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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: |
NCT01161459 |
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Date of registration:
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12/07/2010 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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Treatment of Idiopathic Membranous Nephropathy With Tripterygium Wilfordii Plus Steroid vs Tacrolimus Plus Steroid
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Scientific title:
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Research Institute of Nephrology, Jinling Hospital |
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Date of first enrolment:
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June 2010 |
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Target sample size:
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100 |
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Recruitment status: |
Completed |
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URL:
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http://clinicaltrials.gov/show/NCT01161459 |
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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: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
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Phase:
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N/A
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Countries of recruitment
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China
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Contacts
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Name:
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Zhihong Liu, Master |
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Address:
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Telephone:
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Email:
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Affiliation:
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Research Institute of Nephrology, Jinling Hospital, Nanjing University School of Medicine |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
1. Biopsy-proven idiopathic membranous nephropathy
2. Nephrotic syndrome with proteinuria ( > 3.5 g/day) and serum albumin < 30 g/dl
3. Age 18-65 years with informed consent
Exclusion Criteria:
1. Patient with elevated serum creatinine concentration
2. Prior therapy with sirolimus, CSA, MMF, or azathioprin, cytoxan, chlorambucil,
levamisole, methotrexate, or nitrogen mustard in the last 90 days
3. Active/serious infection
4. Patient with hepatitis B surface antigen or who is hepatitis C antibody positive
5. Patient who is diabetic
6. Patient is allergic or intolerant to macrolide antibiotics or tacrolimus
Age minimum:
18 Years
Age maximum:
65 Years
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Idiopathic Membranous Nephropathy
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Intervention(s)
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Drug: Tripterygium wilfordii
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Drug: FK506
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Primary Outcome(s)
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The number of CR and PR of Tripterygium wilfordii plus steroid in the treatment of membranous nephropathy
[Time Frame: 18 months]
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Secondary Outcome(s)
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Number of Participants with Adverse Events as a Measure of Safety and Tolerabilitysteroid
[Time Frame: 18 months]
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Secondary ID(s)
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NJCT-1004
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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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