NCT02951299

The Protective Effect of Pentoxifylline on Acute Kidney Injury

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

• Status: Unknown
• Phase: Phase 2 / Phase 3
• Study type: Interventional
• Enrollment: 140 (estimated)
• Sponsor: Taipei Medical University Hospital · Academic / Other
• Sex: All
• Age: 20 Years – 70 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Pentoxifylline
• Acute Kidney Injury

Interventions

Type	Name	Description
DRUG	Pentoxifylline 400Mg Tablet	Investigators with AKI will received oral pentoxifylline (400 mg) three times a day for 14 days or no pentoxifylline according to their decision.

Timeline

• Start date: 2017-05-01
• Primary completion: 2017-06-01
• Completion: 2017-08-31
• First posted: 2016-11-01
• Last updated: 2017-04-26