The Protective Effect of Pentoxifylline on Acute Kidney Injury
Primary Purpose
Pentoxifylline, Acute Kidney Injury
Status
Unknown status
Phase
Phase 2
Locations
Study Type
Interventional
Intervention
Pentoxifylline 400Mg Tablet
Sponsored by
About this trial
This is an interventional treatment trial for Pentoxifylline
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 )..
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
pentoxifylline group
no treatment group
Arm Description
Received oral pentoxifylline (400 mg) three times a day for 14 days.
No intervention.
Outcomes
Primary Outcome Measures
Renal outcome
Need of dialysis
Secondary Outcome Measures
Renal function tests
Serum and urine test (Blood urine nitrogen, Serum creatinine, Daily urine amount)
inflammation marker
Transforming Growth Factor-β; Monocyte chemoattractant protein-1
Full Information
NCT ID
NCT02951299
First Posted
October 25, 2016
Last Updated
April 24, 2017
Sponsor
Taipei Medical University Hospital
1. Study Identification
Unique Protocol Identification Number
NCT02951299
Brief Title
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
2. Study Status
Record Verification Date
November 2016
Overall Recruitment Status
Unknown status
Study Start Date
May 1, 2017 (Anticipated)
Primary Completion Date
June 1, 2017 (Anticipated)
Study Completion Date
August 31, 2017 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Taipei Medical University Hospital
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pentoxifylline, Acute Kidney Injury
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2, Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
140 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
pentoxifylline group
Arm Type
Experimental
Arm Description
Received oral pentoxifylline (400 mg) three times a day for 14 days.
Arm Title
no treatment group
Arm Type
No Intervention
Arm Description
No intervention.
Intervention Type
Drug
Intervention Name(s)
Pentoxifylline 400Mg Tablet
Intervention Description
Investigators with AKI will received oral pentoxifylline (400 mg) three times a day for 14 days or no pentoxifylline according to their decision.
Primary Outcome Measure Information:
Title
Renal outcome
Description
Need of dialysis
Time Frame
4 weeks
Secondary Outcome Measure Information:
Title
Renal function tests
Description
Serum and urine test (Blood urine nitrogen, Serum creatinine, Daily urine amount)
Time Frame
4 weeks
Title
inflammation marker
Description
Transforming Growth Factor-β; Monocyte chemoattractant protein-1
Time Frame
4 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
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 )..
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
The Protective Effect of Pentoxifylline on Acute Kidney Injury
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