Hepatorenal Syndrome Type I and Type II Clinical Trial
Official title:
A Phase 1 Study of LJPC-501 in Patients With Hepatorenal Syndrome
Hepatorenal syndrome (HRS) is a life-threatening condition marked by rapid decline in kidney function in patients with liver cirrhosis or fulminant liver failure. Vasodilation in the gastrointestinal region is largely thought to contribute to the disease. LJPC-501 is a vasoconstrictor that may restore proper circulation and kidney function in patients with HRS.
Vasoconstrictors are considered a promising approach to treat HRS due to the significant vasodilation of the splanchnic circulation that contributes to systemic arterial underfilling and leads to functional decline of the kidney in these patients. Vasoconstrictors currently in use are associated with reduced organ perfusion and have marginal effect on sodium excretion. The vasoconstrictor angiotensin II has been shown to produce significant sodium excretion and urine output in patients with cirrhosis and ascites, supporting its potential utility in the treatment of HRS. ;
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment