A Phase 1 Study of LJPC-501 in Patients With Hepatorenal Syndrome

Stopped early · Phase 1

Conditions studied: Hepatorenal Syndrome Type I and Type II

In brief

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.

Key facts

Study ID: NCT01906307
Run by: La Jolla Pharmaceutical Company
People needed: 6
Starts: 2014-03-01
Expected to finish: 2015-12-01
Last updated by the study team: 2016-03-03

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

Patients with HRS, as defined by the International Ascites Club [1]:
Cirrhosis with ascites
Serum creatinine > 1.5 mg/dL
No improvement of serum creatinine (decrease to a level of ≤ 1.5 mg/dL) after at least 2 days with diuretic withdrawal and volume expansion with albumin
Absence of shock
No current or recent treatment with nephrotoxic drugs
Absence of parenchymal kidney disease, as indicated by proteinuria > 500 mg/day, microhematuria (> 50 red blood cells per high power field) and/or abnormal renal ultrasonography
Or patients with HRS due to acute alcoholic hepatitis
Patient is able to undergo a reliable neurologic exam, as determined by the investigator
Patient or legal surrogate is willing and able to provide written informed consent
Patient is willing and able to comply with all protocol requirements

You may not qualify if…

Evidence of shock
Current or recent treatment with nephrotoxic drugs
Use of midodrine, octreotide, or other vasopressors within 48 hours of screening
Current treatment with dialysis
Serum creatinine > 7 mg/dL
Active cardiovascular disease within 3 months of screening
History of transient ischemic attacks or prior stroke
History of organ transplant
Ongoing infection requiring intravenous administration of antibiotics (patients with documented infections considered by the Investigator to be controlled within 48 hours of screening may be permitted in the study upon consultation with the Sponsor's Medical Monitor)
Participation in a clinical trial within 30 days of screening
Patient unlikely to survive more than 72 hours in the opinion of the investigator
Patient is pregnant or planning to become pregnant during study

Where it is running

Annette C. & Harold C. Simmons Transplant Institute @ Baylor University Medical Center — Dallas, Texas, United States

Full record on ClinicalTrials.gov

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