the trial in the future.
Trial commencement in Turkey comes after the Ministry of Health granted approval to proceed with a Phase II trial of LSALT peptide for CS-AKI in the country, in January.
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By GlobalDataSubsequently, the company also obtained a No Objection Letter from Health Canada for the trial in the country.
The Arch Biopartners team is coordinating with Canadian hospital sites to facilitate their involvement in this international study.
The global, multicentre, randomised, double-blind, placebo-controlled trial is designed to assess LSALT peptide’s safety and efficacy.
It aims to recruit 240 patients, both male and female, aged 18 years and above.
Participants will be equally randomised to receive either LSALT peptide or a placebo.
The primary goal is to determine the percentage of participants with acute kidney injury (AKI) within seven days post-surgery based on the Kidney Disease: Improving Global Outcomes (KDIGO) criteria.
Trial subjects will be monitored for safety and efficacy until day 28, with day 1 being the day of randomisation when the study drug is administered a minimum of one hour before anaesthesia induction.
An independent Data and Safety Monitoring Board (DSMB) will oversee participants evaluations, focusing primarily on safety assessments and meeting at least monthly or more often, depending on enrolment rates.
