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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: |
NCT00956059 |
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Date of registration:
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10/08/2009 |
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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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Therapeutic Effect of Low-dose Prednisone Combined With MMF and FK506 in Focal Segmental Glomerulosclerosis
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Scientific title:
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Therapeutic Effect of Low-dose Prednisone Combined With MMF and FK506 in Focal Segmental Glomerulosclerosis |
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Date of first enrolment:
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September 2009 |
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Target sample size:
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40 |
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Recruitment status: |
Not yet recruiting |
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URL:
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http://clinicaltrials.gov/show/NCT00956059 |
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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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Baosong Gui, MD |
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Address:
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Telephone:
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86-29-87679917 |
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Email:
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guibsdoctor@sina.com.cn |
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Affiliation:
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Name:
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Baosong Gui, MD |
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Address:
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Telephone:
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86-29-87679917 |
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Email:
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guibsdoctor@sina.com.cn |
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Affiliation:
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Name:
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Baosong Gui, MD |
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Address:
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Telephone:
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Email:
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Affiliation:
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The second affiliated hospital of Medical College, Xi'an Jiaotong University |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- Urinary protein=1.0g/24h
- Biopsy-proved FSGS
- Age=16years
- Understanding of the content of this study,signing informed consent form
- Adherence to drug taking and being able to be long-term followed up
Exclusion Criteria:
- Sharp deterioration of renal function
- Refractory hypertension
- Secondary FSGS
- Serious disease of liver,active stage of viral hepatitis,or AST?ALT=2.5 times of
baseline
- Serious myelosuppression
- Being unable to be long-term followed up
Age minimum:
16 Years
Age maximum:
70 Years
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Focal Segmental Glomerulosclerosis
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Intervention(s)
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Drug: prednisone
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Drug: prednisone, FK506, MMF
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Primary Outcome(s)
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proteinuria,serum protein,Scr,blood routine examination,liver function test,blood glucose and lipid test
[Time Frame: 16~24 weeks]
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Secondary ID(s)
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JL-5MG-50MG-500MG
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DX-FSGS-1
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CSX-090630-SAHXJTU
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JG-YX-1
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DBDZL-1
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YW-JS-XX-TKMS
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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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