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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: 4 December 2018
Main ID:  ChiCTR1800019833
Date of registration: 2018-12-02
Prospective Registration: Yes
Primary sponsor: Department of Nephrology, The First Affiliated Hospital of Zhejiang Chinese Medical University
Public title: Dynamic changes of TCM syndrome types of idiopathic membranous nephropathy treated with cyclophosphamide combined with hormone
Scientific title: Dynamic changes of TCM syndrome types of idiopathic membranous nephropathy treated with cyclophosphamide combined with hormone
Date of first enrolment: 2019-01-01
Target sample size: PLA2R???:30;PLA2R positive Group:30;
Recruitment status: Pending
URL:  http://www.chictr.org.cn/showproj.aspx?proj=33364
Study type:  Observational study
Study design:  Cohort study  
Phase:  Pilot study
Countries of recruitment
China
Contacts
Name: Hong Bo Chen   
Address:  54 Youdian Road, Shangcheng District, Hangzhou, Zhejiang, China
Telephone: +86 0571-86008671
Email: chenhb521@126.com
Affiliation:  Department of Nephrology, The First Affiliated Hospital of Zhejiang Chinese Medical University
Name: Wen Zhang   
Address:  54 Youdian Road, Shangcheng District, Hangzhou, Zhejiang, China
Telephone: +86 13758118936
Email: 306762827@qq.com
Affiliation:  Department of Nephrology, The First Affiliated Hospital of Zhejiang Chinese Medical University
Key inclusion & exclusion criteria
Inclusion criteria: (1) aged 18-85 years old;
(2) meet the diagnostic criteria of nephrotic syndrome;
(3) renal biopsy showed idiopathic membranous nephropathy.

Exclusion criteria: (1) exclude acute renal failure, renal function stage 3, stage 4 patients;
(2) patients with serious primary diseases such as heart, brain, liver or hematopoietic system;
(3) excluding lupus, hepatitis b, diabetes and other secondary membranous nephropathy;
(4) have a history of mental illness;
(5) patients who did not agree to be included in the study.


Age minimum: 18
Age maximum: 85
Gender: Male
Health Condition(s) or Problem(s) studied
Idiopathic Membranous Nephropathy
Intervention(s)
PLA2R???:Cyclophosphamide combined with hormone therapy ;PLA2R positive Group:Cyclophosphamide combined with hormone therapy;
Primary Outcome(s)
PLA2R;THSD7A;Routine blood;Serum creatinine;Blood urea nitrogen;cholesterol;Serum albumin;TCM syndrome type dialectics;TCM syndrome score;Urine protein quantification for 24 hours;
Secondary Outcome(s)
Glutamate transaminase;Glutamate transaminase;
Secondary ID(s)
Source(s) of Monetary Support
Natural Science Foundation of Zhejiang Province
Secondary Sponsor(s)
Ethics review
Status: Approved
Approval date: 15/05/2018
Contact:
Fang Hu
Results
Results available:
Date Posted:
Date Completed:
URL:
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