Efficacy of Pentoxifylline on Chronic Kidney Disease

This study has been completed.
Sponsor:
Information provided by:
National Taiwan University Hospital
ClinicalTrials.gov Identifier:
NCT00155246
First received: September 8, 2005
Last updated: January 27, 2010
Last verified: January 2010
  Purpose

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


Condition Intervention Phase
Chronic Kidney Disease
Drug: pentoxifylline (drug)
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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

Resource links provided by NLM:


Further study details as provided by National Taiwan University Hospital:

Primary Outcome Measures:
  • spot urinary proteinuria between groups

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

Enrollment: 60
Study Start Date: July 2004
Study Completion Date: January 2007
Primary Completion Date: July 2006 (Final data collection date for primary outcome measure)
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.

  Eligibility

Ages Eligible for Study:   20 Years to 70 Years
Genders Eligible for Study:   Both
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
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: 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
  More Information

No publications provided

Responsible Party: Shuei-Liong Lin/Attending Physician, National Taiwan University Hospital
ClinicalTrials.gov Identifier: NCT00155246     History of Changes
Other Study ID Numbers: 930202
Study First Received: September 8, 2005
Last Updated: January 27, 2010
Health Authority: Taiwan: Department of Health

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
Pharmacologic Actions
Platelet Aggregation Inhibitors
Hematologic Agents
Therapeutic Uses
Radiation-Protective Agents
Protective Agents
Physiological Effects of Drugs
Vasodilator Agents
Cardiovascular Agents
Free Radical Scavengers
Antioxidants

ClinicalTrials.gov processed this record on October 01, 2014