Treatment of Type I Hepatorenal Syndrome (HRS) With Pentoxyfylline

Stopped early · Not applicable · Has a placebo group

Conditions studied: Hepatorenal Syndrome

In brief

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.

Key facts

Study ID

NCT02123576

Run by

Patrick Northup, MD

People needed

12

Starts

2014-04-01

Expected to finish

2017-12-31

Last updated by the study team

2019-05-29

Who can join

Age: 18 and older, up to 75. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

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

You may not qualify if…

• 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

Where it is running

• University of Virginia Health System — Charlottesville, Virginia, United States

Full record on ClinicalTrials.gov

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