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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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ChiCTR |
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Last refreshed on:
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6 November 2017 |
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Main ID: |
ChiCTR-IPR-17011702 |
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Date of registration:
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2017-06-19 |
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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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Compare of the treatment of membranous nephropathy with mizoribine and steroid or cyclophosphamide and steroid
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Scientific title:
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Compare of the treatment of membranous nephropathy with mizoribine and steroid or cyclophosphamide and steroid |
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Date of first enrolment:
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2017-07-01 |
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Target sample size:
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mizoribine group:50;cyclophosphamide group:50; |
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Recruitment status: |
Pending |
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URL:
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http://www.chictr.org.cn/showproj.aspx?proj=18548 |
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Study type:
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Interventional study |
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Study design:
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Randomized parallel controlled trial
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Phase:
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Post-market
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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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Wang Xichao
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Address:
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24 Fukang Road, Nankai District, Tianjin, China
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Telephone:
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+86 15122198335 |
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Email:
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ctxichao@outlook.com |
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Affiliation:
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Tianjin First Central Hospital |
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Name:
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Wang Xichao
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Address:
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24 Fukang Road, Nankai District, Tianjin, China
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Telephone:
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+86 15122198335 |
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Email:
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ctxichao@outlook.com |
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Affiliation:
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Tianjin First Central Hospital |
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Key inclusion & exclusion criteria
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Inclusion criteria: 1. pathological diagnosis of membranous nephropathy;
2. 24hr urinary protein excretion > 3.5g;
3. normal renal function;
4. aged 55 years and older;
5. No previous use of immunosuppressants (except mizoribine and cyclophosphamide);
6. Sign informed consent.
Exclusion criteria: 1. secondary nephritic syndrome;
2. leukocyte reduction
3. pregnancy;
4. serious hematuria;
5. serious heart or liver disease;
6. Poor compliance.
Age minimum:
18
Age maximum:
65
Gender:
Both
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Health Condition(s) or Problem(s) studied
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membranous nephropathy
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Intervention(s)
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mizoribine group:treated with mizoribine and steroid;cyclophosphamide group:treated with cyclophosphamide and steroid;
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Primary Outcome(s)
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total remission rate=complete remission rate+partial remission rate;complete remission rate;partial remission rate;
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Secondary Outcome(s)
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assessment of the changes of leukocyte, hemoglobin, liver function, blood electrolyte, blood glucose, serum albumin, serum creatinine, eGFR, cholesterol, triglyceride, uric acid, urine ruotine examinnation;
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Source(s) of Monetary Support
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self-financing
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Ethics review
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Status: Approved
Approval date: 12/07/2016
Contact:
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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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