We updated the design of this site on December 18, 2017. Learn more.
ClinicalTrials.gov
ClinicalTrials.gov Menu

Efficacy of Pentoxifylline on Chronic Kidney Disease

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00155246
Recruitment Status : Completed
First Posted : September 12, 2005
Last Update Posted : January 29, 2010
Sponsor:
Information provided by:
National Taiwan University Hospital

Brief Summary:
To study whether pentoxifylline has additive renoprotective effect in patients taking ARB

Condition or disease Intervention/treatment Phase
Chronic Kidney Disease Drug: pentoxifylline (drug) Phase 4

Detailed Description:
In patients with CKD and serum creatinine 1.3~6.0 md/gl, having taken losartan 100 mg/day for at least 3 months, with stable renal function, will be recruited to a randomized open-label trial. Patients taking pentoxifylline or not will be compared for their spot urinary proteinuria, estimated glomerular filtration, spot urine tumor necrosis factor-α/creatinine ratio, spot urine monocyte-chemoattractant protein-1/creatinine, and aldosterone concentration between groups in a 2-year study. Add-on pentoxifylline in control group in the same dose as in treat group will be performed to observe the renoprotective effect if any protective potential is demonstrated in the end of maintenance 12 months.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Phase 4 Study of the Efficacy of Pentoxifylline in Patients With Chronic Kidney Disease Receiving Angiotensin Receptor Blockade
Study Start Date : July 2004
Primary Completion Date : July 2006
Study Completion Date : January 2007

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Kidney Diseases
U.S. FDA Resources




Primary Outcome Measures :
  1. spot urinary proteinuria between groups

Secondary Outcome Measures :
  1. estimated glomerular filtration, spot urine tumor necrosis factor-α/creatinine ratio, spot urine monocyte-chemoattractant protein-1/creatinine, and aldosterone concentration between groups.


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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

Inclusion Criteria:

  • Chronic kidney disease with serum creatinine 1.3~6.0 mg/dl

Exclusion Criteria:

  • History of allergy to pentoxifylline
  • Females are nursing or pregnant
  • Obstructive uropathy
  • Unable to stop chronic immunosuppressive therapy, NSAID
  • Congestive heart failure (New York Heart Association functional class III or IV)
  • Unstable angina, myocardial infarction, coronary artery bypass graft surgery, percutaneous coronary intervention, within the past 6 months prior to signing the informed consent form
  • Cerebral hemorrhage within the past 6 months prior to signing the informed consent form
  • Retinal hemorrhage within the past 6 months prior to signing the informed consent form
  • Known or suspected secondary hypertension (e.g., primary aldosteronism, renovascular hypertension, pheochromocytoma)
  • Severe uncontrolled hypertension with SBP > 220 mmHg and/or DBP > 115 mmHg
  • Hepatic dysfunction as defined by the following laboratory parameters: ALT or AST > 2 times the upper limit of the normal range
  • Biliary obstructive disorders (e.g. cholestasis)
  • Active malignancy

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00155246


Locations
Taiwan
National Taiwan University Hospital
Taipei, Taiwan, 100
Sponsors and Collaborators
National Taiwan University Hospital
Investigators
Principal Investigator: Tun-Jun Tsai, MD, PhD National Taiwan University Hosptial

Responsible Party: Shuei-Liong Lin/Attending Physician, National Taiwan University Hospital
ClinicalTrials.gov Identifier: NCT00155246     History of Changes
Other Study ID Numbers: 930202
First Posted: September 12, 2005    Key Record Dates
Last Update Posted: January 29, 2010
Last Verified: January 2010

Keywords provided by National Taiwan University Hospital:
CKD, pentoxifylline

Additional relevant MeSH terms:
Kidney Diseases
Renal Insufficiency, Chronic
Urologic Diseases
Renal Insufficiency
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