Status:
TERMINATED
A Phase 1 Study of LJPC-501 in Patients With Hepatorenal Syndrome
Lead Sponsor:
La Jolla Pharmaceutical Company
Conditions:
Hepatorenal Syndrome Type I and Type II
Eligibility:
All Genders
18+ years
Phase:
PHASE1
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 ...
Detailed Description
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 func...
Eligibility Criteria
Inclusion
- 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
Exclusion
- 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
Key Trial Info
Start Date :
March 1 2014
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2015
Estimated Enrollment :
6 Patients enrolled
Trial Details
Trial ID
NCT01906307
Start Date
March 1 2014
End Date
December 1 2015
Last Update
March 3 2016
Active Locations (1)
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1
Annette C. & Harold C. Simmons Transplant Institute @ Baylor University Medical Center
Dallas, Texas, United States, 75246