Efficacy of Pentoxifylline on Chronic Kidney Disease

Chronic Kidney Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00155246
• Other study ID #: 930202
• Status: Completed
• Phase: Phase 4
• First received: September 8, 2005
• Last updated: January 27, 2010
• Start date: July 2004
• Est. completion date: January 2007

Study information

• Verified date: January 2010
• Source: National Taiwan University Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Taiwan: Department of Health
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: January 2007
• Est. primary completion date: July 2006
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 20 Years to 70 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Chronic Kidney Disease
• Kidney Diseases
• Renal Insufficiency, Chronic

Intervention

Drug:
• pentoxifylline (drug)

Locations

Country	Name	City	State
Taiwan	National Taiwan University Hospital	Taipei

Sponsors (1)

Lead Sponsor	Collaborator
National Taiwan University Hospital

Country where clinical trial is conducted

Taiwan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	spot urinary proteinuria between groups
Secondary	estimated glomerular filtration, spot urine tumor necrosis factor-a/creatinine ratio, spot urine monocyte-chemoattractant protein-1/creatinine, and aldosterone concentration between groups.