The Protective Effect of Pentoxifylline on Acute Kidney Injury

Study Overview
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Brief Summary
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Acute kidney injury (AKI) has a frequency of 7.0 % in hospital inpatients and is especially common in critically ill patients, in whom the prevalence of acute kidney injury is greater than 40% at admission to the intensive care unit if sepsis is present. Therefore, alternative strategies are required to confer better or more complete renoprotection for those who suffered from AKI. There had been many studies demonstrated that the phosphodiesterase inhibitor pentoxifylline (PTX) is a potent anti-inflammatory, anti-proliferative, and anti-fibrotic agent capable of attenuating experimental renal disease such as drugs, ischemic and sepsis induced AKI. We thereby design this controlled, non-randomized clinical trial, aiming at investigating the potential renoprotective efficacy of PTX, as compared to placebo, in 200 patients with AKI.

Detailed Description
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Acute kidney injury (AKI) refers to a clinical syndrome characterized by a rapid (hours to days) decrease in renal function, which is a common and important diagnostic and therapeutic challenge for clinicians. The disorder has a frequency of 7.0 % in hospital inpatients and is especially common in critically ill patients, in whom the prevalence of acute kidney injury is greater than 40% at admission to the intensive care unit if sepsis is present. AKI is independently associated with important morbidity and mortality although many efforts have been used in past years. Therefore, alternative strategies are required to confer better or more complete renoprotection for those who suffered from AKI. There had been many studies demonstrated that the phosphodiesterase inhibitor pentoxifylline (PTX) is a potent anti-inflammatory, anti-proliferative, and anti-fibrotic agent capable of attenuating experimental renal disease such as drugs, ischemic and sepsis induced AKI. We thus hypothesized that PTX may have therapeutic value for AKI in human. We thereby design this controlled, non-randomized clinical trial, aiming at investigating the potential renoprotective efficacy of PTX, as compared to placebo, in 200 patients with AKI.

Official Title
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Branch Director, Division of Nephrology, Department of Internal Medicine, Taipei Medical University Hospital.

Conditions
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Pentoxifylline, Acute Kidney Injury

Intervention / Treatment
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* Drug: Pentoxifylline 400Mg Tablet


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients aged between 20   70 y/o who had admitted for acute kidney injury (renal function decreased within 48hours which meets following criteris: GFR decreased > 25 %, serum creatinine elevated > 0.3 mg/dl or 50%、urine amount less than 0.5 ml/kg/hour > 6 hours). Exclusion Criteria: 1. Those who had been received regular dialysis or GFR < 30 ml/min before test. 2. Those who with acute bleeding. 3. Those who allergy to pentoxifylline or methylxanthine derivatives (such as caffeine, theophylline and theobromine )..

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: pentoxifylline group<br>Received oral pentoxifylline (400 mg) three times a day for 14 days. | Drug: Pentoxifylline 400Mg Tablet<br>* Investigators with AKI will received oral pentoxifylline (400 mg) three times a day for 14 days or no pentoxifylline according to their decision.<br>|
| No Intervention: no treatment group<br>No intervention. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Renal outcome | Need of dialysis | 4 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Renal function tests | Serum and urine test (Blood urine nitrogen, Serum creatinine, Daily urine amount) | 4 weeks | 
| inflammation marker | Transforming Growth Factor-β; Monocyte chemoattractant protein-1 | 4 weeks |