Clinical Trial: A Phase 1 Study of LJPC-501 in Patients With Hepatorenal Syndrome
Study Status: Terminated
Recruit Status: Terminated
Study Type: Interventional
Official Title: A Phase 1 Study of LJPC-501 in Patients With Hepatorenal Syndrome
Brief Summary: 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.
Detailed Summary: 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.
Sponsor: La Jolla Pharmaceutical Company
Current Primary Outcome: Adverse events through 5 days of treatment [ Time Frame: 5 days ]
Original Primary Outcome: Same as current
Current Secondary Outcome:
- Maximum Tolerated Dose [ Time Frame: 5 days ]
- Effects on serum creatinine through 5 days of treatment [ Time Frame: 5 days ]
- Effects on ascites through 5 days of treatment [ Time Frame: 5 days ]
- Effects on urine output through 5 days of treatment [ Time Frame: 5 days ]
- Effects on sodium excretion through 5 days of treatment [ Time Frame: 5 days ]
Original Secondary Outcome: Same as current
Information By: La Jolla Pharmaceutical Company
Dates:
Date Received: July 17, 2013
Date Started: March 2014
Date Completion:
Last Updated: March 1, 2016
Last Verified: March 2016
