Treatment of Type I Hepatorenal Syndrome (HRS) With Pentoxyfylline

Study Results

Results available

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Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

NA

Total Enrollment

12 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-04-30

Study Completion Date

2017-12-31

Brief Summary

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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.

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Detailed Description

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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

Conditions

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Hepatorenal Syndrome

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Treatment

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

Group Type EXPERIMENTAL

Pentoxyfylline

Intervention Type DRUG

AMO Therapy

Intervention Type DRUG

Albumin, midodrine and octreotide therapy (standard of care for HRS)

Placebo

This is a standard placebo pill.

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

AMO Therapy

Intervention Type DRUG

Albumin, midodrine and octreotide therapy (standard of care for HRS)

Interventions

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Pentoxyfylline

Intervention Type DRUG

Placebo

Intervention Type DRUG

AMO Therapy

Albumin, midodrine and octreotide therapy (standard of care for HRS)

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Hospitalized patients with acute or chronic liver disease
* Type I HRS
* Aged greater than or equal to 18
* Non-pregnant

Exclusion Criteria

* Allergy or hypersensitivity to PTX or intolerance to methylxanthines (e.g. caffeine, theophylline)
* Concurrent use of nephrotoxic drugs
* Age less than 18
* Pregnancy
* Uncontrolled bacterial infection
* Renal parenchymal disease (e.g. acute tubular necrosis, glomerular disease, interstitial nephritis and urinary obstruction)
* Shock
* TNF alpha antagonist use
* Subject is institutionalized or a prisoner
* Recent cerebral or retinal hemorrhage (contraindication to PTX)
* Severe or poorly controlled cardiovascular disease as determined by the principal investigator to hinder the ability to adhere to study protocols

Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No