The Protective Effect of Pentoxifylline on Acute Kidney Injury

NCT02951299 | Unknown Phase 2

• 2 other identifiers: 201507004104-TDU-B-212-113001
• Study Type: interventional
• Target: 140
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Pentoxifylline; Acute Kidney Injury

Outcome Measures

Primary Outcomes (1)

• Renal outcome

  Need of dialysis

  4 weeks

Secondary Outcomes (2)

• Renal function tests

  4 weeks

• inflammation marker

  4 weeks

Study Arms (2)

pentoxifylline group

EXPERIMENTAL

Received oral pentoxifylline (400 mg) three times a day for 14 days.

Drug: Pentoxifylline 400Mg Tablet

no treatment group

NO INTERVENTION

No intervention.

Interventions

Pentoxifylline 400Mg Tablet DRUG

Investigators with AKI will received oral pentoxifylline (400 mg) three times a day for 14 days or no pentoxifylline according to their decision.

pentoxifylline group

Eligibility Criteria

• Age: 20 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).

You may not qualify if:

• \. 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 )..

Sponsors & Collaborators

• Taipei Medical University Hospital: lead

MeSH Terms

Conditions

Acute Kidney Injury

Interventions

Pentoxifylline; Tablets

Condition Hierarchy (Ancestors)

Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases

Intervention Hierarchy (Ancestors)

Theobromine; Xanthines; Purinones; Purines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Dosage Forms; Pharmaceutical Preparations

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Medical attending

Study Record Dates

• First Submitted: October 25, 2016
• First Posted: November 1, 2016
• Study Start: May 1, 2017
• Primary Completion: June 1, 2017
• Study Completion: August 31, 2017
• Last Updated: April 26, 2017

Record last verified: 2016-11

Data Sharing

• IPD Sharing: Will not share