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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

Tracking Information
First Submitted Date  ICMJE October 25, 2016
First Posted Date  ICMJE November 1, 2016
Last Update Posted Date April 26, 2017
Estimated Study Start Date  ICMJE May 1, 2017
Estimated Primary Completion Date June 1, 2017   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: November 1, 2016)
Renal outcome [ Time Frame: 4 weeks ]
Need of dialysis
Original Primary Outcome Measures  ICMJE
 (submitted: October 31, 2016)
  • Renal function test [ Time Frame: 4 weeks ]
    Serum BUN
  • Renal function test [ Time Frame: 4 weeks ]
    Serum Creatinine
  • Renal function test [ Time Frame: 4 weeks ]
    Daily urine amount
  • Patient Prognosis [ Time Frame: 4 weeks ]
    Need of dialysis
Change History Complete list of historical versions of study NCT02951299 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: November 1, 2016)
  • Renal function tests [ Time Frame: 4 weeks ]
    Serum and urine test (Blood urine nitrogen, Serum creatinine, Daily urine amount)
  • inflammation marker [ Time Frame: 4 weeks ]
    Transforming Growth Factor-β; Monocyte chemoattractant protein-1
Original Secondary Outcome Measures  ICMJE
 (submitted: October 31, 2016)
  • inflammation marker [ Time Frame: 4 weeks ]
    TNF-α
  • inflammation marker [ Time Frame: 4 weeks ]
    MCP-1
  • inflammation marker [ Time Frame: 4 weeks ]
    TGF-β
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE The Protective Effect of Pentoxifylline on Acute Kidney Injury
Official Title  ICMJE Branch Director, Division of Nephrology, Department of Internal Medicine, 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.

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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Phase 3
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Pentoxifylline
  • Acute Kidney Injury
Intervention  ICMJE 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.
Study Arms  ICMJE
  • Experimental: pentoxifylline group
    Received oral pentoxifylline (400 mg) three times a day for 14 days.
    Intervention: Drug: Pentoxifylline 400Mg Tablet
  • No Intervention: no treatment group
    No intervention.
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Unknown status
Estimated Enrollment  ICMJE
 (submitted: October 31, 2016)
140
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE August 31, 2017
Estimated Primary Completion Date June 1, 2017   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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 )..
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 20 Years to 70 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02951299
Other Study ID Numbers  ICMJE 201507004
104-TDU-B-212-113001 ( Other Grant/Funding Number: MOHW )
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Hsi-Hsien Chen, Taipei Medical University Hospital
Study Sponsor  ICMJE Taipei Medical University Hospital
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Taipei Medical University Hospital
Verification Date November 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP