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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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19 February 2015 |
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Main ID: |
NCT00354198 |
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Date of registration:
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18/07/2006 |
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Prospective Registration:
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Yes |
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Primary sponsor: |
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Public title:
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Efficacy of Pentoxifylline on Rapidly Progressive Glomerulonephritis
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Scientific title:
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Clinical Efficacy of Combined Pentoxifylline and Conventional Immunosuppressive Regimens on Patients With Rapidly Progressive Glomerulonephritis |
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Date of first enrolment:
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August 2006 |
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Target sample size:
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7 |
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Recruitment status: |
Terminated |
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URL:
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http://clinicaltrials.gov/show/NCT00354198 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
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Phase:
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Phase 3
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Countries of recruitment
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Taiwan
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Contacts
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Name:
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Yung-Ming Chen, M.D. |
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Address:
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Telephone:
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Email:
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Affiliation:
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NTUH |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- biopsied-proved crescentic glomerulonephritis, with rapidly progressive renal failure
Exclusion Criteria:
- Anti-GBM disease, Dialysis-dependency or pulmonary hemorrhage, History of allergy to
pentoxifylline, Females are nursing or pregnant, Congestive heart failure, 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 or diabetes, Liver cirrhosis or hepatic dysfunction as defined by liver
enzymes > 2 times the upper limit of the normal range, Biliary obstructive disorders,
Active malignancy or infection
Age minimum:
20 Years
Age maximum:
80 Years
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Glomerulonephritis
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Intervention(s)
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Drug: pentoxifylline
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Drug: corticosteroids
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Primary Outcome(s)
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initiation of acute dialysis or doubling of serum creatinine levels
[Time Frame: 3 months]
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Secondary Outcome(s)
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end-stage renal disease (ESRD)
[Time Frame: 6 months]
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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