Clinical Trial: Treatment of Type I Hepatorenal Syndrome (HRS) With Pentoxyfylline
Study Status: Terminated
Recruit Status: Terminated
Study Type: Interventional
Official Title: Treatment of Type I Hepatorenal Syndrome (HRS) With Pentoxyfylline: A Placebo Controlled, Blinded Pilot Study
Brief Summary: Pentoxyfylline therapy in addition to the standard of care of albumin, midodrine and octreotide therapy is superior to the standard of care alone in the treatment of Type I hepatorenal syndrome in the first 14 days of hospitalization.
Detailed Summary:
Each hospitalized subject will undergo pre-dosing screening with review of his or her history and physical exam from the day of enrollment and safety assessment to ensure no contraindication to use of PTX. Type I HRS will be defined according to the criteria put forth by the American Association for the Study of Liver Disease as (1) cirrhosis with ascites; (2) serum creatinine greater than 1.5 mg/dL; (3) no improvement of serum creatinine (decrease to a level of 1.5 mg/dL or less) after at least two days with diuretic withdrawal and volume expansion with albumin; (4) absence of shock; (5) no current or recent treatment with nephrotoxic drugs; and (6) 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. Baseline testing will be obtained from hospitalization records, including but not limited to chemistry panel, liver function testing, urinalysis, urine electrolytes, coagulation studies, blood cultures, chest x-ray, diagnostic paracentesis, abdominal ultrasound with Doppler.
Subjects will take either placebo three times a day or pentoxyfylline 400mg three times a day or 400mg twice a day for eGFR 10-50 and 400mg once a day for eGFR <10 for 90 days in addition to standard AMO therapy. Treatment will be continued for 14 days unless a study endpoint has been reached at which time either PTX or placebo will be stopped
Sponsor: Patrick Northup, MD
Current Primary Outcome: Incidence of treatment success [ Time Frame: 14 days ]
Original Primary Outcome: Same as current
Current Secondary Outcome:
- Change in serum creatinine from baseline [ Time Frame: 14 days ]
- Incidence of treatment failure [ Time Frame: Day14 ]Defined as creatinine level above baseline value after day 7, dialysis or death
- Combined increase of treatment success and "partial response [ Time Frame: 14 days ]We define as serum creatinine level decreased by >50% from baseline but not to <1.5 mg/dL, without dialysis or HRS recurrence
- Transplant free survival [ Time Frame: day 30 and 180 ]
- Composite survival index [ Time Frame: day 30 and 180 ].This will be the combination of transplant free survival and those patients who received liver transplant
Original Secondary Outcome: Same as current
Information By: University of Virginia
Dates:
Date Received: April 18, 2014
Date Started: April 2014
Date Completion: December 31, 2017
Last Updated: May 1, 2017
Last Verified: May 2017