Lucassin is being developed for the treatment of hepatorenal syndrome (HRS) Type 1.
Lucassin is a synthetic vasopressin analogue that acts via the vasopressin V1a receptor as a systemic vasoconstrictor, mainly in the splanchnic (abdominal) circulation, which appears to increase effective arterial volume and improves renal blood flow, thereby improving renal function in patients with HRS.
The Reverse Trial will compare terlipressin in combination with albumin to placebo with albumin, and will have a primary endpoint of HRS reversal, which is defined as two serum creatinine values of less than or equal to 1.5mg/dl taken at least 48 hours apart, without any intervening hemodialysis, transplant or elevation of creatinine above a pre-specified level.
However, transplant-free survival and overall survival are among the secondary endpoints of the trial.
Ikaria Research & Development executive vice president Douglas Greene said that the start of the Reverse trial marks Ikaria’s intent to provide the data necessary to fulfill the regulatory requirement to seek US marketing approval to bring an approved treatment option to the patients with HRS Type 1.