Hepatorenal Syndrome
Conditions
Keywords
hepatorenal syndrome, terlipressin
Brief summary
The purpose of this study is to determine whether terlipressin is safe and effective in the treatment of patients with hepatorenal syndrome (HRS) type 1 when compared to placebo.
Interventions
DRUGterlipressin
DRUGPlacebo
Sponsors
Mallinckrodt
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Chronic, or acute liver disease * Rapidly progressive reduction in renal function, e.g. doubling of serum creatinine to \>2.5 mg/dL in less than two weeks. * No sustained improvement in renal function after diuretic withdrawal and plasma volume expansion * Proteinuria \<500 mg per day * No evidence of granular casts in urinalysis or ultrasonographic evidence of obstructive uropathy or parenchymal renal disease
Exclusion criteria
* Ongoing shock * Uncontrolled bacterial infection * Current significant fluid losses * Current or recent treatment with nephrotoxic drugs (e.g. NSAIDs or aminoglycosides within 4 weeks) * Acute liver disease due to factors known to be also directly nephrotoxic (e.g. acetaminophen overdose) * Confirmed pregnancy * Severe cardiovascular disease * Evidence of intrinsic or parenchymal renal disease (e.g. acute tubular necrosis) * Participation in other clinical studies within 30 days
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Treatment Success | Day 14 |
Secondary
| Measure | Time frame |
|---|---|
| Renal function and survival | Renal funtion to Day 14 and Survival to Day 180 |
Countries
United States
Outcome results
None listed