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OpenTrials
Completed

NCT Number: NCT00155246

Efficacy of Pentoxifylline on Chronic Kidney Disease

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

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Key information

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

pentoxifylline (drug)

Drug

Primary outcomes

  1. spot urinary proteinuria between groups

Secondary outcomes

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

Sponsors and collaborators

Lead sponsor

National Taiwan University Hospital

Other

Registry information

Official study title

Phase 4 Study of the Efficacy of Pentoxifylline in Patients With Chronic Kidney Disease Receiving Angiotensin Receptor Blockade

Important dates

Study start
2004
Primary completion
2006
Study completion
2007
First posted
Sep 12, 2005
Registry last updated
Jan 29, 2010

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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