Clinical trial NCT02951299: The Protective Effect of Pentoxifylline on Acute Kidney Injury
Official title: Branch Director, Division of Nephrology, Department of Internal Medicine, Taipei Medical University Hospital.
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
PHASE3
Conditions: Pentoxifylline
Acute Kidney Injury
Lead sponsor: Taipei Medical University Hospital
Sponsor class: OTHER
First posted: 2016-11-01
Enrollment: 140
Sex: ALL
Minimum age (years): 20
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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: 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.

Eligibility criteria: 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 )..

Primary outcomes:
measure: Renal outcome
timeFrame: 4 weeks
Secondary outcomes:
measure: Renal function tests
timeFrame: 4 weeks
measure: inflammation marker
timeFrame: 4 weeks
Other outcomes:
Locations:
Study officials:
References: