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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
Taipei Medical University Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Pentoxifylline

Eligibility Criteria

20 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

    First Posted
    October 25, 2016
    Last Updated
    April 24, 2017
    Sponsor
    Taipei Medical University Hospital
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    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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