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The Protective Effect of Pentoxifylline on Acute Kidney Injury

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ClinicalTrials.gov Identifier: NCT02951299
Recruitment Status : Unknown
Verified November 2016 by Hsi-Hsien Chen, Taipei Medical University Hospital.
Recruitment status was:  Not yet recruiting
First Posted : November 1, 2016
Last Update Posted : April 26, 2017
Sponsor:
Information provided by (Responsible Party):
Hsi-Hsien Chen, Taipei Medical University Hospital

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.


Condition or disease Intervention/treatment Phase
Pentoxifylline Acute Kidney Injury Drug: Pentoxifylline 400Mg Tablet Phase 2 Phase 3

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.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 140 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Branch Director, Division of Nephrology, Department of Internal Medicine, Taipei Medical University Hospital.
Estimated Study Start Date : May 1, 2017
Estimated Primary Completion Date : June 1, 2017
Estimated Study Completion Date : August 31, 2017

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: pentoxifylline group
Received oral pentoxifylline (400 mg) three times a day for 14 days.
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.

No Intervention: no treatment group
No intervention.



Primary Outcome Measures :
  1. Renal outcome [ Time Frame: 4 weeks ]
    Need of dialysis


Secondary Outcome Measures :
  1. Renal function tests [ Time Frame: 4 weeks ]
    Serum and urine test (Blood urine nitrogen, Serum creatinine, Daily urine amount)

  2. inflammation marker [ Time Frame: 4 weeks ]
    Transforming Growth Factor-β; Monocyte chemoattractant protein-1



Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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 )..

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Responsible Party: Hsi-Hsien Chen, Medical attending, Taipei Medical University Hospital
ClinicalTrials.gov Identifier: NCT02951299     History of Changes
Other Study ID Numbers: 201507004
104-TDU-B-212-113001 ( Other Grant/Funding Number: MOHW )
First Posted: November 1, 2016    Key Record Dates
Last Update Posted: April 26, 2017
Last Verified: November 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
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Acute Kidney Injury
Renal Insufficiency
Kidney Diseases
Urologic Diseases
Pentoxifylline
Phosphodiesterase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Platelet Aggregation Inhibitors
Radiation-Protective Agents
Protective Agents
Physiological Effects of Drugs
Vasodilator Agents
Free Radical Scavengers
Antioxidants