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.
| Status | Terminated |
| Enrollment | 6 |
| Est. completion date | December 2015 |
| Est. primary completion date | November 2015 |
| Accepts healthy volunteers | No |
| Gender | Both |
| Age group | 18 Years and older |
| Eligibility |
Inclusion Criteria: 1. 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 2. Patient is able to undergo a reliable neurologic exam, as determined by the investigator 3. Patient or legal surrogate is willing and able to provide written informed consent 4. Patient is willing and able to comply with all protocol requirements Exclusion Criteria: 1. Evidence of shock 2. Current or recent treatment with nephrotoxic drugs 3. Use of midodrine, octreotide, or other vasopressors within 48 hours of screening 4. Current treatment with dialysis 5. Serum creatinine > 7 mg/dL 6. Active cardiovascular disease within 3 months of screening 7. History of transient ischemic attacks or prior stroke 8. History of organ transplant 9. 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) 10. Participation in a clinical trial within 30 days of screening 11. Patient unlikely to survive more than 72 hours in the opinion of the investigator 12. Patient is pregnant or planning to become pregnant during study |
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
| Country | Name | City | State |
|---|---|---|---|
| United States | Annette C. & Harold C. Simmons Transplant Institute @ Baylor University Medical Center | Dallas | Texas |
| Lead Sponsor | Collaborator |
|---|---|
| La Jolla Pharmaceutical Company |
United States,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Other | Change in biomarkers of disease activity from baseline on Day 5 | baseline and Day 5 | No | |
| Primary | Adverse events through 5 days of treatment | 5 days | Yes | |
| Secondary | Maximum Tolerated Dose | 5 days | Yes | |
| Secondary | Effects on serum creatinine through 5 days of treatment | 5 days | No | |
| Secondary | Effects on ascites through 5 days of treatment | 5 days | No | |
| Secondary | Effects on urine output through 5 days of treatment | 5 days | No | |
| Secondary | Effects on sodium excretion through 5 days of treatment | 5 days | No |