The Protective Effect of Pentoxifylline on Acute Kidney Injury

Acute Kidney Injury Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT02951299
• Other study ID #: 201507004
• Secondary ID: 104-TDU-B-212-11
• Status: Not yet recruiting
• Phase: Phase 2/Phase 3
• First received: October 25, 2016
• Last updated: April 24, 2017
• Start date: May 1, 2017
• Est. completion date: August 31, 2017

Study information

• Verified date: November 2016
• Source: Taipei Medical University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 140
• Est. completion date: August 31, 2017
• Est. primary completion date: June 1, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years to 70 Years

Eligibility

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 )..

Related Conditions & MeSH terms

• Acute Kidney Injury
• Pentoxifylline

Intervention

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.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Taipei Medical University Hospital

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Renal outcome	Need of dialysis	4 weeks
Secondary	Renal function tests	Serum and urine test (Blood urine nitrogen, Serum creatinine, Daily urine amount)	4 weeks
Secondary	inflammation marker	Transforming Growth Factor-ß; Monocyte chemoattractant protein-1	4 weeks