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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.
Register: ChiCTR
Last refreshed on: 18 April 2017
Main ID:  ChiCTR-TRC-09000539
Date of registration: 2009-09-30
Prospective Registration: No
Primary sponsor: Second Hospital of Jilin University
Public title: Clinical studies of tacrolimus in idiopathic membranous Nephropathy with nephrotic syndrome therapy
Scientific title: Clinical studies of tacrolimus in idiopathic membranous Nephropathy with nephrotic syndrome therapy
Date of first enrolment: 2004-03-01
Target sample size: S:10;L:10;
Recruitment status: Completed
URL:  http://www.chictr.org.cn/showproj.aspx?proj=8996
Study type:  Interventional study
Study design:  Randomized parallel controlled trial  
Phase:  Pilot study
Countries of recruitment
China
Contacts
Name: Li-ning Miao   
Address:  No.218, Ziqiang Road, Changchun City, Jilin Province 130041
Telephone: +86 13904303985
Email: miaolining@yahoo.com.cn
Affiliation: 
Name: Hang Yuan   
Address:  No.218, Ziqiang Road, Changchun City, Jilin Province 130041
Telephone: +86 0431 88796526
Email: hangyuan75@gmail.com
Affiliation:  Second Hospital of Jilin University
Key inclusion & exclusion criteria
Inclusion criteria: 1. Diagnosis of primary NS;
2. Renal biopsy-proven IMN and diagnosis of class I to III;
3. Scr<221umol/L;
4. No therapy with other immunosuppressive or non-steroidal anti-inflammatory drugs prior to the inclusion in the study.

Exclusion criteria: 1. Pregnancy;
2. Combined with serious complications such as severe infection, tumor, HIV infection, and active HBV infection;
3. Other serious renal disease including diabetic nephropathy;
4. Known allergy to the calcineurin inhibitors.


Age minimum: 16
Age maximum: 69
Gender: Both
Health Condition(s) or Problem(s) studied
Nephrotic Disease
Intervention(s)
S:Patients receive tacrolimus combined with prednison for six months;L:Patients receive tacrolimus combined with prednison for 24 months;
Primary Outcome(s)
Serum albumin level;24hours urinary protein;
Secondary Outcome(s)
Secondary ID(s)
Source(s) of Monetary Support
Social development division of Jilin Province
Secondary Sponsor(s)
Ethics review
Results
Results available:
Date Posted:
Date Completed:
URL:
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