Efficacy of Pentoxifylline on Primary Nephrotic Syndrome

• Register: ClinicalTrials.gov
• Last refreshed on: 19 February 2015
• Main ID: NCT00354731
• Date of registration: 18/07/2006
• Prospective Registration: Yes
• Primary sponsor: National Taiwan University Hospital
• Public title: Efficacy of Pentoxifylline on Primary Nephrotic Syndrome
• Scientific title: Clinical Efficacy of Pentoxifylline on Patients With Primary Nephrotic Syndrome
• Date of first enrolment: August 2006
• Target sample size: 62
• Recruitment status: Completed
• URL: http://clinicaltrials.gov/show/NCT00354731
• Study type: Interventional
• Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
• Phase: Phase 3

Countries of recruitment

Taiwan

Contacts

• Name: Yung-Ming Chen, M.D.
• Affiliation: NTUH

Key inclusion & exclusion criteria

Inclusion Criteria:

- biopsied-proved primary glomerular diseases, and nephrotic syndrome

Exclusion Criteria:

- History of allergy to pentoxifylline, Females are nursing or pregnant, 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, Uncontrolled
hypertension with systolic blood pressure > 200 mmHg and/or diastolic blood pressure
> 110 mmHg, Liver cirrhosis, Biliary obstructive disorders, Active malignancy or
infection, Uncontrolled diabetes mellitus, GFR ? 30 ml/min/1.73 m2



Age minimum: 20 Years
Age maximum: 80 Years
Gender: Both

Health Condition(s) or Problem(s) studied

Nephrotic Syndrome

Intervention(s)

Drug: pentoxifylline

Drug: Corticosteroid

Primary Outcome(s)

changes from baseline in urinary protein excretion [Time Frame: 18 months]

Secondary Outcome(s)

change from baseline in creatinine and estimated GFR [Time Frame: 18 months]

Secondary ID(s)

941103

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

National Science Council, Taiwan